Oh no! Do I have COVID-19 again? Photo by Ayo Ogunseinde on Unsplash
On August 22, 2024, the U.S. Food and Drug Administration (FDA) approved and granted emergency use authorization (EUA) for the updated mRNA COVID-19 vaccines (2024-2025 formula).
This comes just in time, as the COVID-19 numbers are climbing again.* Covid is actively growing in the following states: South Dakota, Nebraska, New Mexico, Illinois, Indiana, Kentucky, Tennessee, Alabama, Georgia, West Virginia, Massachusetts and Maine.
It is believed the following states are “likely growing”: Michigan, Washington, Idaho, California, Arizona, Oklahoma, Minnesota, Iowa, Ohio, Pennsylvania, Rhode Island and Vermont.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
Marks added: “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
The new vaccine is a monovalent, or single component as others have been, but they have been updated to more closely target currently circulating variants, namely Omicron variant KP.2 strain of SARS-CoV-2.
The updated mRNA COVID-19 vaccines are being made by ModernaTX Inc. and Pfizer Inc.
The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks.
The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age.
What You Need to Know
- 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.
- 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 the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
- Individuals 5 years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines. If previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine.
- Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated. The dose is administered at least 2 months since the last dose of any COVID-19 vaccine.
- Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine fact sheets.
The FDA anticipates that the COVID-19 vaccines will need to be assessed annually, the same as seasonal influenza vaccines.
The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc.
The approval of Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to ModernaTX Inc., and the EUA amendment for the Moderna COVID-19 Vaccine (2024-2025 Formula) was issued to ModernaTX Inc.
https://www.cdc.gov/cfa-modeling-and-forecasting/rt-estimates/index.html
*As of May 10,2024, Rt is estimated using data on Emergency Department visits reported through the National Syndromic Surveillance Program (NSSP). Prior to May 10,2024, Rt was estimated using data on COVID-19 and influenza hospital admissions. Preliminary internal comparisons showed that data on emergency department visits and hospital admissions produced similar Rt estimates. Estimates of influenza Rt have ended for the 2023-2024 season and will begin again in fall 2024.