The Centers for Disease Control and Prevention on Thursday recommended the updated COVID-19 booster vaccines from Pfizer and BioNTech and Moderna, one day after the Food and Drug Administration granted emergency authorization.
Following the FDA’s clearance, the CDC recommends Pfizer and BioNTech’s new shot for adults and children aged 12 and older, and Moderna’s booster for those 18 and older. Recommendations for children are expected in future weeks, should the FDA also authorize the reformulated vaccines for younger age groups.
The updated “bivalent” shots are designed to target the BA.4 and BA.5 subvariants of omicron, as well as the original coronavirus strain. The FDA urged developers to pursue this approach in June, as the subvariants spread widely.
The BA.5 strain, which has shown the ability to evade immunity from prior vaccination and infection, currently accounts for nearly 90% of COVID-19 cases in the U.S., the CDC estimates.
Data from preclinical studies and human studies of earlier booster formulations suggest the bivalent shots can help restore protection. According to the CDC, the boosters showed a “superior response to omicron,” and increased immune responses. Advisers to the agency considered the risk of side effects to be similar to the original vaccines, although in a meeting Thursday they flagged uncertainty around the rates of a kind of heart inflammation called myocarditis following administration of the bivalent shots.
The FDA and CDC decisions come just before the Biden Administration begins a fall booster campaign to curb an expected spike in COVID-19 cases this winter.
The U.S. government has bought approximately 171 million of the updated booster doses from Pfizer and BioNTech and Moderna. But with federal COVID-19 funds running out, the government has started to plan a transition toward private market sale of vaccines and drugs. U.S. residents could have to pay for their vaccinations as early as January, an HHS official said this week.
Over 200 million individuals are eligible to receive a second booster vaccination. According to the CDC, most individuals between the ages of 5 and 49 are six months or more away from their last vaccine dose and could receive a bivalent shot. For people who have recently contracted COVID-19, the CDC recommends to wait three months after symptoms or a positive test before receiving a booster.
Already the rollout has begun. On Friday, CVS Pharmacy announced the distribution of the new boosters is in progress.