Gaithersburg's Novavax Delays Applying For FDA Vaccine Approval

GAITHERSBURG, MD — The federal government has paused funding for Gaithersburg-based Novavax, a COVID-19 vaccine creator, until the company more closely aligns its methods of analysis with the Food and Drug administration.

The government said Novavax should not continue manufacturing more vaccines until that happens, The New York Times first reported.

"The U.S. government has recently instructed the Company to prioritize alignment with the U.S. Food and Drug Administration on the Company's analytic methods before conducting additional U.S. manufacturing and further indicated that the U.S. government will not fund additional U.S. manufacturing until such agreement has been made," says Novavax's quarterly report, released Thursday.

Novavax is not applying for FDA emergency approval this quarter, but applied for use in India, Indonesia and the Philippines, according to a statement Thursday.

"We are highly encouraged by the filing of regulatory submissions in multiple markets, made in partnership with Serum Institute of India. We view these submissions as the first of many filings to come, which will allow NVX-CoV2373 to be made available at a global scale," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Our clinical successes over the second quarter reaffirm our confidence in NVX-CoV2373's differentiated efficacy profile. We continue to see the circulation of new variants and inequitable access to vaccine globally, demanding that we bring our COVID-19 vaccine to market as swiftly as possible."

Novavax was given $1.75 million to develop and manufacture a vaccine for COVID-19. In June it reported that its vaccine was 100 percent effective against moderate and serious disease, and 90 percent effective overall.

"Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection," said Erck in a news release in June. "Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines."