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Source: Fierce Biotech
By Nick Paul Taylor | Mar 2, 2021 8:05am
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.