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Canada joins UK in approving Pfizer/BioNTech COVID-19 vaccine

Health Canada will continue to monitor safety of jab

Health Canada has approved Pfizer/BioNTech’s COVID-19 vaccine, becoming the second nation to do so after the UK approved the shot for emergency use last week.

The Canadian approval, alike to the UK authorisation, is based on data from a phase 3 study demonstrating that the vaccine, BNT162b2, was 95% effective in prevention SARS-CoV-2 infection, which causes COVID-19.

Health Canada added that it has conducted a ‘rigorous’ review of the available evidence to assess the safety of the vaccine, saying that it found no major safety concerns.

The health agency added that it will continue to monitor the safety of the Pfizer/BioNTech COVID-19 vaccine, and will also monitor any adverse events that may develop after immunisation with BNT162b2.

Canada’s Prime Minister Justin Trudeau said that the country is expected to receive up to 249,000 doses of BNT162b2 this month.

Canada has already secured 20 million doses of the vaccine in total and has the option to expand this to 56 million more doses.

The approval in Canada comes following updated guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which recommends that people with a history of allergic reactions should not receive BNT162b2.

This new guidance was issued after two NHS workers who received the shot this week developed allergic reactions after initial immunisation.

According to the BBC, Health Canada is advising that only those with an allergy to any of the ingredients used within BNT162b2 to not get the jab, adding that they will monitor the developments in the UK before deciding to update this guidance.

Reviewers at the US Food and Drug Administration (FDA) have also confirmed the efficacy of the Pfizer/BioNTech vaccine, ahead of an advisory committee meeting set to convene today.

In a briefing document published earlier this week, FDA reviewers said that ‘the efficacy, safety and immunogenicity data in this emergency use authorisation (EUA) application support a positive assessment of risks and benefits for the Pfizer-BioNTech COVID-19 vaccine and fulfil the data requirements outlined in the FDA EUA guidance’.

‘The efficacy data suggest highly effective protection against COVID-19 in a broad population of individuals across demographic characteristics,’ the reviewers added.

Article by
Lucy Parsons

10th December 2020

From: Healthcare

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