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An Experimental H.I.V. Vaccine Fails in Africa

An Experimental H.I.V. Vaccine Fails in Africa

An advanced H.I.V. vaccine trial in Africa has been shut down after data showed the shots offered only limited protection against the virus, researchers announced on Tuesday.

The vaccine, made by Johnson & Johnson, is one in a long line found to offer little defense against H.I.V., one of medicine’s most intractable adversaries. One candidate vaccine even increased the risk of infection.

Another trial was halted last year in South Africa after a different experimental vaccine failed to offer sufficient protection. Some 1.5 million people were infected with H.I.V. worldwide in 2020, and 38 million are living with the infection.

Scientists were dismayed by the most recent failure.

“I should be used to it by now, but you’re never used to it — you still put your heart and soul into it,” said Glenda Gray, the principal investigator of the trial and chair of the South African Medical Research Council. Dr. Gray has been working to develop an H.I.V. vaccine for more than 15 years.

Entirely new approaches may be needed. This month, Moderna announced that it would test a vaccine based on the mRNA platform used to devise the company’s coronavirus vaccine.

The trial, called Imbokodo, tested an experimental vaccine in 2,600 young women deemed at high risk of H.I.V. infection in five sub-Saharan African countries. Women and girls accounted for almost two-thirds of new H.I.V. infections in the region last year.

The trial was funded by Johnson & Johnson, the Bill and Melinda Gates Foundation, and the National Institutes of Health.

The vaccine relied on an adenovirus called Ad26, modified to carry fragments of four H.I.V. subtypes into the body in hopes of provoking an immune response that might defend against infection.

Mitchell Warren, executive director of AVAC, an advocacy group that lobbies for AIDS prevention and treatment, said the cancellation of the trial was a “reality check” amid excitement about new vaccine technologies.

“It’s a grand reminder that H.I.V. is a pathogen unlike any other in its complexity,” he said. “We know the platform worked, but what do we put in it? Because this virus is infecting the exact same immune system that we’re trying to boost with a vaccine.”

Participants in the Imbokodo trial, which began in 2017, were given two initial shots and two boosters over the course of a year. Researchers tracked the numbers of new infections in the placebo and vaccine groups from the seventh month (one month after the third vaccination) through the 24th month.

Over two years, 63 of 1,109 participants who received the placebo were infected with H.I.V., compared with 51 of 1,079 participants who received the vaccine — giving the vaccine an efficacy rate of 25 percent.

Earlier studies, including one carried out in Thailand, had indicated that the kind of antibodies this vaccine provoked might be sufficient to offer good protection from H.I.V. for at least an initial period of time.

“But in South Africa, the higher rates of H.I.V. incidence means you need something much more potent,” Dr. Gray said. “The kind of immune responses that were induced were just not enough to stop the high attack rates we see in Africa.”

When the disappointing data showed a low efficacy rate, guidelines set up before the trial dictated it should be shut down. A vaccine that offered only 25 percent protection risked giving women a “false sense of security,” Dr. Gray said.

But a parallel trial that uses a different iteration of this vaccine will continue, Johnson & Johnson said. It is being tested on men who have sex with men and transgender people, in eight countries including Poland, Brazil and the United States.

That study, called Mosaico, is testing the vaccine against different subtypes of H.I.V. in different populations, and could produce different efficacy results.

Dr. Gray said that the lesson from the failed trial lies in figuring out why it worked for the 25 percent of people who were protected and not for the others, and then trying to translate those clues into a recipe for a future vaccine.

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F.D.A. Grants Full Approval to Pfizer-BioNTech Covid Vaccine

F.D.A. Grants Full Approval to Pfizer-BioNTech Covid Vaccine

The Food and Drug Administration on Monday gave Pfizer-BioNTech’s coronavirus vaccine full approval for people aged 16 and over, making it the first to go beyond emergency status in the United States.

The decision will trigger a cascade of vaccine requests from hospitals, colleges, corporations, and other organizations. Secretary of Defense Lloyd J. Austin III will send vaccination guidelines to the country’s 1.4 million active military personnel, the Pentagon said on Monday.

United Airlines recently announced that its employees must provide proof of vaccination within five weeks of regulatory approval.

Oregon has introduced a similar requirement for all government employees, as have a variety of universities in the states of Louisiana through Minnesota.

Approval comes as the nation’s fight against the pandemic has re-intensified, with the highly contagious Delta variant dramatically slowing the country’s progress in the first half of the year. The Biden administration hopes the development will motivate at least some of the roughly 85 million unvaccinated Americans eligible for syringes.

President Biden plans to commemorate this in a speech urging vaccination, which is scheduled for 1:30 p.m. Eastern time on Monday afternoon. “If you haven’t been vaccinated, now is the time,” the president said on Twitter.

“While millions of people have safely received Covid-19 vaccines, we recognize that FDA approval of a vaccine may now create additional confidence for some to get vaccinated,” said Dr. Janet Woodcock, acting FDA commissioner, in a statement. “Today’s milestone brings us one step closer to changing the course of this pandemic in the US”

Pfizer said it provided the FDA with data from 44,000 participants in clinical trials in the United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine 91 percent prevented infection – a slight decrease from the 95 percent effectiveness rate the data showed when the FDA decided to approve the emergency vaccine in December. Pfizer said the decrease reflects the fact that researchers had more time to capture infected individuals.

