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FDA finds poor situations at Baltimore plant that ruined J&J doses

FDA finds poor conditions at Baltimore plant that ruined J&J doses

A detail of Janssen Johnson & Johnson’s COVID-19 vaccine that is not currently being issued because it has been on hold.

Allen J. Cockroaches | Los Angeles Times | Getty Images

The Food and Drug Administration said Wednesday a facility in Baltimore that ruined millions of Johnson & Johnson Covid-19 vaccine doses was unsanitary and unsuitable for making the shots.

The FDA asked Emergent BioSolutions, which operates the facility, to temporarily suspend production of materials for Covid-19 vaccines earlier this month as the U.S. agency initiated an inspection.

“The company has not adequately trained personnel involved in manufacturing operations, quality control sampling, weighing and dispensing, and engineering operations to prevent drug cross-contamination,” FDA investigators wrote in the report.

The eight-day inspection earlier this month revealed a number of alarming quality issues throughout the facility.

In a 13-page report, the inspectors wrote that the facility used to manufacture the vaccine “was not kept in a clean and sanitary condition” and “was not of the appropriate size, design and location for cleaning, maintenance and to facilitate proper operation. “”

FDA inspectors said paint was peeling in multiple places and walls were damaged, which could affect the facility’s “ability to adequately clean and disinfect.” They also found that when handling waste or materials used to make vaccines, employees did not follow standard operating procedures to ensure they were not contaminated.

The facility has not been approved by the FDA to manufacture or distribute Johnson & Johnson’s Covid-19 vaccine, and none of the doses manufactured at this facility have been marketed for use in the United States.

In a statement, J&J said it had “stepped up its oversight of drug manufacturing at the Emergent BioSolutions Bayview facility, including additional controls and personnel, to ensure that the quality standards of our company and the US Food & Drug Administration ( FDA) are complied with. “”

“Johnson & Johnson will exercise its regulatory authority to ensure that all FDA observations are promptly and fully considered,” it said.

Robert Califf, former FDA commissioner under the Obama administration, said that while the problems at the Baltimore plant appear “troubling”, manufacturing issues are emerging and one reason FDA oversight is so important.

“Supply chain and manufacturing are really complicated issues, but that’s why you need an FDA and inspections, and it’s the shared responsibility of the FDA and the companies themselves,” he told CNBC in a telephone interview.

Earlier this month, the Biden administration hired J&J to run the Baltimore facility after US officials learned that Emergent, a contract manufacturer that made vaccines for J&J and AstraZeneca, mixed the ingredients for the two shots would have. Officials also stopped production of the AstraZeneca vaccine.

The interruption in production of new materials is the most recent setback for J & J. Last week, the FDA and Centers for Disease Control and Prevention advised states to temporarily discontinue use of J & J’s vaccine “out of caution” after six Women had developed a rare but potentially life-threatening bleeding disorder in which one person was dead and one was in critical condition. A key CDC panel is due to meet on Friday to make a recommendation on how to use the vaccine.

The FDA said Wednesday that its actions at the Baltimore facility had nothing to do with the ongoing evaluation of the coagulation cases.

This is a developing story. Please try again.

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FDA asks Emergent plant to pause manufacturing throughout probe of botched Covid vaccines

FDA asks Emergent plant to pause manufacturing during probe of botched Covid vaccines

The Emergent BioSolutions facility, a manufacturing partner for Johnson & Johnson’s Covid-19 vaccine, on April 9, 2021 in Baltimore, Maryland.

Saul Loeb | AFP | Getty Images

The Food and Drug Administration has asked Emergent BioSolutions to temporarily suspend production of materials for Covid-19 vaccines while U.S. regulators investigate their Baltimore plant, responsible for the destruction of millions of Johnson & Johnson shots, shared Emergent in a registration application filed on Monday.

The FDA initiated an inspection of the facility on April 12, asking the company to stop production four days later until the review and remediation was complete. In a filing with the Securities and Exchange Commission, the company also said it had quarantined all material produced at the facility.

Emergent stocks were down more than 9% on the news.

In a statement to CNBC, J&J said it would work with Emergent and the FDA “to clarify any results after the FDA inspection is complete”.

“Our goal remains to ensure that all drug substances for our COVID-19 vaccine meet our high quality standards and receive emergency use approval for drug substances manufactured in Emergent Bayview,” the company said. “At this point it is premature to speculate about the potential impact this may have on the timing of our vaccine shipments.”

