The Food and Drug Administration signed off on a reformulated COVID-19 booster shots Wednesday designed to target the omicron variant just in time for fall.
“The FDA’s authorization of our updated bivalent booster, mRNA-1273.222, provides Americans with access to broader protection against Omicron variants,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Receiving a booster that specifically targets the Omicron BA.4/.5 variant, currently the most prevalent strain of SARS-CoV-2, is an important public health measure that people can take to help protect themselves, especially as we head into a season filled with indoor gatherings. We are grateful to the FDA for their decisive leadership.”
mRNA-1273.222, which targets the BA.4/.5 subvariants of Omicron, was developed under guidance from the U.S. FDA, which based today’s authorization on pre-clinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying mRNA-1273.214, another Omicron-targeting bivalent booster vaccine developed by Moderna. In addition, a vast and growing body of real-world evidence provides strong evidence for the effectiveness and safety of mRNA-1273, the original Moderna COVID-19 vaccine which is the basis for the company’s updated, bivalent vaccines. A Phase 2/3 clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year.
AM I ELIGIBLE FOR THE BOOSTER SHOT?
The updated boosters are only for people who have been fully vaccinated for at least two months or have received the most recent COVID-19 booster shot, the FDA stated. People 18 and older would be eligible for a single booster dose of the Moderna COVID-19 bivalent vaccine. Individuals 12 and older would be eligible for a dose of the Pfizer-BioNTech COVID-19 bivalent vaccine.
- CVS Pharmacy offers Pzifer and Moderna boosters, depending on the location. It also offers shots at its locations inside Target. Appointments can be made here.