In a blow to vaccine choice, the Food and Drug Administration (FDA) has severely limited the only traditional protein-based COVID vaccine available to Americans.
Specifically, Novavax’s COVID-19 shot received full approval but with harsh restrictions.
Healthy Americans under 65 will not be able to access this alternative to Pfizer and Moderna’s mRNA options.
The FDA quietly announced that Novavax’s COVID-19 vaccine would only be available to adults 65 and older or those aged 12 to 64 with underlying health conditions that put them at higher risk from COVID-19.
This decision significantly narrows who can receive this vaccine compared to its previous emergency authorization status, which had allowed its use in all Americans 12 and older.
Unlike the mRNA shots from Pfizer and Moderna, Novavax uses a traditional protein-based technology that many vaccine-hesitant Americans have been seeking.
For those concerned about the relatively new mRNA technology, Novavax represented the only mainstream alternative in the U.S. market.
The FDA’s approval letter did not provide any substantive explanation for these unprecedented restrictions.
Novavax’s vaccine was proven safe and effective in a large 30,000-person clinical trial.
The company’s stock has plummeted 21% since the beginning of the year as investors react to the agency’s handling of the approval process.
According to reports, the FDA had initially planned to grant full approval without restrictions by April 1 but changed course and imposed additional trial requirements.
Novavax chief executive John C. Jacobs stated:
“Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option.”
While Jacobs attempted to put a positive spin on the decision, others criticized the FDA’s actions as limiting Americans’ freedom to choose their preferred vaccine technology.
This decision comes as Health and Human Services Secretary Robert F. Kennedy Jr., a noted vaccine safety advocate, has gained influence in health policy discussions.
The restrictions reflect a growing skepticism about vaccines from health leaders who question the need for universal COVID vaccination policies, particularly for young healthy individuals at minimal risk from the virus.
“This is incredibly disappointing,” said infectious disease physician Dr. Camille Kotton.
She added,” I don’t know why they would make this restriction; I don’t know of any indication to make this change. This is a dark day in American medicine.”
The FDA’s actions have far-reaching implications. The CDC’s scientific advisers are currently debating vaccine recommendations for vulnerable Americans, but these discussions are now constrained by the FDA’s decision to limit vaccine options.
Meanwhile, Pfizer and Moderna vaccines remain fully licensed for those 12 and older and authorized for children as young as 6 months, maintaining their dominance in the vaccine marketplace.
For Americans seeking alternatives to mRNA technology, this decision represents a blow that limits personal health choices.
Many citizens who remain cautious about newer vaccine technologies are now left with fewer options.
