Novavax delays timelines for COVID-19 vaccine regulatory filings, production

© Reuters. FILE PHOTO: A Novavax logo is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration/File Photo

By Carl O'Donnell

(Reuters) -Novavax Inc on Monday again delayed its timeline for ramping up COVID-19 vaccine production and said it does not expect to seek regulatory authorization for the shot in the United States, Britain and Europe until the third quarter of 2021, sending its shares tumbling.

The Maryland-based company has repeatedly pushed back production forecasts and has struggled to access raw materials and equipment needed to make its vaccine. Novavax (NASDAQ:NVAX) shares fell more than 9% in extended trading after closing nearly 9% lower on Monday.

The pushback of regulatory filings "to Q3 (from Q2) and a downward revision to time to full production to Q4 (from Q3), represent delays to prior timelines and difficulty in growing," said Kelechi Chikere, an equity analyst at Jefferies (NYSE:JEF) in a Monday note.

Novavax said it does not expect to hit its production target of 150 million shots per month until the fourth quarter of 2021, later than its previous forecast of sometime in the third quarter. It had also previously said it could see U.S. regulatory authorization as soon as May.

But on a call to discuss first-quarter results, Chief Executive Stanley Erck said major manufacturing hurdles have been cleared and that all of its facilities can now produce COVID-19 vaccine at commercial scale.

"We know that we're delayed from where we thought we'd be at this point," Erck said. "Now we're giving guidance that nearly all of the major challenges have been overcome and we can clearly see the light at the end of the tunnel."

He said Novavax currently has about 30 million to 40 million doses on the shelves and its factories are making more each week.

While vaccine demand is declining in the United States, the Novavax shot is expected to play an important role in global inoculation efforts. Many countries such as India and much of South America still have low vaccination rates and are desperate for supplies.

"Unmet demand outside of the United States has resulted in continued demand for Novavax's vaccine," said Chief Commercial Officer John Trizzino.

The company has promised to supply 200 million shots to countries around the globe, in addition to the 1.1 billion doses it has committed to the COVAX international vaccine sharing program, Trizzino said.

Novavax's shot has yet to be authorized in any country, but the company reported late-stage data from a UK trial that showed it to be highly effective against the original version of the coronavirus and a newer, more contagious variant first found in Britain. (https://refini.tv/3bfL38D)

The European Medicines Agency (EMA) started a rolling review of the shot in February.

A source familiar with the regulator's work told Reuters this month the company still needs to submit data about their large-scale production of the jab for commercial use, which must also be approved before the vaccine can be used.

"In June or July, they should send us the new data on the production of commercial batches," the official said, adding that no date was yet set for a decision on possible approval.

The EMA did not immediately reply to a request for comment.

Data from its pivotal U.S. and Mexico trial is expected to be released in the current quarter.

Novavax reported a net loss for the first quarter of $223 million. It had $447 million in revenue, mostly payments from the U.S. government for its COVID-19 vaccine research, and spent $593 million on research and development.