CDC, NIH Officials Still Uncertain About Pfizer-BioNTech Booster Vaccine

Federal health officials have remained steadfast against the suggested necessity of a regulated booster dose of Pfizer-BioNTech’s COVID-19 vaccine, BNT162b2, according to reports following a meeting between the companies and US health authorities on Monday.

Just 3 days after Pfizer-BioNTech announced intentions to submit real-world clinical data to the US Food and Drug Administration (FDA) in an application for an emergency-authorized third dose of its mRNA vaccine, experts from the US Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) told Pfizer officials that relevant data supporting a booster COVID-19 dose remains inconclusive.

Pfizer’s intention to seek FDA authorization comes at a time when the company is also assessing a booster dose designed to prevent that vastly circulating Delta variant of SARS-CoV-2. The variant has been identified in nearly 100 countries as of this week, and US states with lesser adult COVID-19 vaccination rates have reported weekly new case surges upwards of 50,000.

However, previous research has indicated that available mRNA vaccines BNT162b2 and Moderna’s mRNA-1273 have retained their approximate 90% symptomatic COVID-19 prevention efficacy against more transmissible variants.

Last week, a joint statement from the FDA and CDC reiterated the sustained efficacy of two-dose mRNA vaccines against preventing COVID-19 severe disease and. They noted that efficacy included “variants currently circulating in the country such as Delta.”

“Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated,” they wrote. “Americans who have been fully vaccinated do not need a booster shot at this time.”

Now, the message has been expressed directly to the would-be booster vaccine developers, who have not yet published clinical data on third dose-administered persons.

Israel, the fastest nation to majority adult population vaccination rates after BNT162b2’s Emergency Use Authorization (EUA) grant last December, has begun administering a third dose of the Pfizer-BioNTech vaccine to immunocompromised and heart transplant recipients, according to a report.

The population’s response to the third dose will comprise some of the companies’ FDA-submitted application data in the coming weeks.

Final recommendation on the necessity of booster doses, however, will likely depend on CDC-collected data on breakthrough COVID-19 infections.