FDA Simplifies COVID-19 Vaccines

On April 18, 2023, the FDA authorized an amendment to the Emergency Use Authorization (EUA) for COVID-19 bivalent vaccines for all patients ages 6 months and older. Monovalent COVID-19 vaccines offered through Pfizer-BioNTech and Moderna are no longer authorized in the United States

Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNACOVID-19 Vaccines

The amended EUA provides the following information:

- Patients who had a monovalent COVID-19 vaccine only may receive one bivalent vaccine

- Unvaccinated patients may receive one bivalent vaccine

- Most patients who have already had one dose of bivalent are considered fully vaccinated at this time. The FDA may revise this decision after the FDA Advisory Committee meeting in June

Exceptions to this include:

- Patients aged 65 or older ? may receive an additional bivalent vaccine at least four months following the first

- Patients with immunocompromised conditions ? may receive an additional bivalent vaccine at least two months following the first with additional doses as determined by the healthcare provider The FDA states there are additional considerations for patients aged 6 months ? 4 years

The FDA offers additional recommendations for children ages 6 months through 5 years depending upon previous COVID-19 vaccination administrations