“Our conclusion is that these clotting disorders are very rare side effects of vaccines,” said Sabine Strauss, chair of the EMA’s assessment committee. An incident and scientific study, as the organization says, the immune response after vaccination is the “probable” cause of obstruction.
Until now, most of the patients reported being born in women under 60, regulators said. But it was not possible to conclude that either group was more at risk than the other.
But as British officials have become the latest European country to adjust vaccination guidelines, saying adults under 30 should be offered an alternative to the homegrown vaccine developed in collaboration with Oxford University.
AstraZeneca did not immediately respond to a request for comment on Wednesday. But it said safety is still a top priority and is analyzing a database of tens of millions of patients to better understand whether there is a higher or unexpected blockage rate elsewhere.
The vaccine has been under intense scientific scrutiny since earlier this month when a 49-year-old nurse died of complications from blood clots following vaccination in Austria.Other cases followed across Europe, leading some countries to hold. Vaccine use until a scientific review
Concerns about a rare condition called cerebral venous thrombosis or CVST, a clot that stops blood from flowing out of the brain. The regulator said it happened among those who received higher rates of vaccination than they would expect to see in the normal population.
A total of 169 CVST cases were reported out of 34 million patients with AstraZeneca across Europe as of April 4, the EMA said.There were also 52 other cases of rare blood clots. It said from an initial scientific review of 62 and 18 deaths until March 22, but the ongoing reports did not change their assessments.
Wednesday’s announcement marks the latest blow for a vaccine touted as a vital tool in taking the world out of the epidemic. It’s cheaper and easier to store than any other store on the market.It plans to launch in more than 140 countries through a program designed to ensure even distribution.
Scientists are still trying to find out if any part of the population is at high risk. The UK has recorded about 1 in 500,000 fatal blockages, but the higher rates in countries where AstraZeneca’s vaccine was initiated, only among younger people, has led to debate whether the risk could be higher for certain age groups or for. The EMA assessed the risk for people under the age of 60 as about 1 in 100,000, saying the majority of blood clots occurred in women under that age. But it was not yet possible to determine whether it was due to a higher risk or if there were more young women being vaccinated.
In Germany, 29 out of 31 patients with cerebral blood clots were women. But European regulators said it could be because countries like Germany started off with community vaccinations like health care workers, which included more women.
The EMA says most blood clots occur in women under 60. The risk outweighs the benefit of the vaccine for certain parts of the population, such as younger women: “At the moment this is very difficult to answer.” Say
In the UK, regulators often advise that, if possible, people under the age of 30 should receive Pfizer or Modena vaccine, if applicable, rather than the AstraZeneca prod.
The UK’s vaccine advisory and regulatory agency said there was “firmer” evidence that the AstraZeneca shot could cause these very rare blood clots.
June Raine, head of the drug and health products regulatory agency, said that at the end of March, more than 20 million people in the UK had received AstraZeneca at least once. According to the review, 79 people received rare blood after one vaccination: 51 women and 28 men. Nineteen of those people died, and three of 19 were under the age of 30.
Raine said four in a million people could die due to a blood clot from the AstraZeneca vaccine.
Public health officials stressed that investigations of the causal link between vaccination and blockages are ongoing and cannot be concluded.
They press that for most people, especially the elderly, getting a safe and effective vaccine is better than no. British officials said they were giving new advice from “too much caution”.
“This is a course correction,” said Jonathan Van-Tam, British Deputy Chief Medical Officer, in a televised briefing. He compared the UK’s swift and successful vaccine campaign to a fleet of ships, “If you were sailing across the Atlantic, it didn’t make sense that you wouldn’t have to make at least one revision on that trip.” Van Tam said he called the opportunity for everyone, including children, to get a blood clot from the AstraZeneca vaccine a “little bit is missing”.
“The vaccine has proven to be highly effective in preventing severe disease and hospitalizations, and can even save lives,” said EMA Chief Emer Cooke. We are in the fight against COVID-19 and we need a vaccine.
The London reporting booth.