FDA May Authorize Second Booster Doses for Both mRNA Vaccines Soon

It has been reported that the Food and Drug Administration will give both Moderna and Pfizer Emergency Use Authorizations (EUA) for a second booster dose of their COVID-19 vaccines for adults 50 years and older, according to a report in the NY Times.

The decision is expected to happen prior to the next Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on April 6, according Eric Topol, MD, director of the Scripps Translational Research Institute San Diego.

Earlier this month, both Pfizer and Moderna had applied for EUAs for the second booster doses with the former requesting the authorization in people 65 years and older, and the latter requesting it in people 18 years and older.

At this moment in time, public health officials, clinicians, scientists, and others have mixed opinions on whether the second booster dose in people over 50 is warranted.

In addition, the mRNA vaccines’ effectiveness has been waning quicker with the emergence of the Omicron variant.

The VRBPAC meeting’s agenda includes the following topics:

• What might warrant updating the composition of COVID-19 vaccines to address specific variants.
• Timing and populations for COVID-19 vaccine booster doses in the coming months.

The FDA noted that no vote is planned for the meeting and that they would not be discussing any product-specific applications.