Earlier this month, the Biden administration hired J&J to run the Baltimore facility after US officials learned that Emergent, a contract manufacturer that made vaccines for J&J and AstraZeneca, mixed the ingredients for the two shots would have. Officials also stopped production of the AstraZeneca vaccine.

The government’s move to let the facility manufacture only the J&J single-dose vaccine is intended to avoid future confusion, the New York Times reported, citing two senior federal health officials.

The production hiatus for new materials is the most recent setback for J & J. Last week, the Food and Drug Administration and Centers for Disease Control and Prevention advised states to temporarily “cease” use of J & J’s vaccine, after six women developed a rare but potentially life-threatening bleeding disorder in which one died and one was in critical condition.

The women developed the condition known as cerebral sinus thrombosis within about two weeks of receiving the shot, an official said. CVST is a rare form of stroke that occurs when a blood clot forms in the venous sinuses of the brain. It can eventually leak blood into the brain tissue and cause bleeding.

J.& J has privately asked Covid-19 vaccine rivals Pfizer and Moderna to participate in a study examining the risk of blood clots. The companies refused, however, the Wall Street Journal reported on Friday, citing people familiar with the matter.

–Reuter contributed to this report.

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Regeneron to request FDA clearance for antibody drug as preventative remedy

Regeneron to request FDA clearance for antibody drug as preventative treatment

View of Regeneron Pharmaceuticals corporate, research and development headquarters on Old Saw Mill River Road in Tarrytown, New York.

Lev Radin | LightRocket | Getty Images

Regeneron Pharmaceuticals announced Monday that it would ask the Food and Drug Administration to approve the use of its Covid-19 antibody therapy as a preventative treatment.

The therapy, given to former President Donald Trump shortly after he was diagnosed with Covid-19 last year, has already been approved by the FDA to treat adults with mild to moderate Covid-19 and pediatric patients aged 12 and over approved age who tested positive for the virus and is at high risk of serious illness.

Regeneron said it plans to expand the use of its treatment in the United States after a Phase 3 clinical study jointly conducted by the National Institutes of Health found the drug reduced the risk of symptomatic infections in individuals by 81%.

The company also said that people who were symptomatic and treated with the drug resolved their symptoms an average of two weeks faster than those who received a placebo.

“As more than 60,000 Americans continue to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail can help provide immediate protection to unvaccinated people exposed to the virus,” said Dr. George Yancopoulos, President and Chief Scientific Officer of Regeneron, said in a press release.

The study included 1,505 people who were not infected with the virus but lived in the same household as someone who recently tested positive. Participants received either a dose of Regeneron therapy or a placebo.

The company said 41% of the people in the study were Hispanic and 9% were Black. Additionally, 33% of the participants were obese and 38% were 50 years and older, according to the company.

Regeneron therapy belongs to a class of treatments known as monoclonal antibodies, which act as immune cells to fight infections. Monoclonal antibody treatments attracted widespread attention after it was revealed that Trump had received Regeneron’s drug in October.

In recent months, public health officials have raised concerns that emerging, highly contagious variants of coronavirus could threaten monoclonal antibodies on the market. Dr. However, Myron Cohen, who leads monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network, said the drug has shown that it will retain its effectiveness against new strains.

As the world’s attention has shifted to giving Covid-19 vaccines, health experts say treatments are also crucial to ending the pandemic, which, according to compiled data, has topped 31.1 million in just over a year Infected Americans and killed at least 561,800 people from Johns Hopkins University.

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GlaxoSmithKline asks FDA for emergency authorization for antibody drug

GlaxoSmithKline asks FDA for emergency authorization for antibody drug

In this photo illustration, the UK multinational pharmaceutical company GlaxoSmithKline (GSK) logo is displayed on a smartphone with a computer model of the COVID-19 coronavirus in the background.

Budrul Chukrut | SOPA pictures | Getty Images

GlaxoSmithKline and Vir Biotechnology filed Friday with the Food and Drug Administration for emergency approval for their monoclonal antibody drug.

The companies apply for the permit for high risk individuals aged 12 and over.

The FDA filing is based on an interim analysis of a Phase 3 study evaluating the drug for the early treatment of Covid-19 in adults at high hospital risk. The drug reduced hospital admissions or death from Covid by 85% compared to a placebo. The test results were based on 583 patients.

“As a result, the Independent Data Monitoring Committee recommended that the study be discontinued because of the evidence of profound effectiveness for the registration,” the company said in a statement.

