|Maine Medicine Weekly Update
October 18, 2021
FDA Advisory Committee Recommends Moderna, J&J Boosters. What You Need to Know
A Food and Drug Administration (FDA) advisory committee voted unanimously in favor of a lower-dose Moderna COVID-19 vaccine booster on Thursday.
The recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) was for a half booster of Moderna. Eligibility criteria was identical to eligibility criteria approved for Pfizer last month.
On Friday, the advisory committee voted unanimously on Friday to recommend a booster dose for the Johnson & Johnson COVID-19 vaccine.
Unlike the authorizations for boosters for the Pfizer-BioNTech and Moderna vaccines, no restrictions were put on the J&J booster. Johnson & Johnson representatives told the panel that a second dose given to persons 18 and older either two months or six months after the first shot increased antibody levels.
Despite the committee recommending approval, an FDA summary released earlier in the week highlighted a lack of high-quality data supporting giving a booster six months following the first dose.
The VRBPAC is scheduled to meet again October 26 to discuss arequest to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age. Pfizer aims to give 5- to 11-year-olds one-third of the dose given to everyone 12 and older.
Additional meeting discussions and information
Despite the unanimous vote, many committee members still had concerns over the data they saw from Moderna and the Israel Health Ministry.
Following the Moderna booster vote on Thursday, the FDA advisory committee discussed whether everyone over 18 should receive a third COVID-19 vaccine dose but several committee members pushed back on suggestions that booster shots are needed for all people, concerned the emphasis on boosters may distract from reaching unvaccinated individuals.
“The effect of a booster is much less than vaccinating unvaccinated individuals — that means both here and abroad. If we want to get out of this thing, we’ve got to vaccinate the unvaccinated.” – Advisory Committee member, Eric Rubin, editor of the New England Journal of Medicine.
The FDA is holding off on approving the Moderna Covid-19 vaccine for teens to review more data about whether it could lead in rare cases to the heart condition myocarditis. Officials want to first determine whether there is an elevated risk, and it could take several weeks.
Click here for the latest COVID-19 Information from the FDA.
Materials for the October 26th meeting concerning Pfizer’s request to amend its EUA for persons 5 to 11 years of age will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.
The meeting will be broadcast via YouTube: https://www.youtube.com/watch?v=laaL0_xKmmA&feature=youtu.beNext Article >
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