Health Canada says AstraZeneca shot is safe as U.S

AstraZeneca vaccine is 79% effective against symptomatic COVID-19, company says

In the study of 30,000 people, the vaccine was 79% effective at preventing symptomatic cases of COVID-19 - including in older adults.

Companies sponsoring drug or vaccine trials typically wait for the monitoring board to run analyses and conclude that the study has yielded an answer before they announce trial results.

"We will look at the complete data package (from the U.S.) sometime in April, and will assess and communicate the results", said Supriya Sharma, chief medical adviser at Health Canada, the federal health ministry. CEO Alex Gorsky hit the TV news circuit to get the word out that the J&J vaccine is safe and effective the day after its emergency approval, while Fauci talked about the vaccine's safety in White House Task Force videos on social media. It promised to issue a primary analysis and "most up-to-date efficacy data" within 48 hours.

The apex global public health agency said the AstraZeneca-Oxford vaccine continues to have a "tremendous potential" to prevent infections and reduce deaths across the world.

Tedros Adhanom Ghebreyesus, Director-General, WHO, on Tuesday said he spoke to vaccine manufacturers on how to ramp up production.

An AstraZeneca spokeswoman, whom the company declined to name, said last week that it was "completely incorrect" that the trial data had formatting problems or had not been submitted to the monitoring board in a clean fashion. Despite the suspensions of AstraZeneca vaccines in more than a dozen countries, mostly in Europe, over concerns that the shots may be causing blood clots, Korea is pushing through with its vaccination program. That scepticism carried over to last week, when senior officials at a number of federal health agencies grew suspicious about why AstraZeneca had not announced data from its U.S. study.

The letter also reminded the government that the Serum Institute has received the technology to manufacture Covishield from AstraZeneca-Oxford and need to honour the commitment to supply at least 50 lakh doses of the vaccine. Even within the United Kingdom, which has administered over 10 million doses of the vaccine and where confidence remains high, there are anecdotal reports of increased no-shows and requests for the Pfizer vaccine instead.

All of which is to say, this is yet another avoidable blunder that likely won't change the big picture - that the AstraZeneca vaccine is generally safe and effective - but could further erode the public's trust in this shot, which stands to be a crucial tool in ending the pandemic worldwide. The company is planning to seek emergency use authorization from the USA drug regulator.

In the United States, officials suspended AstraZeneca's study in 30,000 Americans for an unusual six weeks last fall, as frustrated regulators sought details about neurological problems reported in Britain; ultimately there was no evidence the vaccine was to blame.

This data snafu is the latest in a serious of complications regarding AstraZeneca's vaccine. "The numbers don't lie", said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

But public confidence in America and Europe was dented by early questions over trial data and then by reports of unusual blood clots among those who had taken it.

AstraZeneca shares fell 1.8% in London trading.



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