The U.K.’s medicines regulator has said under 30s should be offered an alternative vaccine to AstraZeneca’s Covid-19 shot Wednesday after finding a possible link between it and a rare, potentially lethal form of blood clotting, an abrupt course correction that could complicate the country’s strong immunization program and yet another knock to the AstraZeneca shot, which has suffered numerous setbacks around the world.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said it had established a potential link between a rare type of blood clotting and the AstraZeneca shot after studying reports of 79 people suffering clots after vaccination by the end of March.
The regulator’s findings echoed those of the European Medicines Agency’s (EMA), which were also released Wednesday.
Unlike the EMA, which recommended the clotting be added to the list of side effects but did not make a significant policy change, the MHRA made a major reversal in recommending those under the age of 30 be offered an alternative shot where available.
The course correction does not prevent the vaccine from being used in this age group—recipients generally cannot chose their vaccine in the U.K.—but stipulates they be offered a Pfizer-BioNTech or Moderna shot, the only ones authorized for use in the U.K., if available.
Dr. June Raine, head of the MHRA, emphasized that while the benefits of vaccination continue to outweigh any risks, this trade-off is more “finely balanced” in young people, who are believed to be more vulnerable to the clotting and are at less risk from Covid-19.
People who have already received one dose of the AstraZeneca vaccine are still advised to get the second—which typically comes after 12 weeks in the U.K.—unless they were one of the few people to suffer a blood clot.
Raine said the “public’s safety is always at the forefront of our minds,” urging all to come forward and be vaccinated when invited to do so. She said the agency takes every reported side effect very seriously but added: “No effective medicine or vaccine is without risk.” Raine said the agency continually monitors safety during widespread use to ensure they are performing as expected and that the “benefits continue to outweigh the risks.”
AstraZeneca’s vaccine is considered to be the leading weapon for most of the world in fighting the pandemic, a more accessible, affordable and practical alternative to other offerings. However, and in spite of clinical trials showing it to be safe, well-tolerated and effective, it has been mired in seemingly endless controversy due to methodological issues in its clinical trial, production squabbles and reports of links to blood clots. Until now, the U.K. has stood apart from the repeated political flip flopping over the vaccine in Europe, making its change as European member states are divided on the shots suitability for all ages.
What We Don’t Know
The MHRA said it would continue to review the vaccine and had not yet found definitive proof it causes blood clots. Similarly, and like the EMA, it could not pinpoint a particular group that was more likely to suffer the side effect, though the majority of the cases it reviewed involved women.
20 million. As of March 31, the MHRA says this is how many doses of the AstraZeneca vaccine have been administered in the U.K.. By this point, 79 cases of rare blood clotting had been recorded, 19 of whom died, working out at an overall risk of 4 people in one million being vaccinated.
What To Watch For
At the moment, the guidance recommends those who have already received the shot safely to carry on with the same type. If further age restrictions are brought into effect, countries may have to explore mixing Covid-19 vaccines for people who have received the first dose of the AstraZeneca vaccine. The U.K. actually launched a trial in February to see whether vaccines could be used interchangeably, which could possibly provide better protection against the disease and featured the AstraZeneca shot. Russia’s Sputnik V vaccine, which early results indicate to be 92% effective at preventing Covid-19, makes use of the principle, varying the modified virus used in each shot to carry the immunity-conveying instructions into the body.
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Europe’s Mixed Messages On AstraZeneca Vaccine Jeopardize Global Covid Response (Forbes)
EU Agency OKs AstraZeneca Vaccine Ruling Out Broad Link To Blood Clotting (Forbes)
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