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FDA advisory committee to consider boosters for Moderna, J&J COVID vaccines

by Lester Blair
FDA advisory committee to consider boosters for Moderna, J&J COVID vaccines
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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.

Although the vaccine is considered safe, little evidence has been available. The government encourages people to continue using the same vaccine. 

Booster doses of the Pfizer-BioNTech vaccine, which has been given to more than 230 million Americans since December, were approved last month for people over 65 as well as younger people whose medical conditions or jobs put them at higher risk for disease.

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.

After data suggesting that vaccination protection was possible against infections, the country started offering booster shots this summer to all citizens.It was beginning to fade. It’s not clear whether people were also more vulnerable to severe disease, but the data suggested that protection had begun to wane, too.

According to another study, Qatar suffered a similar drop in the effectiveness of mild and moderate diseases.

There is no similar nationwide “natural experiment” for either the Moderna or the J&J vaccines.

Instead, it will be up to the FDA panel to decideThe Moderna vaccine was able to collect smaller data during Thursday and Friday meetings. This suggests that the Moderna vaccination is on a similar path as Pfizer BioNTech.

Shyrel Ritter, a certified nursing assistant at the Hebrew Home at Riverdale, receives her COVID-19 booster shot at her workplace in New York, Monday, Sept. 27, 2021.

Moderna as well as Pfizer BioNTech have similar mRNA technologies and both vaccines.

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. After the second shot, levels of the so-called neutralizing antibody had dropped significantly. The booster was administered about six months later.

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.

Moderna conducted another study this summer, as the beta variant surged. Participants who received two doses of active vaccine thirteen months prior were compared to those who received the second dose. Eight months before the shooting.

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. There were only 19 severe cases, and slightly more among those who had been vaccinated previously. 

Independent experts have not reviewed either study.

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. The company claims that a booster dose six months following the first shot offers even greater protection. 

With all of the COVID-19Supplemental doses of vaccines appear to be as safe and effective as the original ones. However, it is possible that rare side effects may emerge when millions more people 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.

Each group indicated that they may reconsider their recommendation if more information becomes available on the effectiveness of vaccines for the general public.

President Joe Biden receives a COVID-19 booster shot in the South Court Auditorium on the White House campus Monday, Sept. 27, 2021.

An FDA committee is also expected to review a report that examines the potential risks and benefits associated with combining vaccines.

According to the CDC, it is better to receive the second and third doses of the vaccine with the same dose as the original. ButAlthough the study is small, it’s expected to be significant.Provides information on whether mixing different vaccines can be safer than using the same shot.

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 can vote to approve booster shots. However, it cannot vote on vaccine mixing. 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. 

VRBPAC will later in the month consider authorizing the Pfizer BioNTech vaccine to be used in children aged 5-11 years. The CDC committee will also examine this topic in early January.

Contact Karen Weintraub at [email protected]

USA TODAY’s coverage of patient safety and health is possible in part thanks to a grant from Masimo Foundation for Ethics, Innovation and Competition in Healthcare. Editorial input is not provided by the Masimo Foundation.

Source: USAToday.com

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