US health advisers on Friday discussed who should get their single-shot COVID-19 vaccine boosters from Johnson & Johnson and when — and whether using a competing brand of second-dose may offer better protection.
The push for a boost began last month after the Food and Drug Administration authorized third doses of the Pfizer vaccine for seniors and young adults with health problems, jobs or living conditions that put them at greater risk from the coronavirus. On Thursday, an advisory panel from the U.S. Food and Drug Administration unanimously recommended a half-dose booster dose of a similar Moderna vaccine for the same groups.
On Friday, the same committee discussed boosting the J&J vaccine but the decision is more complicated. Moderna and Pfizer asked the FDA to approve the boosters at least six months after immunization, but J&J suggested a sliding schedule with an additional dose two months later.
Adding to another development, experts will also discuss preliminary data from a government mixed-and-match study that suggests J&J recipients may have a much stronger immune response if they get a booster dose of Moderna or Pfizer rather than a second dose of J&J.
The J&J single-shot vaccine is made with a different technology than the Pfizer and Moderna vaccines – and has consistently shown lower levels of effectiveness.
On Friday, J&J executives introduced a booster dose as a way to boost a potent vaccine that they said retains its protective ability over eight months. But FDA scientists have challenged that assertion.
There is data to suggest that the efficacy of this vaccine is actually less robust than the company’s presentation here, said Dr. Peter Marks, the FDA’s chief vaccine officer. .
The committee chair said regulators had a responsibility to strengthen protections for Johnson & Johnson recipients.
There is some urgency here to do something, said Dr. Arnold Munto of the University of Michigan.
The Food and Drug Administration (FDA) will use its advisors’ recommendations to decide whether to allow the use of boosters for both J&J and Moderna, and then another government agency will judge who should roll up their sleeves.
All three vaccines in the United States still provide strong protection against severe illness and death from COVID-19 — and the nation’s priority remains to get the first doses to the 66 million eligible but unvaccinated Americans who are most at risk as the highly contagious delta variant continues to spread.
J&J presented results of a large study that found giving a second dose just two months after the first shock protection against symptoms of COVID-19 to 94% from 70% in the United States. Instead, giving this booster six months later led to an even bigger jump in anti-virus antibodies.
But in their own review, FDA scientists note a number of shortcomings in the J&J booster studies, including only a small portion of cases involving the delta variant, by far the dominant strain in the US The reviewers also cautioned that J&J may It only followed the booster recipients for just over a month after the second dose, making it difficult to draw conclusions about the durability of the protection. Finally, FDA employees confirmed that they did not have time to independently confirm J&J’s findings, which were presented shortly before the meeting.
FDA reviewers found no new safety concerns after a second dose of Johnson & Johnson, but again cautioned about the small number of patients studied and the short follow-up period.
The J&J vaccine was highly anticipated for its individual formulation. But its introduction earlier this year was hit by a series of problems including manufacturing problems and some rare and serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barré syndrome. Either way, regulators decided that the benefits of the shot outweigh those risks.
The vast majority of the 188 million Americans who were fully vaccinated against COVID-19 have received Pfizer or Moderna options, while J&J recipients represent only about 15 million.
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