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Friday, November 26, 2021

FDA panel unanimously recommends Johnson & Johnson booster shots

WASHINGTON — A major federal advisory committee voted unanimously on Friday to recommend Johnson & Johnson booster shots, most likely clearing the way for all 15 million people who need the company’s one-dose coronavirus vaccine. Got to get the second shot.

If the Food and Drug Administration and the Centers for Disease Control and Prevention accept this recommendation, as expected, a booster could be offered by the end of next week. But several committee members clarified that they believe Johnson & Johnson recipients may benefit from the booster option of Pfizer-BioNtech or Moderna Vaccine, a top FDA official said the agency is considering. Was.

With a series of votes over the past month to recommend boosters for all three coronavirus vaccines used in the United States, the panel put aside significant division and doubt about whether additional shots are needed and that goal. that President Biden had set out. August when he called for boosters for all adults.

If the FDA and CDC support the committee’s latest recommendations, more than 100 million fully vaccinated people would be eligible for a booster, even though some scientists say the evidence supporting boosters is weak and non-vaccinated. It would be prudent to focus on reaching out to countries, including abroad.

Johnson & Johnson’s vaccine crashed in Friday’s session, as did the FDA to push for a decision without verifying all the data the company submitted.

But panel members were impressed by the argument that it would be unfair to deny Johnson & Johnson recipients an additional shot after endorsing boosters to recipients of the other two vaccines, especially in the face of evidence that Johnson & Johnson has the weakest protection. provides. three.

Dr. Arnold Monto, the committee’s acting chair and professor of epidemiology, said, “There is a public health imperative here, because what we are seeing is that this is the overall low efficacy group that we saw with mRNA vaccines. Is.” at the University of Michigan School of Public Health. “So there’s some urgency to do something.”

On their second day in a row discussing the booster, the group remained unconvinced whether it would be wise to offer additional shots to younger recipients of Pfizer and Moderna vaccines sooner.

The government’s strategy now is to offer boosters of those vaccines to people age 65 and older and young adults at high risk because of their medical conditions or jobs. No decision was made about broad eligibility criteria, but Dr Monto and others described the issue as increasingly pressing.

The panel also seemed intrigued by preliminary data that suggested Johnson & Johnson recipients might be better off with a booster shot from Moderna or Pfizer. Although no vote was taken, Dr. Peter Marx said regulatory action was “possible” to allow a booster with a different vaccine.

While some experts emphasized that the data was based on small groups of volunteers and short-term findings, others urged the FDA to move quickly to what is known as a rapid mix-and-match approach, Specifically for recipients of the Johnson & Johnson vaccine. , which is much less widely available.

“I’m already sold out,” said Dr. Mark Sawyer, an infectious disease specialist at the University of California San Diego School of Medicine. “We need flexibility and improve access for all.”

Others said they worried the public would be left puzzled if the government continued to expand the categories of people eligible for boosters and which vaccines could be used for additional shots.

“I hope we can do it in a way that doesn’t feel like we’re changing the rules all the time,” said Dr. Stanley Perlman, a professor of immunology at the University of Iowa.

Health officials and committee members suggested on Friday that the single-shot Johnson & Johnson vaccine was less protective over the long run. In a particularly biting criticism, Dr. Amanda Cohn, a highly placed CDC medical official, said that one dose of Johnson & Johnson’s vaccine provided less protection than two doses of mRNA vaccines made by Pfizer or Moderna – one The difference that would only increase if this one-shot regimen was maintained, while other two-shot vaccines were followed by a booster.

Dr. Marks insisted that the one-shot, easily stored Johnson & Johnson shot had worked partly as an “outreach” vaccine – suggesting that refusing to offer boosters would harm vulnerable populations. Will happen.

To date, more than 104 million people in the United States have been fully vaccinated with Pfizer’s product, more than 69 million with Moderna and nearly 15 million with the Johnson & Johnson shot.

The government last month decided to offer booster shots of Pfizer’s vaccine to older Americans and other high-risk groups, and the panel voted Thursday to recommend a similar approach for Moderna recipients. More than eight million people in the United States have already received a Pfizer booster dose, and nearly 1.6 million have received a third dose of Moderna, even though only Moderna recipients with immune deficiencies are officially eligible.

For Johnson & Johnson recipients, the committee recommended an additional shot for everyone receiving the vaccine — a reflection of its low efficacy. Although the added injection was administered as a booster, some experts on the committee argued that the vaccine should consist of two doses from the start, spaced approximately two months apart.

