New versions of the two most popular COVID-19 vaccines that specifically target the Omicron variant are now available for use in the United States.
The U.S. Food and Drug Administration changed the emergency use authorizations for the Pfizer and Moderna vaccines this week to include “updated boosters” for both shots meant to protect against the contagious variant. The Pfizer booster is authorized for adults and children 12 and older, while the Moderna dose is authorized for adults 18 and older.
According to Reuters, the Centers for Disease Control and Prevention will work on a recommendation at the end of this week, and use of the boosters could begin as early as this weekend. Pfizer reportedly has several million doses of its updated shot ready to ship immediately.
FDA Commissioner Dr. Robert Califf, MD, reiterated that the vaccines are safe and effective, and having a Omicron-specific booster is important as the weather changes toward the end of the year.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes of COVID-19,” he said in the FDA statement. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
The updated boosters contain mRNA from the original strain of the virus plus mRNA targeting the BA.4 and BA.5 strains of the Omicron variant.
The director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, MD, PhD, said the Administration has been working to include Omicron protection in vaccines for some time and that the new formula has been thoroughly tested.
“We sought input from our outside experts on the inclusion of an Omicron component in COVID-19 boosters to provide better protection against COVID-19,” Marks said in the FDA statement. “We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations.”
The FDA says both vaccines went through clinical testing with hundreds of participants, and researchers found improved immune responses in people who received both boosters in addition to a primary phase of vaccines.
For all adults, the CDC currently recommends a primary series of two shots for both the Pfizer and Moderna vaccines, with a single booster at least five months after the second shot. For adults over 50, a second booster (or a fourth dose overall) is recommended for people four months removed from their first booster shot. The booster shots can be Pfizer or Moderna, regardless of the vaccines in the primary series.