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The FDA’s Vaccine Expert Panel recommends approving a J&J booster for anyone who has had a first vaccination

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The Food and Drug Administration (FDA) panel of experts on vaccines recommended a booster dose of the Johnson & Johnson-Janssen COVID-19 vaccine on Friday, October 15. In a unanimous vote, the 19-member panel recommended booster vaccination for anyone previously vaccinated with the vaccine, at least two months after the first dose. With the advice, the panel has now endorsed booster vaccinations for all three vaccines currently available in the United States.

J & J’s vaccine is the only US (and worldwide) approved vaccine that requires a single dose. If the FDA accepts the committee’s decision on what to expect, the Centers for Disease Control will then determine which specific groups should receive the additional dose.
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The recommendation comes a day after the committee recommended a booster shot of the Moderna vaccine, which uses a different technology than J&J and requires two doses initially. The FDA is expected to make a formal decision shortly on whether to follow the committee’s advice on this vaccine. The FDA and CDC have already approved the Pfizer BioNTech booster for people over 65 and for adults at a higher risk of severe COVID-19 and its complications, such as workers whose workplaces place them at increased risk of exposure and therefore more severe COVID-19 can suspend.

Continue reading: FDA Panel Votes to Recommend Moderna COVID-19 Booster Shot

J & J’s request was complex and the committee had to decide whether to recommend a booster dose two months or six months after the single dose. From the start, J & J’s vaccine was less effective than Pfizer-BioNTech’s and Moderna’s, but the committee endorsed the vaccine because it offered practical benefits in the middle of a pandemic – unlike Pfizer-BioNTech’s and Moderna’s vaccines, J&J only needed it a single syringe, and the vaccine does not need to be shipped and stored in ultra-cold conditions, but can be frozen at normal freezing temperatures. These are significant advantages for reaching a large part of the world’s population, especially in countries with fewer resources.

At the committee meeting, J&J presented data showing that after the comparatively lower immune response generated after the single dose, a second booster dose given two months later increased that response. These data led most members to wonder whether the J&J shot should originally have been a two-dose vaccine. “I think it was always a two-dose vaccine,” said Dr. Paul Offit, Professor of Pediatrics at Children’s Hospital of Philadelphia and member of the committee. “It’s hard to recommend the single dose [now] given the two-month data. ”He noted that the committee would likely have recommended two doses of the vaccine if the two-month data on the immune response to the second dose had been available by the time the companies originally did it applied for an emergency permit (EUA) in February, rather than one. Because of this, the committee ultimately voted to approve a booster dose of two months or more for anyone after receiving an initial shot of the J&J vaccine.

However, the data becomes more complicated. At the FDA meeting on Friday, J&J researchers presented studies showing their vaccine provides strong and sustained protection against COVID-19 disease that lasts for up to eight months after the individual vaccination. According to J & J’s studies, J & J’s effectiveness remains stable for months while J & J’s effectiveness remains stable for months, while both Pfizer BioNTech and Moderna have documented a drop in virus-fighting antibody levels from about six months after the second dose.

One of the committee members, Dr. Hayley Gans, Professor of Pediatrics at Stanford University, noted the obvious paradox inherent in J & J’s application for a booster vaccination: If a single dose of J&J offers this consistent protection, especially against serious illness, why should a booster be needed?

In response, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, notes that the data on J&J efficacy may not be as robust as the companies suggested, citing recent CDC studies showing vaccine efficacy as low as 50% detect a few months after vaccination. “There’s more data out there than we see,” said Marks. “All data do not fully agree that this is a vaccine that maintains excellent activity over time against all forms of disease or even against severe forms of disease.”

The balance between the rigorous scientific evidence required by regulators like the FDA and the real urgency of addressing the threat of an ongoing pandemic has been the recurring theme when reviewing the booster. Committee members have repeatedly raised the question of what the goal of booster vaccinations should be, as existing therapies appear to continue to provide adequate protection against serious illness based on currently available data. The question for the committee was weighing how comfortable they feel with the protection offered by the original dosage and how preventive they want to be when the public comes up with boosters to prevent the dwindling immunity before it gets to the point where more vaccinated people become infected and become seriously ill – especially with variants like Delta.

In theory, one goal of the extra vaccinations could be to increase immunity to such an extent that humans are less likely to transmit the virus if they become infected, but there isn’t enough data to show that vaccines actually do this . Another goal would be to establish higher immunity against new variants of SARS-CoV-2, in particular against the now dominant Delta strain, which is responsible for almost all new infections worldwide – booster vaccinations increase the antibody level against the virus, and assuming that a rising tide drives all ships up, the more antibodies the body forms against SARS-CoV-2, the more likely it is that some of them can block different variants.

In fact, the J&J team presented data showing that adding a second dose, particularly six months after the first, increased the effectiveness of the vaccine to around 90%.

And their data also indicated that the immunity generated by the vaccine has a “unique immune profile with antibody titers that are later reached and are largely reactive against multiple strains” [of the virus] Variants, and they will remain, ”said Dr. Penny Heaton, Head of Global Therapeutics at Janssen Research & Development. That means immunity may be longer or more permanent than other vaccines. Dr. Dan Barouch, a professor of medicine at Harvard Medical School who developed the vaccine in collaboration with J&J, noted that the vaccine “produces a distinctive, complex immunological profile with a robust shelf life.”

As part of this line of reasoning, the companies highlighted what they see as the defining characteristic of their vaccine: triggering the T-cell response, which is sort of an immunological backup for the immediate SWAT team of antibodies that the body receives the first time sets in meets a new virus; Antibodies can flood the zone quickly, but tend to wear off over time if the virus is not constantly present. T-cell responses, on the other hand, are memory cells that can remember previous infections, recognize the threat when it recurs, allowing the body to respond faster and more consistently. A booster dose could potentially exacerbate this process in people immunized with the J&J vaccine.

Before disbanding, the committee also heard the results of the newly published and much-anticipated study by the National Institutes of Health on mixing and matching doses of the three currently approved vaccines. While the research did not directly compare different combinations, the results support the fact that giving a booster vaccine other than the one they were originally vaccinated with was both safe and effective. In fact, people who originally received the J&J vaccine were boosted with an mRNA vaccine – like those from Moderna and Pfizer-BioNTech – about 7-10 times higher levels of virus-neutralizing antibodies than a second dose of the same vaccine.

Continue reading: A new study advocates mixing and matching vaccine doses from Pfizer-BioNTech, Moderna and J&J

These results showed how scientists’ knowledge of the protection offered by vaccines is evolving and how vaccinations can best be optimized. In anticipation of a steady stream of new studies and new data, some of which could result in the need to amend previous vaccine recommendations, committee members discussed how the FDA will handle the extension of current booster approvals to the wider adult population that is currently Boosters (those without health problems or in high-risk situations) and finally children are not eligible for the vaccines. Given the evolving knowledge of vaccines and their effectiveness, the committee emphasized the need for the FDA to be flexible and transparent in making decisions. For example, each of the three types of booster vaccination is already recommended for different population groups: anyone who originally received the J&J vaccine is entitled to a booster vaccination, while for those vaccinated with Moderna or Pfizer-BioNTech, only those over 65 years of age are eligible are old, or those between the ages of 18 and 64 with health problems or in high-risk jobs are eligible.

“I hope we can present it to the public in a way that is not confusing,” said committee member Dr. Stanley Perlman, Professor of Microbiology and Immunology at the University of Iowa. “We follow science, but people who don’t think the rules are always changing. I hope we can do this so that it doesn’t seem like we’re constantly changing the rules. “

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