AstraZeneca Issues Revised Information on COVID-19 Vaccine


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Asked by correspondents about safety concerns over the AstraZeneca Covid vaccine and others distributed through global vaccine access mechanism Covax, he said the Pharmacovigilance Risk Assessment Committee, the European Medicines Agency's committee responsible for assessing and monitoring the safety of human medicines, has concluded that the vaccine's benefits far outweigh its potential risks, and that cases of blood clots are exceedingly rare.

AstraZeneca Plc said Wednesday that its coronavirus vaccine was 76 percent effective at preventing symptomatic illness in a clinical trial, slightly lowering the rate after facing questions in the United States over its data.

"Health Canada has assessed the available data on the reported events and has determined that the AstraZeneca COVID-19 Vaccine and COVISHIELD (the version of the AstraZeneca COVID-19 Vaccine manufactured by the Serum Institute of India that is now being distributed in Canada) have not been associated with an increase in the overall risk of thrombosis", the regulator wrote.

The company added the vaccine efficacy in people 65-years-old and over was 85%, but the statistical range for this figure - anywhere between 58 and 95% - make it less meaningful and the sample size was not mentioned.

AstraZeneca said on Thursday the trial's results had been presented to the board and would be the basis for a regulatory submission for emergency use to the US Food and Drug Administration in coming weeks. "We look forward to filing our regulatory submission for Emergency Use Authorization in the United States and preparing for the rollout of millions of doses across America", Mene Pangalos, executive vice president for biopharmaceuticals research for the company, said in a statement.

"We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible".

"There were 190 cases in the primary analysis".

NIAID director Dr. Anthony Fauci earlier this week called the company's release of premature data an "unforced error" - a sports term meaning it was their own mistake.

The ongoing drama surrounding the COVID-19 vaccine developed jointly by AstraZeneca and the University of Oxford took another turn late Wednesday when the drugmaker released updated information about its effectiveness. The study didn't turn up safety concerns.

He told ABC's Good Morning America on Tuesday that the AstraZeneca vaccine "is very likely a very good vaccine", and this situation does nothing but cast doubt about the vaccines and maybe contribute to vaccine hesitancy.

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

The Oxford-AstraZeneca vaccine has been the leading choice in the developing world because of its low cost and simple storage requirements.

The European Medicines Agency has since said there's no evidence the vaccine can cause blood clots.

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