Novavax says its COVID-19 shot is on track for full FDA approval after delay

WASHINGTON — Novavax’s closely watched COVID-19 vaccine is on track for full approval after additional discussions with the Food and Drug Administration, the company said Wednesday.

The news sent company shares soaring more than 21% in morning trading and appeared to resolve concerns that Trump administration officials might be holding up a decision on the shot.

Novavax makes the nation’s only traditional protein-based COVID-19 vaccine. It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups.

The FDA recently asked Novavax to develop a plan for collecting additional clinical data from those who have gotten the shot, the company said in a statement. It said it is ‘’engaging with the FDA expeditiously’’ in hopes of receiving approval ‘’as soon as possible.‘’

At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters.

But FDA’s acting commissioner, Dr. Sara Brenner, directed the agency’s lead official overseeing the vaccine to pause the decision, according to one of the people. The delay, first reported by The Wall Street Journal, sparked concerns of political interference under Robert F. Kennedy Jr., who spent decades leading antivaccine groups before joining the federal government as health secretary.

Last month, FDA’s longtime vaccine chief, Dr. Peter Marks, was forced out over disagreements with Kennedy about vaccine safety.

With full FDA approval, Novavax would have permission to keep its shot on the market indefinitely. Products that receive emergency authorization can be removed by FDA after there is no longer a health emergency.

All the COVID-19 vaccines used in the U.S. train the body to fight the coronavirus by recognizing its outer coating, the spike protein.

The Pfizer and Moderna options deliver genetic instructions for the body to temporarily make copies of the protein. In contrast, the Novavax vaccine uses lab-grown copies of the spike protein packaged into nanoparticles and combined with an immune-revving ingredient. Protein-based vaccines have been used for years to prevent other diseases including hepatitis B and shingles.

Each year, the three manufacturers update their vaccine recipes to better match the latest COVID-19 variants that are circulating, just like flu shots are updated yearly.

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