These moves by the four largest countries in the European Union after a pause in some of the smaller member states – and mark a new crisis of confidence towards a affordable vaccine that is considered the best hope for accelerating COVID-19 vaccination across the developing world.
Experts stressed that there is still no clear evidence that the vaccine caused these reported blood clots and that the cases are being investigated by regulators. But the newest concerns follow before that Questions from scientists on how the company has communicated the issues with Safe and effective its vaccine. It also comes just before AstraZeneca is expected to release results from a large-scale clinical trial to determine if the FDA will allow the vaccine in the US.
The suspension of vaccination in Europe was triggered by reports of three hospitalizations, including one patient who died, among those vaccinated in the United States. Norway, and one more death in Denmark. In one declare enacted on March 11, the European Medicines Agency – the equivalent regulator of the EU’s FDA – said there had been a total of 30 cases of “thromboembolic events”, or blood clots, in Some 5 million people have been injected with AstraZeneca in the EU.
“There is currently no indication that vaccination has caused these conditions, and these side effects are not listed as side effects,” the EMA said. “The EMA’s safety committee’s view … is that the benefits of the vaccine continue to outweigh its risks and that the vaccine can continue to be used.”
AstraZeneca says there have been a total of 37 reported cases of pulmonary embolism and deep vein thrombosis, both conditions caused by blood clotting, less than expected for the general population.
Medical director Ann Taylor said: “About 17 million people in the EU and UK have now received our vaccines, and the number of reported coagulation cases in this group is hundreds of less than expected. . a declare released on March 14.
And the World Health Organization is urges countries to continue using the vaccine, echoing that there is no evidence that it causes blood clots. WHO experts are meeting to discuss the clot reports on Tuesday.
However, some incidents are causing some countries to pause. According to German Health Minister Jens Spahn, there have been seven reported cases of a rare condition, Cerebral venous sinus thrombosis (CVST), of the 1.6 million people who received the AstraZeneca vaccine in Germany. The Paul Ehrlich Institute, a division of the German Health Ministry, said on Monday that concerned This condition has been reported along with abnormal bleeding and low platelet counts in the blood, clot formation and prevention of bleeding.
The handful of cases seen in Germany so far would have been more than expected, but it could be a statistically good luck. “[T]Paul Hunter, public health specialist at the University of East Anglia, said in a comment distributed via the UK’s Center for Scientific Communications, the probability of such a statistical cluster giving an outcome. is actually quite high even with no cause or effect.
The EMA will meet to discuss clotting concerns on Tuesday and is expected to draw its conclusions on Thursday. Prolonged immunization interruptions will be a worrying prospect, as cases of COVID-19 are rising again in some EU countries – with Italy already the increase is particularly alarming – when there are more variations it is more contagious.
The experts contacted by BuzzFeed News said that without more knowledge of the patient’s cases, there is not enough evidence to draw conclusive conclusions about whether the vaccine is causing blood clots. Orly Vardeny of the University of Minnesota, a pharmacist specializing in cardiovascular health, said: “We want to know the age of the cases, their previous medical history and conditions that could lead to blood clotting. or bleeding.
“It may or may not have been vaccine. If it has something to do with the vaccine and if it’s not seen everywhere, the most likely explanation is the production batch problem, ”said John Moore, virologist at Weill Cornell Medical College in New York. , who works on vaccine development, told BuzzFeed News. (Some countries, including Austria, yes special suspension of vaccination from specific batches of AstraZeneca vaccine.)
The new concern is the latest in a series of stumbles to AstraZeneca’s COVID-19 vaccine, developed at Oxford University. Back in November, AstraZeneca announced in one Press Release that its vaccine is 70% effective overall and can be up to 90% effective if given a half-dose given to the first of the two shots. But many scientists was skeptical, especially after the pharmaceutical company admitted that the regimen was the result of one wrong dosage calculation. AstraZeneca then added confusion by way change its explanation for the reported efficacy of 90% from the dose itself to the delay between the two doses.
A more serious blow occurred in February, when trials in South Africa showed the vaccine inefficient against the more contagious variant of the coronavirus circulating there. South Africa abruptly halted AstraZeneca’s vaccine plan and switched to a vaccine made by Johnson & Johnson and Pfizer / BioNTech.
Currently scientists are waiting for the result of one great test The AstraZeneca vaccine administered in the United States and other countries will serve as the foundation for the FDA-approved vaccine registrar to use. But some experts wonder if adding AstraZeneca to the stock of vaccines currently in use in the US is causing more problems, with The anti-vaxxer is likely to capture the negative publicity surrounding it to sabotage the larger vaccination site.
“Does it really have a niche to fill? Is it reliable enough? Or will it just be another headache? “Moore said.
Child health protection, an organization has peddling wrong information and conspiracy theories about vaccines for many years, already emphasize news that some European countries are halting their vaccine use.
Where vaccines can make a big difference is in the developing world, especially in Africa, where vaccines are in place. lag far behind. The Biden administration has come under pressure to donate ready-made doses of AstraZeneca vaccine to poorer countries, New York Times reported March 11th, meanwhile, COVAX – a partnership formed by WHO, the Coalition for Disease Readiness Innovation and Gavi, the Vaccine Alliance, to provide affordable vaccines for poorer country – is based on the vaccine use of AstraZeneca to deliver hundreds of millions of doses across the developing world.
“Safety is our top concern: We know that the national authorities and WHO are monitoring the situation closely and the COVAX Facility will follow their instructions and recommendations,” says A Gavi spokesman said in advance queries from BuzzFeed News. “There is currently no established causal link between vaccines and thromboembolic events in individuals, and vaccines remain an important and effective public health tool in this war against pandemic. “