By Lee Berthiaume
Ottawa — Canada’s hopes to speed up COVID-19 vaccination as regulators begin work to approve new vaccinations, despite the federal government’s attempt to lift restrictions on vaccine shipments from Europe Became slightly brighter on the weekends.
Pharmaceutical company Novabax released the COVID-19 vaccine for regulatory approval on Friday, less than two weeks after Ottawa signed a 52-million dose contract with a Maryland-based company. I submitted it quietly to Health Canada.
Due to the urgency of the pandemic, Health Canada is accepting vaccine applications before final study data is ready, and the review team should begin to scrutinize the document continuously rather than waiting for everything to finish. I can.
Rolling reviews allow for much faster approval once the final results of a clinical trial are complete.
“Health Canada is facilitating a review of all COVID-19 vaccines,” Health Canada spokesman Andre Gagnon said in an email. “This is done through rolling submissions and the data will be reviewed when it becomes available from the manufacturer.”
Novavax is the fifth vaccine manufacturer to submit a rolling review application. AstraZeneca, Pfizer-BioNTech, and Moderna were all submitted in early October, with Johnson and Johnson following up at the end of November.
Health Canada approved the Pfizer-BioNTech vaccine on December 9th and gave Moderna a green light on December 23rd. Both are about three weeks after the company completes the Phase 3 trial. Decisions on AstraZeneca are planned for the coming weeks.
Johnson and Johnson reported the results of last week’s Phase 3 trial.
Novavax also reported the results of the UK trial on Thursday, but large trials in the United States will take at least a month or two to reach final results.
The company states that the vaccine was 89% effective in a UK trial. It also advertises that it is highly effective against the new UK and South Africa strains of COVID-19, and states that it can be started in the spring with regulatory approval.
“The final dose delivered to Canada is outside the United States,” Novabacs spokeswoman Amy Speak said in an email.
Novavax’s application was filed because the Commonwealth Liberal government faced criticism of the pace of vaccination across the country, and opposition parties and some state governments complained about the lack of firing.
These criticisms arose as Pfizer delayed the delivery of vaccines to Canada and was able to expand its Belgian production plant. European pharmaceutical giants are also pressing Canada to allow six injections per vial of vaccine instead of the current five.
Modana also said it would offer lower doses than originally promised, but the Liberal government has claimed that the slowdown is temporary and that the two companies will do well over the next few months.
It is also concerned that Canada’s problematic vaccine supply will be further affected by the new regulations on vaccine exports imposed by the European Union. The European Union is also suffering from a shortage of deliveries from manufacturers.
This measure allows the European Union to refuse to export vaccines if the manufacturer fails to fulfill its promised delivery to the block in 27 countries where most of Canada’s shots are taking place.
Ottawa is working to avoid impacts on Canada’s supply, and International Trade Minister Mary Ng spoke to the EU counterpart on Saturday for the second time in three days.
It argued that the new export restrictions would not affect vaccines for Canada after European Commission Chairman Ursula von der Leyen and Prime Minister Justin Trudeau called late last week.
According to a summary of the conversation provided by Global Affairs Canada, Ng was said the same during a call with Valdis Dombrovskis, a trade commissioner of the European Commission.
The federal government said Ng’s call was “a wide range of ongoing government-wide efforts to minimize the impact of EU transparency and licensing mechanisms on vaccines manufactured in Europe for Canada. It’s part of it. “
Former Canadian diplomat Colin Robertson (now Vice Chairman of the Canadian Global Affairs Institute) said the number of calls between the government and European authorities, and the fact that they were publicly disclosed, was unusual. It’s like you. If you’re worried, you’ll do it. “
Nonetheless, Robertson, along with a contract between Ottawa and a pharmaceutical company, has formalized close ties between Ottawa and the EU in various trade and political agreements, reducing shipments to Canada by Europeans. He expressed hope that it would prevent him from doing so.
Von der Leyen said on Friday that the commission is tracking threats to force COVID-19 vaccine makers to show which vaccines they are making and where they are going in Europe.
She said the export transparency rules are temporary but need to be implemented as the continent is in an ongoing battle for delays in delivery with vaccine manufacturers.
Both Pfizer-BioNTech and AstraZeneca lag behind scheduled deliveries to European countries, but Europe is at the forefront of the latter.
The EU is demanding doses for company vessels made in the United Kingdom to make up for shortages due to production problems at European factories.
-Use files from MiaRabson.
Novavax submits vaccine for Health Canada approval