Novavax COVID-19 Vaccine Gets Limited FDA Approval Amid Skepticism

The FDA approved Novavax's COVID-19 vaccine for older adults and at-risk individuals over 12, raising concerns about its limited use. Despite missed deadlines and regulatory hurdles, the approval marks a milestone for Novavax. Discussions continue on vaccine recommendations and the potential need for strain updates.

The U.S. Food and Drug Administration has approved Novavax's COVID-19 vaccine, Nuvaxovid, but limited its use to older adults and those over 12 with health conditions increasing their COVID-19 risk. The approval follows regulatory delays and skepticism from U.S. Health and Human Services Secretary Robert F. Kennedy Jr., who questioned the vaccine's efficacy.

Novavax's Chief Corporate Affairs Officer, Silvia Taylor, expressed that the limited approval aligns with trends indicating a move away from universal vaccine recommendations. Additional approvals may be needed if virus strain updates are required for the forthcoming immunization season, according to Taylor.

While the approval is seen as a milestone, some experts, such as former FDA Chief Scientist Jesse Goodman, argue that the FDA overstepped by restricting access, limiting patients' choice of vaccine. Discussions are ongoing about populations that should receive annual COVID-19 shots.

(With inputs from agencies.)