Pfizer/BioNTech may not win FDA renewal for pediatric COVID shot: report

The U.S. Food and Drug Administration (FDA) is unlikely to renew the authorization granted to use Pfizer (NYSE:PFE) and BioNTech’s (BNTX) COVID-19 vaccine in young children this fall, The Guardian reported, citing an email sent by a federal agency tasked with immunizations.

The messenger RNA-based shot marketed as Comirnaty for those aged 12 years and above is currently available in the U.S. under the regulator’s emergency use authorization (EUA) for children between the ages of six months and four years.

According to an email from the National Center for Immunization and Respiratory Diseases, Pfizer (NYSE:PFE) has disclosed a communication from the FDA, which suggested the EUA granted for its pediatric COVID shot may not be renewed for the 2025 respiratory season.

The move is expected to allow Moderna (MRNA) to market its messenger RNA-based shot for the age group after the Cambridge, Massachusetts-based biotech received FDA approval in July to use its Spikevax vaccine in children as young as six months.

The email from the NCIRD further indicated Pfizer’s (NYSE:PFE) expectations of a potential full FDA licensing of its vaccine for those aged five to 11 years and the CDC’s ongoing discussions with Moderna (MRNA) to ramp up its vaccine supplies for young children.

Novavax (NVAX), the third player in the U.S. COVID vaccine market, can only target children aged 12 years and above with its protein-based COVID vaccine, Nuvaxovid.