By maria cheng and DANICA KIRKA, Associated Press
LONDON (AP) – The European Union Drug Regulator said on Wednesday that it found a “possible link” between the AstraZeneca coronavirus vaccine and a rare clotting disorder but refused to enforce any new age restrictions, saying the shot The benefits of still reduce the risk. However, its UK counterpart said it would offer a choice of other product to people under 30.
The European Medicine Agency described clots as “very rare” side effects. It added that the majority of reported cases occurred in women under 60 within two weeks of vaccination – but based on currently available evidence, it was not able to identify specific risk factors. Experts reviewed several dozen cases that came mainly from Europe and the United Kingdom, where approximately 25 million people have received the AstraZeneca vaccine.
The agency’s executive director Emer Cook said “the potential side effects of abnormal blood clot vaccination after vaccination with the AstraZeneca vaccine should be listed”.
But it did not impose any new restrictions on the use of the vaccine in people 18 years and older, as some countries have done.
“Cook stated that the death rate from COVID is higher than the risk of mortality from these side effects.”
Head of the UK’s Medicine and Healthcare Products Regulatory Agency, Drs. June Rhyne echoed that sentiment, stating that the benefit “continues to reduce risk for the vast majority of people.”
She called the unusual clots a “potential side effect” of the vaccine and said the evidence was “strengthening”, but more studies were needed to ascertain this.
The EMA, the World Health Organization and several other health officials have repeatedly stated that the AstraZeneca vaccine is safe and effective and provides protection that protects against the small risks of rare blood clots against COVID-19.
The declarations can have far-reaching effects on the use of the shot which is the key to global efforts to end the epidemic.
The EMA investigation specifically focused on two types of rare blood clots: one that appears in multiple blood vessels and the other in a vein that draws blood from the brain. It also evaluated reports of people who had low platelet levels in their blood, which puts them at risk of severe bleeding.
As recently as last week, the EMA stated “there is no evidence that would support prohibiting the use of this vaccine in any population” – a backlash for many countries doing just that – although one expert said Said to be more reported than brain clots. Be expected.
In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca on the issue of blood clots. Most of the restarts – with some age restrictions – followed the EMA stating that countries should continue to use the potentially life-saving vaccine.
Meanwhile, Britain, which relies heavily on AstraZeneca, never suspended the use of the vaccine.
For AstraZeneca, the suspension was seen as particularly damaging as they repeatedly see the company report data on the vaccine’s effectiveness after concerns of missteps and expressed concern that its shots What a great job did the old people. This has led to repeated changes in some countries over who can take the vaccine, raising concerns that AstraZeneca’s credibility may be permanently damaged, over-vaccine inhibition and prolonging the epidemic.
Dr. Peter English, who previously chaired the Public Health Medicine Committee of the British Medical Association, said that the back-and-forth of the AstraZeneca vaccine globally could have serious consequences.
“We cannot use this vaccine if we are going to end the epidemic,” he said.
This is because this vaccine is cheaper and easier than many others, important for Europe’s vaccination campaign and known as a pillar of a UN-supported program aimed at vaccines to some of the world’s poorest countries To be installed. It has been endorsed for use in more than 50 countries, including the 27-nation EU and WHO. US officials are still evaluating the vaccine.
The governor of Italy’s northern Veneto region said earlier on Wednesday that any decision to change guidance on AstraZeneca would impede major immunizations – at a time when Europe is already struggling to tease them – and shot. Can cause more confusion about.
“If they like Germany, and allow the Astra Zeneca only to people over 65, it would be absurd. Before that it was only for people under 55. In place of the citizens themselves Keep it, it’s hard to understand anything, ”Luca Xia told reporters on Wednesday.
AstraZeneca’s latest suspension came in Spain’s Castilla y Leon region, where health chief Veronica Casado said Wednesday that the “principle of prudence” prompted her to create a temporary hold on vaccines that still support being both effective and necessary. Does.
“If there are indeed individuals of a certain age group who may be at greater risk (of clots), then we need to adjust its use,” Casado told Spanish public radio. “We are not questioning AstraZeneca. We need all vaccines to reach the target of 70% of the adult population. “
French health officials said they, too, were awaiting the EMA’s findings and would follow the agency’s recommendations, especially for the 500,000 people who received their first dose of AstraZeneca.
Asia officials also said they were eager to hear the EMA’s decision. On Wednesday, South Korea said it would temporarily suspend the use of AstraZeneca vaccines in people 60 and younger. In that age group, the country is only currently vaccinating health workers and people in long-term care settings.
The Korea Disease Control and Prevention Agency said it would prevent a vaccine rollout for school nurses and teachers starting on Thursday, awaiting the outcome of the EMA’s review.
English, a former chairman of the British Medical Association Committee, said that rare, serious side effects are seen even with established vaccines, and policymakers often decide that large public health targets use them, citing polio vaccines. For every million doses given for the oral polio vaccine, approximately one child is paralyzed by the live virus contained in the vaccine.
On Tuesday, AstraZeneca and the University of Oxford, which developed the vaccine, halted a study of shot in children, while a UK regulator evaluates the link between shot and rare blood clots in adults.
This version has been updated to correct an incorrect title for English on the second reference. He is the former chairman of the Public Health Medicine Committee of the British Medical Association.
Associated Press writer Joseph Wilson in Barcelona, Spain, Coleen Barry in Milan, Kim Tong-hyung in Seoul and Angela Charlton in Paris contributed to this report.
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