These moves by the four largest EU countries follow pauses in several smaller member nations – and mark a new crisis in confidence for a vaccine on good terms which is seen as the best hope to accelerate COVID-19 vaccination in the developing world.
Experts point out that there is still no clear evidence that the vaccine caused these reported clots, and the cases are being investigated by regulators. But the last concerns followed sooner questions from scientists on how the company communicated issues with the safety and effectiveness of his vaccine. It also comes shortly before AstraZeneca is expected to release results from a large-scale clinical trial that will determine whether the FDA authorizes the vaccine for use in the United States.
Vaccination pauses in Europe have been triggered by reports of three hospitalizations, including one patient who died, among people given the vaccine in Norway, and a new death in Denmark. In a statement issued on March 11, the European Medicines Agency – the regulator that is the EU’s equivalent to the FDA – said there had been a total of 30 cases of “thromboembolic events,” or blood clots. blood, among the 5 million people who have received AstraZeneca strokes in the EU.
“There is currently no indication that the vaccination caused these conditions, which are not listed as side effects with this vaccine,” the EMA said. “The position of the EMA safety committee … is that the benefits of vaccination continue to outweigh its risks and vaccination can continue to be administered.”
AstraZeneca said there had been a total of 37 reported cases of pulmonary embolism and deep vein thrombosis, both conditions caused by blood clotting, which is less than expected from the rate in the general population.
“About 17 million people in the EU and the UK have received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases we expected,” said Ann Taylor. , the chief physician a statement issued March 14th.
And the World Health Organization is encouraging countries to continue to use the vaccine, reiterating that there is no evidence that it causes blood clots. WHO experts are meeting to discuss reports of blood clots on Tuesday.
However, a handful of incidents give some countries a break. According to German Health Minister Jens Spahn, there have been seven reported cases of a rare situation, cerebral venous sinus thrombosis (CVST), on the 1.6 million people who have been given the AstraZeneca vaccine in Germany. The Paul Ehrlich Institute, which is part of the German health ministry, said Monday that it was concerned that the condition was reported along with unusual bleeding and a low number of blood platelets, which form clots and clog the blood.
The handful of cases seen in Germany so far would be more than expected, but it could be a blow to statistics. “[T]the probability of a similar statistical grouping for an outcome is actually quite high even when there is no cause and effect, ”said Paul Hunter, a public health specialist at the University of East Anglia, in a comment distributed through Science UK Media Center.
EMA meets to discuss concerns about blood clotting on Tuesday and is expected to release its findings Thursday. A prolonged hiatus in vaccination would be a worrying prospect, as COVID-19 cases grow again in many EU nations – with Italy experiencing a especially particularly alarming – as more contagious variants spread.
Experts contacted by BuzzFeed News said that without knowing more about the patients ’cases, there was not enough evidence to draw clear conclusions if the vaccine caused clotting. “We would like to know the age of the cases, their previous medical history, and the conditions that could predispose them to risk for both a clot and a bleeding,” said Orly Vardeny of the University of Minnesota, a pharmacist specializing in health. cardiac.
“It may or may not be linked to vaccination.” If it’s connected to the vaccine, and if it’s not seen everywhere, the most likely explanation would be a question of production batches, ”John Moore, a virologist at Weill Cornell Medical College in New York, told BuzzFeed News. York working on vaccine development. (Some countries, including Austria, to get specifically stop vaccination from particular parts of the AstraZeneca vaccine.)
The new concerns are the latest in a series of setbacks for AstraZeneca’s COVID-19 vaccine, developed at Oxford University. In November, AstraZeneca claimed in a press release that his vaccine was 70% effective overall, and could be up to 90% effective if given in a half dose for the first of two shots. But many scientists they were skeptical, especially after the pharmaceutical company admitted that this regime was the result of a miscalculing dosing. AstraZeneca then added to the confusion by changing their explanation for the claimed efficacy of 90% from the dosage itself to the delay between the two doses.
A more serious blow came in February, when tests in South Africa showed the vaccine it was not effective against the most contagious variant of the coronavirus circulating here. South Africa has abruptly interrupted plans to use the AstraZeneca vaccine and has instead switched to vaccines made by Johnson & Johnson and Pfizer / BioNTech.
Now scientists are waiting for the results of a great process of the AstraZeneca vaccine made in the United States and other countries that will be the cornerstone of the company’s application to have the vaccine authorized for use by the FDA. But some experts are wondering if adding AstraZeneca to the vaccine armory used in the United States will create more problems, with anti-vaxxers likely to take negative publicity the environment to undermine the wider vaccination vehicle.
“Does it need a niche to fill?” Would she be trustworthy enough? Or is it just another headache? said Moore.
Defense for Children’s Health, an organization that has peddled misinformation and conspiracy theories about vaccines for years, he already has highlighted the news that many European countries are pausing their use of the vaccine.
Where vaccination could make a huge difference is in the developing world, particularly in Africa, where the vaccine is being implemented. lagging far behind. The Biden administration is already under pressure to donate already manufactured doses of the AstraZeneca vaccine to the poorest nations, the The New York Times said on March 11th. Meanwhile, COVAX – the partnership formed by WHO, the Coalition for Epidemic Preparedness Innovations, and Gavi, the Vaccine Alliance, to provide accessible vaccines to the poorest countries – is based on the use of the AstraZeneca vaccine to provide hundreds of millions of doses worldwide in the developing world.
“Safety is our top priority: We know that national authorities and the WHO are following the situation closely and the COVAX Facility will follow its guidance and recommendations,” a Gavi spokesman said in response to questions from BuzzFeed News. “Currently no causal link has been established between the vaccine and thromboembolic events in individuals, and the vaccine remains an important and effective public health tool in the fight against this pandemic.”