U.K. Regulator Says Astra Covid Shot Benefits Outweigh Risks

(Bloomberg) -- Benefits of AstraZeneca Plc’s Covid vaccine continue to outweigh the risks, according to the U.K.’s drugs regulator, which issued renewed guidance as the European Union reviews the shot following reports of blood clots.

The Medicines and Healthcare Products Regulatory Agency issued its recommendation after five cases -- all of them men ages 19 to 59 -- developed an unusual combination of blood clotting in the brain with low levels of platelets. One of the men died. The agency is working with experts to determine whether the cases were linked to the vaccine, the MHRA told reporters Thursday.

The cases are extremely rare and represent less than one in every million people vaccinated to date, the agency said. A U.K. panel of immunization experts met with circulatory system doctors on Wednesday to discuss the events. If a link with the vaccine is established, the product information for the shot may need to be updated, but it shouldn’t require any pause to the inoculation program, Munir Pirmohamed, one of the scientists on the committee, said at the briefing.

“The risk-benefit of the vaccines continues to be positive,” said June Raine, chief executive of the MHRA. The agency advised that people should still get their Covid-19 vaccine when given the opportunity.

A number of similar cases that were reported across the EU post-vaccination led to more than a dozen countries pausing use of the Astra vaccine. The European drugs regulator has been investigating the situation and is expected to provide an update Thursday.

The MHRA has done a detailed analysis of reports of side effects from the vaccines, along with doctors records and hospital admission data. It showed that the rates of dangerous vein clots were no greater after either the Astra or Pfizer Inc. vaccines than they would be among an unvaccinated population, the agency said. The five reports of the more serious illness were separate to this analysis.

The risk of such clots, called venous thromboembolism, is one in 10,000 a year for people under 40. The number rises to one in 100 for those over the age of 80, according to the MHRA.

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