European Union medicine said on Wednesday it had found a “possible link” between the AstraZeneca coronavirus vaccine and a rare coagulation disorder, but recommended that vaccinations continue in adults and said the benefits of the shot still outweighed the risks.
The European Medicines Agency described blood clots as “very rare” side effects. It is said that most reported cases have occurred in women under 60 within two weeks of vaccination – but based on the available evidence, it could not identify specific risk factors. Experts examined several dozen cases, mainly from Europe and the United Kingdom, where about 25 million people have received the AstraZeneca vaccine.
“The reported cases of unusual blood clots following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine,” said Emer Cooke, the agency’s executive director.
However, it did not place any new age restrictions on the use of the vaccine in people over the age of 18, as some countries have done.
“The risk of mortality from COVID is much greater than the risk of mortality due to these side effects,” Cooke said.
The EMA, the World Health Organization and many other health authorities have repeatedly said that the AstraZeneca vaccine is safe and effective and that protection against COVID-19 outweighs the small risks of rare blood clots – a statement that the EMA reiterated on Wednesday.
The announcement could have far-reaching effects on the use of the shot, which is the key to global efforts to end the pandemic.
EMA is particularly focused on two types of rare blood clots: one that occurs in several blood vessels and another that occurs in a vein that drains blood from the brain. It also evaluated reports of people who had low platelet levels, which means they risk severe bleeding.
As recently as last week, the EMA said “there is no evidence to support restricting the use of this vaccine in any population” – in response to several countries doing just that – although one expert said more brain clots were reported than would be expected.
In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted – some with age restrictions – after the EMA said countries should continue to use the potentially life-saving vaccine.
The suspensions were considered particularly harmful to AstraZeneca because they came after repeated inaccuracies in how the company reported data on the vaccine’s effectiveness and concerns about how well its shots worked in the elderly. This has led to frequent changes in advice in some countries about who can take the vaccine, which worries that AstraZeneca’s credibility could be permanently damaged, which stimulates more hesitation about the vaccine and prolongs the pandemic.
Dr Peter English, former chairman of the British Medical Association’s Public Health Medicine Committee, said back and forth over the AstraZeneca vaccine globally could have serious consequences.
“We can not afford not to use this vaccine if we are to end the pandemic,” he said.
This is because the vaccine is cheaper and easier to store than many others, is crucial to Europe’s immunization campaign and a pillar of the UN – funded program known as COVAX, which aims to get vaccines to some of the world’s poorest countries. It has been approved for use in more than 50 countries, including by the 27-nation EU and WHO. US authorities are still evaluating the vaccine.
The governor of Italy’s northern Veneto region had said earlier on Wednesday that any decision to change AstraZeneca’s guidelines would cause major disruptions to vaccinations – at a time when Europe is already struggling to increase them – and could create more confusion about the shot.
“If they like Germany and only allow Astra Zeneca to people over 65, it would be absurd. Before it was only for people under 55 years. Position yourself for the citizens’ place, it is difficult to understand anything, says Luca Zaia to journalists on Wednesday.
The latest shutdown of AstraZeneca came in the Castilla y León region of Spain, where health chief Verónica Casado said on Wednesday that the “precautionary principle” had driven her to temporarily seize the vaccine she still supported as both effective and necessary.
“If there are actually individuals in a certain age group who may have a higher risk (of coagulation), we need to adjust its use,” Casado told Spanish public radio. “We do not question AstraZeneca. We need all possible vaccines to reach the target of 70% of the adult population. ”
The French health authorities said they were also waiting for the EMA’s conclusions and would follow the authority’s recommendations, especially for the 500,000 people who have received a first dose of AstraZeneca.
Even officials in Asia said they were anxious to hear the EMA’s decision. On Wednesday, South Korea said it would temporarily suspend the use of AstraZeneca’s vaccine in people 60 years and younger. In that age group, the country currently only vaccinates care staff and people in long-term care.
The Korea Disease Control and Prevention Agency said it would also pause a rollout of vaccines for nurses and teachers that would begin on Thursday, pending the outcome of the EMA’s review.
English, the former chairman of the UK Medicines Agency, said that even rare, serious side effects are seen with established vaccines and that decision-makers often decide that major public health goals justify their use, citing the polio vaccine as an example. For every million doses of the oral polio vaccine, approximately one child is paralyzed by the live virus contained in the vaccine.
On Tuesday, AstraZeneca and Oxford University, which developed the vaccine, paused a study of the shot in children while the UK regulator evaluates the link between the shot and rare blood clots in adults.