Companies began testing the antibody on early-stage Covid patients in August in hopes of preventing symptoms from getting worse. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.

U.S. health officials say antibody drugs already approved for use – by Regeneron and Eli Lilly – are not being used adequately.

GSK said the companies would also continue talks with the European Medicines Agency and other global regulators to make the drug available to Covid patients as soon as possible.

-Reuter contributed to this report.

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Pandemic Forces F.D.A. to Sharply Curtail Drug Firm Inspections

Pandemic Forces F.D.A. to Sharply Curtail Drug Company Inspections

Remote exam advocates say they can do the same thing virtually. Peter Miller, president of New Jersey-based Dynamic Compliance Solutions, which helps life science companies comply with FDA regulations, says his remote audit kit can do an excellent inspection. The kit includes a tiny 360-degree camera that an on-site host carries on a tripod while the investigator watches on a computer screen.

“The inspector can say, ‘I see a stack of boxes over there. Can we get a little closer I would like to see if they have the right stickers, ”he said. “I believe the examiner should be in control of what he sees. We’re doing a live stream, an unrecorded broadcast. “

Industry lawyers believe the FDA is too picky about the current backlog to refuse remote inspections. Mark I. Schwartz, a former FDA assistant director who oversaw inspections by the agency’s Center for Biologics Evaluation and Research, believes wider use of remote inspections is overdue. Mr Schwartz believes remote inspections, if done properly, will produce results similar to face-to-face visits – which he said more than a dozen of his customers are dying to do.

“To suggest that being there makes a big difference is a fallacy,” said Schwartz, now a director at Hyman, Phelps & McNamara, a law firm with a large practice in the pharmaceutical industry. At best, according to Schwartz, the on-site investigators only see around 15 percent of a company, even if they are there in person.

The subject caught the attention of Congress. Dr. Denigan-Macauley, due to testify Tuesday before the budget subcommittee that oversees FDA Representative Sanford Bishop, a Georgia Democrat who chairs the panel, said, “The pressure to ensure the FDA continues to assess safety and security The effectiveness of the drug supply is growing day by day. ”

While public health experts have been hit by the sharp decline in inspections, most believe virtual inspections are a poor substitute for in-person reviews.

“Remote inspections are just not going to make it,” said Dr. Carome. “Often times the FDA identifies serious problems and when you are away they go undetected.”

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Altria asks FDA to unfold the phrase that nicotine does not trigger most cancers

Altria asks FDA to spread the word that nicotine doesn't cause cancer

A Marlboro cigarette.

Daniel Acker | Bloomberg | Getty Images

Marlboro’s parent, Altria, has asked the Food and Drug Administration to help spread the word that nicotine doesn’t cause cancer.

CNBC received a copy of a letter Altria sent to the FDA on Thursday asking the agency to spread the word about nicotine as part of a proposed publicity campaign about the risks of tobacco use.

“We received the letter and we will respond directly to the company,” FDA spokeswoman Alison Hunt told CNBC in an email.

Altria was not immediately available to comment on the matter.

In the February 25 letter signed by Paige C. Magness, senior vice president of Regulatory Affairs, Altria cited government studies on misperceptions about nicotine. It was said that eliminating such misperceptions would help traditional smokers switch to non-flammable methods of using nicotine, which may be less risky than products containing smoke.

Bloomberg News first reported the letter Thursday.

While the vast majority of Altria’s revenue comes from the sale of cigarettes and cigars, the company is also involved in vaping firm Juul and the nicotine pouch brand On! Involves and markets IQOS, a smokeless tobacco product that heats tobacco instead of burning it in the United States

There are at least 60 carcinogens in cigarette smoke, but these newer products deliver nicotine without the smoke.

As the regulator of Altria, the FDA can determine what claims it can make of its products. The FDA has allowed Altria to market IQOS in a way that would reduce the exposure of users to harmful chemicals than cigarette smoke.

Nicotine is the addicting ingredient to tobacco and it can have other negative health effects. In its report, Bloomberg said studies have shown that nicotine can affect brain development and birth outcomes, and in large doses acts as an agricultural poison.

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Democrats push FDA to manage poisonous metals in child meals

Democrats push FDA to regulate toxic metals in baby food

Democrats urge FDA to regulate toxic metals in baby food after research finds high levels.

Chris Tobin | DigitalVision | Getty Images

Top Democrats are urging the FDA to regulate toxic metals in baby formula after a Congressional investigation found metals like arsenic, lead, and cadmium to be found in far higher amounts than permitted in bottled water and other products.

