The Food and Drug Administration (FDA) today gave its official Blessing Granted to Novavax’s COVID-19 vaccine, a decision long awaited by some swaths of industry insiders. This full approval is saddled with stranglehold limits. The FDA has cleared the vaccine, but only for use in adults 65 and older. It is available for the same age group (12-64) who have one or more underlying health conditions that increase their risk of severe illness from COVID-19.
The FDA’s approval letter, released on Friday, failed to explain the reasoning for these limitations. This failure to explain has deepened confusion about the agency’s position and further fanned the flames of historic anti-vaccine sentiment. Some critics point to the influence of Health Secretary Robert F. Kennedy Jr. and former officials from the Trump administration as contributing factors to these unusual constraints.
According to market research and statistics from the CDC, older adults are more likely to pursue seasonal COVID-19 vaccinations. It turns out that people with pre-existing health concerns show a high desire to be vaccinated. This trend further bolsters the FDA’s more focused approach with its recent 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,” – John C. Jacobs, Novavax chief executive.
The decision comes as these discussions have largely unfolded inside the CDC over whether or not to recommend yearly COVID vaccinations. Advisers will determine whether making these vaccinations is necessary for all individuals. Further, they will decide whether or not they should be restricted to people designated as being at increased risk.
That approval of Novavax’s vaccine came at long last more than a year later. In addition, the pharma company was committed during that time to an aggressive regulatory environment. This approval does not include the general population, only certain groups. Yet critical questions about longer-term vaccination strategies go unanswered.
