FDA advisory committee to consider boosters for Moderna and J&J COVID-19 vaccines
A federal advisory committee will meet for two days this week to discuss the safety and need for a booster shot for people who already received Moderna’s or Johnson & Johnson’s COVID-19 vaccine.
Members of the federal advisory panel, called the Vaccines and Related Biological Products Advisory Committee, also will hear data about the likely safety and effectiveness of giving people booster shots from a different vaccine manufacturer than their original doses.
While presumed safe, there has been little data so far and the government has encouraged people to stick with the same vaccine.
So far, people who received Moderna or J&J for their first round of shots have been told to sit tight.
Data is clearer for Pfizer-BioNTech, because most of Israel’s population of 9.2 million people received that vaccine earlier in the year and have been carefully tracked.
The country began offering booster shots to everyone this summer after data suggested vaccine protection against infectionwas fading. It’s not clear whether people were also more vulnerable to severe disease, but the data suggested that protection had begun to wane, too.
Qatar experienced a similar decline in effectiveness against mild and moderate disease, according to another recent study.
There is no similar nationwide “natural experiment” for either the Moderna or the J&J vaccines.
Instead, the FDA panel will have to considerduring its Thursday and Friday meetings smaller-scale data, which suggests the Moderna vaccine is following a similar, though perhaps slower, trajectory than Pfizer-BioNTech’s.
The Moderna and Pfizer-BioNTech vaccines are both based on mRNA technology and are similar to one another.
In a follow-up study of participants from an earlier research trial, Moderna found that a third shot, with half the dose of the first two, provided a major immune boost. Levels of so-called neutralizing antibodies had waned significantly before the booster, which was given about six months after the second shot.
The third shot brought antibody levels in people of a variety of ages and health conditions significantly above where they had been after the second shot, according to the company’s study, which was released last month but has not yet been independently reviewed. The safety profile following that third dose was similar to that seen with the previous two.
In the analysis, there were 88 cases of COVID-19 in those who were in the more recently vaccinated group, compared with 162 cases in those vaccinated last year. Only 19 people saw severe infections, with slightly more in the group vaccinated longer ago.
Neither study has been reviewed by independent experts.
J&J, which was initially given as a single shot, may need a second dose to provide better long-term protection, data from the company shows. Initial trial data showed the single shot protected against more than 70% of infections in the U.S. and nearly 100% of deaths.
In a study released last month, the company found that a second dose given two months after the first provided 94% protection against moderate-to-severe COVID-19 symptoms. A booster dose given six months after the single shot provides even more protection, the company said.
With all the COVID-19vaccines, supplemental doses seem to be just as safe as earlier ones, though it’s possible rare side effects will emerge as millions more get boosters.
VRBPAC and a similar independent advisory group to the Centers for Disease Control and Prevention decided last month not to recommend booster doses to everyone because of unclear need, and the possibility of rare side effects.
Both groups said they might reconsider a recommendation as more data becomes available about the long-term effectiveness of the vaccines in the general population.
The FDA committee will also consider a new report looking at the risks and benefits of combining different vaccines.
The CDC has already said it’s preferable to get second and third doses with the same vaccine as the first dose. Butthe new study, though small, is expected tooffer hints about whether combining different types of vaccines is safe and perhaps more effective than sticking with the same shots.
A study in the United Kingdom has found mixing and matching vaccines to be safe and effective, but its protocol for using the vaccines was different – with a wider gap between first and second doses that might alter long-term effectiveness, experts said.
VRBPAC will vote on whether to authorize the booster shots but will not take a vote on mixing vaccines. Assuming the FDA commissioner signs off on the group’s recommendations, the CDC committee will consider on Oct. 20 and 21 who should be eligible for Moderna and J&J boosters, with the shots likely becoming available within a few days of its decision.
Later in the month, VRBPAC will consider whether to authorize the Pfizer-BioNTech vaccine for use in children ages 5-11, a topic the CDC committee will take up early next month.
Contact Karen Weintraub at firstname.lastname@example.org.
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