Tag: Johnsons

Health

F.D.A. Releases One other Batch of Johnson & Johnson’s Vaccine

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Post date July 5, 2021

WASHINGTON — Federal regulators on Friday cleared a batch of vaccine that could furnish up to 15 million doses of Johnson & Johnson’s one-shot coronavirus vaccine, deciding they can be safely distributed despite production failures at the factory that ruined 75 million other doses.

The move brings the total number of Johnson & Johnson doses made at the Baltimore facility and cleared by the Food and Drug Administration for distribution in the United States to roughly 40 million. But Johnson & Johnson remains far short of its commitment to deliver 100 million doses to the federal government by the end of June. European Union officials have said the company is missing its delivery targets there, as well.

The vaccine cleared on Friday is not yet bottled, and the Biden administration’s plans for it remain unclear. But with new coronavirus cases dropping and the country awash in vaccines from two other authorized manufacturers, most new Johnson & Johnson doses produced in the United States are likely destined for export.

Johnson & Johnson has been unable to produce much of its vaccine since April, when regulators shut down the Baltimore factory, operated by Emergent BioSolutions, because of major production errors. Johnson & Johnson had been relying on Emergent, its subcontractor, to produce vaccine for use in the United States as well as to meet its commitments overseas while it expanded its own plant in Leiden, the Netherlands.

Even with the newly cleared batch, Johnson & Johnson remains nearly 40 million doses short of the 100 million doses called for in its federal contract. The F.D.A. did not disclose the precise number of doses cleared Friday, but multiple people familiar with Emergent’s operation said the batch amounted to as many as 15 million doses.

Also on Friday, European regulators approved the reopening of Johnson & Johnson’s Dutch plant, a piece of good news for the company amid its supply woes. “Today’s approval represents progress in expanding our global manufacturing network to supply our Covid-19 vaccine worldwide,” the company said in a statement.

The Baltimore factory is expected to remain shuttered for at least several more weeks while Emergent tries to bring it up to standard, according to people familiar with its operation who spoke on condition of anonymity. The F.D.A. said in a statement Friday that it was not yet ready to certify that the plant was following proper manufacturing practices.

After the discovery in March that Emergent workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient for AstraZeneca’s Covid vaccine being made at the same plant, regulators cited Emergent for a series of regulatory violations. Emergent was forced to throw out the equivalent of 75 million doses of Johnson & Johnson vaccine. European authorities discarded another 17 million more doses, and South Africa, which is desperate for vaccine, pulled two million more.

The Biden administration also had to pivot from relying on AstraZeneca doses to fulfill its pledge to donate vaccine to poorer nations, swapping in supplies from other makers. The F.D.A. has yet to rule on whether the equivalent of more than 100 million doses of both Johnson & Johnson and AstraZeneca vaccines produced by Emergent are suitable for use.

The F.D.A. has been conducting a painstaking review of every vaccine batch from the Emergent plant, matching up records of deviations from manufacturing standards with production lots to determine whether the batches can be released. In a letter to Johnson & Johnson released late Friday, the agency said the batch it was releasing was suitable for distribution even though the factory was not adhering to proper manufacturing practices at the time it was produced.

As deliveries of Johnson & Johnson’s vaccine stalled, the Biden administration ended up relying almost entirely on doses made by Pfizer-BioNTech and Moderna. With the pandemic now waning in the United States, demand for shots has plummeted. Johnson & Johnson has teamed up with the pharmaceutical giant Merck to make more doses, but the factory they intend to use is not expected to start operating until the fall.

Although the Johnson & Johnson vaccine was once considered a game changer in the nation’s vaccination campaign, state health officials have struggled to use up even the limited supply they received in the spring. Roughly 12.5 million people in the United States have taken the vaccine, accounting for a little more than half of the available supply, and millions of doses are set to expire by August. It is still being used in doctors’ offices and at smaller events, state officials said.

Enthusiasm for the Johnson & Johnson vaccine dropped in part because of a federally recommended pause in its use in April after a rare blood-clotting disorder was discovered in a few recipients.

But federal health officials are still hoping that surplus doses of Johnson & Johnson’s vaccine will be useful overseas, where vaccine doses remain desperately scarce. White House officials said this week that some countries had requested the vaccine because it is easier to store and transport than the others, and because some people prefer a one-shot regimen. The vaccine has been deployed in 27 countries so far.

On Thursday, Johnson & Johnson reported that early results of unpublished studies showed that its vaccine was effective against the highly contagious Delta variant, even eight months after inoculation. That was a reassuring finding for those who have gotten the company’s shot.

The news came after earlier data showed Pfizer’s and Moderna’s mRNA vaccines as effective against the Delta variant, which is much more contagious than previous variants and is expected to quickly become the dominant version of the virus in the United States. Because Johnson & Johnson’s vaccine rolled out more slowly, information about its effectiveness against variants has also lagged.

Tags Batch, FDA, Johnson, Johnsons, releases, Vaccine

Politics

Excessive Hopes for Johnson & Johnson’s Covid Vaccine Have Fizzled within the U.S.

Post author By
Post date June 18, 2021

But manufacturing problems at a factory in Baltimore run by Emergent BioSolutions, Johnson & Johnson’s subcontractor, have had serious consequences for the vaccine. Because of a major production mishap that resulted in a two-month shutdown in operations, Johnson & Johnson has essentially been forced to sit out the brunt of the pandemic in the United States while Pfizer and Moderna, the other federally authorized vaccine makers, provided almost all the nation’s vaccine stock.

Johnson & Johnson has had to throw out the equivalent of 75 million doses, and the regulatory authorities in Canada, South Africa and the European Union also decided to pull back millions more doses made at the Baltimore plant. The company has been able to deliver only one-fourth of the 100 million doses it promised the federal government by the end of this month.

Dr. Anne Zink, Alaska’s chief medical officer, said that in her state, Johnson & Johnson’s shot had become a victim of its own timing. By late February, when it was authorized by the Food and Drug Administration, Alaska had figured out how to get two-dose vaccines to remote areas, leaving the one-shot regimen less crucial than she had initially imagined.

Dr. Clay Marsh, West Virginia’s Covid-19 czar, said that the pause and Johnson & Johnson’s later authorization — more than two months after Pfizer’s and Moderna’s — deprived it of a “halo effect.” By the time West Virginia had an ample supply of all three vaccines, he said, “people started to get this concept that maybe there’s something better about being immunized with Pfizer and Moderna.”

The Johnson & Johnson shot had also suffered from a “social network effect,” said Andrew C. Anderson, a professor of public health at Tulane University who researches vaccine hesitancy. Most Americans who were inoculated in the early months of the vaccine campaign received Moderna and Pfizer shots, and so their friends and family were less likely to deviate and accept a different brand.

In Louisiana, hospitals in the New Orleans area have started offering the Johnson & Johnson shot to people on their way out of the emergency room; the thinking is that people will be more likely to accept the vaccine when a doctor who has treated them asks them to take it. And in Arkansas, where only a third of the population is fully vaccinated, state officials are offering Johnson & Johnson doses to agriculture, manufacturing, wastewater and poultry workers, with gift certificates for hunting and fishing licenses as a reward.

Tags Covid, Fizzled, high, hopes, Johnson, Johnsons, Vaccine

Health

One and Executed: Why Folks Are Looking forward to Johnson & Johnson’s Vaccine

Post author By
Post date March 4, 2021

One and Done: Why People Are Eager for Johnson & Johnson’s Vaccine

In North Dakota, health officials this week are sending their first Johnson & Johnson Covid-19 vaccines to pharmacies and emergency clinics where people who don’t necessarily have a regular doctor can get the only push. In Missouri, cans are dispensed to community health centers and rural hospitals. And in North Carolina, health care providers use it to vaccinate meat packers, farm and food workers.

Ever since Johnson & Johnson revealed data showing that its vaccine, while very protective, had a slightly lower rate of effectiveness than the first shots made by Moderna and Pfizer-BioNTech, health officials have feared that the new shot might be considered by some Americans as the could be considered worse choice.

But the early days of the rollout suggest something else: some people are excited to get it because they want the convenience of a single shot. And public health officials are excited about how much faster they can distribute a single shot, especially in vulnerable communities that may otherwise not have access to a vaccine.

“This is a potential breakthrough,” said Dr. Joseph Kanter, the chief health officer in Louisiana. With its first allotted doses, the state is hosting a dozen large Johnson & Johnson vaccination events in community centers and other public places, modeled on flu vaccines.

As Johnson & Johnson’s production grows over the next several months, Dr. Kanter, the shot would allow his state to cut the staff and surgery costs associated with the second dose: “The J&J vaccine brings a lot to the table.”

In terms of how well it prevents serious illness, hospitalizations, and deaths, the Johnson & Johnson shot is comparable to that of Moderna and Pfizer-BioNTech. And while there is a lower overall effectiveness rate in the U.S. – 72 percent compared to around 95 percent in the others – experts say comparing these numbers is problematic because the companies’ studies were conducted at different times in different locations.

The Johnson & Johnson vaccine can also be stored at normal refrigerated temperatures for three months – ideal for distribution in non-medical locations such as stadiums and convention centers.

“There are circumstances when this will be a really good, or perhaps the best, option,” said Dr. Matthew Daley, senior investigator at Kaiser Permanente Colorado’s Institute for Health Research and member of the Centers for Disease Control and Prevention Independent Vaccine Advisory Board.

Only four million cans have been shipped this week, and the company’s production delays mean it will be at least a month before the states receive significant shipments. Because of this loophole, state officials are treating the first wave of doses as a moment to test different ways it can be used.

Patrick Allen, the director of the Oregon Health Authority, said the first doses in the state went to various facilities “to see if we could learn from their use.” This included mass vaccination sites in the Portland area, adult nursing homes, and pharmacies not included in the federal government’s pharmacy program. Health officials will evaluate the success of each of these locations to develop a plan for the larger shipments.

Many state health officials said they were focused on getting the vaccine to people who may be harder to reach for a second dose, such as the homeless or about to be released from prison. In North Carolina, this category includes the state’s mobile farming communities with three- or four-week working seasons. Mandy Cohen, the state’s health secretary, said large meat packers in the state such as Smithfield and Tyson Foods were interested in Johnson & Johnson’s vaccine and had consulted with their department.