Sens. Amy Klobuchar, D-Minn. And Tammy Duckworth, D-Ill. As well as the representatives Raja Krishnamoorthi, D-Ill. And Tony Cardenas, D-Calif., Told CNBC that they are asking regulators to limit the levels of toxic heavy metals in baby food.

The Food and Drug Administration does not currently set limits for heavy metals in baby food, particularly for arsenic in rice grain. The agency regulates other toxins in consumer products such as lead, arsenic, and cadmium in bottled water.

The four Democrats said Thursday they had drafted laws that would tighten regulations on baby food safety and sent them to FDA staff for technical review. However, lawmakers want the FDA to use their existing regulator to take immediate action.

“Through our legislation and FDA regulations, we will ensure that the baby foods we put on the market are safe and that our children are safe,” Krishnamoorthi said in a statement. “I am proud to work with my colleagues, along with the FDA, stakeholders and health professionals across the country, to develop major reforms.”

An FDA spokeswoman said the agency takes exposure to toxic metals in food “extremely seriously” and that the agency is reviewing the results of the Congressional investigation. She added that “The FDA has not commented on whether it has received requests for technical assistance regarding the legislation, but we would look forward to working with Congress on the matter.”

Rep. Raja Krishnamoorthi, D-Ill., During the House Oversight and Reform Committee hearing titled Protecting the Timely Delivery of Mail, Medicines and Postal Ballots on Monday, Aug. 24, 2020, in the Rayburn House office building.

Tom Williams | CQ Appeal, Inc. | Getty Images

A subcommittee of the House Committee on Oversight and Reform, chaired by Krishnamoorthi, released the results of its 15-month investigation in February. It used data from four companies – Nurture, Hain Celestial Group, Beech-Nut Nutrition, and Gerber, a unit of Nestle – that responded to the subcommittee’s requests for information on testing guidelines and test results for their products.

The research found that “baby food companies weren’t looking for parents and young children the way we all expected – instead they knowingly sold us tainted products,” said Krishnamoorthi.

Hain said at the time that the investigation “did not reflect our current practices,” adding that the company’s internal standards “meet or exceed current federal guidelines.”

Gemma Hart, a spokeswoman for Nurture, told the New York Times at the time that their products were safe and that the metals were only present in “trace amounts”. Beech-Nut said Thursday that the company is “committed to continuously improving its internal standards and testing processes as technology and knowledge evolve.” Dana Stambaugh, a spokeswoman for Gerber, said the company is taking steps to minimize metals in its products.

Three other baby food companies – Walmart, Sprout Organic Foods, and Campbell Soup – did not provide all of the information requested. At the time the investigation was published, Campbell said its products were safe and cited the lack of FDA standards for heavy metals in baby food.

A Walmart representative told Reuters at the time that private label product suppliers must meet their own specifications, “which for baby and toddler foods means the levels must meet or fall below the limits set by the FDA.”

Sprout did not immediately respond to CNBC’s request for comment.

“Like parents across America, I was horrified to learn that trusted baby food brands knowingly sell products that are high in toxic lead, arsenic, mercury and cadmium,” Rep. Cardenas said Thursday. “I urge the FDA to use their existing agencies to take immediate regulatory action.

The investigation found that heavy metals are naturally found in some grains and vegetables, but added that levels can be increased if manufacturers add other tainted ingredients to baby food. According to the report, companies rarely test their products for contamination before sending them to stores.

“It is unacceptable that, despite parents’ efforts to protect their children, some leading baby formula manufacturers have launched products that expose children to dangerous toxins,” Klobuchar said in a statement. “This legislation will protect children and ensure a healthy start by holding manufacturers accountable for removing toxins from infant and toddler foods.”

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Novavax expects FDA clearance as early as Might

Novavax expects FDA clearance as early as May

The Food and Drug Administration could approve Novavax’s Covid-19 vaccine for emergencies as early as May, the company’s CEO Stanley Erck told CNBC on Monday.

Novavax’s Phase 3 trial in the US with 30,000 participants is ongoing, Erck said. The company hopes the FDA will allow it to use data from its UK clinical trial when it files its emergency use application later this year, he added.

The UK health authorities are likely to review the vaccine in April, followed by the FDA “probably a month after,” he said in an interview with CNBC’s “Closing Bell”.

That schedule could be postponed for a month or two while the FDA waits for the U.S. trial dates, he said.

