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Novavax submits vaccine for approval as Ottawa seeks EU reassurances on exports guidelines


Canada’s hopes of rushing up COVID-19 vaccinations brightened barely over the weekend as regulators started work to approve a brand new inoculation, even because the federal authorities sought to move off any restrictions on vaccine shipments from Europe.

Pharmaceutical firm Novavax quietly submitted its COVID-19 vaccine to Health Canada for regulatory approval on Friday, lower than two weeks after Ottawa finalized a take care of the Maryland-based firm for 52 million doses of the shot.

Due to the emergency nature of the pandemic, Well being Canada is accepting functions for vaccines earlier than the ultimate trial information is prepared, permitting the overview crew to begin poring over the paperwork on an ongoing foundation somewhat than ready till all the things is completed.

The rolling overview permits for a lot sooner approval as soon as the ultimate outcomes from medical trials are full.

Novavax is the fifth vaccine maker to submit an software for rolling overview. AstraZeneca, Pfizer-BioNTech and Moderna all submitted in early October; Johnson and Johnson adopted swimsuit on the finish of November.

Well being Canada permitted the Pfizer-BioNTech vaccine on Dec. 9 and gave Moderna the inexperienced mild on Dec. 23, each about three weeks after the businesses accomplished their Part 3 trials. A choice on AstraZeneca is anticipated within the subsequent couple of weeks.

Johnson and Johnson reported outcomes from its Part 3 trial simply final week.

Novavax additionally reported outcomes Thursday from a trial in the UK, however a big trial within the U.S. continues to be at the least a month or two away from yielding ultimate outcomes.

Novavax has mentioned its vaccine was 89 per cent effective in the U.K. trial. It additionally touts its product as very efficient towards the 2 coronavirus variants first detected within the U.Ok. and South Africa.

Johnson and Johnson’s long-awaited COVID-19 vaccine seems to guard towards symptomatic sickness with only one shot, though it isn’t as sturdy as some two-shot rivals. (AP)

Utility comes as Ottawa faces criticism over vaccine rollout

Novavax’s software comes because the federal Liberal authorities faces withering criticism for the tempo of vaccinations throughout the nation, with opposition events and a few provincial governments complaining a couple of lack of photographs.

These critiques have come as Pfizer slows delivery of its vaccines to Canada so it could possibly develop a manufacturing plant in Belgium. The European pharmaceutical large can also be urgent Canada to permit six photographs per vial of vaccine as an alternative of the present 5.

Moderna has additionally mentioned that it’s going to deliver fewer doses than originally promised, although the Liberal authorities insists the slowdowns are momentary and that each firms will make good on their promised deliveries over the approaching months.

There are additionally issues that Canada’s troubled vaccine provides might be additional affected by new controls on vaccine exports which were imposed by the European Union, which can also be combating supply shortfalls from producers.

The measures enable the European Union to disclaim vaccine exports if the producer has not fulfilled its promised deliveries to the 27-country bloc, which is the place most of Canada’s photographs are being made.

Ottawa receives assurances Canada will not be affected

Ottawa has been working to move off any impression on Canada’s provide, with Worldwide Commerce Minister Mary Ng talking by cellphone to her EU counterpart on Saturday for the second time in three days.

That adopted Prime Minister Justin Trudeau’s personal cellphone name with European Fee President Ursula von der Leyen late final week, after which Trudeau asserted that the brand new export controls wouldn’t have an effect on vaccines destined for Canada.

European Fee President Ursula von der Leyen mentioned the export transparency rule is momentary however must be executed because the continent is in an ongoing battle with vaccine-makers about sluggish deliveries. (Francisco Seco/Related Press)

Ng was instructed the identical factor throughout her cellphone name with Valdis Dombrovskis, the European Fee’s commissioner for commerce, based on a abstract of their dialog supplied by World Affairs Canada.

“I used to be actually clear that Canada’s expectation is that our buy contracts with the vaccine makers will not be disrupted,” Ng mentioned in a Sunday interview on Rosemary Barton Live. “I’d word that of their regulation, there’s completely consideration for advance buy agreements which were made, like that of Canada, with the vaccine makers, and our expectation is that there isn’t any disruption or delay.

Ng additionally instructed CBC Chief Political Correspondent Rosemary Barton that Ottawa is taking a “complete of presidency method” to sort out the difficulty.

“Minister Garneau has already spoken to a few of his counterparts and continues that work, as will Minister Hajdu,” she mentioned. “Minister Anand, after all, is in fixed contact with the suppliers, and I have been chatting with my worldwide counterparts.”

Von der Leyen mentioned Friday the fee is following by on a menace to drive COVID-19 vaccine makers to indicate them what vaccines they’re producing in Europe and the place these are going.

She mentioned the export transparency rule is momentary however must be executed because the continent is in an ongoing battle with vaccine-makers about sluggish deliveries.

Each Pfizer-BioNTech and AstraZeneca are behind on their scheduled deliveries to European nations, however it’s the latter with which Europe is having the loudest struggle.

The EU is demanding the corporate ship doses made within the U.Ok. to make up for shortfalls as a result of manufacturing points in its European vegetation.



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