FDA Approves Novavax COVID-19 Vaccine Under Strict Conditions
The approval is limited to specific high-risk populations amidst ongoing health policy changes.
The U.S. Food and Drug Administration (FDA) has officially approved the complete authorization of the Nuvaxovid COVID-19 vaccine developed by Novavax, a move that comes after an unusual delay beyond the agency's initial commitment to reach a decision by April 1, 2025. The vaccination was previously available under emergency use authorization for individuals aged 12 and older.
This extended approval, announced on May 19, specifically targets two well-defined segments of the population: Americans aged 65 and older, as well as those aged 12 to 64 who suffer from comorbidities placing them at a higher risk of severe COVID-19 outcomes.
John Jacobs, the president of Novavax, expressed optimism regarding the approval, noting that it enhances access for specific at-risk groups to a non-mRNA vaccine.
Unlike mRNA vaccines from Pfizer-BioNTech and Moderna, Novavax's vaccine utilizes a more traditional technology akin to that used in the pertussis vaccine.
This narrowing of the vaccine's eligibility comes amid apprehensions in the medical community regarding ongoing revisions in health policy, particularly under the current administration and the leadership of Health Secretary Robert Kennedy Jr. The latter has been known for disseminating vaccine misinformation and appointing several vaccine-skeptical figures to significant public health positions.
The shift in approval conditions may prompt further scrutiny of U.S. vaccination strategies as public health officials navigate the complexities of vaccine uptake and community health safety.
This extended approval, announced on May 19, specifically targets two well-defined segments of the population: Americans aged 65 and older, as well as those aged 12 to 64 who suffer from comorbidities placing them at a higher risk of severe COVID-19 outcomes.
John Jacobs, the president of Novavax, expressed optimism regarding the approval, noting that it enhances access for specific at-risk groups to a non-mRNA vaccine.
Unlike mRNA vaccines from Pfizer-BioNTech and Moderna, Novavax's vaccine utilizes a more traditional technology akin to that used in the pertussis vaccine.
This narrowing of the vaccine's eligibility comes amid apprehensions in the medical community regarding ongoing revisions in health policy, particularly under the current administration and the leadership of Health Secretary Robert Kennedy Jr. The latter has been known for disseminating vaccine misinformation and appointing several vaccine-skeptical figures to significant public health positions.
The shift in approval conditions may prompt further scrutiny of U.S. vaccination strategies as public health officials navigate the complexities of vaccine uptake and community health safety.
