FDA advisory panel to convene to consider second booster dose

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster dose.

Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster. 

Pfizer and its partner BioNTech SE (Nasdaq:BNTX) are seeking authorization for a second booster in adults 65 and older, while Moderna is hoping FDA will authorize a second booster in adults 18 and older. 

The VRBPAC does not plan to discuss any product-specific applications, and there is no vote scheduled for the meeting. 

Instead, the VRBPAC will discuss broader considerations. In particular, they will focus on the timing and populations for booster doses in the coming months and what criteria might dictate when COVID-19 vaccines need to be updated based on circulating SARS-CoV-2 variants. 

“Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a news release. “Bringing together our panel of expert scientific external advisors in an open, transparent discussion about booster vaccination is an important step to gain insight, input and expert advice as we begin to formulate the best regulatory strategy to address COVID-19 and virus variants going forward.”

While several studies indicate that the protection of a booster dose fades within a matter of months, protection against COVID-19–related hospitalization and death remains strong. 

Federal authorities have already authorized a fourth dose for moderately to severely immunocompromised individuals. Experts, however, remain divided regarding the role of a second booster in the broader public. 

In the United Kingdom, authorities recently greenlighted a fourth dose for individuals 75 and older. 

A number of additional; countries such as Israel, Chile and Denmark have also begun administering fourth doses of the COVID-19 vaccine.