Novavax expects delayed U.S. COVID-19 vaccine trial to start in coming weeks

(Reuters) - Novavax Inc on Monday pushed back the start of a U.S.-based, late-stage trial for its experimental COVID-19 vaccine for the second time and now expects it to begin in the coming weeks instead of November.

While the U.S. trial has been hampered by issues in scaling up the vaccine’s manufacturing, Novavax has a late-stage study underway in the UK which finished enrollment on Monday.

Shares of the U.S.-based company were up 10% in late-afternoon trading.

The U.S. trial delay was not meaningful and it could provide more information into Novavax’s “second-generation” vaccine that already lags behind larger rivals, said Cantor Fitzgerald analyst Charles Duncan.

Pfizer Inc and Moderna Inc are seeking U.S. emergency use authorization for their experimental vaccines, but experts have said more than one vaccine would be needed to end the pandemic that has killed over 1.4 million people globally.

Novavax expects interim data from the UK trial in the first quarter of 2021, and could also pursue approval globally in the United States and UK after that initial data, Duncan added.

The company plans to use vaccine material produced at commercial scale for the trial in the United States and Mexico and has been working closely with the U.S. Food and Drug Administration to allow the use of the vaccine made at a North Carolina plant.

More than 25% of enrollees in the UK trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.

Novavax is also running a fully enrolled Phase 2b trial in South Africa with over 4,400 volunteers, including 245 who are medically stable, HIV positive participants.

Efficacy data from that trial could also be available in the first quarter of next year.

NOVEMBER 30, 2020

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