AstraZeneca strongly defended its vaccine, saying on Friday that there was “no evidence of increased risk” of blood clots, and drug regulators in Europe and the UK said the link between the vaccine and blood clots did not. has been confirmed and that launches are expected to continue.
“When there is an adverse event, we don’t have to be in a hurry,” said Piyasakol Sakolsatayadorn, senior member of the country’s vaccination committee.
Bulgaria became the last country to stop using the vaccine on Friday, pending safety investigations. Prime Minister Boyko Borissov ordered the suspension of all vaccines with the AstraZeneca Covid-19 vaccine until the European Medicines Agency “dismisses all doubts” about the safety of the vaccine, according to a government statement.
All of this in response to reports of blood clots in some people inoculated in Denmark, including a fatality. Denmark was the first country to take the precautionary measure, announcing a 14-day break while the authorities investigated further.
Norway and Iceland shortly thereafter. The Norwegian Institute of Public Health says the country has also reported cases of blood clots shortly after receiving the Covid-19 vaccination in Norway, but “mainly in the elderly, where there is often another underlying disease”.
Other countries, including Austria and Italy, have suspended specific vaccine batches.
But a number of nations – including Germany, France, the United Kingdom, the Netherlands, Mexico and Nigeria – have been vigilant and have assured citizens of their safety.
Health agencies tell countries to continue launching
The European Medicines Agency (EMA) said Thursday that it did not recommend suspending the use of the AstraZeneca vaccine, saying that “there is no indication” that the vaccine caused blood clots in people who received the vaccine. The agency told countries that they could continue to fire while investigations are underway.
“The benefits of the vaccine continue to outweigh its risks and the vaccine can continue to be administered while investigating cases of thromboembolic events is ongoing,” the agency said.
The UK drug regulator – the Medicines and Health Products Regulatory Agency (MHRA) – also issued a statement on Thursday, assuring the public that the vaccine is still safe and that “people must still get the vaccine COVID-19.”
The episode, however, represents another headache for the pharmaceutical giant, whose vaccine has been plagued by political disputes, delays in delivery and other concerns.
But the tone in most of Europe was calm, while other governments sought to contextualize the reports.
“Investigations are carried out systematically every time serious adverse effects are reported,” French Health Minister Olivier Véran said in his weekly briefing on Thursday. “But what are we talking about? About 30 people in more than five million Europeans received an injection.”
The UK’s MHRA, where 11 million doses of the vaccine were administered, said blood clots “can occur naturally and are not uncommon”. Vaccine safety leader Phil Bryan added that blood clot reports “are not greater than the number that would have occurred naturally in the vaccinated population”.
And Germany confirmed on Thursday night that it will stick to its deployment plans. “We are planning to continue vaccinating with AstraZeneca, like most other European countries,” said German Health Minister Jens Spahn.
‘No evidence’ of coagulation binding
AstraZeneca said on Friday that its analysis not only shows “no evidence of an increased risk” of blood clots in the vaccine’s recipients, but shows a lower number than in the general population.
“An analysis of our safety data from more than 10 million records showed no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country with COVID-19 Vaccine AstraZeneca, “the company said in a statement.
“In fact, the observed number of these types of events is significantly lower in those vaccinated than would be expected among the general population,” he added.
Danish health leaders emphasized that their decision to announce a two-week pause in vaccine use was a precautionary one, reminding people that there is “good evidence that the vaccine is safe and effective”, but saying “they would act early” to investigate coagulation reports.
Spain has delayed the application of the vaccine to people aged 55 to 65 until a review is carried out, but Dutch Health Minister Hugo de Jonge said on Thursday that “there is no cause for concern” and no reason to stop using the AstraZeneca vaccine.
Earlier this week, several EU countries stopped using doses from a specific batch of the AstraZeneca vaccine, after a 49-year-old woman in Austria died of multiple thrombosis on Sunday. The EMA said on Wednesday that “there is no indication” that vaccination is behind the cases of clotting or death.
And on Thursday, the Italian drug agency AIFA also banned the use of another batch of AstraZeneca vaccines. The agency said it was responding to “some serious adverse events” that occurred at the time of vaccinations on a specific batch. He did not say what the events were and said that no causal link between the events and the vaccine was established.
Real-world data also showed that the vaccine is having a significant impact in reducing Covid-19 hospitalizations.
Concerns over the vaccine’s safety, however, come at a difficult time for AstraZeneca, with disputes over its supplies to the EU still unresolved. After announcing it would suspend the vaccine, the Danish health authority said on Thursday that the country will now receive approximately 900,000 fewer doses of the vaccine.
“The fact that AstraZeneca is once again decreasing the number of doses delivered to the EU and therefore Denmark is obviously unsatisfactory and a serious challenge,” said Ole Jensen, deputy director of the Statens Serum Institut.
Polish authorities also announced on Friday that AstraZeneca will reduce the number of doses of the coronavirus vaccine delivered there.
CNN’s Antonia Mortensen, Schams Elwazer, Arnaud Siad and Vee Intarakatug contributed reporting.