Novavax Extends COVID-19 Vaccine Approval and Production Deadline to End of 2021 – National – fr

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Novavax Extends COVID-19 Vaccine Approval and Production Deadline to End of 2021 – National – fr


Novavax again postponed its schedule for ramping up COVID-19 vaccine production on Monday and said it did not plan to seek regulatory clearance for the shooting in the United States, Britain and Europe until ‘in the third quarter of 2021, causing its shares to fall.

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

The pushback of regulatory filings “in Q3 (from Q2) and a downward revision of the time to full production in Q4 (from Q3), represent delays in relation to previous deadlines and growth difficulties”, Jefferies equity analyst Kelechi Chikere said in a Monday Note.

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Novavax said it does not plan to meet its production target of 150 million shots per month until the fourth quarter of 2021, later than its previous forecast for the third quarter. He had also previously said he could see U.S. regulatory clearance as early as May.

But on a call to discuss first quarter results, chief executive Stanley Erck said major manufacturing hurdles have been lifted and all of its facilities can now produce the COVID-19 vaccine on a commercial scale.

“We know we’re behind what we thought we were at this point,” Erck said. “We are now indicating that almost all of the major challenges have been overcome and that we can clearly see the light at the end of the tunnel.”

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









Coronavirus: Trudeau announces agreement to produce Novavax vaccine in Canada

Coronavirus: Trudeau announces agreement to produce Novavax vaccine in Canada – February 2, 2021

As demand for vaccines is declining in the United States, the Novavax vaccine is expected to play an important role in global immunization efforts. Many countries like India and much of South America still have low immunization rates and are in desperate need of supplies.

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“Unmet demand outside of the United States has resulted in continued demand for the Novavax vaccine,” said business manager John Trizzino.

The company has pledged to deliver 200 million vaccines to countries around the world, in addition to the 1.1 billion doses it has committed to the international COVAX vaccine sharing program, Trizzino said.

In February, Prime Minister Justin Trudeau announced that Canada had signed an agreement with Novavax to produce vaccines at a newly built facility in Montreal, although this will not be operational until later this year.

Health Canada is currently conducting a “continuous review” of the vaccine as Novavax submits data from ongoing trials.


Click to watch video: `` Coronavirus: Trudeau discusses role of Novavax, national vaccine production in Canada's deployment plan ''







Coronavirus: Trudeau discusses role of Novavax, national vaccine production in Canada’s deployment plan


Coronavirus: Trudeau discusses role of Novavax and national vaccine production in Canada’s deployment plan – February 2, 2021

Novavax shooting has not yet been licensed in any country, but the company reported late stage data from a UK trial which showed it to be highly effective against the original version of the coronavirus and a variant newer and more contagious first found in Britain.

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

Novavax reported a first quarter net loss of $ 223 million. He had revenues of $ 447 million, mostly payments from the US government for his research on the COVID-19 vaccine, and spent $ 593 million on research and development.

(Reporting by Trisha Roy in Bengaluru and Carl O’Donnell in New York; Editing by Bill Berkrot and Richard Pullin)

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