A recent survey by the Kaiser Family Foundation, which tracked public attitudes during the pandemic, found that three in ten unvaccinated people said they were more likely to be vaccinated with a fully approved vaccination.

But pollsters and other experts warned that the percentage could be exaggerated. “I think that’s a tiny number of people in real life,” said Alison Buttenheim, an associate professor of nursing at the University of Pennsylvania and an expert on vaccination hesitation.

More important, says Dr. Buttenheim, is the effect of requirements. “Mandates make things easier for people,” she said.

Government action gives doctors more leeway to prescribe patients a third shot of the Pfizer vaccine, but federal officials strongly advised people not to seek additional vaccinations until regulators decide they are safe and effective. Pending regulatory approval, the federal government plans to offer booster syringes for adults next month.

The vaccine continues to be approved for emergency use in children ages 12-15 as Pfizer collects the data necessary for full approval. A decision on whether to approve the vaccine for children under the age of 12 could be at least several months away, and Dr. Woodcock said no child this age should get a Covid-19 vaccine due to a lack of safety data from regulators.

To date, more than 92 million Americans – 54 percent of those fully vaccinated – have received Pfizer vaccinations. Most of the others got the vaccine from Moderna.

Dr. Peter Marks, the FDA’s lead vaccine regulator, said the approval of Pfizer vaccine followed a rigorous review of hundreds of thousands of pages of data and included inspections of the factories where the vaccine is made. “The public and the medical community can rest assured that while we were swiftly approved this vaccine, it met our existing high standards for vaccines in the United States,” he said.

He said federal health officials would continue to monitor the safety of the vaccine and that the FDA would require Pfizer to assess the risks of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the membrane surrounding the heart, including long-term results for the recipients. The FDA added warnings to the Pfizer-BioNTech and Moderna vaccines in June indicating a possible increased risk for these conditions after the second dose.

Although Pfizer can now market the drug under the Comiraty name, the company said only the federal government will be distributing doses in the United States.

Understand US vaccination and mask requirements

    • Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people aged 16 and over, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly demanding vaccines for employees. Such mandates are legally permissible and have been confirmed in legal challenges.
    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
    • College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
    • schools. Both California and New York City have introduced vaccination mandates for educational staff. A survey published in August found that many American parents of school-age children are opposed to mandatory vaccines for students but are more likely to support masking requirements for students, teachers and staff who are not vaccinated.
    • Hospitals and medical centers. Many hospitals and large health systems require their employees to have a Covid-19 vaccine, due to increasing case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
    • New York City. Proof of vaccination is required by workers and customers for indoor dining, gyms, performances, and other indoor situations, though enforcement doesn’t begin until September 13. Teachers and other educational workers in the city’s vast school system are required to have at least one vaccine dose by September 27, with no weekly testing option. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
    • At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.

Health experts and state officials welcomed the development. With the delta variant driving up case numbers across the country, “full approval could not come at a more important time,” said Dr. Richard Besser, President of the Robert Wood Johnson Foundation and former acting director of the Centers for Disease Control and Prevention. He urged schools and businesses to require a vaccination before people can gather indoors.

Less than two months after the spread of the virus appeared to be contained, the US is now recording an average of around 150,000 new cases per day and more than 90,000 hospitalized Covid-19 patients. An average of around 1,000 per day die from Covid-19 – a toll that federal health experts recently dismissed as highly unlikely before the delta variant fully caught on. Many children under the age of 12 also become infected.

Vaccination rates have also risen in the past few weeks, in part because of the greater fear of the virus. Vendors were delivering approximately 837,000 shots a day, a significant increase from earlier this summer.

Some experts estimated that full consent could only convince five percent of the unvaccinated to get injected. Even if that is the case, “that is still a huge part of the people,” Dr. Thomas Dobbs, the Chief Health Officer of Mississippi, a state particularly hard hit by the Delta variant. He said the approval will help “get rid of this false claim that the vaccines are an ‘experimental’ thing”.

Dr. Marks, the vaccines agency, cited a number of other myths about the vaccines as a major stumbling block in fighting the pandemic, including false claims that the vaccinations cause infertility, promote Covid disease rather than prevent it, or have resulted in thousands of deaths. “Let me be clear. These claims are just not true,” he said.

The FDA is in the middle of a decision marathon related to coronavirus vaccines. The next important question emerging for regulators is whether or not to approve booster injections. The Biden government said last week it plans to offer third vaccinations starting September 20, for adults who received the Pfizer and Moderna vaccines eight months after their second injection. Third vaccinations are already approved for some people with immunodeficiency, but the risk-benefit ratio is different for the general population.

Federal health officials said that both Pfizer-BioNTech and Moderna’s vaccines, which are based on similar technology, lose effectiveness over time. That trend is converging with the advent of the particularly dangerous Delta variant, making those who completed their vaccinations earlier in the year increasingly more susceptible to infection.

