FDA panel endorses a booster shot for J&J’s COVID-19 vaccine

U.S. health advisors on Friday voted to shore up protection for more than 15 million Americans who have relied on Johnson & Johnson’s COVID-19 vaccine for protection against the coronavirus, urging the Food and Drug Administration to greenlight a booster dose for those who got their jab at least two months earlier.

The unanimous vote came a day after the FDA’s independent advisory panel on vaccines recommended boosters be made available to virtually any adult vaccinated at least six months earlier with the COVID-19 vaccine made by Moderna. Despite their many reservations,

Panel members voted in favor of making boosters more widely available. Both the manufacturers of booster shots failed to show that every vaccine recipient needs them or that universal availability would be safe.

But with the pandemic’s persistence, along with mounting evidence that the protection afforded by all COVID-19 vaccines has waned, the advisors said the FDA must make booster shots widely accessible to virtually all who want them.

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If the agency agrees, it is possible to narrow the endorsement. A second group of advisors to Centers for Disease Control and Prevention could recommend that booster shots be given to certain groups, such as older Americans and people with compromised immune systems. However, they would not be recommended for younger people.

The CDC could respond with narrower recommendations. The agency could also leave the decision up to the doctors and vaccinated adults to decide if a booster shot is necessary.

This decision could become more complicated with new information on mixing, matching vaccines that have different design and formula. A federally funded study is ongoing that suggests that coronavirus antibody levels rise dramatically when initial doses (made in the USA) of a vaccine are augmented with a booster dose.

While still preliminary, the findings turned up no evidence that serious adverse reactions increased when disparate COVID-19 vaccines are used together.

” “In the real world, all these kinds of combinations are already occurring, so I think it’s an urgent matter for the FDA to help us sort out this admittedly complicated and challenging situation,” stated Dr. Ofer Levy from Boston Children’s Hospital. At Friday’s meeting, members of the advisory committee were clearly frustrated by data that was often limited, short in follow-up, and focused only on one aspect of vaccine response: production of antibodies.

But the committee, made up of experts in vaccines, viruses, immunity and public health, also expressed worry that if it withheld support for boosters, vaccinated Americans could die in yet another wave of COVID-19 illnesses. New coronavirus infections have begun to slow down in the country, after a summer of death and illness. On Thursday, Dr. Peter Marks , the FDA’s chief for drug and vaccine assessment, reminded the panel of the fact that credible modeling groups have predicted further waves and that the possibility that they will come to pass cannot yet be dismissed.

” We can’t just look at the pandemic curve now and say it’s over,” Marks stated. “We do have to think ahead.”

That worry was evident in the panel’s broad discussions over two days of dense briefings.

Although he sympathized with a colleague’s concern about “a lot of uncertainties in the data”, panel chair Dr. Arnold Monto stated that the stakes were too high to delay booster shots.

” There’s a public-health imperative here,” Monto, an epidemiologist from the University of Michigan, said. “There’s some urgency here to do something.”

A little over 15 million Americans have received a single dose of the J&J vaccine, and more than 19 million additional doses have been administered across the globe.

The J&J vaccines won widespread support among both the FDA’s and CDC’s independent advisors “because of where it could go and what it could do,” said Oveta Fuller, a University of Michigan immunologist who serves on the FDA advisory panel. It’s much easier to transport and administer than mRNA formulations from Moderna or Pfizer-BioNTech.

The J&J vaccine conferred complete protection after one dose. This was despite the fact that it was widely used by populations who might not be able to return to their doctors due to job requirements, transportation difficulties, and limited access to healthcare. If the FDA accepts the recommendation of its advisory panel, the “one-and-done” vaccine may begin to look more like two-dose vaccines from Moderna and Pfizer BioNTech.

J&J on Friday presented evidence that after about five months, a single shot of the vaccine reduced the risk of moderate to severe COVID-19 by roughly 45%, and reduced the risk of severe or critical disease by 72%.

Booster doses were administered between two and six months after the first dose. They more than tripled the amount of virus-blocking antibodies among study participants and sometimes increased them by six to one, J&J representatives stated.

Older recipients of vaccines saw higher levels of antibodies than those who received them earlier. The rise in antibodies for those who received a booster within six months of their first shot was greater than that experienced by those who had it two months later.

But the J&J studies that reflected conditions in the United States had small numbers of recruits; in one study, the outcomes of just 81 study participants were used to make the case for boosters.

Drawing from larger international studies, however, company representatives told the panel that providing boosters would “optimize immune response,” prevent cases of severe COVID-19, and better protect people against future viral variants. Concerns about safety issues associated with boosters were raised by the small study populations and the short follow-up period of subjects.

The initial roll-out of COVID-19 vaccines made by Moderna and J&J was roiled by concerns over side effects, including certain types of heart inflammation in some younger people who received the Moderna vaccine and a highly unusual blood disorder linked to J&J vaccine. Moderna and J&J consider both conditions extremely rare. There is no evidence that boosters made them more common.

But, each company admitted that these rare adverse reactions might not be noticed until larger groups start taking them.

The Associated Press contributed to this report.

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