Washington – A panel of independent advisers from the US Food and Drug Administration will convene on Thursday and Friday to review the data and vote on whether to get a booster shot for the millions of Americans receiving Moderna or the Johnson & Johnson COVID-19 vaccine.
The FDA’s Vaccines and . Biological Products Advisory Committee, which is scheduled to meet from 8:30 a.m. to 5 p.m. on both days, is the first step in the review process to decide whether additional doses should be given, and if so, So who should get them and when?
Experts will discuss whether the third shot of Moderna’s two-dose vaccine should contain only half of the original dose and the best timing for a second shot of the single-dose J&J vaccine. The panel will also look into Safety and effectiveness of mixing and matching different brands of vaccines – Some regulators have not yet supported.
After FDA advisors make their recommendation, the agency will decide for itself whether to authorize the booster. Then next week, a panel convened by the US Centers for Disease Control and Prevention will offer more specifics about who should get them. Its decision is subject to approval by the CDC director.
Health officials say all vaccines used in the US offer strong protection against serious illness or death from COVID-19.
But amid signs that protection against minor infections is waning, the government has started introducing booster doses of the Pfizer vaccine for some people six months after their last shot. Those eligible include people who are immune, Americans 65 and up, and other groups at high vulnerability to COVID-19.
An estimated 103.5 million Americans have been fully vaccinated with Pfizer’s vaccine, CDC shows data. Another 69 million have been fully vaccinated with the Moderna shot, and about 15 million have received the J&J vaccine. Regulators first raised the question of Pfizer Booster because the company submitted its data before other vaccine makers.
The FDA meetings come as the US vaccination average has climbed above 1 million per day, a more than 50% increase in the past two weeks.
Growth has been primarily driven by the Pfizer booster and employer vaccine mandates. According to the CDC, an estimated 8.9 million Americans have received a Pfizer booster dose since Aug.
The lengthy review process to review data on boosters is meant to increase public confidence in the vaccines. But this has already given rise to conflict between experts and agencies – and FDA issued documents The suggestion is that this week’s decisions will be equally difficult.
In an earlier vaccine controversy, the CDC’s advisory panel last month endorsed a Pfizer booster at the six-month point for older Americans, nursing home residents, and people with underlying health problems. But CDC Director Dr. Rochelle Valensky dismissed his advisors And fixed boosters should also be offered for high-risk jobs such as teachers and health care workers, adding millions more Americans to the list.
Some health experts fear back-and-forth discussions are getting messy public effort To persuade non-vaccinated people to get their first shots. He worries that talk of boosters will lead people to falsely doubt the effectiveness of vaccines in the first place.
A pharmacist gives a booster dose of the COVID-19 vaccine to a customer at a pharmacy in Livonia, Michigan on August 17, 2021. Photographer: Emily Elkonin/Bloomberg via Getty Images
In an online review made public this week, FDA scientists indicated they were grappling with whether those receiving the J&J vaccine needed another dose, and if so when they should take it: at six months or as early as two months. Experts did not reach any firm conclusions, citing the shortcomings of the J&J data, including little information on protection against the additional infectious delta variant.
FDA reviewers wrote that a study of a two-month booster plan suggests “there may be a benefit,” while only pointing to the small number of people who got another shot at six months.
Overall, the J&J vaccine “still provides protection against serious COVID-19 illness and death,” FDA reviewers concluded. But data about its effectiveness is “consistently low” compared to the safety seen with Pfizer and Moderna Shots.
For its part, J&J filed data with the FDA from a real-world study showing that its vaccine is about 80% effective against hospitalizations in the US.
J&J’s single-dose vaccine was highly anticipated for its single-dose formulation. But its rollout was hurt by manufacturing problems and a slew of troubles, including some rare but serious side effects, including a blood clotting disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided that the benefits of the shot outweighed those risks.
In a new review of data from Moderna, the FDA this week did not indicate whether it was leaning toward cleaning up the company’s boosters. It said vaccines used in the US still provide protection, and it questioned some of Moderna’s data.
The two initial Moderna shots each contain 100 micrograms of the vaccine. But the drugmaker says 50 micrograms should be enough for a booster for healthy people.
One company study of 344 people given them a 50-microgram shot six months after their second dose, found a jump in the levels of virus-fighting antibodies. Moderna said the booster triggered a 42-fold increase in antibodies capable of targeting the extra-infectious delta variant.
Side effects were similar to the fever and pain that Moderna recipients typically experience after their second regular shot, the company said.
On Thursday, FDA panel will debate the benefits versus risks of the Moderna booster shot With a non-binding vote scheduled for Thursday afternoon.
On Friday, the committee will discuss and vote on the J&K booster. It will also hear a presentation by the National Institutes of Health. Mix and match on booster data.
This was reported from Cincinnati.