Some health experts have challenged the decision to recommend booster vaccinations as premature, as the data showed the vaccines withstand serious illness and hospitalization, including the Delta variant. Boosters would only be justified if the vaccines didn’t prevent hospital stays with Covid-19, some of these experts said.

Regulators are still examining Moderna’s application for full approval of its vaccine. This decision can take several weeks. Johnson & Johnson is expected to file for full approval shortly.

Helene Cooper contributed to the reporting.

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U.S. increasing Covid vaccine manufacturing to donate extra doses to world

U.S. expanding Covid vaccine manufacturing to donate more doses to world

The United States is expanding manufacturing of Covid-19 vaccines to donate more doses to countries that don’t have as much access to the lifesaving shots.

“We are now working on greatly expanding the capacity to allow us to donate hundreds and hundreds of millions of doses to the low- and middle-income countries,” Dr. Anthony Fauci, medical advisor to President Joe Biden, said in an interview Thursday on CNBC’s “Closing Bell.”

Scientists around the world, including officials at the World Health Organization, have condemned wealthy nations for administering booster shots to fully vaccinated people while millions in other countries cannot get the vaccine.

Dr. Mike Ryan, director of the WHO’s health emergencies program, said wealthy nations that decide to give booster doses are “handing out extra life jackets” to those who already have one while letting other people drown.

Fauci said the U.S. has given more than 120 million doses to 80 countries and has donated $4 billion in resources to the COVAX vaccine-sharing initiative, which is coordinated by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations and the WHO.

“We are doing both,” Fauci said of distributing booster shots and helping other countries. “We’re very sensitive to the needs of the developing world who need vaccine doses, but we believe we can do both.”

Worries about the delta variant continue to be on the minds of many Americans as health systems in states with high infection rates struggle to keep up with the demand for hospital beds. A continued acceleration of cases could be avoided in the U.S. if more people get vaccinated, Fauci said.

“There’s a lot we can do about it,” Fauci said, noting that 90 million people in the U.S. are eligible for vaccines but still haven’t gotten the shots. “We want to vaccinate the unvaccinated to the highest extent that we possibly can.”

He said it’s hard to know when the current delta outbreak will peak.

“It’s very difficult to predict. We’ve seen in the U.K. that after several weeks of a high acceleration, it’s turned around,” Fauci said.

Once delta infections begin to slow down, Covid could become an endemic disease that remains in the population at low levels, like the flu, though Covid is much deadlier. Fauci said he doubts that Covid — unlike the flu, which requires annual shots — will need recurrent boosters to maintain high levels of protection.

“I don’t think that’s going to be the case. I think this third shot will take us a long way,” Fauci said.

Correction: This article has been updated to reflect that the COVAX vaccine-sharing initiative is coordinated by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations and the WHO.

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FDA approval for Pfizer Covid vaccine might come Monday, report says

FDA approval for Pfizer Covid vaccine could come Monday, report says

Empty Pfizer COVID-19 vaccine vials will be delivered on Jan.

Paul Hennessy | NurPhoto | Getty Images

The Food and Drug Administration is working on the approval of the Pfizer-BioNTech Covid-19 vaccine on Monday, the New York Times reported, citing sources.

The review process could go beyond that date, the Times said, as paperwork and negotiations with the company continue.

The move would make it the first Covid vaccine to move from emergency approval to full FDA approval.

The FDA declined to comment on the Times report to CNBC.

White House senior medical advisor Dr. Anthony Fauci, told the Associated Press on Aug. 8 that he hoped vaccines would get full approval “within the month of August,” adding that full approval would lead to more companies and schools requiring vaccines.

U.S. companies have tightened vaccination regulations for employees as Covid cases have increased across the country in recent weeks, and some cited full FDA approval as part of the decision-making process.

Full approval could also help convince people who are reluctant to get vaccinated until the FDA has fully approved the vaccination.

According to CDC data on Friday, more than 203 million doses of the Pfizer BioNTech vaccine have been administered nationwide, fully vaccinating more than 91 million people in the United States.

Pfizer and BioNTech began applying for their biologics license for the two-dose vaccine in May after receiving emergency clearance from the FDA in December. The FDA sets a six month target for approval of high priority drugs.

If formally approved, Pfizer and BioNTech’s vaccine would remain available in the market after the pandemic ended and the companies could promote the vaccine directly to consumers. Pharmaceutical manufacturers with an EUA are banned from promoting their vaccines, CNBC previously reported.

The companies announced on Aug. 16 that they had initiated the approval process for a booster dose for fully vaccinated individuals after submitting clinical trial data to the FDA.

Top health officials from agencies like the Centers for Disease Control and Prevention, the White House and the FDA said in a statement Wednesday that the effectiveness of mRNA vaccines declines over time, especially in those with compromised immune systems. They said the US would start distributing booster shots to the public in September.

Read the full New York Times report here.

