The Food and Drug Administration authorized updated versions of the COVID-19 vaccines on Wednesday developed by Pfizer and Moderna to target the Omicron strains of the virus.
The shots should be available after Labor Day, despite the lack of data from human trials. The FDA approved the retooled mRNA vaccines as Pfizer said its human trial was underway.
The BA.5 variant comprises the majority of COVID cases currently reported in the U.S. The new vaccines target the strain directly.
This approval came without input from an FDA advisory committee, suggesting the agency’s new approach will mirror the flu vaccine. Both companies submitted requests for emergency authorization last week.
The updated formulas include each company's original vaccine with a new one that targets both the BA.4 and BA.5 variations. Pfizer's vaccine is 30 micrograms and can be given to people 12 or older. Moderna's 50-microgram dose is authorized for adults 18 and older.
The Centers for Disease Control and Prevention must still recommend approval of the vaccines for them to get into arms. The CDC's vaccine advisory group meets Thursday for an expected vote.
Some healthcare workers worry the public will hesitate to get the reformatted shots without more information.