And because the vaccine tends to have fewer side effects than the other options, it appeals to people who don’t want to risk missing a work day to recover from chills or a fever. She said, “There are a lot of people who are. For example,” I’m much more interested now that you tell me I only need to get one shot instead of two. “

“I don’t think it’s an inferior vaccine, so I’m taking it for myself,” said Ms. Cohen, who was supposed to get the shot from Johnson & Johnson on Friday.

The vaccine has caused a stir in small, independent pharmacies. Steve Hoffart, the owner of Magnolia Pharmacy in Magnolia, Texas, a small town outside of Houston, has received calls and emails from residents waiting to arrive this week. He hopes to hold a Johnson & Johnson teacher event on March 13th. Schools in the area struggled to find replacement teachers during the pandemic, and a vaccine that doesn’t require a second visit and more free time has been a significant development. he said.

Tim and Joyce Staab, who live in Chillicothe, Ohio, a town about 20,000 hours’ drive from Columbus, were two of the first Americans to receive the Johnson & Johnson vaccine. Both had general vaccination appointments scheduled for later in the week. But then they learned on Wednesday that an independent pharmacy near them had received 100 doses of Johnson & Johnson’s shot. Ms. Staab, 68, hesitates with needles and liked the one-and-do approach.

Mr Staab, 67, said he thought the vaccine would be a better choice for healthcare providers like the pharmacy where he got it. “You don’t have the resources, I don’t think, to deal with really hard-to-store vaccines,” he said.

States were able to adjust and craft distribution plans, in part because the federal government did not issue guidelines on where and to whom the vaccine should go.

That winter, as the Food and Drug Administration’s approval of the Johnson & Johnson vaccine approached, federal officials involved in vaccine distribution pushed for a more centralized use of the shot, either at large stadiums or at mass vaccination sites, which operated by the Federal Emergency Management Agency or only at pharmacies, according to officials familiar with these discussions. However, the White House preferred to allow states to tailor their own plans, as they had for the Moderna and Pfizer-BioNTech vaccines.

While health professionals are excited about the potential public health benefits of the new vaccine, some also fear that once vaccines run out, public interest will wane. When some people have a choice of brands, they may reject Johnson & Johnson’s, viewing it as an inferior choice.

In the mid-Atlantic black churches, Darrell J. Gaskin, professor of health policy at Johns Hopkins University and pastor, and Rupali Limaye, scientist at the university studying vaccine reluctance, have advised and reassured hundreds of people pastors and parishioners in Africa Methodist Episcopal Zion Churches in virtual presentations highlighting the safety of the Johnson & Johnson vaccine and the prevention of major Covid-19 and death, including among the black volunteers at the company’s trial.

Dr. Gaskin said it was vital for officials to highlight the benefits of the vaccine at the beginning of its distribution so that people “don’t feel like there’s a luxury vaccine and then the non-luxury vaccine”.

“We are facing differences when it comes to Covid,” said Dr. Limaye. “How do we reduce differences? We bring out a product that contains a dose and is stable. “

One of the members of the Church of Dr. Gaskin, Patricia Cooper, a teacher in Washington, DC, said President Donald J. Trump’s efforts to get a vaccine approved last year and the “Emergency Use Approval” label suggested that the federal government could I’ve rushed reviews of vaccines and made them nervous about their safety. But she said she was eager to get a vaccine, particularly from Johnson & Johnson.

“This one is more appealing to me,” she said. “Who likes to get stuck more than once?”

But Oregon health officer Mr. Allen warned that a more specific use could lead to skepticism about its quality.

“When you start getting a little too cute, when you specifically target its use, you may feed the distrust of, ‘Well why am I getting this vaccine? And I’m in that particular population and people who aren’t in that particular population aren’t getting this vaccine, ”he said.

Federal health officials have promised a way to crack down on the Johnson & Johnson vaccine, which may be used in unequal ways. Dr. Marcella Nunez-Smith, chair of the Biden administration’s new Health Justice Task Force, told a press conference at the White House this week that the vaccine distribution “should be evenly distributed among communities.”

“We’ll be tracking biometrics like zip code and social vulnerability to see where the vaccines are going,” she said. “And if certain vaccines are consistently delivered to certain communities, we can intervene.”

Some state officials believe pairing the new and old vaccines can help show that they are equally important.

Mr Allen said Oregon has similar sales plans for Johnson & Johnson and Moderna because both vaccines can be refrigerated for short term. The state treats the Pfizer BioNTech vaccine as the vaccine with “special considerations” as it has stricter shipping requirements and large packs of vials that are better suited for mass vaccination sites, he said.

Managing Johnson & Johnson and Moderna vaccines in a similar manner would help “avoid equity issues and potential concerns based on perceived differences between vaccines, some of which are real and some of which are not”.

Tags Eager, Johnson, Johnsons, people, Vaccine

Health

Biden to announce Merck will assist make Johnson & Johnson’s shot

Post author By
Post date March 2, 2021

President Joe Biden will announce Tuesday that pharmaceutical company Merck will help manufacture the Covid-19 vaccine from Johnson & Johnson, a senior administrative official who has been confirmed to NBC News.

The decision is made as the administration is working to ramp up production of J & J’s single-shot vaccine. Senior government officials said Sunday the US government will ship J & J’s entire inventory of 3.9 million cans this week, adding that supply would be “uneven” over the following weeks. Another 16 million doses are expected by the end of the month.

Under the agreement, Merck will deploy two facilities in the US for J & J’s vaccine, the Washington Post previously reported. One will make the vaccine and the other will provide “fill-finish” services when the vaccine is put into vials.

Officials began scouring the country for additional manufacturing capacity after discovering in the early days of the government that J&J had fallen behind in vaccine production, according to NBC. They soon sought a deal with Merck, which abandoned plans to develop its own Covid vaccine in January after a clinical study showed its shots were ineffective.

J&J declined to comment on the deal with CNBC. In a statement, Merck said it was “unwavering in our commitment to contribute to the global response to the pandemic and prepare us to deal with future pandemics”.

The Washington Post reported the news earlier.

Biden is expected to make the announcement from the White House on Tuesday afternoon.

The Food and Drug Administration on Saturday approved J & J’s vaccine for use in people aged 18 and over. Unlike Pfizer and Moderna vaccines, patients with the single dose of J&J do not need to take a second dose and can be stored at refrigerator temperature for months.

In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that keep between minus 112 and minus 76 degrees Fahrenheit. However, the FDA recently allowed the company to store its vaccine for two weeks at temperatures commonly found in pharmaceutical freezers. Moderna vaccine must be shipped at 13 to 5 degrees above zero Fahrenheit.

The New York Times first reported in January that unexpected delays in manufacturing would result in decreased primary care of J & J’s medication if it were given emergency approval.

The Chief Medical Officer of the White House, Dr. Anthony Fauci said last month he was “disappointed” with the number of doses J&J originally expected, adding that the federal government had assumed there would be “significantly more”. The New Jersey-based company has signed a contract with the United States to supply 100 million cans by the end of June.

“It can take June, July and August to get everyone vaccinated,” Fauci told CNN on February 16. I don’t think anyone will disagree that this will be good by the end of summer and we’ll get into early fall. “

At the time, Bidens Covid Tsar Jeff Zients said the federal government was “doing everything it can to work with the company to expedite the delivery schedule”.

This is not the first partnership between two drugmakers to help improve vaccine supply.

In late January, French drug maker Sanofi announced it would help fill and package millions of doses of Pfizer’s two-shot vaccine to meet demand. Moderna has a partnership with the Swiss company Lonza, which makes most of the medicines for the company’s vaccine.

The Biden government has also announced that it is using the Defense Equipment Act to improve supplies of Pfizer’s vaccine.

Tags announce, Biden, Johnson, Johnsons, Merck, shot

Health

Right here is How Johnson & Johnson’s Vaccine Differs from Pfizer and Moderna’s

Post author By
Post date February 28, 2021

A third effective weapon was added to the American arsenal against the coronavirus on Saturday when the Food and Drug Administration granted emergency approval for a vaccine developed by Johnson & Johnson.

The company announced it would begin shipping millions of cans earlier this week and ship 100 million cans to the US by the end of June. Together with 600 million doses of the country’s first two approved vaccines, manufactured by Pfizer-BioNTech and Moderna, due to be dispensed over the next four months, that should be enough to cover every American adult who wants to be vaccinated.

The new vaccine is very different from the two already used in the US. Here’s how they compare.

One shot instead of two

The Johnson & Johnson vaccine is given in one shot, while the Pfizer BioNTech and Moderna vaccines are given in two shots several weeks apart.

Thats how it works

The Johnson & Johnson vaccine uses a different method to prepare the body to fight Covid-19: a viral vector called Ad26. Viral vectors are common viruses that have been genetically modified so that they do not cause disease, but can still cause the immune system to build up its defenses. The vaccines Pfizer-BioNTech and Moderna use messenger RNA for this.

How well it works

The Johnson & Johnson vaccine is found to be highly effective in preventing serious illness and death, as are Pfizer-BioNTech and Moderna vaccines. It’s also very effective in preventing milder diseases, albeit a little less than either of these. It appears to be good against the highly contagious variant B.1.351, which was first identified in South Africa and has caused problems at least one other vaccine candidate.

Storage and handling

The Johnson & Johnson vaccine does not need to be stored at extremely low temperatures like the Pfizer BioNTech vaccine. It can be safely stored in a regular refrigerator for three months, much longer than the Moderna vaccine, which spoils after a month if left frozen.

Side effects

The Johnson & Johnson vaccine appears to be less susceptible than the Pfizer-BioNTech and Moderna vaccines to causing the types of side effects that need to be monitored after injection, which may make it more suitable for drive-through vaccination site use. It has been reported that side effects tend to be more felt after second doses that the Johnson & Johnson vaccine doesn’t need.

Tags Differs, Johnson, Johnsons, Modernas, Pfizer, Vaccine

Business

Covid Vaccines: Johnson & Johnson’s shot licensed by F.D.A.

Post author By
Post date February 28, 2021

Covid Vaccines: Johnson & Johnson's shot authorized by F.D.A.

WASHINGTON – The Food and Drug Administration on Saturday approved Johnson & Johnson’s one-of-a-kind emergency Covid-19 vaccine, starting millions of doses of a third effective vaccine that could hit Americans early next week.

The announcement came at a critical time as the sharp drop in coronavirus cases appears to have plateaued and millions of Americans are on waiting lists to be shot.