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Journey searches for Germany after Singapore’s vaccine journey lane

Singapore to lift quarantines for some travelers from Germany, Hong Kong

A Singapore Airlines aircraft is parked next to Scoots passenger aircraft on the tarmac of the Changi International Airport terminal in Singapore on March 15, 2021.

Facebook Facebook logo Sign up on Facebook to connect with Roslan Rahman AFP | Getty Images

Interest in traveling between Singapore and Germany skyrocketed after the announcement of a so-called vaccinated itinerary between the two countries, which means vaccinated travelers can skip the quarantine.

Popular online travel booking site Expedia said that Friday afternoon searches for trips from Singapore to destinations in Germany increased almost ten times the average for the past seven days.

There is also great interest in traveling from Germany to Singapore, it said. “While Singapore was never among the top 10 travel destinations for German travelers, it was interesting to see that interest in traveling from Frankfurt and Munich to Singapore has increased by 70% in the past 24 hours,” said Lavinia Rajaram, APAC -Communication manager at Expedia, in a Friday statement.

“With the launch of the Vaccinated Itinerary Program, it will certainly bode well for those who are already vaccinated and have the desire to travel, and will give the travel industry a welcome boost,” added Rajaram.

Singapore’s vaccinated travel route with Germany was announced on Thursday by the city-state, which extended the initiative to Brunei as well.

Applications for quarantine-free travel to Singapore from Germany or Brunei will be open from September, but are subject to certain conditions. Fully vaccinated people traveling to Singapore are required to take four Covid tests – one two days before departure, one on arrival, one on the third day, and another on the seventh day.

Further conditions for traveling to Singapore from Germany or Brunei are:

  • Travel on designated non-stop flights for the vaccinated itinerary (VTL);
  • Stay in Germany or Brunei for 21 consecutive days before the flight;
  • Download a contact tracking app in Singapore.

On ticket prices, Expedia’s Rajaram added that airlines offering flights under the program have announced “competitive prices”.

Still, Rajaram said, “It is too early to say if prices will rise in the next few days – but we can expect demand to grow closer to Christmas time.”

The search queries for trips from Hong Kong and Macau are also increasing

Singapore had also announced that travelers from Hong Kong and Macau can now apply for a flight pass to travel to Singapore regardless of their vaccination status.

They don’t have to be in quarantine either, they have to take a Covid test upon arrival in Singapore and self-isolate until they get a negative test result, Singapore authorities said.

Search queries for trips to Singapore from the two Chinese territories also increased after the announcement – by almost 450%, according to Expedia.

“This comes as no surprise to us as travelers in Hong Kong (HK) have been eagerly hoping for this first vacation trip. Singapore is still a top destination for Hong Kong travelers in the second half of the year, ”said Expedia.

– Abigail Ng of CNBC contributed to this report.

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What to Know About Boosters if You Obtained the Johnson & Johnson Vaccine

Vaccine Booster Shot Distribution to Begin Next Month in US

Without robust data on the long-term effectiveness of the Johnson & Johnson vaccine, it is difficult for health officials to recommend booster vaccinations, said John Moore, a virologist at Weill Cornell Medicine. “If you are making data-driven decisions and you don’t have the data, what can you do?” He said. “It’s kind of a dilemma. Public trust in vaccines generally depends on how the sausage is made, as it is a data-driven, transparent process. “

Clinical studies conducted prior to the distribution of the Delta variant found that the Johnson & Johnson vaccine was 72 percent overall effective in the United States, less than the approximately 95 percent effectiveness of the Pfizer and Moderna vaccines. However, direct comparisons between vaccines tested in different places and at different times are difficult.

All available vaccines seem to be becoming less effective against Delta, which may evade some antibodies of the immune system. The Johnson & Johnson vaccine is no exception. “You would expect there to be some resistance to Delta because there always is,” said Dr. Moors.

Small laboratory studies have produced conflicting results about how well the Johnson & Johnson vaccine protects against Delta. Last month, Johnson & Johnson said a single dose of its vaccine produced a strong immune response against Delta and that the reaction lasted for at least eight months.

Updated

Aug. 20, 2021, 8:20 p.m. ET

But data from another recent laboratory study suggested that a single dose of the vaccine produced a relatively weak antibody response to Delta, which could make boosters more important.

The first real data on the vaccine’s effectiveness against the variant were released this month. The data, which are preliminary results from a clinical study of nearly 500,000 healthcare workers in South Africa, suggest that a single dose of the vaccine has an effectiveness of up to 96 percent against deaths and 71 percent against hospitalizations due to infection Delta had.

It was “a very extensive analysis and very clear results that showed that the single-shot J. & J. Vaccine provided significant protection against the Delta variant, ”said Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston who conducted studies for Johnson & Johnson but was not involved in the South Africa study.

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Vaccine Effectiveness In opposition to An infection Might Wane, C.D.C. Research Discover

Vaccine Effectiveness Against Infection May Wane, C.D.C. Studies Find

The Centers for Disease Control and Prevention published three studies on Wednesday that federal officials said provided evidence that booster shots of the Pfizer BioNTech and Moderna coronavirus vaccines would be needed in the coming months.

