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WASHINGTON — Novavax’s COVID-19 vaccine is progressing toward complete approval following further discussions with the Food and Drug Administration (FDA), the company announced Wednesday. This development signals a potential resolution to earlier concerns regarding delays in the approval process.
Novavax Shares Surge Amid FDA Approval Progress
The announcement triggered a surge in company shares, escalating by more than 21% in morning trading. This positive market response indicates a dissipation of anxieties that previous administrative obstacles might have impeded the vaccine’s progress.
Novavax’s Unique Protein-Based COVID-19 Vaccine
Novavax produces the nation’s singular, traditional protein-based COVID-19 vaccine. It currently operates under an emergency use authorization, unlike the mRNA vaccines developed by Pfizer and Moderna, which have already secured full FDA approval for specific age demographics.
Path to Full FDA Approval
The FDA recently requested Novavax to formulate a strategy for gathering supplementary clinical data from vaccine recipients, as detailed in a company statement. Novavax has stated it is “engaging with the FDA expeditiously” to obtain final approval “as soon as possible.”
The Significance of Full Approval
Full FDA approval is considered the regulatory gold standard for vaccines. According to sources familiar with the matter, the FDA was initially poised to approve Novavax’s license by its target date in April.
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Concerns and Delays
However, reports indicate that the agency’s acting commissioner instructed a pause on the decision, raising concerns about potential interference. Last month also saw changes in FDA leadership concerning disagreements over vaccine safety.
Implications of Full Approval for Novavax
With complete FDA endorsement, Novavax would be authorized to maintain its COVID-19 vaccine on the market indefinitely. Products under emergency authorization can be withdrawn by the FDA if the health emergency subsides.
How Novavax Works
All COVID-19 vaccines in use within the U.S. work by preparing the body to combat the coronavirus through recognition of its external coating, known as the spike protein.
Comparing Vaccine Technologies
- Pfizer and Moderna vaccines utilize genetic instructions to prompt the body to temporarily produce copies of the protein.
- Conversely, the Novavax vaccine employs lab-cultivated copies of the spike protein, encapsulated in nanoparticles and combined with an ingredient that boosts immune response.
Protein-based vaccines have a longstanding history of use in preventing diseases such as hepatitis B and shingles.
Annual Updates to Vaccines
Annually, all three manufacturers refine their COVID-19 vaccine formulations to better align with emerging variants, mirroring the approach used for flu shots.