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

by yyctimes
February 1, 2021
in Politics
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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 go off any restrictions on vaccine shipments from Europe.

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

Due to the emergency nature of the pandemic, Well being Canada is accepting purposes for vaccines earlier than the ultimate trial information is prepared, permitting the assessment group to start out poring over the paperwork on an ongoing foundation reasonably than ready till every thing is completed.

The rolling assessment 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 utility for rolling assessment. AstraZeneca, Pfizer-BioNTech and Moderna all submitted in early October; Johnson and Johnson adopted swimsuit on the finish of November.

Well being Canada accepted the Pfizer-BioNTech vaccine on Dec. 9 and gave Moderna the inexperienced gentle on Dec. 23, each about three weeks after the businesses accomplished their Section 3 trials. A call on AstraZeneca is predicted within the subsequent couple of weeks.

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

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

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

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

Utility comes as Ottawa faces criticism over vaccine rollout

Novavax’s utility 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 few lack of photographs.

These critiques have come as Pfizer slows supply of its vaccines to Canada so it will possibly increase a manufacturing plant in Belgium. The European pharmaceutical big 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 ship fewer doses than initially promised, although the Liberal authorities insists the slowdowns are short-term and that each corporations will make good on their promised deliveries over the approaching months.

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

The measures permit 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 go 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 short-term however must be carried out because the continent is in an ongoing battle with vaccine-makers about sluggish deliveries. (Francisco Seco/Related Press)

Ng was informed the identical factor throughout her cellphone name with Valdis Dombrovskis, the European Fee’s commissioner for commerce, in accordance with a abstract of their dialog offered by World Affairs Canada.

“I used to be actually clear that Canada’s expectation is that our buy contracts with the vaccine makers usually are not disrupted,” Ng mentioned in a Sunday interview on Rosemary Barton Reside. “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 is no such thing as a disruption or delay.

Ng additionally informed CBC Chief Political Correspondent Rosemary Barton that Ottawa is taking a “complete of presidency strategy” to sort out the problem.

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

Von der Leyen mentioned Friday the fee is following via on a risk to pressure COVID-19 vaccine makers to point out them what vaccines they’re producing in Europe and the place these are going.

She mentioned the export transparency rule is short-term however must be carried out 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 combat.

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



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