However, some experts said the new research did not support the decision to recommend a booster dose to all Americans.

Taken together, the studies show that while the vaccines are still highly effective against hospital admissions and deaths, their bulwark against infection with the virus has weakened in recent months.

The finding is consistent with early data from seven states compiled this week by the New York Times, suggesting an increase in breakthrough infections and a smaller increase in hospital admissions among vaccinated people as the Delta variant spread in July.

The decline in effectiveness against infections may be due to declining vaccine immunity, failure of precautionary measures like wearing masks, or the rise of the highly contagious Delta variant, experts said – or a combination of all three.

“We are concerned that this pattern of decline that we are seeing will continue in the coming months, which could result in decreased protection from serious illness, hospitalization and death,” said Dr. Vivek Murthy, the surgeon general, at a press conference at the White House on Wednesday.

Citing the data, federal health officials outlined a plan for Americans who received the two vaccines to receive a booster dose eight months after receiving their second dose starting September 20.

People who have received the Johnson & Johnson vaccine may also need additional doses. That vaccine wasn’t launched until March 2021, however, and a plan to deploy boosters will be drawn up after reviewing new data expected over the next few weeks, officials said.

Some scholars were skeptical of the government’s new initiative.

“These data support the administration of additional doses of the vaccine to severely immunocompromised individuals and nursing home residents, not the general public,” said Dr. Celine Gounder, Infectious Disease Specialist at Bellevue Hospital Center and former advisor to the administration for the pandemic.

Boosters would only be justified if the vaccines didn’t prevent hospital stays with Covid-19, she said.

“Feeling sick like a dog and staying in bed but not lying in hospital with severe Covid is not reason enough,” said Dr. Gounder. “We will be better protected by vaccinating the unvaccinated here and around the world.”

It’s unclear whether a third dose would help people who didn’t evoke a robust immune response to the first two doses, said Bill Hanage, an epidemiologist at Harvard TH Chan School of Public Health.

And the recommendation for boosters could also undermine confidence in the vaccines, he warned: “A third shot will increase skepticism among people who have not yet received a dose that the vaccines will help them.”

Taken together, the new studies show overall that vaccines are about 55 percent effective against all infections, 80 percent against symptomatic infections, and 90 percent or more against hospitalization, noted Ellie Murray, an epidemiologist at Boston University.

“These numbers are actually very good,” said Dr. Murray. “The only group for which this data would suggest boosters for me are the immunocompromised.”

Updated

Aug. 19, 2021, 10:57 a.m. ET

The apparent decrease in the vaccine’s effectiveness against infection could instead have been caused by increased exposure to the highly contagious Delta variant during a period of unrestrained social interaction, she added: “This seems like a real possibility to me, given many early vaccines motivated were the desire to see friends and family and return to normal. “

Dr. Murray said a booster vaccination would undoubtedly boost a person’s immunity, but the added benefit can be minimal – and just as easily achieved by wearing a mask or avoiding indoor dining and crowded bars.

The government’s focus on vaccines has undermined the importance of building other precautions into people’s lives in a convenient and sustainable way and strengthening testing capacity, said Dr. Murray and other experts.

“This is one of the reasons I think the government’s focus on vaccines is so damaging to morality,” she added. “We probably won’t get back to normal anytime soon.”

Before people can start the booster, the Food and Drug Administration must first authorize a third dose of the vaccines manufactured by Pfizer-BioNTech and Moderna, and an advisory committee from the CDC must review the evidence and make recommendations.

One of the new CDC studies analyzed the effectiveness of vaccines in residents of nearly 4,000 nursing homes from March 1 to May 9 before the advent of the Delta variant and of nearly 15,000 nursing homes from June 21 to August 1 as the new infections variant dominated in the country.

The effectiveness of the vaccines in preventing infection dropped from about 75 percent to 53 percent between those dates, the study found. The protection of the vaccines against serious illness has not been assessed.

Understand the state of vaccination and masking requirements in the United States

    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
    • Vaccination regulations. . . and B.Factories. Private companies are increasingly demanding corona vaccines for employees with different approaches. Such mandates are legally permissible and have been confirmed in legal challenges.
    • College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
    • schools. On August 11, California announced that teachers and staff at both public and private schools would have to get vaccinated or have regular tests, the first state in the nation to do so. A survey published in August found that many American parents of school-age children are against mandatory vaccines for students, but are more supportive of masking requirements for students, teachers and staff who do not have a vaccination.
    • Hospitals and medical centers. Many hospitals and large health systems require their employees to receive a Covid-19 vaccine, due to rising case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
    • new York. On August 3, New York City Mayor Bill de Blasio announced that workers and customers will be required to provide proof of vaccination when dining indoors, gyms, performances, and other indoor situations. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
    • At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.

Nursing homes did not have to report the number of residents vaccinated until after June 6, which “makes comparisons over time very difficult,” said Dr. Murray. “It is entirely possible that the effectiveness of the vaccine reported here has not really diminished over time.”

The decline in effectiveness could also be due to the spread of the Delta variant, said Dr. Gounder.