Novavax is among several companies working to develop vaccines against the virus, which on Monday infected more than 114 million people worldwide and killed at least 2.53 million people, according to Johns Hopkins University. Three vaccines – from Pfizer, Moderna, and Johnson & Johnson – have so far been approved for use in the United States.

In late January, Novavax released results of its Phase 3 trial data in the UK, showing that the vaccine was 89.3% overall effective, despite being used against B.1.1.7, the strain first discovered in the UK, and B.1.351 was a little less effective. the tribe first discovered in South Africa.

The company said the vaccine was well tolerated, adding that “serious, serious and medically treated adverse events occurred in low levels and were balanced between vaccine and placebo groups”.

Novavax has signed a contract with the US government to supply 110 million cans. The company could complete those shipments in June or July, Erck said.

If the company’s vaccine is approved in the US, it doesn’t worry about demand, even though three vaccines are already widely available.

“The US has a huge need for vaccines and it’s a big world,” he said, adding the company has commitments for 200 million doses elsewhere.

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

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.

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FDA approves J&J’s single-shot Covid vaccine for emergency use

FDA approves J&J's single-shot Covid vaccine for emergency use

The Food and Drug Administration has approved Johnson & Johnson’s Covid-19 vaccine for emergency use. This gives the US a third tool to fight the pandemic as highly contagious variants are gaining a foothold across the country.

With the FDA’s approval for the emergency on Saturday, the federal government’s plan begins to distribute nearly 4 million doses of J & J’s vaccine to states, pharmacies and community health centers across the country next week. 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.

J & J’s vaccine “makes it easier to use in many contexts,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases of the CDC, told the Journal of the American Medical Association during a question and answer session Friday. “I suspect that much of the national health consideration given to these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited to some populations.”

Initially, doses would be limited, J&J said. The company expects to drop 20 million doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told the House legislature on Tuesday. J&J has signed a contract with the US government to supply 100 million doses of its vaccine by the end of June. US officials say they are working with the company to increase supply as soon as possible.

In the past few weeks, US health officials have urged Americans to get vaccinated as soon as possible. Officials are increasingly concerned about new, emerging variants of the virus, particularly strain B.1.351, which has been shown to decrease the effectiveness of vaccines both in market and in development. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, the declines in Covid-19 cases reported in the US since early January could flatten as the variants spread.

J&J submitted its Covid vaccine data to the FDA on February 4th. The vaccine’s level of protection varies from region to region, J&J said, with the shot showing an effectiveness of 66% overall, 72% in the US, 66% in Latin America and 57% in South Africa, where variant B.1.351 is spreading rapidly. However, FDA documents show that the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospital stays and deaths.

The Pfizer vaccine was found to be 95% effective against Covid-19, while the Moderna vaccine was around 94% effective. Infectious disease experts pointed out that J & J’s numbers cannot be used as a head-to-head comparison with the other two vaccines because it is a single dose and the company’s study was conducted when more infections, as well as new, more contagious variants occurred.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

The FDA has approved J & J’s vaccine for people 18 years of age and older. This is not the same as a full approval which requires more data and which can typically take several months longer. J&J, like Pfizer and Moderna, has only submitted safety data for two months, but the agency typically takes six months for full approval. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no indication of benefit” in coronavirus patients.

The FDA was expected to approve J & J’s emergency vaccine.

The agency’s announcement comes after a key panel unanimously endorsed the emergency vaccine on Friday. The FDA’s Advisory Panel on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not have to follow the advisory board’s recommendation, it often does.

After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and voting committee member, said J & J’s vaccine will help “meet the needs of the moment” as states complain that there is insufficient supply Pfizer and Moderna gives vaccinations.

“We have to get this vaccine out now,” said Dr. Jay Portnoy, professor at UMKC School of Medicine and voting committee member, after the vote. He added, “We are in a hurry” as the variants pose a threat to the nation’s progress on the pandemic.

No specific safety concerns were identified with J & J’s vaccine. Headache, fatigue, and muscle aches were some of the most common side effects among people who received the vaccination, according to an FDA report released Wednesday. There have also been reports of nausea, fever and injection site pain, the report said.

Macaya Douoguih, director of clinical development and medical affairs for the vaccines division at J & J, Janssen, told the FDA panel on Friday that two people had severe allergic reactions shortly after receiving the vaccine. One of the people participated in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.

The company has announced that it will ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that are 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.

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