FDA Asks Pfizer/BioNTech, Moderna To Expand COVID-19 Vaccine Trials In Children: NYT

Pfizer Inc PFE - BioNTech SE BNTX and Moderna Inc MRNA will expand the size of ongoing COVID-19 vaccine trials in children ages five to 11 to detect potential rare side effects, The New York Times reports.

What Happened: The trial expansions come at the urging of the FDA, a precautionary measure designed to detect rare side effects, including heart inflammation problems that turned up in vaccinated people younger than 30.

The agency informed the companies that the size and scope of their pediatric studies were inadequate to detect rare side effects in mRNA vaccines. The FDA has asked that 3,000 children in the age group be included in the studies.

A spokesman for Moderna, Ray Jordan, confirmed that the company intends to expand its trial “to enroll a larger safety database which increases the likelihood of detecting rarer events” and expects to seek emergency authorization in “winter 2021/early 2022.”

Why It Matters: The Moderna trial began recruiting patients in March and aims to enroll 6,795 participants between six months and less than 12 years. Mr. Jordan said the company is “actively discussing” a proposal with the FDA.

On the other hand, Pfizer may be able to meet the FDA’s expectations on a bigger trial size and still file a request to expand emergency authorization by the end of September. 

Price Action: PFE shares are up 0.3% at $41.82, BNTX stock is +0.6% at $283.77, while MRNA shares are down 2.3% at $340.82 during the market session the last check Monday.

Photo by Johaehn from Pixabay