“It makes sense to give vaccinated nursing home residents an extra dose of vaccine, but what will have an even bigger impact on protecting these nursing home residents is vaccinating their caregivers,” she said. Many caregivers in long-term care facilities remain unvaccinated.

A second study evaluated data from New York State from May 3 to July 25, when the Delta variant grew to more than 80 percent of new cases. The effectiveness of vaccines in preventing cases in adults fell from 91.7 percent to 79.8 percent during that time, the study found. But the vaccines remained just as effective at preventing hospital stays.

In those weeks, New York recorded 9,675 breakthrough infections – about 20 percent of the state’s total cases – and 1,271 hospital admissions of vaccinated people, accounting for 15 percent of all Covid-19 hospital admissions.

Although fully immunized people of all ages contracted the virus, the vaccine’s effectiveness fell the most, from 90.6 percent to 74.6 percent in people ages 18 to 49 – who are often the least likely to take precautions and are most likely to socialize .

Data from Israel suggests immunity to infection has declined in vaccinated adults aged 65 and over. But in the New York data, the effectiveness of the vaccines in this group hardly diminished.

Adults aged 65 and over were hospitalized more often than other age groups, regardless of their vaccination status. But the vaccines did not show a decrease in effectiveness against hospital admissions in any of the age groups.

The CDC’s third study found the vaccines showed 90 percent effectiveness against hospital stays in the country, “which is excellent,” noted Dr. Gounder.

The vaccines provided less protection against hospitalization in immunocompromised people. “But not all immunocompromised people will respond to an extra dose of vaccine,” noted Dr. Gounder.

To protect these vulnerable people, everyone around them should be vaccinated and continue to wear masks, she added.

The vaccines appear to be less effective than the studies that led to their approval, as those studies were done before the delta variant emerged.

Statistically, as more unvaccinated people become infected, recover, and gain natural immunity, the vaccines may lose relative effectiveness. And scientists always expected that the proportion of those who were vaccinated among those infected would increase if more people were vaccinated.

If preventing infection is the goal, it would be smarter to develop a booster shot of a nasal spray vaccine that will create better immunity in the nose and throat where the virus enters the body, said Dr. Gounder.

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U.S. to start extensive distribution of third vaccine doses subsequent month

U.S. to begin wide distribution of third vaccine doses next month

The United States will begin distributing Covid-19 booster vaccinations on a large scale next month as new data shows vaccine protection wears off over time, US health officials said on Wednesday.

It is now “very clear” that immunity declines after the first two doses, and with the dominance of the delta variant, “we see evidence of decreased protection against mild and moderate disease,” according to the CDC. signed declaration Director Dr. Rochelle Walensky, Acting FDA Commissioner Dr. Janet Woodcock, the White House Senior Medical Advisor, Dr. Anthony Fauci, and other US health leaders.

“Based on our latest assessment, current protection against serious illness, hospitalization and death could decline in the coming months, especially for those at higher risk or who were vaccinated during the earlier stages of vaccination.”

As a result, U.S. authorities are preparing to offer booster shots to all eligible Americans starting the week of September 20, eight months after their second dose of Pfizer or Moderna vaccines, officials said. While they said recipients of the Johnson & Johnson single vaccine will likely need booster vaccinations, they are waiting for more dates in the next few weeks before making a formal recommendation.

“With this data, we will also keep the public informed with a timely schedule for J&J booster shots,” officials said.

The plan is subject to formal recommendation by a CDC Vaccine Advisory Committee and FDA approval, also a formality.

The announcement came ahead of a Covid press conference at the White House on Wednesday, where federal health officials further outlined their plan for boosters. President Joe Biden is expected to speak about the U.S. efforts after the briefing, the White House told reporters on Tuesday.

The decision to recommend booster vaccinations comes as the public becomes increasingly concerned about the Delta variant and an increase in breakthrough cases – infections in fully vaccinated individuals. It marks a departure from previous comments by U.S. health officials who said in recent months that fully vaccinated Americans did not need a booster at this point.

U.S. officials changed their embassy to boosters in the past few days as cases continued to rise. Fauci said Thursday that everyone is “likely” to need a booster at some point. On Friday, federal officials approved the administration of booster shots to Americans with compromised immune systems, which include cancer and HIV patients, as well as people who have had organ transplants.

The director of the National Institutes of Health, Dr. Francis Collins, who also signed the statement, said Tuesday that new Covid data, including from Israeli health officials, had caused US health leaders to reconsider their position on vaccine boosters. Israel on Monday released new data showing a reduction in the effectiveness of Pfizer’s Covid vaccine against serious illness in people 65 and over who were fully vaccinated in January or February.

There are similar trends in vaccine effectiveness in the United States, Collins said. He said the surge in breakthrough cases could be due to a combination of the rapidly spreading Delta variant and the deterioration in Covid vaccine protection over time.

The effectiveness of Pfizer’s Covid vaccine has steadily declined over time, dropping to around 84% around four to six months after receiving the second dose for vaccinated people, according to CEO Albert Bourla. Moderna said his vaccine remained 93% effective for the first six months after the second dose, but expects protection to decrease and boosts to be needed.

