FDA sets meeting for Pfizer COVID-19 booster authorization

The march toward COVID-19 booster shots is picking up pace as the Food and Drug Administration (FDA) will hold a meeting of outside advisors to discuss the additional doses.

According to the FDA website, the Vaccines and Related Biological Products Advisory Committee will hold an open meeting Sept. 17 to discuss allowing third doses of the Pfizer COVID-19 vaccine, COMIRNATY.

The meeting will take place just three days before when the Biden administration will make the additional shots available to the general public on Sept. 20.

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.

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 Aug. 25, slightly more than half of eligible Americans, 167.1 million, have been fully vaccinated.