The U.S. Food and Drug Administration on Monday approved updated COVID vaccines from Moderna Inc. and Pfizer Inc., opening the door for the shots to hit the commercial market.
The FDA approved the new mRNA shots as single-dose vaccines for people 12 and older and gave the shots emergency-use authorization for children as young as 6 months. Both Pfizer PFE, -0.88% and Moderna MRNA, -1.82% said they expect the shots to be available in the coming days.
The new vaccines were designed to target the omicron subvariant XBB.1.5, which was dominant at the time the shots were being developed but has since declined. But the updated shots also appear to be effective against newer variants, according to the vaccine makers.
The Centers for Disease Control and Prevention’s advisory committee on immunizations has scheduled a meeting on Tuesday to discuss and vote on updated COVID vaccine recommendations, with the final decision to be made by CDC director Dr. Mandy Cohen. After the CDC makes its recommendation, the vaccines will enter the commercial market — raising new questions about accessibility for people who lack insurance to cover the cost of the shots, which are expected to have a list price of $110 to $130 per dose. The federal government previously purchased COVID vaccines and made them available for free.
The decision comes as COVID cases are once again on the rise. New hospital admissions climbed nearly 16% in the week ending Aug. 26.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The EG.5 variant, known as Eris, is now dominant in the U.S., accounting for more than 21% of new cases in the two weeks ending Sept. 2, according to the CDC. Pfizer and Moderna have said their updated shots appear to be effective against several omicron variants, including EG.5.1 and BA.2.86, known as Pirola, which is being closely tracked because it has a large number of mutations.
Novavax Inc., which also has an updated COVID shot in the works, was not included in the FDA action Monday. Novavax shares NVAX, -11.57% were down more than 9% on Monday.
People who have health insurance will still generally be able to receive the COVID vaccines with no out-of-pocket cost, experts say. For those who are uninsured, the picture is less clear. The CDC this summer announced a new program to provide free COVID shots. Last month, the agency said the shots would be provided through local health departments and federally qualified health centers starting in mid-September but may not be available at retail pharmacies until mid-October. Asked for an update on the timeline, a CDC spokesperson said Monday that the agency plans to release more information on the program later this week.
Pfizer has said the list price for its updated shot will be $110 to $130 per dose for patients 12 and older. The company also said eligible U.S. residents without health coverage will have free access to the updated shot through its patient-assistance program. Moderna did not respond to questions from MarketWatch about pricing but has previously said its list price will be around $130.
Pfizer and its vaccine partner BioNTech BNTX, -1.87% have been manufacturing the vaccine in advance to ensure supplies are available ahead of the fall and winter season, the companies said in a statement Monday. Moderna said in a release Monday that with the FDA’s decision, it will begin shipping doses to vaccination sites across the U.S.
Pfizer, BioNTech and Moderna shares moved lower on Monday, dropping roughly 1% to 2%.