Raising questions about the agency’s reasons behind the decision, the Food and Drug Administration (FDA) has approved a new COVID-19 vaccine.
The Novavax-made shot comes with huge restrictions: only seniors 65+ and high-risk individuals aged 12-64 can access it.
The move limits the scope of this traditional protein-based alternative to the controversial mRNA shots.
Although the FDA imposed strict limitations on Novavax’s vaccine, these do not apply to Pfizer and Moderna vaccines.
This decision effectively blocks healthy Americans under 65 from accessing the only traditional protein-based coronavirus vaccine available in the United States, even if they prefer it to mRNA technology.
The restrictions are particularly concerning as they arrive without explanation from the FDA.
Previously, Novavax’s vaccine had emergency authorization for all individuals 12 and older.
This new approval narrows access considerably despite the vaccine being proven safe and effective in a 30,000-person trial.
Novavax chief executive John C. Jacobs praised the approval:
“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.”
For Americans who have long been skeptical of rushed vaccine approvals and government mandates, this situation presents a troubling contradiction.
While the restrictions might seem to align with calls for vaccine caution, they actually represent another form of government control.
This time, access to a more traditional vaccine option that many Americans might prefer has been limited.
The CDC is poised to debate recommending yearly COVID vaccines for everyone or just high-risk groups, but the FDA’s decision has already restricted Americans’ choices.
Meanwhile, Pfizer and Moderna vaccines remain fully licensed for those 12 and older without similar restrictions.
This creates an uneven playing field that favors the pharmaceutical giants.
The restrictions may reflect a shifting approach to vaccine approvals under pressure from vaccine skeptics, including Health and Human Services Secretary Robert F. Kennedy Jr.
However, rather than providing more freedom for Americans to make informed choices about their health, this decision actually limits options for those who might prefer Novavax’s traditional approach over the newer mRNA technology.
Novavax shareholders have felt the impact of these decisions. The company’s stock price has decreased by 21% since the beginning of the year.
