New Vaccines Target Current Variants and Enhance Protection Against Covid Variants
By Dolores Quintana
On Monday, September 11, the U.S. Food and Drug Administration (FDA) took a significant step by granting approval and emergency use authorization for updated COVID-19 vaccines. These vaccines have been reformulated to specifically target the presently circulating variants and enhance protection against severe COVID-19 outcomes, including hospitalization and fatalities.
The approvals pertain to the 2023-2024 versions of mRNA vaccines manufactured by ModernaTX Inc. and Pfizer Inc. Notably, these updated vaccines now incorporate a monovalent (single) component designed to combat the Omicron variant XBB.1.5. The bivalent vaccines from last year will no longer be in use.
On Tuesday, the CDC’s experts will meet to make recommendations as to who should be getting the new vaccine this fall. Once they make their recommendations and the CDC director signs off, the new vaccine shots could be available later this week.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death. The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
- Individuals aged 5 years and older, regardless of prior vaccination status, are eligible to receive a single dose of the updated mRNA COVID-19 vaccine, provided that at least 2 months have passed since their last COVID-19 vaccine dose.
- For individuals aged 6 months through 4 years, who have previously received a COVID-19 vaccine, one or two doses of the updated mRNA COVID-19 vaccine are recommended. The specific timing and number of doses will depend on the previous COVID-19 vaccine received.
- Unvaccinated individuals aged 6 months through 4 years are eligible to receive either three doses of the updated authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated authorized Moderna COVID-19 Vaccine.
- The FDA has full confidence in the safety and efficacy of these updated vaccines, with a comprehensive benefit-risk assessment demonstrating that the benefits far outweigh the risks for individuals aged 6 months and older.
- Individuals who receive an updated mRNA COVID-19 vaccine may experience side effects similar to those reported by recipients of prior mRNA COVID-19 vaccines, as outlined in the respective prescribing information or fact sheets.
- These updated vaccines are expected to offer robust protection against COVID-19, even in the face of current variants. The FDA foresees that, unless a significantly more virulent variant emerges, the composition of COVID-19 vaccines may need annual updates, akin to the seasonal influenza vaccine.
- On September 12, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will convene to discuss clinical recommendations regarding who should receive the updated vaccine. Further considerations will be made for specific populations, including immunocompromised and elderly individuals.
- Manufacturers have publicly announced the availability of these updated vaccines for this fall. The FDA anticipates that they will be accessible to the public in the near future.