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Johnson & Johnson officials said the second dose is given two or six months after the first shot has increased levels of antibodies, which are part of the immune response to the vaccines. He also noted that unlike Pfizer’s vaccine, Johnson & Johnson’s capacity has not decreased significantly over time.

Experts generally agreed that the protection provided by a single dose was insufficient, but at least some did not agree that a second dose would significantly increase that protection.

What to know about Covid-19 booster shots

The FDA authorized booster shots for a select group of people who received a second dose of the Pfizer-BioEntech vaccine at least six months ago. That group includes: those receiving the vaccine who are 65 years of age or older or who live in long-term care facilities; Adults who are at high risk of severe Covid-19 because of an underlying medical condition; Health care workers and others whose jobs put them at risk. People with a weakened immune system are eligible for a third dose of Pfizer or Moderna four weeks after the second shot.

The CDC states that conditions that qualify a person for a booster shot include: high blood pressure and heart disease; diabetes or obesity; cancer or blood disorder; weakened immune system; chronic lung, kidney or liver disease; Dementia and some disabilities. Pregnant women and current and former smokers are also eligible.

The FDA authorized boosters for workers whose jobs put them at high risk of coming into contact with potentially infectious people. The CDC says the group includes: emergency medical workers; education worker; food and agricultural workers; construction workers; improvement worker; US Postal Service employees; public transport workers; Grocery store workers.

It is not recommended. For now, Pfizer vaccine recipients are advised to get the Pfizer booster shot, and Moderna and Johnson & Johnson recipients should wait until booster doses are approved from those manufacturers.

Yes. The CDC says the Covid vaccine can be administered regardless of the timing of other vaccines, and many pharmacy sites are allowing people to schedule a flu shot at the same time as a booster dose.

They were critical of the company’s data, saying FDA regulators had challenged the sensitivity of a key test used to measure antibodies in people receiving booster doses. He emphasized the size of a study given at six-month intervals on Johnson & Johnson booster doses, which was based on only 17 volunteers. And they were clearly distressed to see slide after slide of data with the big warning: “Not Verified by the FDA.”

Dr. Archana Chatterjee, dean of the Chicago Medical School, asked bluntly why the FDA was insisting on the decision without doing a thorough review.

But she later said she was convinced by the totality of the data, especially a CDC report that found Johnson & Johnson was only 71 percent effective against hospitalization, compared with 88 percent for Pfizer and 93 for Moderna. was the percentage.

Further decisions are up to the FDA and its outside experts. The group is set to meet again this month to discuss Pfizer-BioNtech’s request for authorization of a low-dose vaccine in children 5 to 11. Also pending is whether or not to authorize Moderna’s vaccine for teens – a step complicated by conflicting data about possible side effects associated with the heart.

Regulators are expected to soon consider whether to allow people to receive boosters of a different vaccine than they had initially received, which could generate a stronger immune response. “It’s real-world, practical questions that people want to know,” said Dr. Kirsten Laik of the University of Maryland School of Medicine, who presented the results of the mix-and-match study to the committee.

Preliminary findings showed that Johnson & Johnson recipients who received a booster with Moderna Vaccine increased their antibody levels 76-fold within 15 days, compared with only a four-fold increase when Johnson & Johnson received a booster shot. A Pfizer-BioNTech booster increased antibody levels 35-fold in Johnson & Johnson recipients.

The test only looked at antibody levels, which in itself is an inadequate measure of how different combinations of vaccines would protect people.

CDC official Dr. Cohn suggested that the FDA could include language in its booster authorizations that would allow for a switch between brands.

“From a public health perspective, there is a clear need for individuals to receive a different vaccine in certain situations,” she said. She said that some people may not have access to the same vaccine again, or using it again as a booster may have increased the risk of certain side effects.

Dr. Ofer Levy, an infectious disease physician at Boston Children’s Hospital, said the FDA should act because some people were already seeking boosters on their own.

“In the real world, all these kinds of combinations or additional boosters are already happening,” he said. “We can’t hide from this, and I think we need to guide the public.”

Also, the government needs to “make sure we don’t confuse the public already,” said Dr. Janet Lee, a professor at the University of Arkansas for Medical Sciences.

World Nation News Deskhttps://www.worldnationnews.com
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