Novavax signaled a positive outlook for its vaccine pipeline Wednesday with announcements at the World Vaccine Congress and an update on its COVID-19 vaccine.
Dr. Gregory Glenn, president of research and development, told attendees at the World Vaccine Congress the company was optimistic about its COVID-19 emergency use authorization (EUA).
In a statement later in the day, the company said, "We continue to have a productive dialogue with the FDA as they review data and we answer inquiries related to clinical and manufacturing data as expected. We look forward to scheduling our VRBPAC [Vaccines and Related Biological Products Advisory Committee] meeting in the near future as indicated by the FDA."
At an advisory committee for the U.S. Centers for Disease Control and Prevention (CDC) Wednesday, a U.S. Food and Drug Administration official indicated that the FDA was still awaiting manufacturing data from Novavax.
But an FDA spokesperson later said it was nothing more than the usual back-and-forth as part of the regulatory process.
"While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the EUA request as expeditiously as possible using its thorough and science-based approach. The agency plans to schedule a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the EUA request with the FDA’s panel of outside scientific and medical experts," according to the spokesperson.
The longer-than-hoped timeline has spurred questions from those who awaiting the option on the market.
The company has published its clinical data in the New England Journal of Medicine soon after filing its EUA application, but it still not received a date for its FDA advisory committee meeting. By comparison, the other three vaccines available in the U.S. were authorized prior to data publication in a journal.
Novavax's manufacturing data is coming from the Serum Institute of India, the world's largest vaccine maker, and the basis for Novavax's approvals globally.
Neither side indicated that there was any delay in the process. Still, it hasn't stopped rumors from swirling about why the review for Novavax has taken longer than other companies.
Requests for comment from the government were not immediately returned. Novavax said in a statement, "Novavax and the U.S. government will determine the timing and amounts for delivery of NVX-CoV2373 doses upon U.S authorization."
Meanwhile, Novavax says it continues to receive input from health care providers and consumers who are "anxiously awaiting" another vaccine option.
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