Novavax’s COVID-19 vaccine is moving forward with full approval from the US Food and Drug Administration (FDA), the company announced Wednesday. This news sent shares soaring 21% in morning trading, alleviating concerns that Trump administration officials might be holding up a decision.
The Novavax vaccine, which uses a traditional protein-based approach, has been sold under emergency use authorization since its release. Unlike mRNA vaccines from Pfizer and Moderna, which have received full FDA approval for certain age groups, the Novavax shot does not yet meet this standard.
In April, the FDA had set a target date to review Novavax’s license, but the agency recently asked the company to collect additional clinical data on those who received the vaccine. The delay was attributed to the Trump administration and concerns of potential political interference under Robert F. Kennedy Jr., a vocal antivaccination advocate.
The delay sparked fears that the FDA might remove the vaccine from the market if it did not meet certain safety standards. However, with full FDA approval, Novavax would be granted permission to keep its shot on the market indefinitely, unlike products authorized under emergency use which can be removed at any time.
Unlike mRNA vaccines, protein-based vaccines like the Novavax have been used for years to prevent other diseases such as hepatitis B and shingles. The three manufacturers update their vaccine recipes annually to match the latest COVID-19 variants.
Source: https://apnews.com/article/fda-vaccine-novavax-kennedy-1ed7d31da33e71d8f054a613b6634799