Johnson & Johnson has pledged to make 100 million cans available to the US by the end of June. Combined with the 600 million doses of two-shot vaccines manufactured by Pfizer-BioNTech and Moderna due to arrive in late July, there will be more than enough shots to cover any American adult who wants one.

But federal and state health officials are concerned that some people may view Johnson & Johnson’s shot as an inferior option despite poor data.

The 72 percent effectiveness of the new vaccine at the clinical trial site in the US – as a number of scientists have celebrated – is below the rate of around 95 percent found in trials testing the Moderna and Pfizer-BioNTech vaccines. Across all trial sites, the Johnson & Johnson vaccine showed 85 percent effectiveness against severe forms of Covid-19 and 100 percent effectiveness against hospitalizations and deaths.

“Don’t necessarily get involved in the numbers game because it’s a really good vaccine and we need as many good vaccines as possible,” said Dr. Anthony S. Fauci, the government’s leading infectious disease expert, in an interview on Saturday. “Instead of analyzing the difference between 94 and 72, accept the fact that you now have three highly effective vaccines. Period.”

If the Johnson & Johnson vaccine had been the first to be approved in the US instead of the third, “everyone would be doing handstands and backflips and high-fives,” said Dr. James T. McDeavitt, Dean of Clinical Affairs, Baylor College of Medicine.

On Sunday, a committee of vaccine experts advising the Centers for Disease Control and Prevention will meet to discuss whether certain populations should be prioritized for the vaccine. These guidelines have been eagerly awaited by state health authorities in anticipation of FDA approval.

A administration official familiar with the distribution of the vaccine said deliveries would start Monday and deliveries could arrive as early as Tuesday.

Johnson & Johnson has announced that it will ship nearly four million cans once the FDA clears distribution and another 16 million cans by the end of March. That’s far less than the 37 million cans foreseen in his $ 1 billion federal contract, but the contract states that deliveries 30 days late are still considered to be on time.

The federal government is paying the company $ 10 per dose for a total of 100 million doses that should be ready by the end of June, significantly less per dose than agreed to pay Moderna and Pfizer, who developed their vaccine with a German partner, BioNTech .

With Johnson & Johnson’s single-dose vaccine, states can rapidly increase the number of people fully vaccinated. Unlike the other two vaccines, it can be stored at standard refrigeration temperatures for at least three months.

Dr. Danny Avula, the vaccine coordinator for Virginia, said supplies from Johnson & Johnson would add nearly a fifth to the state’s vaccine allotment next week.

“I’m super excited,” he said. “One hundred percent effectiveness against deaths and hospitalizations? That’s all I need to hear “

He said the state is planning mass vaccination events specifically for the Johnson & Johnson vaccine, in part to suppress suspicions that it is a lesser product targeted at specific groups.

“It will be very clear that this is Johnson & Johnson. Here’s what you need to know about it. If you want to do this, come in with your eyes open, ”he said. “If not, keep your place on the list.”

Michele Roberts, assistant secretary for the Washington State Department of Health, said it was difficult to explain the technical aspects of the differences between Johnson & Johnson’s vaccine studies and those of other drug companies. Because the studies were conducted at different times and with different protocols, accurate comparisons can be problematic. All three studies showed that the vaccines offer strong protection against Covid-19, especially in severe illness.

Updated

Apr. 27, 2021, 6:11 p.m. ET

Understanding the subtle contrasts requires a lot of “scientific expertise,” she said. “There are so many different factors at play. But that’s not quick public news. “

Even some clinicians misinterpret the differences between the Covid-19 vaccines, health officials said. “They assume it’s apples to apples, but it’s apples to oranges, or worse, apples to ripening,” said Dr. Nirav Shah, the director of the Maine Center for Disease Control and Prevention.

Last week, said Dr. Shah, the head of a group of specialist clinics in his state initially turned down his offer to ship doses of the Johnson & Johnson vaccine, saying his doctors were concerned that this would be less effective than the other two.

He said he said to him, “Stop right there. We now need to have a Zoom talk with all of your medical staff. “Instead, he carefully explained the results from Johnson & Johnson to the vendor, who then spoke to their employees. Twenty minutes later the provider sent him a message: “We are on board. Send us the J & J. ”

Some state officials have been frustrated with what they see as the lack of a coordinated plan by the Biden government to introduce the new vaccine. The governors have sought advice from the White House, but government officials have so far left it to the states to decide.

Although Johnson & Johnson received ample federal support and agreed to manufacture at risk, federal officials familiar with the way it worked said the company had an overly conservative approach to manufacturing and emphasized scaling at the back of its contract.

As a result, Johnson & Johnson is expected to ship the majority of its 100 million cans in late spring or early summer. The country will continue to need them: by the end of May, Pfizer and Moderna have promised to ship enough doses to vaccinate 200 million Americans, so that around 60 million eligible adults are not yet covered. However, with more contagious variants of the virus spreading, health officials are keen to vaccinate as many Americans as possible as soon as possible.

Johnson & Johnson produced its first batch of approximately four million cans at its Dutch facility, federal officials said. The company’s new facility in Baltimore is expected to supply the majority of its cans for the United States.

Americans are becoming more open to Covid-19 vaccines, according to the latest survey by the Kaiser Family Foundation, which has been overseeing attitudes since December. Fifty-five percent of adults say they either received a dose or will receive it as soon as possible, up from 34 percent in December.

However, Rupali Limaye, who studies vaccine hesitation at Johns Hopkins University, said she was concerned about whether health officials and community leaders would emphasize the strengths of the Johnson & Johnson vaccine, including how well it did the occurrence of Severe Covid-19, hospitalization and hospitalization prevents death.

“People will want to know: why is this so much less and what does it mean to us?” She said. “I worry that there will be more questions than trust.”

Without further instructions from the federal government, the state health authorities consult with each other as to where the new source of supply should be directed.

Dr. Marcus Plescia, the chief medical officer of the Association of State and Territorial Health Authorities, which represents state health authorities, predicted that “many states will be a little careful” about where they originally ship the vaccine.

“They don’t mean to say, ‘OK, we’re going to use this vaccine for our rural population because it’s easier to ship.'” This can spark a backlash from people who, for some reason, mistakenly suspect a second-rate vaccine is being offered , he said.

Dr. Maine-based Shah said the new vaccine is particularly good for drive-through vaccination sites, also because it is less likely to cause the kind of side effects that need to be monitored. Health officials in other states also said it might make sense to target the doses at transient populations who are less likely to show up in second shots. Universities could be particularly interested.

Dr. Jennifer Dillaha, the state epidemiologist with the Arkansas Health Department, said the simpler storage conditions for the vaccine could also increase the number of vaccinations in other non-medical facilities such as senior centers or locations in underserved communities with no pharmacies or health care providers.

To limit possible confusion, some state health officials said they plan to initially route the new vaccine to new locations, not those who are already administering the other vaccines.

Dr. Shah said some Maine pharmacists would prefer to treat one type of Covid-19 vaccine at a time. Although that can change, said Dr. Shah: “Every day is important. Anything that is introduced into the workflow that slows the rate of vaccination hurts us. “

Carl Zimmer contributed to the reporting.

Tags authorized, Covid, FDA, Johnson, Johnsons, shot, vaccines

World News

Covid-19: F.D.A. Panel Offers Inexperienced Mild to Johnson & Johnson’s Vaccine

Post author By
Post date February 27, 2021

Empty vials of the Johnson & Johnson vaccine at a hospital in South Africa.

Here’s what you need to know:

Credit…Phill Magakoe/Agence France-Presse — Getty Images

Johnson & Johnson’s Covid-19 vaccine was endorsed on Friday by a panel of experts advising the Food and Drug Administration, clearing the last hurdle before a formal authorization expected on Saturday, according to two people familiar with the agency’s plans. The nation’s first shipments will go out in the days after that.

It will be the third shot made available to the United States in the year since the first surge of coronavirus cases began washing over the country, and it will be the first vaccine to require just one dose instead of two.

Johnson & Johnson’s formulation worked well in clinical trials, particularly against severe disease and hospitalizations, even though it did not match the sky-high efficacy rates of the first two vaccines made by Pfizer-BioNTech and Moderna.

The panel, made up of independent infectious disease experts, statisticians and epidemiologists, voted unanimously in favor of authorizing the vaccine.

“We’re dealing with a pandemic right now,” said Dr. Jay Portnoy, an allergist at Children’s Mercy Hospital in Kansas City, Mo., and a member of the board. “It’s great that we have this vaccine.”

During Johnson & Johnson’s presentation to the panel, Dr. Gregory Poland, a virologist at the Mayo Clinic and a paid external consultant for the company, noted the vaccine’s efficacy, ease of use and low rate of side effects. It “nearly checks all the boxes,” he said. “To me, it is clear that the known benefits vastly outweigh the known risks.”

The vaccine had an overall efficacy rate of 72 percent in the United States and 64 percent in South Africa, where a concerning variant emerged in the fall. The shot showed 86 percent efficacy against severe forms of Covid-19 in the United States, and 82 percent against severe disease in South Africa.

Those are strong numbers, but lower than the roughly 95 percent efficacy rates of Pfizer-BioNTech and Moderna’s vaccines against mild, moderate and severe cases of Covid.

Johnson & Johnson’s vaccine is a single dose and uses a different kind of technology than the authorized vaccines. And the scale and size of the Johnson & Johnson trial was vast, spanning eight countries, three continents and nearly 45,000 participants.

Although the vaccine works with one shot, studies are underway to determine if a second dose would increase its protective effects.

Dr. Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia and one of the panelists, pointed out on Friday that in early clinical trials that took place over the summer, Johnson & Johnson found that a second dose led to levels of coronavirus antibodies that were almost three times higher than those produced by one dose alone.

The results of Johnson & Johnson’s two-dose, late-stage clinical trial are not expected until July at the earliest. If those results turn out to be better than a single dose, Dr. Offit asked, “Does this then become a two-dose vaccine?”

Dr. Johan Van Hoof, the global head of vaccine research and development at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, said that the company decided to pursue the one-shot strategy after its studies on monkeys last spring showed that a single dose was enough to provide strong protection against the disease.

“It’s clear that in a situation of an outbreak, in a raging epidemic, the big challenge is to get the epidemic under control,” he said. “The regimen is extremely well positioned to be used in outbreak situations.”

