Pfizer seeking expanded COVID-19 booster EUA

Pfizer has asked the Food and Drug Administration (FDA) to expand the emergency use authorization (EUA) for their COVID-19 booster shots so that anyone 18 or older can receive one.

According to a report from The New York Times, the agency is expected to permit the expansion in the coming weeks, possibly even before the holiday travel rush.

The additional shots have been available since Sept. 24, but only for certain groups. The current Centers for Disease Control and Prevention (CDC) recommendations for the booster are:

• people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
• people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
• people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
• people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

The company 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.

Pfizer is also seeking an EUA for their 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.