FDA Restrictions Could Push COVID Shot Prices to $225

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Millions of Americans may struggle to find Covid-19 vaccines this fall, and the shots they do find are likely to be more expensive after the Food and Drug Administration this week narrowed their approvals.

The FDA on Wednesday approved Covid-19 boosters from Moderna Inc., Pfizer Inc., and Novavax for individuals with qualifying conditions that put them at greater risk for the virus. The shots are also approved for seniors age 65 and older, while age limits for children vary by manufacturer.

The Centers for Disease Control and Prevention is expected to follow suit, meaning health plans, which follow CDC recommendations, will no longer have to cover the costs of the vaccines for many policy holders.

Anyone under 65 without an underlying condition would technically be seeking the vaccine “off label,” potentially exposing them to high out-of-pocket costs if their health plans don’t choose to cover the shots more generally.

Moderna and Pfizer vaccines cost $225 at CVS pharmacies without insurance, a spokesperson for the retailer said. Sanofi SA, which partnered with Novavax to roll out its Covid vaccine, said the list price for its shot, which starts lower than the retail price, will likely be similar to the others.

The uncertainty is the latest to surface under the tenure of Health and Human Services Secretary Robert F. Kennedy, Jr., a prominent vaccine skeptic who is radically overhauling longstanding policy related to immunizations. But the vaccines’ narrowed eligibility also largely aligns with the World Health Organization’s recommendations, which several European countries are already following.

Questions around how the CDC will recommend the shots’ use also sharpened after Kennedy recently confirmed Director Susan Monarez, prompting a trio of senior CDC leaders to resign in protest.