Novavax targets May approval for COVID-19 vaccine in the U.S.

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Novavax sees “the potential for several billion dollars in revenue in the next 12 months." (Novavax)

Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the first half of the year.

The success of the vaccine in a 15,000-subject U.K. phase 3 clinical trial gives Novavax a clear path to a positive decision by the Medicines and Healthcare products Regulatory Agency (MHRA). However, the lack of data from another phase 3 trial that only recently completed enrolling 30,000 subjects in the U.S. and Mexico makes the route to a FDA OK less clear.

Discussions with the FDA are continuing, but the “hope and expectation is that the FDA will agree to review the U.K. data,” Novavax CEO Stanley Erck told CNBC. If FDA agrees to review the U.K. data, the vaccine could receive emergency use authorization in the U.S. in May.

Novavax will need to wait longer if the FDA requires the inclusion of data from the U.S.-Mexico trial. Erck said it will be “a couple of months” before final data are available from that trial, suggesting that waiting on those results would push authorization in the U.S. back to the second half of the year.

AstraZeneca won authorizations in some markets on the strength of data generated in Brazil, South Africa and the U.K. but is waiting on U.S. data before seeking FDA approval. However, the University of Oxford-sponsored studies that supported AstraZeneca’s ex-U.S. authorizations have been subject to criticisms not leveled at the Novavax trial.

Whatever happens with the FDA, Novavax is likely to receive authorization in parts of the world in the next few months. Erck expects to have completed a rolling submission to the MHRA by the end of the month. Based on how quickly the MHRA reviewed other vaccines, the timeline suggests Novavax could get clearance to sell its vaccine in the U.K. in April. Rolling reviews in Australia, Canada, the EU and New Zealand are also underway. 

The countries make up some of the buyers of the 300 million doses Novavax has agreed to supply to date. Based on the agreements, Novavax sees “the potential for several billion dollars in revenue in the next 12 months.” Even bigger sales figures are possible. Novavax expects to have capacity to make 2 billion doses a year by the midpoint of 2021, in large part due to its agreement with vaccine manufacturing giant Serum Institute of India.

Going into 2020, the idea that Novavax would now be poised to generate several billion dollars in revenue would have struck most people as absurd. As the Financial Times laid out in a recent profile of Novavax, the biotech faced delisting from Nasdaq in 2019 after it suffered the latest in a series of setbacks dating back decades. Today, it has a COVID-19 vaccine that JPMorgan analysts think may be best in class and financial foundations that could support new applications of its technology.