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Novavax seeks FDA emergency approval for COVID-19 vaccine by May

Company is hoping FDA will review data from a UK-based trial

Novavax’s COVID-19 vaccine could receive an emergency use approval from the US Food and Drug Administration (FDA) in May, according to the company’s chief executive officer Stanley Erck.

Earlier this week, Erck told CNBC that the company’s discussions with the FDA are ongoing, but the hope is that the US regulatory agency will agree to review data from a UK-based trial of the COVID-19 vaccine.

In January, Novavax published results from the UK trial, which demonstrated a vaccine efficacy rate of 89.3%.

Preliminary analysis found that the UK COVID-19 variant was detected in over 50% of the PCR-test confirmed cases – with 32 cases being 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.

At the same time, Novavax also published data from a phase 2b trial conducted in South Africa.

In this trial, the vaccine’s efficacy came in lower than that observed in the UK trial, demonstrating 60% efficacy in the prevention of COVID-19. Within the study, 29 COVID-19 cases were observed in the placebo group and 15 in the vaccine group.

The study enrolled over 4,400 people from August 2020, with COVID-19 cases counted from September 2020 to mid-January 2021.

In this time period, the South African variant – that contains three critical mutations in the receptor binding domain (RBD) of the virus – was widely circulating.

According to Novavax’s preliminary sequencing data that was available for 27 of the 44 COVID-19 events in the study, 92.6% were caused by the South African variant.

Rolling reviews of the vaccine have already begin with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), as well as the European Medicines Agency (EMA) and Health Canada.

If the FDA agrees to review the UK data, the vaccine could be granted an emergency use authorisation (EUA) in May, according to Erck.

However, that could be delayed if the FDA asks for data from the US- and Mexico-based phase 3 trials that completed enrolment on 22 February.

Erck added that Novavax could begin shipping the COVID-19 vaccine to the US in June or July. The company has a deal in place with the US government to supply 110 million doses of the jab.

Article by
Lucy Parsons

3rd March 2021

From: Research, Regulatory



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