But Dr. Van Hoof also noted that it will be important to track volunteers who received a single dose to see if their immunity changes in the months to come. It might be necessary to deliver a booster shot for long-term protection. “The big question mark still is, how long does protection last?” he said.

After the vote, the F.D.A. told Johnson & Johnson that it “will rapidly work toward finalization and issuance of an emergency use authorization,” according to a statement. The F.D.A. also said that it had notified other government agencies “so they can execute their plans for timely vaccine distribution.”

United States ›	United StatesOn Feb. 26	14-day change
New cases	78,262	–29%
New deaths	2,266	–20%

World ›	WorldOn Feb. 26	14-day change
New cases	410,857	–5%
New deaths	9,468	–23%

U.S. vaccinations ›

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Decline in Coronavirus Cases ‘May Be Stalling,’ C.D.C. Director Warns

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said on Friday that a recent decline in coronavirus cases across the U.S. “may be stalling” and urged governors not to relax restrictions.

Over the last few weeks, cases in hospital admissions in the United States have been coming down since early January and deaths have been declining in the past week. But the latest data suggest that these declines may be stalling, potentially leveling off at still a very high number. We at C.D.C. consider this a very concerning shift in the trajectory. We are watching these concerning data very closely to see where they will go over the next few days. But it’s important to remember where we are in the pandemic. Things are tenuous. Now is not the time to relax restrictions. Although we’ve been experiencing large declines in cases and admissions over the past six weeks, these declines follow the highest peak we have experienced in the pandemic. We may be done with the virus, but clearly, the virus is not done with us. We cannot get comfortable or give in to a false sense of security that the worst of the pandemic is behind us. Not now, not when mass vaccination is so very close.

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said on Friday that a recent decline in coronavirus cases across the U.S. “may be stalling” and urged governors not to relax restrictions.CreditCredit…Josh Bell/The Sun News, via Associated Press

The federal government warned impatient governors against relaxing pandemic control measures on Friday, saying that a recent steep drop in U.S. coronavirus cases and deaths “may be stalling” and “potentially leveling off at still a very high number” — a worrisome development that comes as more cases of concerning new variants have been found and could suggest that a return to normalcy is not yet quite as near as many Americans had hoped.

“Things are tenuous,” Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said at a White House briefing on the pandemic. “Now is not the time to relax restrictions.”

Her warning was bolstered by Dr. Anthony S. Fauci, the government’s top epidemiologist, as the Biden administration scrambled to stay ahead of any new wave. President Biden himself flew to Houston to showcase the government’s latest mass vaccine site.

According to a New York Times database, virus cases across the United States appear to be leveling off from the steep decline that began in January, with figures comparable to those reported in late October. Cases have slightly increased week over week in recent days, though severe weather limited testing and reporting in Texas and other states the previous week, and not all states reported complete data on the Presidents Day holiday. The seven-day average of new cases was 77,800 as of Thursday.

While deaths tend to fluctuate more than cases and hospital admissions, Dr. Walensky said at the briefing on Friday, the most recent seven-day average is slightly higher than the average earlier in the week. The seven-day average of newly reported deaths was 2,165, as of Thursday.

“We at C.D.C. consider this a very concerning shift in the trajectory,” she said, adding, “I want to be clear: cases, hospital admissions and deaths — all remain very high and the recent shift in the pandemic must be taken extremely seriously.”

Dr. Walensky said some of the rise may be attributable to new variants of the coronavirus that spread more efficiently and quickly. The so-called B.1.1.7 variant, which first emerged in Britain, now accounts for approximately 10 percent of all cases in the United States, up from one to four percent a few weeks ago, she said. The U.S. ability to track variants is much less robust than Britain’s.

“I know people are tired; they want to get back to life, to normal,” she said. “But we’re not there yet.”

As cases had declined, some governors around the United States have begun to relax pandemic restrictions. States with Republican governors appeared to be more eager to make rollbacks, though New York, which has a Democrat as governor, has also been easing restrictions on a variety of activities.

On Friday, Gov. Henry McMaster of South Carolina, a Republican, announced that on Monday, restaurants would be able to serve alcohol past 11 p.m., and residents would not need to get approval from the state to hold events with 250 people or more. To try to limit the spread of the virus, the state last year ordered bars to stop serving alcohol after 11 p.m., which is three hours earlier than the late-night bar crowd was used to.

Brian Symmes, a spokesman for Mr. McMaster, said the governor “appreciates perspectives that differ from his own” but “respectfully disagrees” with Dr. Walensky’s assessment.

In Arkansas, Gov. Asa Hutchinson announced Friday that he’d be lifting restrictions around capacity limits for bars, restaurants, gyms and large venues, but extending the state’s emergency order and mask mandate until March 31. The current emergency order was set to expire February 27.

On Thursday, Gov. Greg Abbott of Texas said he was considering lifting a statewide mask mandate in place since July.

In Mississippi, Gov. Tate Reeves said he was also considering pulling back some restrictions, particularly mask mandates for people who have been fully vaccinated. As of Friday, 13 percent of the state’s population has received at least one shot, and 6.2 percent have received two, according to a Times database.

Dr. Fauci echoed Dr. Walensky’s warnings that more rollbacks at state or local levels would be unwise, noting that case levels remained at a “very precarious position.”

“We don’t want to be people always looking at the dark side of things, but you want to be realistic,” he said. “So we have to carefully look at what happens over the next week or so with those numbers before you start making the understandable need to relax on certain restrictions.”

In Oregon, Gov. Kate Brown extended the state’s emergency order until May 2. The state recorded a sharp decreases in daily cases, hospitalizations and deaths this week, but citing the new variants Ms. Brown said that “now is not the time to let up our guard.”

Eileen Sullivan Remy Tumin, Nicholas Bogel-Burroughs and Mitch Smith contributed reporting.

Credit…Adriana Zehbrauskas for The New York Times

The federal government has agreed to buy 100,000 doses of a recently authorized Covid-19 treatment from Eli Lilly, increasing the supply of such drugs for patients who are high risk of becoming seriously ill but are not yet hospitalized.

Under the deal, announced on Friday, the government will pay $210 million and Eli Lilly will ship out the doses by the end of March. The government has the option to buy 1.1 million more doses of the treatment through November, but how many of those doses ultimately get ordered will depend in part on the course of the pandemic in the United States.

The treatment is a cocktail of monoclonal antibodies combining the Eli Lilly drug known as bamlanivimab — which was authorized last November and is in use for high-risk Covid-19 patients — with a second drug known as etesevimab. The combination received emergency authorization earlier this month from the Food and Drug Administration. Both drugs consist of artificial copies of the antibodies that are naturally generated when a person’s immune system fights off an infection.

The U.S. government previously agreed to buy nearly 1.5 million doses of bamlanivimab alone. Eli Lilly has delivered more than 1 million doses already, with the remainder to be delivered by the end of March. More than 660,000 doses of bamlanivimab have been shipped out to states and other jurisdictions.

Eli Lilly’s new combination therapy could offer an advantage over bamlanivimab alone if worrisome coronavirus variants — particularly B.1.351, the one first identified in South Africa — take off in the United States. While bamlanivimab alone was found in a lab study to be powerless against the B.1.351 variant, preliminary data suggest that the combination therapy may be better able to fight off variants. That’s because so-called escape mutations in the variants that may enable them to avoid one antibody may not work against the second.

Another monoclonal antibody cocktail, made by Regeneron, is also authorized in the United States. Nearly 100,000 doses of that therapy have been shipped out.

Antibody treatments got a publicity boost last fall when they were given to Donald J. Trump when he was infected in the last months of his presidency, and to other high-profile Republicans, but they were surprisingly underused in many places in their first months of availability. Overwhelmed hospitals did not prioritize the treatments, which are cumbersome and must be given via intravenous infusions. Many patients and doctors did not know to ask for them or how to find them.

In December, the federal government’s early data collected from hospitals suggested that they had given only about 20 percent of their supply to patients. But that picture is changing. Eli Lilly has seen usage of bamlanivimab alone rise to around 40 percent nationwide, with uptake much higher in some places, Janelle Sabo, who leads Eli Lilly’s work on Covid-19 antibodies, said in an interview earlier this week.

Credit…Philip Cheung for The New York Times

As more people in the United States learn of someone close to them who has received a Covid-19 vaccine, they are becoming more open to getting the vaccine themselves, according to the latest survey from the Kaiser Family Foundation, which has been monitoring attitudes since December.

Across most demographic groups, vaccine hesitancy, though still substantial, continues to abate. Fifty-five percent of adults now say they have either received one dose or will get it as soon as they can, up from 34 percent in December.

The so-called “wait and see” group is inching down, too, to 22 percent in February from 31 percent in January. But Black adults (34 percent) and Latino adults (26 percent) remain more inclined than white adults (18 percent) to take a wait-and-see approach.

About one in five Americans still refuses to get the shot, or said they would only do so if compelled by work or school.

Kaiser also took note of the political affiliation of its survey respondents. From December to February, the proportion of Democrats who had either gotten the shot or wanted to soared to 75 percent from 47 percent. Republicans remained more hesitant, but there was a notable increase in the amount who were vaccinated or hoped to be, to 41 percent from 28 percent.

Views of the vaccine were divided by age as well. People 65 and older, among the first demographic groups eligible for the shot, were among the most enthusiastic, an attitude that crossed racial lines. But while nearly half of older white people said they had already received at least one dose, only about one-third of older Black people said they had.

The survey also examined the most common reasons for hesitation. People were most concerned about side effects and also about the rapidity with which the vaccines were developed. They were also still gripped by misinformation, fearing they would have to pay for the vaccine (it is available at no cost) and that it would give them Covid (it does not).

The Centers for Disease Control and Prevention said on Friday about 47.2 million people in the U.S. have received at least one dose of a vaccine, including about 22.6 million people who have been fully vaccinated.

Credit…Mark Weber/Daily Memphian, via Associated Press

The top health official in Memphis submitted her resignation after state health officials accused her department, which oversees the vaccine rollout in the state’s most populous county, of wasting thousands of doses, the mayor of Shelby County, Tenn., said on Friday.

The swift downfall of Alisa Haushalter, the Shelby County Health Department director, came hours after a news conference in which Dr. Lisa Piercey, Tennessee’s health commissioner, laid out a series of stunning accusations of mismanagement by Ms. Haushalter’s department, including episodes in which a volunteer may have stolen doses and another administered shots to two children.

