Moderna Inc (NASDAQ:MRNA, XETRA:0QF) stock fell sharply on the news that the Food and Drug Administration (FDA) plans to implement stricter approval requirements for vaccines.
The announcement raised investor concerns about potential delays and increased scrutiny for the company’s pipeline of new products.
The FDA issued an internal memo late last week detailing enhanced safety testing requirements for vaccine approvals. The changes are expected to affect Moderna’s development timeline for upcoming vaccines, including a seasonal flu shot and a combined flu/COVID vaccine.
The stricter rules come amid reports linking COVID-19 vaccines to pediatric deaths and calls for heightened oversight of vaccines, particularly those targeting children, pregnant individuals, and seasonal flu.
Vinay Prasad, a senior FDA official, cited the deaths of 10 children in the memo and indicated that the agency would require vaccine makers to conduct additional testing to address safety concerns.
The announcement weighed on the stocks of companies heavily reliant on COVID-19 vaccine revenue. Moderna stock was down 6%, while Novartis AG (ADR) (NYSE:NVS) also saw its shares down more than 3%.