Saturday, 18 September, 2021


AstraZeneca lowers vaccine efficacy in trial amid data concerns in US

AstraZeneca New AstraZeneca report says vaccine 76 per cent effective in preventing symptoms
Noah Ferguson | 26 March, 2021, 21:06

The request comes after a monitoring panel said the British pharmaceutical company may have released outdated information, giving an incomplete view of its efficacy.

Participants were randomised on a 2:1 ratio between the vaccine and placebo group.

AstraZeneca's Mene Pangalos, executive vice president of biopharmaceutical research and development, said: "The primary analysis is consistent with our previously released interim analysis, and confirms that our Covid-19 vaccine is highly effective in adults, including those aged 65 years and over".

U.S. scientists were taken aback on Tuesday by a midnight news release issued from the National Institutes of Health (NIH) raising doubts about the company's announcement a day earlier that the vaccine was 79 per cent effective at preventing Covid-19 in the United States trial. However, the DSMB put out a stern statement saying that the company's statement didn't include the most up-to-date information, something they wanted to be addressed as soon as possible, which has been with the release of these final results.

Uncertainty over how the dosing error came about raised questions about the robustness of the data, and differing accounts from AstraZeneca and Oxford added to concerns Trust in the vaccine - and its developers - took a further hit this month, when more than a dozen countries temporarily suspended its use after reports of a rare blood clotting disorder in a very small number of people shortly after they were inoculated.

"We look forward to filing our regulatory submission for Emergency Use Authorisation in the U.S. and preparing for the rollout of millions of doses across America". But he added that concerns with accuracy could cast some doubt about vaccines and may contribute to the hesitancy of people getting vaccinated.

The release of the interim results caused a bit of a media storm this week, as it appeared AstraZeneca had jumped the gun announcing its results, perhaps to mitigate the recent concerns surrounding blood clots and the vaccine - which European Union regulators ultimately found was not linked.

The latest analysis is based on 190 cases of infection among the almost 33,000 people enrolled in the company's late-stage US study.

And as with other coronavirus vaccine trials, the volunteers were not regularly tested for COVID-19, so it's not known how many may have gotten asymptomatic infections.

It was still 100 percent effective at preventing severe illness and hospitalization, and there were no safety concerns, AstraZeneca said.

At the time the EMA couldn't say if the clots were related to the vaccine.

It was the first immunization out of the gate in the western world, going into the arms of volunteers on January 4.

Health Canada said it has not received any reports of these blood clots to date.

Health Canada's chief medical adviser Dr. Supriya Sharma says she agrees with European health authorities that the benefits of the vaccine outweigh any potential risks, and that all four vaccines approved for use in Canada are considered safe.

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