Health Canada expects first COVID-19 vaccine to be approved next month

AstraZeneca Covid-19 Vaccine

AstraZeneca may initiate an additional global trial to evaluate the efficacy of its Covid-19 vaccine candidate, AZD1222, using a lower dosage.

Decisions about which, if any, vaccines to authorize will be made by the independent Medicines and Healthcare Products Regulatory Agency.

It has secured 100 million doses of the vaccine developed by AstraZeneca and Oxford University and has targeted a rollout to begin before Christmas.

The vaccine was 90% effective in preventing COVID-19 when administered in two different doses a month apart, late-stage trials showed.

Oxford and AstraZeneca reported this week that their vaccine appeared to be 62% effective in people who received two doses, and 90% effective when volunteers were given a half dose followed by a full dose.

"Now that we've found what looks like a better efficacy we have to validate this, so we need to do an additional study", he said, adding that the new, likely global, study could be faster because it would need fewer subjects as the efficacy was already known to be high.

United Kingdom authorities are on the brink of approving the coronavirus vaccine developed by BioNTech and Pfizer, with the Financial Times revealing deliveries of the shot could begin just hours after approval. Europe's drug regulator has said it will not set a minimum level of efficacy.

He said he would be surprised if a vaccine was available by next week, but that there could be "an announcement" within the next fortnight.

Nonetheless, Britain's top science adviser said the interim results showed the AstraZeneca vaccine was successful.

Earlier in the day, British Prime Minister Boris Johnson named Nadhim Zahawi, now a junior business minister, as the minister responsible for the deployment of Covid-19 vaccines. The Moderna vaccine, which also needs to be stored at freezer temperatures, was also about 95% effective in clinical trials, the company said.

Shares in AstraZeneca were down 0.9% at around 1310 GMT.

Moderna shares have rallied 22% since it released its trial data on November 16, while Pfizer and BioNTech are up 6% and 14% respectively since announcing data on November 9.

US approval for distributing a vaccine produced by Pfizer Inc and German partner BioNTech could come as soon as December 11, Dr. Moncef Slaoui, chief scientific adviser for "Operation Warp Speed", told television news shows. The European Medicines Agency said on Thursday it would "assess data on the efficacy and safety of the vaccine in the coming weeks".

"Moderna's vaccine was an important addition to our portfolio and securing an additional two million doses further adds to the protection we can provide to the public to end the pandemic".

"There are a number of variables that we need to understand, and what has been the role of each one of them in achieving the difference in efficacy", Slaoui told a briefing on Tuesday.



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