FDA OKs New Monovalent COVID-19 Vaccines
13 Sept 2023 • The U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.
What You Need to Know
- Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least two months after the last dose of any COVID-19 vaccine.
- Individuals 6 months through 4 years of age who previously were vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine. Timing and number of doses to administer depend on the previous COVID-19 vaccine received (see resources).
- Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated authorized Moderna COVID-19 vaccine.
The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age.
Source: FDA | Read full story