Pfizer, Moderna COVID-19 boosters get greenlight for all adults from FDA

Pfizer COVID-19 boosters get greenlight for all adults from FDA

The Food and Drug Administration (FDA) has authorized booster doses of Pfizer and Moderna's COVID-19 vaccines for all adults who’ve already received a full two-dose regimen.

According to press release, the agency has authorized the booster shots starting six months after a patient 18 years or older has received their second dose of the vaccine. The move now enables millions of Americans who have so far been ineligible for the additional shots to have their immunity boosted against COVID-19.

Arkansas, Colorado, California, and New Mexico had already broadened access to the additional shots to all adults. This move was more in line with President Joe R. Biden’s initial planning for the booster doses.

Initially, Biden had planned to make third doses of the Pfizer and Moderna vaccines to the whole country beginning in September with a determination being made later on the effectiveness of Johnson and Johnson boosters.

That plan was stymied when regulators limited the extra Pfizer and Moderna shots to those patients who are 65 years and older, adults with an underlying medical condition, and adults who are at increased risk of the disease due to their occupational or institutional setting.

Pfizer has been having success in developing tools to battle the COVID-19 pandemic as the CDC recommended children 5 to 11 years receive the pediatric doses of the vaccine. At least two months after the two-dose regimen, the vaccine proved to produce more neutralizing titers against the original strain of COVID-19 and the Delta variant than the larger doses did in teenagers. The juvenile vaccine was shown to be 90.7 percent effective against COVID-19 at least seven days after the second dose.

Antiviral pill

The New York Times reports that the federal government is planning to pay more than $5 billion for a stockpile of an antiviral COVID-19 pill being developed by Pfizer. The stockpile would contain enough doses for about 10 million patients and is set to be delivered in the next 10 months.

Pfizer is seeking an EUA from the FDA for the antiviral COVID-19 pill. The pill, PAXLOVID, was shown to be 89 percent effective in an interim analysis of Phase 2/3 EPIC-HR study of non-hospitalized adult patients with COVID-19 who are at-risk of progressing to severe illness. Only three patients who received the antiviral pill were hospitalized due to COVID-19 and none died of the disease, compared to 27 patients on the placebo who were hospitalized and seven who died.

The company sees PAXLOVID as being prescribed broadly as an at-home treatment to reduce severity, hospitalizations, and deaths due to COVID-19. It could also be used to reduce the probability of infection after exposure among adults.