Novavax gathers its COVID-19 vaccine data for long-delayed FDA filing

Novavax vaccine
After missing several of its own deadlines last year, Novavax plans to finalize its application by the end of January. (Novavax)

Novavax spent much of 2021 working to file its COVID-19 vaccine with U.S. regulators but falling short of its own deadlines. As the year came to a close, the company celebrated the fact that it was nearly there. 

Friday, Novavax said it "completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request."

This step is not an official emergency use application. Novavax plans to complete that process by the end of this month, the company said.

The news comes after a 2021 filled with missed deadlines for the Gaithersburg, Maryland-based biotech. The company originally hoped to file for an EUA by 2021's second quarter, but later pushed that deadline to the third quarter thanks to a manufacturing issue. By October, Novavax said it was eyeing an end-of-year deadline to submit its "complete regulatory package" to the FDA.

Novavax's latest FDA move comes after some notable wins for the program. Last month, NVX-CoV2373 nabbed a World Health Organization (WHO) emergency use listing. With that WHO blessing in hand, Novavax and partner Serum Institute of India (SII) can now ship doses to the COVAX program, which helps supply vaccines to low- and middle-income countries.

Less than a week after the WHO nod, the European Medicines Agency recommended conditional marketing authorization for the shot in the EU.

“Novavax remains confident in our progress, following positive decisions on our COVID-19 vaccine from the European Commission (CMA) and World Health Organization (EUL), and submission of our final data packages to the U.S. FDA in December,” the company said in an emailed statement. “We expect to submit a request for EUA for the vaccine in the U.S. within a month,” Novavax added.

RELATED: Novavax's COVID-19 vaccine scores WHO emergency listing, opening up supply to COVAX

Novavax’s New Year's Eve submission included complete chemistry, manufacturing and controls information, which was achieved with the help of production partner SII. Novavax “expects to later supplement the submission with data from additional manufacturing sites” across its global supply chain, the company added. 

Novavax has reportedly suffered a string of manufacturing problems that lowered the quality of the vaccine, anonymous sources claimed in a Politico story from October.

Meanwhile, with cases surging around the world, officials are counting on Novavax’s shot to help meet global vaccination goals. Potential difficulties getting world regulators to sign off on U.S. and European sites could put Novavax’s 2022 supply targets in jeopardy, Politico reported Dec. 31.

Further, Novavax's move to apply for authorization using SII data “raises questions about the extent” of the company’s manufacturing problems in Europe and the U.S., Politico reports. 

RELATED: After EMA recommendation, Novavax's COVID-19 vaccine nears rollout in Europe

Novavax, for its part, sees things differently.

“The most expeditious path forward for our initial submissions was to harmonize all regulatory filings, leveraging our manufacturing partnership with Serum Institute” the company said via email. “Their extensive capabilities helped Novavax achieve these filings and to ensure we have doses ready to ship."

The company added that it plans to supplement its applications with information from facilities across its global supply chain in the “near future.”

Last month, the company said in an emailed statement that it was producing vaccines at an overall capacity of 150 million doses per month, in line with its previous guidance for the end of the year. In 2022, Novavax said it expects its global supply chain to hit an excess of 2 billion doses.

Editor's note: This story has been updated with additional comments from Novavax.