The FDA approved a new coronavirus booster targeting the BA.4 and BA.5 omicron variants on Wednesday, ahead of an anticipated rise in COVID-19 cases this fall and winter. The BA.4 and BA.5 are currently the two most common variants of the virus in the U.S.
The Moderna version of the new booster has been approved for adults 18 and older, while the Pfizer BioNTech version was approved for persons 12 and older. Now that the FDA has authorized the vaccine boosters, manufacturers can begin shipping the product to clinics, pharmacies, and hospitals.
However, no booster shot can be administered until the CDC recommends it. The Advisory Committee on Immunization Practices is scheduled to review the data on the new booster today. If the advisers recommend the shots and CDC Director Rochelle Walensky concurs, the new boosters may be available to the public as soon as this weekend.
Some medical professionals are concerned that the new booster has not been sufficiently tested. Paul A. Offit, one of the FDA’s vaccine advisers, said it is unclear whether the new booster is more effective than the current version.
In addition, there have not yet been any studies on human subjects for the new vaccine; only trials with mice have been conducted. Eric Topal, a professor of molecular medicine at Scripps Research, noted that the paucity of human data for the new shot could make people wary of it.
Human trials are currently underway, but the resulting data from these trials could be one-to-two months away. Delaying the deployment of the booster shots until then could be too late to prevent or reduce an anticipated COVID-19 surge this fall.
Peter Marks, a top vaccine expert with the FDA, stated that the agency is “very confident” in the new boosters, adding that the mRNA-type vaccines have been administered to billions of people, have a strong safety record, and are well-understood by scientists.
As with previous coronavirus vaccines and boosters, the new version, if recommended by the CDC, will be offered free to the public, paid for by government tax dollars. The U.S. government has already purchased 170 million doses of the new boosters.
How well the new version will be received by the public remains to be seen. According to the CDC, only about 35% of U.S. residents have availed themselves of the previous booster shots.