US regulators grant full approval to Novavax shot but sharply limit eligibility. New studies on heart risks required, raising concerns over future vaccine access.
The US Food and Drug Administration (FDA) has given full approval to Novavax’s Covid-19 vaccine, known as Nuvaxovid, but with significant limitations. The decision, announced on Friday, restricts the shot’s use to people aged 65 and older, and individuals aged 12 to 64 who have at least one underlying medical condition that increases the risk of severe illness.
This move marks a shift in federal vaccine policy, as previous approvals did not impose such clinical criteria on eligibility. According to Reuters and The New York Times, the approval introduces new research requirements and tightens access, raising concerns among healthcare professionals and patients alike.
Approval includes major access restrictions and costly conditions
Unlike earlier Covid-19 vaccine approvals, which were guided primarily by recommendations from the Centers for Disease Control and Prevention (CDC), this latest action by the FDA imposes medical eligibility conditions as part of the regulatory approval itself.
According to the FDA’s approval letter, only individuals over 65, or those over 12 with at least one qualifying health condition, are now authorised to receive the vaccine.
The letter, however, does not define which specific conditions qualify, creating ambiguity for healthcare providers. CDC data typically considers conditions such as asthma, diabetes, obesity, and pregnancy as risk factors for severe Covid-19, but the lack of clarity could lead to inconsistent application in clinical settings.
Prescribing the vaccine to healthy individuals under 65 may be considered “off-label” use, which could hinder insurance reimbursement and access.
This decision diverges from past practice, where eligibility was determined after approval by CDC advisory panels. As Dr Paul Offit from the Children’s Hospital of Philadelphia told the New York Times, “I think we’re left confused about what this means for the consumer.”
Post-marketing studies imposed amid safety concerns
As part of the FDA’s approval, Novavax is now required to conduct new post-marketing studies focusing on potential links between the vaccine and rare cases of myocarditis and pericarditis—inflammations of the heart or surrounding tissue. These side effects were observed in small numbers during clinical trials.
While some of the safety data can be gathered retrospectively, one of the studies may require tracking thousands of healthy participants aged 50 to 65 over time. According to experts cited by the New York Times, such research could cost tens of millions of dollars, potentially straining the company’s finances.
Dr Ofer Levy, director at Boston Children’s Hospital, noted the challenge: “We’ve got to make sure the vaccine safety is crystal clear… where’s that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?”
Novavax CEO John Jacobs called the approval a “significant milestone” but acknowledged the hurdles ahead in making the vaccine widely available.
