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September 17, 2021

Health Canada grants full approval to Moderna and Pfizer Covid-19 shots

Both vaccines received Canadian authorisation under an Interim Order in December last year.

Health Canada has granted full approval to Moderna and Pfizer-BioNTech Covid-19 vaccines, Spikevax (elasomeran mRNA vaccine) and Comirnaty respectively for use in people aged 12 years and above.

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This marks the first full approval for Moderna’s Spikevax, which is indicated for active immunisation to prevent Covid-19.

The vaccine secured Canadian authorisation under an Interim Order for individuals aged 18 years and above in December last year. The authorisation was expanded last month to include adolescents aged 12 years and above.

Health Canada’s latest approval of Spikevax is based on results from the Phase III COVE clinical trial performed on over 30,000 subjects in the US.

According to final analysis data from COVE, the vaccine demonstrated 93% efficacy, and the efficacy was sustained through six months following the second dose.

In addition, the safety profile observed in extended safety follow-up was similar to that reported in the COVE trial primary data.

Moderna signed a memorandum of understanding with the Government of Canada last month to set up an mRNA vaccine manufacturing plant in the country.

Meanwhile, Pfizer-BioNTech’s Comirnaty to prevent Covid-19 secured its first full approval in the US.

Comirnaty was initially authorised in Canada under an Interim Order in December last year, allowing its deployment across the country.

Health Canada granted the full approval to the vaccine after the review of an extensive data package, including longer-term follow-up results from the Phase III trial.

In the Phase III trial, the vaccine showed efficacy and safety up to six months post the second dose.

Pfizer and BioNTech also submitted the manufacturing and facilities data necessary for licensure.

Pfizer Canada Vaccines lead Fabien Paquette said: “Based on the longer-term follow-up data that we submitted, today’s decision by Health Canada affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed.

“While a significant number of eligible Canadians are fully vaccinated, there is still much work to be done as infection and hospitalisation rates continue to rise across the country, primarily among unvaccinated populations.”

In addition to the US and Canada, Comirnaty holds marketing authorisation in the UK and the EU.

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Navigate your business through the ‘new normal’

COVID-19 continues to dominate headlines the world over. It has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today. 
by GlobalData
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