During a news conference on Wednesday, Walensky said officials based their decision on studies showing immunity to Pfizer and Moderna vaccines decreased over several months. A study in New York from May 3 to July 25 showed that the vaccine’s effectiveness in protecting against infection decreased from around 92% to 80%. Another study by the Mayo Clinic showed that the effectiveness of Pfizer’s vaccine decreased from around 76% to 42%, while that of Moderna’s decreased from 86% to 76%.

“Right now, it’s still like our vaccine protection is working really well,” said Collins. “But we don’t want to wait until it’s oh, too late.”

The move to recommend boosters is likely to trigger criticism, especially since a large part of the world population has not even received a dose of a Covid vaccine.

Earlier this month, the World Health Organization urged rich nations to stop distributing booster vaccinations until at least the end of September to allow poorer countries to vaccinate their populations with the first rounds of vaccination. The application is part of WHO Director General Tedros Adhanom Ghebreyesus’ plan to vaccinate 40% of the world’s population by December.

The US released the statement minutes after the WHO condemned wealthy nations who support boosters for the general public.

“We clearly believe that the data so far does not suggest the need for boosters,” said Dr. Soumya Swaminathan, WHO senior scientist, during a press conference. “And we need to know which groups and at what point in time after the vaccination and which specific vaccinations the people received in their basic course.”

Lawrence Gostin, director of the WHO Collaborating Center for National and Global Health Law, called the US booster shot plan “a slap in the face” of the international health agency.

“There is a better way to create a win-win situation,” he said in a telephone interview. “We should only empower our health workers and vulnerable people. At the same time, Biden should undertake a bold campaign to vaccinate the world, including significantly increased donations and an increase in vaccine production. “

“In this way we are doing good to America and good to the world. It is in our national interest to stop the development of even more dangerous varieties,” he added.

During a briefing at the White House Tuesday, press secretary Jen Psaki said the government believes it can empower the American people while ensuring that the rest of the world is vaccinated.

“We believe this is a wrong decision. We can do both,” said Psaki. “The United States is by far the largest contributor to the global fight against Covid. We will continue to be the vaccine arsenal around the world. We also have enough supplies and had planned long enough should a refresher be required for those eligible. “Population.”

Giving third shots appears safe. Early data from small studies on the effects of booster doses in immunocompromised patients showed no serious side effects from a third vaccination with an mRNA vaccine, nor did recipients develop side effects beyond those already seen after the initial two-dose treatment.

Once the booster is approved, nursing home residents, health care providers and the elderly – the first groups to be vaccinated in December and January – will likely be given priority for additional vaccinations, Collins said Tuesday. He said “ideally” people should stick with the same manufacturer that they got their first two doses from.

“But if for some reason you don’t have access to it, get the other one,” he said. “Again, as a scientist, I would be more comfortable fixing our plans on real dates, and that means sticking to the same type of vaccine that you had to start with.”

– CNBC’s Rich Mendez and Robert Towey contributed to this report.

Categories
Health

Vaccine Booster Shot Distribution to Start Subsequent Month in US

Vaccine Booster Shot Distribution to Begin Next Month in US

The Biden administration on Wednesday outlined a plan for Americans who received the Pfizer-BioNTech and Moderna coronavirus vaccines to get a booster shot eight months after receiving their second doses, starting Sept. 20.

Health care workers, nursing home residents and other older adults who were vaccinated early will be first in line, starting then, contingent on authorization by federal regulators. “We are starting to see evidence of reduced protection against mild and moderate disease,” officials of several federal agencies said in a prepared statement.

“Here’s what you need to know: If you are fully vaccinated, you still have a high degree of protection from the worst outcomes of Covid-19, severe disease hospitalization and death,” Dr. Vivek Murthy, the surgeon general, said at a White House briefing.

“We are not recommending that you go out and get a booster today. Instead, starting the week of Sept. 20,” he added, but that fully vaccinated adults should “begin getting their booster shots eight months after their second shot of an mRNA vaccine.”

Protection conferred by the vaccines against severe disease, hospitalization and death could diminish in the months ahead, especially among high-risk groups who were vaccinated early, the officials said. “For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”

Still, Dr. Rochelle Walensky, the C.D.C. director, sought to be reassuring. “These data confirm that while protection against infection may decrease over time, protection against severe disease and hospitalization is currently holding up pretty well,” she said.

People who received the Johnson & Johnson vaccine may also require additional doses. But that vaccine was not rolled out until March 2021, and a plan to provide boosters for those individuals will be made after reviewing new data expected over next few weeks, officials said.

Some experts immediately pushed back against the decision, saying only some older adults and people with weakened immune systems needed extra protection. The World Health Organization has asked that wealthy countries defer distributing booster shots until the end of September.

Jeff Zients, the White House pandemic coordinator, said at the briefing on Wednesday that the administration is on its way to donating more than 600 million doses of vaccines to other countries.

