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By Kamal Choudhury
(Reuters) -Vaccine maker Novavax's shares plunged nearly 20% at market close on Thursday, after Health and Human Services Secretary Robert F. Kennedy Jr. raised concerns about the company's COVID-19 vaccine in an interview with CBS News.
The U.S. Food and Drug Administration, an agency that is part of the HHS, missed its deadline last week for deciding on the traditional approval of the vaccine. The vaccine has been sold under an emergency use authorization since 2022.
When asked if the delay resulted from "personnel being shuffled" at the FDA, Kennedy attributed it to the vaccine's composition. He said Novavax's single antigen approach "has never worked" for respiratory illnesses.
"Any delays to the FDA's independent review process for the Novavax (application) are a result of scientific review to ensure safety and efficacy," an HHS official familiar with the situation told Reuters.
The Maryland-based company's protein-based COVID-19 vaccine offers an alternative to mRNA-based vaccines from competitors Pfizer and Moderna.
"If they don't approve Novavax, they put every COVID vaccine at risk," Jefferies analyst Roger Song said, adding that the Novavax vaccine works "as good as, if not better than other COVID vaccines".
Shares of Moderna fell 8% and Pfizer dropped 4% at market close on Thursday.
Novavax said on Thursday it continues to believe its application included data that showed the shot was safe and effective in preventing COVID-19, and that it has not received an official response from the agency regarding the status of the application.
The company said it had responded to the FDA's information requests as of April 1 and that its application is "ready for approval".
Kennedy, who has expressed skepticism about vaccine safety and efficacy for years, initially caused biotech and vaccine company shares to drop in February after he was confirmed by the Senate for the position.
The sector has also been under pressure following 10,000 layoffs undertaken by the Trump administration at health agencies, including the FDA.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Tasim Zahid and Mohammed Safi Shamsi)