State health officials have been investigating the department for at least a week after Ms. Haushalter first reported that vaccine doses had expired, Dr. Piercey said.

Investigators confirmed the expiration of 1,578 doses last week, but it was only this week that Shelby County health officials acknowledged that an additional 840 doses had expired on Feb. 15, bringing the total to more than 2,400.

And Dr. Piercey said that when she met with the mayor on Thursday, he said that he had heard a rumor about a volunteer possibly stealing vaccines on Feb. 3, but Dr. Piercey said the theft was never reported to any state or federal authorities. The state health department alerted the Federal Bureau of Investigation to the possible theft shortly after that conversation, she said. Dr. Piercey also said that a volunteer had wrongly vaccinated two children on Feb. 3.

The City of Memphis on Wednesday took over the responsibility of storing, transporting and allocating the vaccines.

Credit…Christinne Muschi/Reuters

Canada’s drug regulator authorized the AstraZeneca vaccine on Friday as well as a version of it developed by the Serum Institute of India. The vaccine, which was developed with Oxford University, has not yet been authorized for use in the United States but has been key to Britain’s rapid vaccination rollout.

The addition of a third vaccine, in addition to the offerings from Moderna and Pfizer-BioNTech, may help Canada alleviate a growing dissatisfaction about the sluggish pace of vaccination in the country.

“Vaccines will keep arriving faster and faster,” Prime Minister Justin Trudeau told a news conference. “We now have a third safe and effective vaccine.”

Mr. Trudeau said that the government expects to receive, within days, about 500,000 doses out of an order of two million doses of the Serum Institute version of the vaccine, known as Covishield. About 20 million doses will start arriving from AstraZeneca in the spring.

The AstraZeneca vaccine, the first virus vector-based inoculation for Covid-19 authorized in Canada, has had some stumbles. In trials in South Africa, where a more contagious virus variant has become dominant, it did not appear to protect people from mild or moderate illness, which led the country to halt its use of the vaccine.

Drug approval officials with Health Canada said on Friday that while some studies suggested that the AstraZeneca vaccine is less effective overall than others, the sample sizes used were not large enough to yield a clear conclusion. But in Germany, many people regard it as “second-class” compared to the vaccine developed by the German company BioNTech and Pfizer, and are avoiding AstraZeneca’s.

Credit…Lyndon French for The New York Times

Across the United States and the world, the coronavirus seems to be loosening its stranglehold. The curve of cases, hospitalizations and deaths has yo-yoed before, but never has it plunged so steeply and so quickly.

Is this it, then? Is this the beginning of the end?

The road ahead is potholed with unknowns: how well vaccines prevent further spread of the virus, whether emerging variants remain susceptible enough to the vaccines and how quickly the world is immunized, so as to halt further evolution of the virus.

And the greatest ambiguity is human behavior. Will Americans desperate for a return to pre-pandemic lifestyles continue to wear masks and distance themselves from family and friends? How much longer can communities keep businesses, offices and schools closed?

Covid-19 deaths are unlikely to again rise quite as precipitously as in the past, and the worst may be behind us. But if Americans let down their guard too soon and if the variants spread in the United States as they have elsewhere, another spike in cases may well arrive in the coming weeks.

Buoyed by the shrinking rates over all, governors are lifting restrictions across the United States and are under enormous pressure to reopen completely.

“Everybody is tired, and everybody wants things to open up again,” said Ashleigh Tuite, an infectious disease modeler at the University of Toronto. “Bending to political pressure right now, when things are really headed in the right direction, is going to end up costing us in the long term.”

Looking ahead to late March or April, the majority of scientists interviewed by The Times predicted a fourth wave of infections. But they stressed that it is not an inevitable surge if precautions are maintained for a few more weeks.

“Just hang in there a little bit longer,” Dr. Tuite said. “There’s a lot of optimism and hope, but I think we need to be prepared for the fact that the next several months are likely to continue to be difficult.”

Credit…Doug Mills/The New York Times

In Washington, Republicans stand united in opposition to President Biden’s first major legislative proposal, a $1.9 trillion economic rescue plan that they have labeled a bloated, budget-busting “blue state bailout.”

But in rural Maine, Anthony McGill, a self-identified conservative Republican, describes the bill as something else entirely: “Most of it sounds like a good idea,” he said.

While Mr. McGill doesn’t agree with all the provisions, he supports the central thrust of the bill — another round of direct stimulus payments to nearly all Americans.

“There’s a lot of people that could use those checks. I don’t know about needing them, but we could all use them,” said Mr. McGill, 52, who voted for former President Donald J. Trump in November. “The debt is so far out of hand that it’s a fantasy number at this point. We might as well just blow it out till everything collapses.”

As Democrats prepare to vote as soon as Friday to pass the relief package in the House, Republican elected officials are struggling to overcome intraparty divides over whether to embrace the major pieces of the proposal — as well as to reconcile with the fact that many Republican voters support the plan. While Democrats are working swiftly to move their bill, Republicans are consumed by sideshows like false claims of voter fraud and what they call cancel culture, which are two major themes of the annual Conservative Political Action Conference, known as CPAC, starting on Friday in Orlando, Fla.

The lack of a unified Republican economic message reflects an unsettled party that is unable to agree on how to chart a path through a Democratic-controlled Washington. While congressional Republicans take a scattershot approach to try to undermine the legislation, mayors and governors in their party are pushing for the plan, saying their states and cities need the federal aid to keep police officers on their beats, reopen schools and help small businesses.

Polling shows a significant number of Republican voters agree: More than four in 10 Republicans back Mr. Biden’s aid package, according to polling from the online research firm SurveyMonkey for The New York Times. Over all, 72 percent of Americans said they supported the bill, a number that includes 97 percent of Democrats.

Global Roundup

Credit…Andrea Mantovani for The New York Times

BRUSSELS — In vaccine-hungry, cash-rich Europe, the hunt for more doses has nations trading with each other, weighing purchases from Russia and China, and fielding offers from middlemen ranging from real to outright frauds.

Anger has been building over the European Union’s sluggish Covid vaccine rollout, which has left the E.U. member nations far behind several other wealthy countries, and many E.U. states are now looking beyond the bloc’s underwhelming joint purchasing strategy.

An immense black — or at least gray — market has arisen, with pitches from around the world at often exorbitant prices. Sellers have approached E.U. governments claiming to offer 460 million doses of vaccines, according to early results of an investigation by the bloc’s anti-fraud agency that were shared with The New York Times.

While they still plan to get vaccines from the bloc, some nations are also trying to negotiate directly with drug makers and eyeing the murky open market, where they are still unsure of the sellers and the products. Some have also agreed to swap vaccines with each other, deals some of them now have reason to regret.

The European Union last year was slow to make massive advance purchases from drug companies, acting weeks after the United States, Britain and a handful of other countries. This year, the bloc was blindsided by slower-than-expected vaccine production, and individual countries have fumbled the rollout.

About 5 percent of the E.U.’s nearly 450 million people have received at least one dose of a vaccine, versus almost 14 percent in the United States, 27 percent in Britain and 53 percent in Israel, as of earlier this week, according to the Our World in Data database and governments.

The stumbles by the world’s richest bloc of nations have turned vaccine politics toxic. Particularly galling to many Europeans is the sight of a former E.U. member, Britain, forging ahead with its vaccination and reopening plans, while many of their own societies remain under lockdown to contain a new surge of dangerous variants, their economies sinking deeper into recession.

In other international news on the pandemic:

The government in France has announced stricter border checks between Germany and the eastern Moselle region, one of several areas experiencing a spike in coronavirus infections. It is the latest pandemic measure to challenge the E.U.’s open borders. Officials said that starting Monday, those wanting to cross the border would have to present a negative coronavirus test from the past 72 hours. Cross-border workers in the area will be exempt.
President Emmerson Mnangagwa of Zimbabwe threatened this week to punish residents who do not take Covid vaccines. “You are not going to be forced to be vaccinated, but the time shall come when those who are not vaccinated won’t get jobs,” he said on Wednesday. The country of 15 million people received 200,000 donated doses from the Chinese company Sinopharm, and 600,000 more doses are expected in early March. Zimbabwe is also set to receive more than 1.1 million doses as part of the Covax distribution program for poor and middle-income countries.
North Korea’s borders have been closed for a year because of the pandemic, but some Russian diplomats and their families found a way home on a route that included a bus ride and a trip on a hand-pushed railroad trolley. Russia’s Foreign Ministry said on Friday that the journey by trolley was the only possible way for them to cross the border.

Credit…James Estrin/The New York Times

Members of the Congressional Black Caucus and Dr. Anthony Fauci sought to reassure Black Americans that vaccine rollouts would be as equitable as possible and tried to quell anxieties over the safety of the inoculation among people of color during a televised forum Friday night.

Dr. Fauci, the government’s top infectious disease expert, said increasing pharmacies’ vaccine inventory and creating mobile units to get to hard-to-reach areas will help.

Experts say that Black and Latino Americans are being vaccinated at lower rates because they face obstacles like language barriers and inadequate access to digital technology, medical facilities and transportation. But mistrust in government officials and doctors also plays a role and is fed by social media misinformation. And in cities across the country, wealthy white residents are lining up to be vaccinated in low-income Latino and Black communities.

“It’s affecting us like no other disease, like no other epidemic has. That’s because for Black Americans, we were already behind,” Representative Barbara Lawrence, Democrat of Michigan, said during the forum on MSNBC’s “The Reid Out.”

“We’re looking at historic fear of vaccines and a fear of the health care industry because are they going to hurt us, harm us, ignore us or are they going to help us?” she said.

President Biden has said he wants to make racial equality a centerpiece of his vaccination rollout plan. He has begun shipping vaccines to federally qualified community health centers in Black and Latino communities.

While new data shows rates of vaccination in New York City’s Black and Latino communities are lower than rates in largely white communities and New York State’s Latino and Black residents were behind in vaccination totals, the absence of comprehensive national data on race and ethnicity makes it impossible to know just how equitable vaccine distribution is.

“This vaccine does not discriminate,” Ms. Lawrence said. “It hurts me when I see a line of people getting vaccines and my people are not represented but I’m invited to the funerals of those who have died. I have taken the vaccine. I believe in it. I need my people, my community, to step up.”

