New COVID-19 Vaccine gets FDA approval

Recently, the FDA has granted emergency authorization for the latest COVID-19 vaccine, marking a significant departure from previous vaccines as it does not primarily target the original "ancestral" strain of the virus. Unlike last year's bivalent vaccine that aimed to cover both older and newer strains, this newly authorized vaccine is "monovalent," designed to specifically combat the health risks, hospitalizations, and fatalities associated with more recent variants such as the XBB.1.5 Omicron subvariant.

Additionally, it is anticipated to offer some degree of protection against closely related variants currently in circulation. It's important to note that the FDA's emergency authorization covers vaccines produced by both Pfizer and Moderna.

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 2 months since the last dose of any COVID-19 vaccine.

Individuals 6 months through 4 years of age who have previously been 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 depends on the previous COVID-19 vaccine received).

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 FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.

Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.

The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.

Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.