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Novavax announces further delays for regulatory filings of COVID-19 vaccine

The company had been aiming for FDA emergency approval in May

Novavax has announced that it will not submit its COVID-19 vaccine to regulators in the US, UK and Europe until the third quarter of 2021, following issues with the manufacturing of certain components of the jab.

Previously, Novavax’s chief executive officer Stanley Erck said that the company was aiming for a US Food and Drug Administration (FDA) emergency approval of its vaccine – NVX-CoV2373 – as early as this month.

In a recent interview with CNN, however, Erck said that issues with “getting all the manufacturing data put together [and] getting all the very complex biologic assays that we have to do developed” has taken longer than expected.

He added: "I don't believe we're going to be able to make it by the end of June. Therefore we have to push off the guidance until the third quarter. Obviously, it will be in everybody's benefit for us to get it done as early in the third quarter as possible, but we're not putting a date on it right now."

Novavax is also expecting data from a US-based phase 3 trial of its COVID-19 vaccine, involving 30,000 volunteers, in “a few weeks”, according to Erck.

Erck added that this trial data will reveal how effective Novavax’s vaccine is against currently circulating variants in the US and Mexico, with the company’s president of research and development Gregory Glenn commenting in an investors call that "we've seen the rapid rise of the B.1.1.7 strain [which] now accounts for over 60% of the US cases”.

In March, Novavax announced that a UK trial of NVX-CoV2373 demonstrated an efficacy rate of 89.3%, and the vaccine was also found to be effective against the UK coronavirus variant.

Preliminary analysis found that the UK variant was detected in over 50% of the PCR-confirmed cases – with 32 cases caused by the UK variant, 24 by the non-variant and six ‘unknown’.

Based on this information, Novavax calculated that its vaccine is 95.6% effective against the original COVID-19 strain and 85.6% effective against the UK variant.

The company also announced in its first quarter results that it has secured additional manufacturing capacity for its vaccine globally, with an anticipated capacity revision of 100 million doses each month by the end of Q3.

Peak capacity for the vaccine is expected in the fourth quarter, which will support 150 million doses of NVX-CoV2373 per month.

Article by
Lucy Parsons

12th May 2021

From: Regulatory



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