The debate over whether and how broadly to approve additional “booster” doses of COVID-19 vaccines is expected to play out this month. This much is certain: The FDA’s Vaccines and Related Biological Products Advisory Committee will discuss whether to recommend booster doses for the Pfizer/BioNTech COVID-19 vaccine (COMIRNATY®, BNT162b2) meets on September 17.
After that, it’s anyone’s guess what will happen. The FDA typically follows the recommendations of its advisory panels—as it did last December when it granted an emergency use authorization (EUA) for Pfizer and BioNTech, followed a week later by an EUA for Moderna (mRNA-1273, marketed in Europe as Spikevax®), and in February by an EUA for Johnson & Johnson (Janssen Pharmaceutical Cos)’s single-shot COVID-19 vaccine.
