FDA Approves Updated COVID Vaccines from Pfizer and Moderna

The Food and Drug Administration (FDA) has granted clearance for new versions of Pfizer's and Moderna's COVID-19 vaccines, which have been reformulated to better match the currently circulating strains of the virus in the U.S. These updated vaccines target the KP.2 strain, which was predominant in the spring and is part of the broader JN.1 lineage. The FDA's new clearance allows individuals aged 12 and older to receive a single dose of the updated vaccines. Additionally, an emergency use authorization has been issued for children aged 6 months to 11 years, with dosing adjusted based on age and previous doses received.

The FDA has adopted a strategy similar to its approach for influenza vaccines, holding discussions in the spring and summer to determine the most appropriate strain for the new vaccines. Initially, the focus was on the JN.1 variant, but it was later refined to target the KP.2 strain specifically. The updated vaccines are expected to not only target the KP.2 strain but also offer immune responses that could protect against other strains within the JN.1 lineage.

This approval comes ahead of the fall and winter seasons, which are typically associated with an increase in COVID-19 cases and hospitalizations. Given the waning immunity from previous exposure to the virus and prior vaccinations, the FDA strongly encourages those eligible to get the updated vaccine for better protection against current variants. Peter Marks, head of the FDA's office that reviews vaccines, emphasized this in a statement.

Pfizer, in partnership with BioNTech, announced that shipping of their reformulated vaccine would begin immediately, with doses expected to be available within days. Moderna has also indicated that its updated shot will be available in pharmacies and clinics shortly. Both companies are utilizing similar manufacturing processes as with previous vaccine versions, and their approvals were based on the FDA's review of manufacturing data and nonclinical studies showing the vaccines' safety and effectiveness. Expected side effects include injection site pain and headaches, consistent with previous boosters.

Peter Marks noted that the updated vaccines meet the FDA's rigorous scientific standards for safety, effectiveness, and manufacturing quality. In addition to Pfizer and Moderna, Novavax has developed an updated version of its COVID-19 vaccine, which is protein-based, unlike the mRNA shots by Pfizer and Moderna. Novavax has also submitted an application for authorization to the FDA.

In June, the Centers for Disease Control and Prevention (CDC) recommended that everyone aged 6 months and older receive an updated COVID-19 vaccine when they become available. Despite the anticipated rise in vaccine uptake this fall, both Pfizer and Moderna have reported declining revenues from their COVID-19 vaccines in recent quarters. Consequently, investors have shifted their focus towards the companies' development of combination shots and vaccines for respiratory syncytial virus (RSV).