Credit…Tasos Katopodis/Getty Images

The phone and online registration system set up by the District of Columbia for its residents to use to schedule Covid-19 vaccination appointments has been faltering after the city broadened the eligibility of prioritized residents who can make appointments on Thursday.

D.C. widened the criteria from people 65 and older to include residents with certain health conditions and those working jobs that require contact with multiple people.

But many complained on Thursday and Friday that the phone number listed for scheduling a jab was not in service, and that the website was returning error messages. Some people were able to secure an appointment, though it was not immediately clear why they were successful when others were not.

“In short … it did not go well,” one of the city’s council members, Charles Allen, said in an email to constituents on Thursday.

Mayor Muriel Bowser blamed the problems on the “high volume of traffic” on the city’s vaccination site and said in a tweet that the city was trying to fix the problems quickly. The mayor’s office did not immediately respond to a request for comment.

The city’s health department apologized for the problems and said the “technical review failure” on Thursday had been addressed. However, the problems persisted on Friday when the city released another 4,350 vaccine appointments.

As of Friday, nearly 11 percent of D.C. residents had received one dose of a vaccine, and nearly 5 percent had received two doses, according to a New York Times database.

Credit…Ueslei Marcelino/Reuters

RIO DE JANEIRO — The daily death toll of Covid-19 in Brazil hit a record high of 1,582 on Thursday, according to a news consortium’s survey of local health departments. The painful milestone came as President Jair Bolsonaro railed against face masks, despite compelling scientific evidence that they are effective at preventing infections.

A rise in coronavirus infections in several states in Brazil, which officials say is being driven by more contagious variants, has overwhelmed hospitals across the country.

While epidemiologists and health officials warn of a worsening crisis in the weeks ahead, Mr. Bolsonaro took aim at masks during his weekly address on Facebook Thursday. Citing an unspecified German study, the president said masks were bad for children and that wearing them could lead to headaches, difficulty concentrating and a “decreased perception of happiness.”

Mr. Bolsonaro has been criticized at home and abroad for his cavalier response to the coronavirus pandemic. He has questioned the use of quarantine measures, social distancing and has sowed doubts about vaccines, saying he does not intend to get a shot.

While new cases and deaths are dropping in a number of other countries that were hard hit by the pandemic, including the United States, Brazil is in the grip of a second wave that began in November and shows no sign of easing.

The country began vaccinating medical professionals and older people last month, but the campaign is off to a slow start because the government has struggled to procure enough doses to quickly inoculate its 212 million citizens.

This week, Brazil’s Covid death toll surpassed 250,000, which is second only to the U.S. count of more than 500,000 deaths. The Brazilian health minister, Eduardo Pazuello, said on Thursday that the country had entered a “new stage of the pandemic” as a result of variants that he said are three times more contagious than earlier strains of the virus. “That is the reality we’re living today in Brazil,” he said.

Credit…Neil Hall/EPA, via Shutterstock

For people who have had Covid-19, a single dose of the Pfizer vaccine is enough to provide robust protection from the coronavirus, according to two new studies from Britain that were published late Thursday in The Lancet, a prominent medical journal.

The studies, among the first fully vetted papers to weigh in on how to vaccinate people who have had Covid-19, added strong evidence to the case for inoculating people who already have antibodies against the virus — but only with one dose of the Pfizer vaccine.

One of the studies, led by researchers at University College London and Public Health England, described the benefits of that strategy.

“This could potentially accelerate vaccine rollout,” they said. And that in turn could forestall dangerous new mutations: “Wider coverage without compromising vaccine-induced immunity could help reduce variant emergence,” the paper said.

In recent weeks, several studies on the topic were posted online that were not yet published in scientific journals, showing that one dose of a coronavirus vaccine amplified people’s antibodies from an earlier infection.

People’s immune responses to being infected are highly variable: Most people make considerable and long-lasting antibodies, while others who had milder infections produce relatively few, making it difficult to know how protected they are from the virus.

Vaccines act as a sort of booster for those people’s immune responses, inducing enough antibodies to offer protection. But a single dose, rather than the full two-dose protocol, is enough for those who have been infected, a number of studies have suggested.

Some researchers in the United States are trying to persuade the Centers for Disease Control and Prevention to recommend giving only one dose to people who have recovered from Covid-19. The studies from Britain seem likely to put pressure on health officials there to consider the same approach.

More than 28 million people in the United States and four million people in Britain, along with many others whose illnesses were probably never diagnosed, have been infected so far.

One of the new studies — led by Charlotte Manisty, a professor at University College London, and Ashley D. Otter, a research scientist at Public Health England — tracked 51 health workers in London who have submitted to routine tests for antibodies and infection since March. That gave researchers an unusually detailed picture of any pre-existing protection from the virus.

Roughly half of the health workers had experienced a mild or asymptomatic infection. And a single dose of the Pfizer vaccine increased their antibody levels more than 140-fold from their peak levels before being inoculated, the study said. That appeared to give them better protection against the coronavirus than two doses of the vaccine did in people who had never been infected, the researchers wrote.

The study raised the idea of giving people blood tests in the weeks before they became eligible for a Pfizer vaccine to determine whether they already had antibodies. People’s immune responses to an infection are highly variable, making it difficult to predict without a blood test who can be fully protected with a single dose.

As a further benefit of the single-dose strategy, the researchers wrote that it would spare people who have already been infected from the unpleasant side effects that sometimes follow a booster shot in that group.

The second study, led by scientists at Imperial College London, measured the immune responses of 72 health workers who were vaccinated in late December. A third showed signs of having previously been infected.

For those people, one dose of the Pfizer vaccine stimulated “very strong” antibody responses, the study said, as well as “very strong T-cell responses,” referring to another arm of the immune system.

It is not clear how long the post-vaccine immune response will last in people who have previously been infected compared with those who have not.

Credit…Lucy Nicholson/Reuters

The head of Canada’s largest pension fund stepped down on Thursday evening after news broke that he had flown to the United Arab Emirates to receive a coronavirus vaccine, despite federal rules banning inessential travel and a long line of older and immunocompromised citizens across the country waiting for their shots.

The Canada Pension Plan Investment Board announced in a news release on Friday that it had accepted the resignation of its chief executive, Mark Machin, who had “decided to travel personally to the United Arab Emirates where he arranged to be vaccinated against Covid-19.” The board added: “We take that responsibility of leadership very seriously.”

At about $375 billion, the fund is Canada’s largest, with more than 20 million contributors and beneficiaries.

Mr. Machin, who last year earned about $4.2 million at the helm of the crown corporation, is the latest public figure in the country to be publicly sanctioned for traveling abroad for personal reasons, while much of the country is hunkered down during the pandemic’s second wave.

His trip was perceived as not just selfish, but as queue-jumping by many Canadians, who have grown increasingly impatient with the sluggish rollout of vaccinations across the country. Less than 4 percent of the country’s 38 million people have received a dose — far fewer than most Western nations.

The Canada Pension Plan Investment Board is an independent corporation, but the country’s finance minister appoints its directors. Through her spokeswoman, the deputy prime minister and finance minister, Chrystia Freeland, called Mr. Machin’s decision “very troubling” and said Canadians expect the organization to “be held to a higher standard.”

Mr. Machin’s trip was first reported by The Wall Street Journal on Thursday night. Soon after, he sent an internal memo to staff stating the trip was supposed to be “very private” and that he was disappointed it has become the focus of “expected criticism,” The Globe and Mail reported.

Credit…Cameron Pollack for The New York Times

Even as the overall number of coronavirus cases in South Carolina declines, the situation away from the state’s coastline has remained stubbornly dangerous, with some counties in the central and western parts of the state reporting some of the most dire case counts relative to their populations in the Southeast.

Those regions have kept the state’s case count from declining further, and over the last week, South Carolina has reported more cases per capita than any other state, as of Thursday.

The cases are staying high in a mix of small and large counties, including the metropolitan areas of Columbia, the state’s capital and second-largest city, and Spartanburg. Those two metro areas have reported more cases per capita over the last two weeks than all but three other metro areas in the United States, according to a New York Times database. And they are doing so even as cases in Charleston, the state’s largest city, have consistently fallen.

Gov. Henry McMaster cited the overall decline in U.S. cases on Friday in deciding to roll back several public health measures beginning next week. Starting Monday, there will no longer be an 11 p.m. curfew for alcohol sales at restaurants, and large gatherings can resume, though he encouraged people to voluntarily follow the guidelines that had been in place.

“With the spread of the virus consistently decreasing across the country and more of the most vulnerable South Carolinians being vaccinated every day, I believe these targeted and limited safety measures are no longer necessary,” Mr. McMaster said in a statement. “The virus is still among us and we all must continue to make responsible decisions to take care of ourselves and our loved ones, but those decisions are for South Carolinians to make.”

The move from Mr. McMaster came on the same day that Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, warned that the recent decline in cases may be stalling and said governors should keep public health measures in place. “Now is not the time to relax restrictions,” she said.

Brian Symmes, a spokesman for Mr. McMaster, said the governor “appreciates perspectives that differ from his own” but “respectfully disagrees” with Dr. Walensky’s assessment.

One day earlier, on Thursday, South Carolina’s top epidemiologist, Dr. Linda Bell, said in an interview with a local television station that while it was understandable that residents would be optimistic as vaccines rolled out, it was important for them to not forget that the situation was still severe in much of the state.

“We cannot say yet that we have passed the worst part of the pandemic,” Dr. Bell said on WIS-TV.

“I don’t want people to be too encouraged to the point that they stop doing the preventive measures, looking at the current decline in cases,” she added, “because we have declined to a level that has taken us to the height of cases that we were seeing after the Fourth of July, and I want to remind people that we were actually very alarmed.”

Mitch Smith contributed reporting.

Credit…Charlie Riedel/Associated Press

Colleges and universities across the country are pledging to reopen more fully in the fall, with some administrators worried that students won’t return to campus if normality, or some semblance of it, isn’t restored by September.

Schools from large state institutions to small private ones have announced they are laying plans to bring students back to dormitories, deploy professors to teach most (if not all) classes in person and restart extracurricular activities, in stark contrast to the past academic year of largely virtual courses and limited social contact. The announcements of these changes coincide with the sending of acceptance letters to the class of 2025.

Some schools have taken a financial hit because of deferred admissions or lost room-and-board fees.

Bradley University, in Peoria, Ill., which has 5,600 undergraduate and graduate students, said earlier this month that it would return to “traditional residential education” in the fall, with in-person classes and activities on campus.

