Dive Brief:

• The Serum Institute of India will manufacture the key ingredient of Novavax's experimental coronavirus vaccine, giving the U.S. biotech the capacity to make more than 2 billion doses per year starting in 2021, the company said Tuesday. Novavax's vaccine is currently in Phase 2 trials.
• The partnership expands a deal that had previously focused on development and commercialization in India and low- to middle-income countries. Novavax has also partnered with Takeda and acquired Czech-based Praha Vaccines to help produce its vaccine. The Praha deal provided enough capacity to produce 1 billion doses.
• If Novavax's vaccine is proven safe and effective against COVID-19, the company would now have manufacturing capacity to rival leaders like Pfizer and AstraZeneca. However, those drugamkers have already advanced to the late-stage trials that could be used to gain authorization for wide use, while Novavax expects to begin similar trials "in coming weeks," CEO Stanley Erck said in a statement.

Dive Insight:

Novavax's vaccine is composed of two parts: a protein called an antigen that resembles the SARS-CoV-2 virus' characteristic "spike" protein, and a substance known as an adjuvant that enhances immune response.

The deal with the Serum Institute increases the number of antigen production sites the company can utilize to six, with capacity in Asia, Europe and the U.S. Adjuvant manufacturing, meanwhile, is taking place at three sites: a Novavax-owned factory in Sweden, partner facilities in the U.S. and Denmark, plus a third plant that makes key supplies.

The Maryland-based company is one of the smaller ones in a worldwide push to deliver a coronavirus vaccine. And unlike Germany's BioNTech or the University of Oxford, Novavax hasn't signed a deal with a traditional big pharma partner to take on global manufacturing and commercialization. Its previous deals with the Serum Institute and Takeda were regional in nature, aimed at Japan, India and low- to middle-income countries.

Novavax has, however, matched its larger rivals in raising cash to support its vaccine ambitions. The U.S. government's Operation Warp Speed initiative pledged $1.6 billion to Novavax, while the Coalition for Epidemic Preparedness Innovations has added $388 million. Stock offerings by the company have raised nearly $600 million this year.

The next few months will be crucial for Novavax to show it can keep pace with other developers. Assuming the Phase 2 trials currently underway support earlier findings that its shot is safe and stimulates an immune response, Novavax will likely run a 30,000-patient Phase 3 trial to prove whether NVX-CoV2373 can prevent cases of COVID-19.

Due to the pandemic, manufacturers have ramped up production ahead of receiving regulatory authorization, taking the risk that hundreds of millions of doses could go to waste if the vaccines fail in testing. Pfizer and BioNTech have arranged for production of more than 1 billion doses in 2021, AstraZeneca 2 billion and Moderna 500 million to 1 billion a year.