“We’re going to do both,” he said. “We’re going to both protect the American people and we’re going to do more and more to help vaccinate the world. ”

Before Americans can begin to receive boosters, the Food and Drug Administration must first authorize a third dose of the mRNA vaccines made by Pfizer-BioNTech and Moderna, and an advisory committee of the Centers for Disease Control and Prevention must review the evidence and make recommendations.

Federal officials plan to begin by offering booster shots directly to residents of long-term care facilities, since the vaccines were distributed to this population early in the rollout and the virus poses a particular threat to the elderly.

“We will continue to follow the science on a daily basis, and we are prepared to modify this plan should new data emerge that requires it,” federal officials said.

Still, “there’s nothing magical about this number,” Dr. Murthy said, referring to the recommendation to get a booster eight months after the second dose. “This is where judgment comes in.”

Categories
Politics

Thousands and thousands of People Might Be Eligible for Covid Vaccine Booster

Millions of Americans Could Be Eligible for Covid Vaccine Booster

More than five million Americans could be eligible for a booster dose of the Covid-19 vaccine by the end of September as part of the Biden administration’s plan to combat the Delta variant of the coronavirus through additional doses eight months after the initial vaccinations.

However, the plan depends on several crucial steps that will take place over the coming weeks. Most importantly, the Food and Drug Administration would have to decide that third vaccinations would be safe and effective for Pfizer-BioNTech and Moderna, the two vaccines that were first introduced and most widely used.

Pfizer is further advanced in submitting data to the FDA that it says supports the use of boosters. Moderna and the National Institutes of Health are still investigating whether a half or a full dose for a third shot would work better, but are expecting results soon. Moderna CEO Stephane Bancel said the company plans to file its data with the FDA in September.

Government officials are due to announce the strategy at a White House briefing on Wednesday. Nursing home residents, nurses, and rescue workers would likely come first, as with the first few shots. Other older people would follow next, followed by the rest of the general population.

Officials envision giving people the same vaccine they were originally given and using pharmacies as key distribution points.

Administration officials discourage people from checking for booster doses on their own, noting that the FDA has yet to decide about their safety and effectiveness. They hope to distribute extra shots in an orderly manner so that people can get a booster shot when advised, and not just based on their own fears.

Dr. Danny Avula, the vaccine coordinator for the state of Virginia, said his state already has thousands of vaccine providers and can likely manage booster vaccinations without major changes. “What caused so much of the urgency and frenzy of January through April was the delivery bottleneck,” he said.

Now the government has more than 100 million doses in stock that could be used for boosters, along with tens of millions more doses that have already been shipped to pharmacies and other places. Even more supplies are to be delivered in autumn.

In interviews on Tuesday, hospital officials and doctors generally supported calls for a booster vaccination.

“I think we’re running out of second chances,” said Dr. Matthew Harris, the medical director of the coronavirus vaccination program at Northwell Health, New York’s largest hospital system. “What keeps me up at night is the inevitability of a variant that doesn’t respond to the vaccine. So if we have that head start, I fully support it.”

Understand the state of vaccination and masking requirements in the United States

    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
    • Vaccination regulations. . . and B.Factories. Private companies are increasingly demanding corona vaccines for employees with different approaches. Such mandates are legally permissible and have been confirmed in legal challenges.
    • College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
    • schools. On August 11, California announced that teachers and staff at both public and private schools would have to get vaccinated or have regular tests, the first state in the nation to do so. A survey published in August found that many American parents of school-age children are against mandatory vaccines for students, but are more supportive of masking requirements for students, teachers and staff who do not have a vaccination.
    • Hospitals and medical centers. Many hospitals and large health systems require their employees to receive a Covid-19 vaccine, due to rising case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
    • new York. On August 3, New York City Mayor Bill de Blasio announced that workers and customers will be required to provide proof of vaccination when dining indoors, gyms, performances, and other indoor situations. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
    • At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.

Federal officials envision offering additional vaccinations to recipients of Johnson & Johnson’s single-dose vaccine, as well as those who received Moderna or Pfizer. But the government didn’t start offering this vaccine until March, and only 14 million people have received it. For comparison: 155 million people were fully vaccinated with Pfizer or Moderna.

Data from a Johnson & Johnson clinical trial in which participants were given two doses is likely to be submitted to the FDA later this month and is intended to guide the government’s recommendation on the vaccine.

At the Wednesday briefing, administration officials plan to point out that a booster strategy is essential, even if it needs to be changed as more data comes in. They are expected to provide data showing the overall effectiveness of the vaccine against viral infections is declining, although unvaccinated people still make up the vast majority of people who become seriously ill or hospitalized due to Covid.

The government fears that without boosters, more vaccinated people could get serious Covid disease in the coming months, as there is a double trend: the stronger effect of the delta variant and the decreasing protection of the vaccines.

Data from the Israeli Ministry of Health are seen as a warning sign. It suggests that protection from viral infections fell in June and July relative to the time since a person was vaccinated. According to a data set, the effectiveness of the Pfizer vaccine against serious illnesses in people 65 and over who were vaccinated in January fell to 55 percent. But the margin of error was wide and experts said other data appeared less worrying.