Kansas State University announced on Wednesday that it too is planning a “more normal” fall semester, with largely in-person classes, events and activities. Ohio State announced on Thursday that it plans to offer “robust” in-person activities and classes, allowing students to live in residence halls and fans to attend football games.

Katherine Fleming, New York University’s provost, told colleagues in an email on Tuesday of plans to have “all faculty teaching their classes in-person, in the classroom, in the fall 2021.” She conceded, however, that this would depend in part on whether enough professors were vaccinated by then.

Indeed, most school officials said that whether they can deliver on these promises hinges on factors like how much the virus can be suppressed, the availability of the vaccine — which is still in scarce supply, even for those who are eligible — and guidance from government authorities.

Despite their hopefulness about the fall, schools have struggled with keeping the virus in check. Positivity rates rose among college students, as among the general population, over the holidays, when people traveled. Administrators have put out many stern warnings that small parties and gatherings have been a source of infection. Many have noted, however, that the classroom itself has not proven to be a vector of infection, as long as students and teachers follow safety guidelines like wearing masks and social distancing.

More than 120,000 coronavirus cases have been linked to American colleges and universities since Jan. 1, and more than 530,000 cases have been reported since the beginning of the pandemic, according to a New York Times survey. The Times has identified more than 100 deaths, but the vast majority involved employees, not students.

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Biden Tours Texas Emergency Aid Centers After Winter Storms

President Biden spent the day in Houston touring a local food bank and other areas hit by recent snowstorms. Storm damage is expected to total $20 billion, according to the Insurance Council of Texas.

Mr. President, welcome. This is our emergency operations center, Harris County Emergency Operations Center. For me and these folks you see here, this has been our home away from home. Over fire, flood, Covid and now this winter weather event. These folks are the tip of the sphere. Thank you for What you are doing. All I did is I got a call and before you asked the question I just said yes. He did. He said yes before I even asked the question. Absolutely. It’s incredible. It’s an incredible place. They’re doing — and they have so many talented people here, not just volunteers, really talented people.

President Biden spent the day in Houston touring a local food bank and other areas hit by recent snowstorms. Storm damage is expected to total $20 billion, according to the Insurance Council of Texas.CreditCredit…Doug Mills/The New York Times

At an emergency response center in Houston, President Biden praised officials who’d slept in stairwells as they worked around the clock to answer the call of terrified residents who had no power or drinkable water when devastating snowstorms hit. At a food bank, Mr. Biden hugged a little girl who was volunteering. He then turned to a woman to discuss the death of his eldest son, plugging into the pain of people around him by accessing his own.

“Incredible,” Mr. Biden said as he surveyed what was happening around him. “It’s absolutely amazing, and we could do so much more.”

Infrastructure and coronavirus relief may be on the official agenda in Washington, but the overwhelming nature of grief was the unofficial theme of the week.

On Monday, Mr. Biden presided over a solemn observance of a grim pandemic milestone: more than 500,000 Americans dead. “While we have been fighting this pandemic for so long, we have to resist becoming numb to the sorrow,” he said during a speech at that White House that evening.

And when he traveled to Houston with Jill Biden, the first lady, the president for the first time used his new platform to show support for a community ravaged by twin crises of devastating snowstorms and the pandemic.

“You’re saving people’s lives,” Mr. Biden told a group of officials at an emergency operations center. “As my mother would say, you’re doing God’s work.”

Across Texas, the damage from the storms is extensive and the recovery is expected to be slow. The damage is expected to cost upward of $20 billion, according to the Insurance Council of Texas. Coronavirus vaccinations had all but stalled because of the storm, but are beginning to rebound — Mr. Biden was expected to visit a mass-vaccination site at a nearby stadium later Friday.

As soon as Mr. Biden hit the ground, the tone of his visit was different from what victims of natural disasters encountered when his predecessor, Donald J. Trump, would visit. Mr. Trump more than once threatened to withhold disaster funding if he had toxic political relationships with officials in those places.

Mr. Biden, who has been pushing a $1.9 trillion coronavirus relief package, was joined by Republicans who praised him for approving a major disaster declaration for Texas, ensuring the flow of federal resources to some 126 counties across the state that were hit by the storms — about half the number requested by Gov. Greg Abbott, who joined Mr. Biden on the trip.

“The governor and Senator Cruz and I asked for a declaration from the federal government which provides access to public and private assistance through FEMA,” said Senator John Cornyn, Republican of Texas and another participant on the trip, referring to the state’s junior senator, Ted Cruz. “That’s going to be important for our recovery.”

Mr. Cruz did not participate. He was in Florida, speaking at the Conservative Political Action Conference.

In Harris County, where Houston is, about 50 percent of 4.9 million residents lost power as the storms hit. Nearly two weeks later, about 10,000 residents are still boiling their water, according to county officials. More than 50,000 across the state still do not have access to safe water, according to officials with the Federal Emergency Management Agency.

During the visit to the food bank, Dr. Biden slipped cans of peaches into packages of food for students who rely on free school meals. Mr. Biden talked to children and told them about his own family.

It was a marked difference from Mr. Trump, who was criticized in 2018 for visiting a disaster relief center in Puerto Rico, only to throw paper towels at people who’d survived a Category 5 hurricane. “I was having fun,” Mr. Trump said afterward. “They were having fun.”

Tags Covid19, FDA, Green, Johnson, Johnsons, Light, Panel, Vaccine

Health

F.D.A. Skilled Panel Endorses Johnson & Johnson’s Vaccine

Post author By
Post date February 27, 2021

F.D.A. Expert Panel Endorses Johnson & Johnson’s Vaccine

Johnson & Johnson’s Covid-19 vaccine was approved on Friday by a group of experts advising the Food and Drug Administration and cleared the final hurdle before formal approval expected on Saturday, according to two people familiar with the agency’s plans are. The nation’s first shipments will run out in the days thereafter.

It will be the third shot made available to the United States in the year since the first wave of coronavirus cases washed across the country, and it will be the first vaccine to require just one dose instead of two.

The Johnson & Johnson formulation worked well in clinical trials, especially against serious illness and hospitalization, although it did not match the sky-high efficacy rates of the first two vaccines from Pfizer-BioNTech and Moderna.

The panel, made up of independent infectious disease experts, statisticians and epidemiologists, voted unanimously to approve the vaccine.

“We are dealing with a pandemic right now,” said Dr. Jay Portnoy, an allergist at Children’s Mercy Hospital in Kansas City, MO, and a board member. “It’s great that we have this vaccine.”

During Johnson & Johnson’s presentation to the panel, Dr. Gregory Poland, a virologist at Mayo Clinic and the company’s paid external consultant, noted the vaccine’s effectiveness, ease of use and low side effect rate. It “checks almost all the boxes,” he said. “It is clear to me that the known benefits far outweigh the known risks.”

The vaccine had an overall effectiveness rate of 72 percent in the US and 64 percent in South Africa, where a worrying variant emerged in the fall. The shot showed an effectiveness of 86 percent against severe forms of Covid-19 in the US and 82 percent against serious illnesses in South Africa.

These are strong numbers, but they are below the efficacy rates of Pfizer-BioNTech and Moderna’s vaccines against mild, moderate, and severe cases of Covid of around 95 percent.

The Johnson & Johnson vaccine is a single dose and uses a different technology from the approved vaccines. The scope and size of the Johnson & Johnson trial was huge, spanning eight countries, three continents, and nearly 45,000 participants.

Although the vaccine works with one shot, studies are currently being carried out to see if a second dose would increase the level of protection.

Dr. Paul Offit, a pediatrician at Philadelphia Children’s Hospital and one of the panellists, pointed out Friday that Johnson & Johnson found in early clinical trials that took place over the summer that a second dose resulted in levels of coronavirus antibodies that were almost three times higher than those produced by one dose alone.

The results of the Johnson & Johnson late-stage two-dose clinical trial are not expected until July at the earliest. If these results are found to be better than a single dose, Dr. Offit: “Will this be a two-dose vaccine?”

Dr. Johan Van Hoof, the global director of vaccine research and development at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, said the company decided to pursue the one-shot strategy after its studies on monkeys last spring showed that a single dose was sufficient to provide strong protection against the disease.

“It is clear that in a situation of an outbreak, in a raging epidemic, the big challenge is getting the epidemic under control,” he said. “The regime is very well positioned to be used in outbreak situations.”

Dr. However, Van Hoof also noted that it will be important to track volunteers who have received a single dose to see if their immunity changes over the coming months. Firing a booster shot may be required for long-term protection. “The big question mark is still how long does the protection last?” he said.

Following the vote, the FDA told Johnson & Johnson that it “will work quickly towards completion and emergency clearance,” a statement said. The FDA also said it had notified other government agencies “so they can implement their plans for timely vaccine distribution”.

Sharon LaFraniere contributed to the coverage.

Tags Endorses, expert, FDA, Johnson, Johnsons, Panel, Vaccine

Entertainment

Who Was Dwayne “The Rock” Johnson’s Father, Rocky?

Post author By
Post date February 19, 2021

NEW YORK, NY - OCTOBER 20: Rocky Johnson participates in Unite in the Fight To Prevent Bullying at Hard Rock Cafe New York on October 20, 2011 in New York City. (Photo by John Lamparski / WireImage)

We’re already addicted to CBS Young skirt, a sitcom based on Dwayne “The Rock” Johnson’s youth. Johnson’s show is a fun take on his eccentric upbringing and experience with his iconic wrestling dad Rocky Johnson (plus all of his famous wrestling buddies). It emerges from the premiere that Rocky was a major inspiration for Dwayne as both a father and an athlete. While Rocky sadly passed away in 2020, there is still so much to learn about the man, myth, and legend that helped create The Rock.

Rocky Johnson, also known as Soul Man, was a Canadian-American WWE Hall of Famer in the 1980s. Together with fellow wrestler Tony Atlas he founded “The Soul Patrol” and together they became the first African American tag team world champion in WWE history. He is known to this day as the “king of the drop kick”.

Born in Wayde Douglas Bowles, Rocky was marked by tragedy when his father, a miner, died of lung cancer at the age of just 12. When he moved to Toronto, he changed his name to Rocky Johnson, inspired by his favorite boxing greats Rocky Marciano and Jack Johnson. While doing odd jobs, he boxed at a nearby community center and got good enough even to fight Muhammad Ali.

