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Canada asked to approve new NOVAVAX COVID Vaccine

 

Canada asked to approve new NOVAVAX COVID Vaccine

John Best

The federal government is reviewing a new COVID-19 vaccine for which it has already placed an order to buy up to 72 million doses. Novavax, of Maryland  applied on Friday for Health Canada to approve its vaccine, which studies have suggested is effective against the British and South African variants of the virus.

The application comes less than two weeks after Ottawa finalized an agreement with the company for 52 million doses of the vaccine, with an option to purchase another 24 million.

Final stages of clinical trials

NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19. The Novavax shot which is given in two doses, was shown to be 89.3% effective at preventing Covid-19 in participants in its Phase 3 clinical trial in the UK, and around 86% effective at protecting against the new UK variant. The vaccine’s efficacy against the original Covid-19 strain was calculated to be 95.6%.

“We thank the Government of Canada for their confidence in our program and ongoing partnership in the regulatory review and delivery of a safe, effective COVID-19 vaccine for the citizens of Canada,” said John J. Trizzino, Chief Commercial Officer and Chief Business Officer, Novavax. “Novavax is proud to play our part in working tirelessly together with governments, scientists, regulators and others in the global effort to put an end to the pandemic.”

Could be delivered by April

The company expects to supply NVX-CoV2373 to Canada beginning as early as the second quarter of 2021, following authorization by Canada’s regulatory agency.

The UK has secured 60 million doses of the jab, which will be made in Stockton-on-Tees in north-east England.

The Phase 3 trials – the final stage before a vaccine is looked at by a regulator – enrolled more than 15,000 people aged between 18-84, of whom 27% were older than 65, US firm Novavax said.

In the South African part of the trial, where most of the cases were the South African variant of the virus, the vaccine was 60% effective among those without HIV.

Stan Erck, chief executive of Novavax, said the results from the UK trial were “spectacular” and “as good as we could have hoped”, while the efficacy in South Africa was “above people’s expectations”.

Prof Paul Heath, chief investigator of the UK Novavax trial, said the trial findings were “enormously exciting”, particularly because of the vaccine’s efficacy against the UK variant.

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