AstraZeneca to reissue vaccine trial data following claim it gave 'incomplete view'

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

The group accused AstraZeneca of using "outdated" information from the trial that possibly offered an "incomplete view" of the data.

Early Monday, AstraZeneca issued a press release saying its Covid-19 vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization, citing long-awaited U.S. trial data. The latest phase 3 trial data for the vaccine, coming from the U.S., could potentially boost its profile by helping to assuage some prior efficacy and safety concerns.

The United States has said it is sharing 1.5 million doses of the AstraZeneca vaccine with Canada as early as this week.

After the suspension of the vaccine the pharmaceutical company submitted the vaccine to the Pharmacovigilance Risk Assessment Committee, which concluded that the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it. However, many experts and regulators say. Something about the AstraZeneca vaccine seems to trigger a similar syndrome, the researchers say, which they dubbed vaccine-induced prothrombotic immune thrombocytopenia (VIPIT). "Vaccines are our way out of this, so when you get the call, get the jab.". The group notified the National Institute of Allergy and Infectious Diseases, the Biomedical Advanced Research and Development Authority, and AstraZeneca of concerns they had with the data release.

The Covid-19 vaccine developed by Oxford University and AstraZeneca has been found 79 percent effective in preventing symptomatic illness in a large trial in the United States, Chile and Peru, the company said, paving the way for it to apply for U.S. approval.

This US trial involved over 32,000 people, with over 21,000 receiving at least one dose of the vaccine.

Germany’s Merkel on coronavirus: We are in a very serious situation now
The move marks an about-face for Germany , where leaders earlier this month had set in motion a gradual easing of restrictions . These include the partial closing of non-essential stores and the shutdown of hotels, restaurants, gyms and cultural venues.

Social media reacted swiftly-with many scientists and pundits stunned by both the admonishment from the independent Data and Safety Monitoring Board and National Institutes of Health, as well as AstraZeneca seeming to take another misstep. Furthermore, it claimed to have run the numbers from its intended primary analysis and that these results were "consistent" with the results released yesterday.

"As is often the case", the spokeswoman said, monitoring boards "can request new or clarifying analyses of data from the trial". The European Medicines Agency, which regulations drugs in the European Union, said the vaccine was safe and effective.

A physician prepares a dose of AstraZeneca's COVID-19 vaccine in Bologna, Italy, on 19 March. In recent weeks, more than 20 European countries suspended use of the shots after more than a dozen recently vaccinated people developed unusual clotting disorders. The US trial did not turn up any sign of such problems, although some safety issues can only be detected in the real world, once a drug or vaccine has been widely used.

Stephen Evans, a pharmacoepidemiology professor at London School of Hygiene & Tropical Medicine, told reporters that it was not unheard of for a monitoring board to disagree over the interpretations of trial data. The vaccine has already been approved in more than 70 countries, but clearance from USA regulators would bolster its global reputation. That will give it more opportunities to mutate, and so increase the risk of a new variant emerging that could make the vaccine less effective.

Vietnam began a mass Covid vaccination program using the AstraZeneca vaccine earlier this month, starting with frontline workers. That's in sharp contrast to much of Europe, which is facing a third wave of the pandemic and has been hampered by a limited vaccination campaign.

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