He soon found himself in Jack Wentworth’s wrestling school, where he quickly developed into a fantastic wrestler. Johnson stepped his way into notoriety and got his big break from world heavyweight champion “Whipper” Billy Watson, who made him his protégé. Although Johnson wrote in his memoir that he believes Watson chose him to advance his political career because he “may have been the only black wrestler from Canada,” the wrestling newcomer rose to prominence in both cases.

In the 1980s, Rocky Johnson was a well-known WWE wrestler who used his fights with Ali and George Foreman to build his reputation as a top notch fighter. He soon fell in love with the daughter of Samoan pro-wrestler Peter Maivia, Ata, who would one day become Dwayne Johnson’s mother. The couple took Dwayne out on the streets and gave the future wrestler and actor a glimpse into the business. After Rocky retired from the ring in 1991, he focused on helping his son enter the wrestling arena himself and turning him from college footballer to iconic WWE Smackdown Superstar.

About his father, The Rock wrote on Instagram in 2018: “Little boys naturally look up to their old man and adore him. They want to be just like them, do everything they do and always seek their approval.” He continued his caption and talked about how his father’s deep love made him who he is today, closing with “grateful for the original skirt.” When Rocky passed away in 2020, The Rock hit social media again, this time to share his heartbreak: “You broke color barriers, became a ring legend, and paved your way through this world.” The star left followers in his grief, writing: “You have led a very full, very hard, accessible life and left everything in the ring. I love you, Dad, and I will always be your proud and grateful son.”

Tags Dwayne, Father, Johnsons, Rock, Rocky

Health

Johnson & Johnson’s Vaccine Provides Sturdy Safety however Fuels Concern About Variants

Post author By
Post date January 29, 2021

Johnson & Johnson’s Vaccine Offers Strong Protection but Fuels Concern About Variants

[Live updates: follow our coverage of the coronavirus]

Johnson & Johnson announced on Friday that its one-dose coronavirus vaccine provided strong protection against Covid-19, potentially offering the United States a third powerful tool in a desperate race against a worldwide rise in virus mutations.

But the results came with a significant cautionary note: The vaccine’s efficacy rate dropped from 72 percent in the United States to 57 percent in South Africa, where a highly contagious variant is driving most cases. Studies suggest that this variant also blunts the effectiveness of Covid vaccines made by Pfizer-BioNTech, Moderna and Novavax. The variant has spread to at least 31 countries, including the United States, where two cases were documented this week.

Johnson & Johnson said that it planned to apply for emergency authorization of the vaccine from the Food and Drug Administration as soon as next week, putting it on track to receive clearance later in February.

“This is the pandemic vaccine that can make a difference with a single dose,” said Dr. Paul Stoffels, the chief scientific officer of Johnson & Johnson.

The Johnson & Johnson vaccine was 85 percent effective in preventing severe disease, regardless of what variant caused it, the company said. While less effective than the Moderna and Pfizer vaccines, Johnson & Johnson’s is still considered a strong vaccine by scientists. Annual flu vaccines, for example, are typically 40 to 60 percent effective.

The company’s announcement comes as the Biden administration is pushing to immunize Americans faster even with a tight vaccine supply. White House officials have been counting on Johnson & Johnson’s vaccine to ease the shortfall. But the company may only have about seven million doses ready when the F.D.A. decides whether to authorize it, according to federal health officials familiar with its production, and about 30 million doses by early April.

The variant from South Africa, known as B.1.351, could make things even worse for the vaccine push. Given the speed at which the variant swept through that country, it is conceivable that by April it could make up a large fraction of infections in the United States.

The fact that four vaccines backed by the federal government seem to be less effective against the B.1.351 variant has unsettled federal officials and vaccine experts alike. Facing this uncertainty, many researchers said it was imperative to get as many people vaccinated as possible — quickly. Lowering the rate of infection could thwart the contagious variants while they are still rare, and prevent other viruses from gaining new mutations that could cause more trouble.

“If ever there was reason to vaccinate as many people as expeditiously as we possibly can with the vaccine that we have right now, now is the time,” Dr. Anthony S. Fauci, the government’s top infectious disease expert, said in an interview. “Because the less people that get infected, the less chance you’re going to give this particular mutant a chance to become dominant.”

As the United States scrambles to get enough vaccines, the country is turning into something of an evolutionary experiment. The B.1.351 variant is one of several that have arrived in the country or originated here, all with the ability to spread faster than other variants.

“The pandemic is a lot more complicated now than it was a couple months ago,” said Dr. Dan Barouch, a virologist at Beth Israel Medical Center in Boston.

Vaughan Cooper, an evolutionary biologist at the University of Pittsburgh, said that all the new variants were likely evolving quietly for months before bursting on the scene. “I think we’re going to see many stories like this,” he said.

Federal regulators are also still waiting on data from Johnson & Johnson’s new manufacturing facility in Baltimore that prove it can mass-produce the vaccine. The company is counting on that factory to help reach its contractual pledge to the federal government of 100 million doses by the end of June.

If Johnson & Johnson can deliver vaccines quickly enough to the United States, it might be able to help drive down cases before variants make things worse. Since the vaccine requires only a single shot — unlike the Moderna and Pfizer-BioNTech vaccines, which require two — that delivery would translate into full coverage for 100 million people.

Johnson & Johnson’s vaccine has another advantage that might help speed up the rollout. It can stay viable in a refrigerator for three months, while the two authorized vaccines have to be kept frozen. That gives the company an edge not just in reaching more isolated parts of the United States, but in getting the vaccine to remote areas of the world that could otherwise seed more aggressive mutants.

“I hope this vaccine gets approved as soon as possible to reduce disease burden around the world,” said Akiko Iwasaki, immunologist at Yale University. She pointed out that the shot greatly reduced the number of severe Covid cases, even those caused by the variant. “This is a really great result.”

Still, Johnson & Johnson and other vaccine makers must prepare for the B.1.351 variant or another one surging to dominance and demanding new vaccines. “You’ve got to be nimble enough to be able to adapt by upgrading our vaccines that match the dominant strain,” Dr. Fauci said.

Exactly when to make that switch will be a difficult decision, because the viruses are spreading unpredictably, and manufacturing new doses will be a huge undertaking.

“The implications of that are big. You would not take that choice lightly,” said John D. Grabenstein, an epidemiologist with the Immunization Action Coalition, a nonprofit organization that disseminates information about vaccines. “It’s not doomsday. It’s just that we are going to need a bigger boat.”

Johnson & Johnson’s announcement came one day after Novavax said an early analysis of its 15,000-person trial in Britain had revealed that the two-dose vaccine had an efficacy rate of nearly 90 percent there. But in a small trial in South Africa, the efficacy rate dropped to just under 50 percent.

Johnson & Johnson presented only a summary of findings of its clinical trial. The vaccine was 85 percent effective in preventing severe disease in all three regions where the trial was run: the United States, Latin America and South Africa. After 28 days, none of the vaccinated participants who developed Covid-19 had to be hospitalized.

The company reported that the vaccine’s protective effect seems to increase with time. But without long-term data on immunity, scientists and regulators do not yet know whether the vaccine’s efficacy peaks at some point before dropping.

Covid-19 Vaccines ›

Answers to Your Vaccine Questions

Am I eligible for the Covid vaccine in my state?

Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area

Is the vaccine free?

You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.

Can I choose which vaccine I get?How long will the vaccine last? Will I need another one next year?

That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.

Will my employer require vaccinations?Where can I find out more?

Dr. Stoffels said the company was still waiting for more data on whether the vaccine can protect against asymptomatic infection.

The company is preparing a lengthy briefing document it will submit to the F.D.A. in its application for authorization. The agency’s scientists will review the raw data from the trial and present their own analysis.

Unlike the messenger RNA vaccines made by Pfizer-BioNTech and Moderna, Johnson & Johnson uses an adenovirus, which normally causes the common cold. While adenovirus-based vaccines have been investigated for some three decades, they have yet to be licensed for use in the United States.

Johnson & Johnson’s Ebola vaccine became the first approved adenovirus-based vaccine for any disease when European regulators gave it the green light last July. Astra-Zeneca and the University of Oxford used a different adenovirus for their coronavirus vaccine, which is now authorized in Britain and other countries. Russian scientists created their Sputnik V vaccine from adenoviruses as well.

Johnson & Johnson received $456 million from Operation Warp Speed to support its research. In July, the government agreed to purchase 100 million doses for $1 billion if it proved safe and effective.

That same month, the company moved into clinical trials, which found that a single shot produced a strong immune response, consistent with experiments done on monkeys. Johnson & Johnson began the final “Phase 3” trial in September, again using a single dose. It recruited volunteers in the United States, South Africa and Latin America.

Half of the volunteers received the vaccine, and half received a placebo. The company then had to wait. Only when enough people in the trial got Covid-19 would an independent board of advisers look at the results to see how many sick volunteers were vaccinated — a process known as unblinding.

Late last year, surges of coronavirus infections accelerated the trial toward unblinding. In December, Johnson & Johnson decided it would not need to recruit 60,000 volunteers as it originally planned. It capped the trial at 45,000.

Like other vaccine developers, Johnson & Johnson was required by the F.D.A. to also record information about adverse events experienced by the volunteers for the first few months after vaccination.

Dr. Barouch, who led the team that designed the vaccine and tested it on animals last year, had to wait for months for the unblinding. “I’m thinking a lot about it,” he said in a Jan. 11 interview. “But, no, I don’t have champagne ready to go.”

After he learned the results, Dr. Barouch said he was delighted. “I think this vaccine will have a public health benefit throughout the world,” he said.

Johnson & Johnson is also moving forward with other trials of the vaccine to see how it can be improved. In December it began a trial with two doses. Dr. Fauci was optimistic that people who get a so-called prime boost may enjoy even more protection.

“If they get a prime boost, it’s entirely conceivable that they can get up to 90-plus percent,” he said.

In addition, Dr. Stoffels said that Johnson & Johnson was tailoring a version of its vaccine with a protein patterned after the B.1.351 variant. It could potentially deploy it in countries where that version of the virus was a threat.

“Pretty much all vaccine developers now are having that conversation,” said Dr. Peter J. Hotez, a vaccine expert with the Baylor School of Medicine and the creator of a different coronavirus vaccine.

Tags Concern, Fuels, Johnson, Johnsons, Offers, Protection, Strong, Vaccine, Variants