FDA discusses COVID-19 booster shot

A Food and Drug Administration (FDA) committee is expected to vote on whether to suggest COVID-19 booster shots after hearing conflicting information on the move.

The FDA Vaccines and Related Biological Products Advisory Committee held an open meeting to discuss allowing third doses of the Pfizer COVID-19 vaccine, COMIRNATY. Previously, the Biden administration said the additional shots would be available to the general public Sept. 20.

According to a report from The New York Times, that plan has been in question due to a lack of consensus on whether the shots are necessary and effective and who would benefit from the boosters.

While the committee’s decision isn’t the sole factor in the additional shots being authorized, but a yes vote would pave the way for their rollout.

The agency has already expanded the emergency use authorization for the Pfizer and Moderna two-dose vaccines to allow for a third dose to the estimated 3 percent of Americans, or about 9 million, with weakened immune systems. The vaccines are believed to be less effective in this group of people, but the initial hope was that widespread vaccinations would protect the immunocompromised population. As of Sept. 17, slightly more than half of eligible Americans, or about 180 million, have been fully vaccinated.

On Aug. 23, the Food and Drug Administration (FDA) fully approved the Pfizer-BionTech COVID-19 vaccine for use in people age 16 and older, the first COVID vaccine to receive such approval.

The Pfizer vaccine, along with one manufactured by Moderna, had been operating under an Emergency Use Authorization (EUA) since December 2020 for people age 16 and older, while Johnson & Johnson’s Jansen vaccine received an EUA in February 2021. The FDA is still reviewing Moderna’s application for full authorization. Johnson & Johnson has not yet applied for full authorization.

A study from the National Institutes of Health found that the currently available COVID-19 vaccines have cut the number of fatalities due to the disease by nearly 140,000. The researchers estimate that the economic value of saving these lives was between $625 billion and $1.4 trillion.

The reduction in deaths varied in different states with vaccinations in New York leading to an estimated 11.7 fewer COVID-19 deaths per 10,000 while Hawaii saw the smallest reduction at just 1.1 fewer deaths per 10,000.

Meetings to discuss boosters of the Moderna and Johnson and Johnson have yet to be scheduled.

This article was originally posted on Medical Economics®.