FDA authorizes updated COVID-19 vaccines
The number of hospitalizations and deaths in the United States continues to rise.
Photo: Kathrin Ziegler/Getty Images
The Food and Drug Administration has approved and authorized updated COVID-19 vaccines formulated to more closely target current variants.
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.
The FDA announcement, released on Monday, is related to mRNA vaccines for 2023-2024 manufactured by ModernaTX and Pfizer. These vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5, the FDA said.
The bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
WHY THIS MATTERS
COVID-19 vaccines are available for free to everyone 6 months and older living in the United States, regardless of immigration or insurance status, according to the Department of Health and Human Services.
Manufacturers have publicly announced that the updated vaccines would be ready this fall.
First, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices must vote to approve. That vote is scheduled to take place today, along with a discussion of clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals.
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 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 said it 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 from previous mRNA COVID-19 vaccines.
THE LARGER TREND
The number of COVID-19 hospitalizations and deaths continues to track upward, rising 8.7% and 10.5%, respectively, in the most recent week tracked, according to the CDC Data Tracker.
The FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
ON THE RECORD
"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "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."
Twitter: @SusanJMorse
Email the writer: SMorse@himss.org
