LONDON – The European Medicines Regulatory Agency said on Thursday that the AstraZeneca vaccine does not increase the overall incidence of blood clots and that the benefits from using it outweigh the potential risks, with European countries having to resume shots. Pave the way for
France, Italy and Germany immediately announced that they would start using the vaccine again on Friday. Spain, Portugal and the Netherlands said they would do so next week, although Spain said it could exclude some groups to mitigate any threat.
More than a dozen countries worldwide suspended their use of the vaccine over the past week, following reports of clots in a few dozen out of millions across Europe. The question was whether the vaccine had anything to do with clots and whether any action was needed.
The European Medicines Agency’s safety committee “has reached a clear scientific conclusion,” EMA head Emer Cook announced. “It is a safe and effective vaccine.”
He said: “If it were me, I would have been vaccinated yesterday.”
However, she said the agency “still cannot definitively dismiss a link” between certain rare types of blood clots and the vaccine. The EMA recommends adding details of these cases to vaccine leaflets.
The debate raised fears that questions of safety would seriously undermine public confidence in AstraZeneca’s vaccine, which is key to efforts to immunize some of the world’s poorest countries, and vaccination in the 27-nation European Union at a time of transition Slows down the campaign. Is growing at an alarming rate. Europe also relies on Pfizer and Modern vaccines.
French Prime Minister Jean Castex said he would get an AstraZeneca shot on Friday in which “we can be confident to show it”.
Clots that form in the hands, feet, or elsewhere can break freely and travel to the heart, brain, or lungs, causing strokes, heart attacks, or other fatal blockages.
In its findings on Thursday, the EMA stated that the total number of clotting incidents of various types since the rollout is lower than would be expected in the general population.
But those very common clots are not a cause for concern. Instead, the EMA said it would be closely watching two rare types of blood clots. It cites seven reports of a type that appear in several blood vessels and 18 reports of a type called cerebral venous thrombosis, which occurs in a vein that draws blood from the brain.
It is among 20 million people who have received at least one dose of the AstraZeneca vaccine in the UK and the European Union.
The majority of those cases were under the age of 55 and the majority were female, the EMA said.
Experts said it would be important to highlight if those people should do something for these rare clots. For example, prior to an epidemic, brain-related clots almost always occur in any of the list of underlying risk factors affecting certain risk factors, such as taking birth control pills or clotting.
Sabine Strauss, head of the EMA’s safety committee, said birth control pills are “a distinct possibility” that will be investigated.
Est Taylor, AstraZeneca’s chief medical officer, welcomed the EMA’s findings and said: “We are confident that after careful decisions by regulators, vaccination can once again begin across Europe.”
The World Health Organization has previously said that there is no evidence that the vaccine was to blame for the clot. AstraZeneca’s vaccine is COVAX, a UN-supported project central to supplying COVID-19 shots to poor countries around the world.
AstraZeneca expects the US authority for its vaccine to come into force in the coming weeks. The US now relies on Pfizer, Modern and Johnson & Johnson vaccines.
Britain was not among the countries that suspended the use of the vaccine. Ahead of the EMA’s announcement on Thursday, Britain’s drug regulatory agency said there was no evidence that the formula caused clots, and it urged people to get the shot.
However, like the EMA, British regulators followed their counterparts on the continent urging people to seek medical attention if they suffer from a headache that lasts for more than four days after vaccination, or some Gets beyond the injection site after days.
With AstraZeneca’s formula comes as a halt to vaccination, tens of thousands of new daily cases have prompted new lockdown measures in Italy, which led to hospitalization in France and German officials raising the third surge of COVID-19 Announcement has started.
“Rarely is an immunization program more important to the well-being of a population,” said Pauline Patterson, co-director of the Vaccine Confidence Project team at the London School of Hygiene and Tropical Medicine.
However, another setback, British officials said the country was facing a reduction in vaccine delivery that could delay the onset of shots for people under 50 in the coming weeks.
There is an estimated 7 million unused doses of the AstraZeneca vaccine in the European Union.
Clinical trials are typically performed in the tens of thousands of participants. As a result, a rare rare side effect is not detected in many millions of people until the product reaches the market.
For example, a year after the vaccination campaign against the 2009 swine flu pandemic for European authorities saw an increase in narcolepsy in children and adolescents receiving the glucosmithkline vaccine.
“It’s perfect to check for any possible signs of problems, but when you continue vaccinating, you can do so,” said Michael Head, senior research fellow at Global Health at the University of Southampton. “If we stop the vaccine rollout every time there is a possible indication, it will not be too much of a rollout.”
The chief cautioned that there are costs to go slowly: the coronovirus is allowed to circulate widely, and the greater the chance it will be to turn it into a lethal version.
“People may be more hesitant to take the AstraZeneca vaccine when vaccination begins,” he said. “And this is at a time when we need to stop the virus from moving forward to reduce the likelihood of further variants.”
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