On Monday 9/11/23, the FDA took significant actions concerning COVID vaccines, focusing on those from Moderna and Pfizer-BioNTech. These vaccines are being updated to target the omicron variant XBB.1.5. While this variant has been replaced by others, early research suggests the updated vaccines will offer protection against these new variants. The FDA approved the use of updated Comirnaty (Pfizer-BioNTech) for those 12 and older, Spikevax (Moderna) for those 18 and older, and authorized their use for emergency use in children aged 6 months to 11 years.
On Tuesday, the Advisory Committee on Immunization Practices will convene to discuss the vaccines’ recommendations. They may suggest universal use or focus on high-risk individuals. This committee advises the CDC and will discuss vaccine safety, effectiveness, economic aspects, and long COVID. The CDC Director, Mandy Cohen, will need to approve any recommendations. Moderna and Pfizer-BioNTech are ready to deliver vaccines once recommendations are issued. Importantly, the government will no longer fully cover COVID-19 vaccination costs, potentially requiring uninsured individuals to pay $110 to $130 per shot.
Additionally, the Novavax vaccine, a protein-based alternative to mRNA vaccines, has arrived in the U.S., but it was not covered in the FDA’s recent actions. Novavax will present updated data at the committee meeting, with the FDA considering emergency authorization for those aged 12 and up.
| Vaccine (XBB.1.5.) | Manufacturer | Doses | Approved for Age | Authorized for Emergency Use in Children aged 6 months to 11 years |
| Comirnaty | Pfizer-BioNTech | 1 | 12 years of age and Older | Yes |
| Spikevax | Moderna | 1 | 12 years of age and Older | Yes |
The Pharmers Almanac 