Novavax Expands Global Production Capabilities for Its Vaccine as It Prepares for Regulatory Filings

As Novavax gears up to file for authorizations for its two-dose COVID-19 vaccine, the U.S. drugmaker has been working to significantly expand its manufacturing capabilities in Europe and other parts of the globe and believes it can supply well over 100 million doses a month by the fall.

A company spokesperson told FDAnews that the company anticipates being able to manufacture 150 million doses per month globally in the third quarter of 2021, a quantity that could provide a much-needed supply of vaccines for Europe, which has fallen far behind the U.S. and UK in inoculations.

Authorization for the vaccine in the UK and EU could arrive as soon as the summer, the company said, as it intends to file for authorization — beginning with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) — sometime in the second quarter.

There is a clearer timeframe for Emergency Use Authorization (EUA) in the U.S., with the company’s CEO, Stanley Erck, pledging at the beginning of March that the vaccine could receive FDA authorization by May. However, that projection could be pushed back if the FDA wants to see U.S. trial data for the vaccine. Erck said that Novavax hopes to support its EUA filing with data from its late-stage UK trial, which found the inoculation demonstrated 89.3 percent efficacy (DID, Jan. 29).

The company declined to comment on whether it has delayed signing off on an EU supply agreement due to difficulties in obtaining raw materials, saying only that discussions with the EU bloc are ongoing. A spokesperson did acknowledge supply hurdles, saying that “we believe that any raw materials supply challenges that the industry experiences are short-term and are ones that we will continue to resolve over the coming months.”

The U.S. government signed a $1.6 billion deal with the company in November for delivery of 100 million doses (DID, Nov. 13, 2020), as well as an additional 10 million-dose deal arranged by the Department of Defense. Erck has said that the company will have tens of millions of doses ready to go in the U.S. upon authorization.

Currently, Novavax is using eight manufacturing sites to produce its COVID-19 vaccine, including at the Serum Institute of India (SII), the largest producer of vaccines in the world.

The antigen component of its vaccine is being made at Novavax’s Czech Republic plant, SII, Fujifilm Diosynth Biotechnologies’ U.S. plants in North Carolina and Texas, and elsewhere. The vaccine’s adjuvant is being manufactured by Novavax’s Swedish site and two partnered manufacturers — AGC Biologics’ U.S. and Denmark facilities and PolyPeptide Group’s U.S. and Sweden sites.

Still, supply of the vaccine outside of India could be complicated by the fact that that country has significantly tightened its restrictions on vaccine exports. Europe, too, intends to closely scrutinize authorizations of exports in an effort to conserve vaccine supplies there (DID, March 25). — James Miessler