AstraZeneca strongly defended its vaccine, saying on Friday that there was “no evidence of an increased risk” for blood clots, and European and British medicine regulators each said that the link between the vaccine and blood clots had not been confirmed and that the deployment must continue.
“If there is an adverse event, we do not have to be in a hurry,” said Piyasakol Sakolsatayadorn, a senior member of the country’s vaccination committee.
Bulgaria on Friday became the youngest country to suspend vaccine use pending safety investigations. Prime Minister Boyko Borissov has ordered that all vaccinations with the AstraZeneca Covid-19 vaccine be stopped until the European Medicines Agency rejects ‘all doubts’ about the safety of the vaccine, according to a government statement.
This is all in response to reports of blood clots in some vaccinated people in Denmark, including one fatal death. Denmark was the first country to take the precautionary measure and announced a 14-day break while authorities investigated further.
Norway and Iceland soon followed. The Norwegian Institute of Public Health says the country also reported cases of blood clots shortly after receiving a vaccination in Covid-19 in Norway, but “mainly in the elderly, where there is also another underlying disease on a regular basis.”
Other countries, including Austria and Italy, have suspended specific groups of the vaccine.
But a number of nations – including Germany, France, the United Kingdom, the Netherlands, Mexico and Nigeria – have stood by and reassured citizens of its security.
Health agencies tell countries to continue development
The European Medicines Agency (EMA) said on Thursday that it does not recommend suspending the use of the AstraZeneca vaccine, stating that there is no indication that the vaccine causes blood clots in the people who received the vaccine. . The agency said countries could continue to roll out the shot while investigations take place.
“The benefits of the vaccine still outweigh the risks and the vaccine can still be administered while investigating cases of thromboembolic events,” the agency said.
The British Medicines and Healthcare Products Regulatory Agency (MHRA) also issued a statement on Thursday assuring the public that the vaccine is still safe and that “people still need their COVID-19 vaccine. go fetch.”
The episode nevertheless holds another headache for the pharmaceutical giant, whose vaccination is plagued by political disputes, delays in delivery and other concerns.
But the tone in most of Europe was calm as other governments tried to put the reports in context.
“Investigations are being carried out systematically every time serious adverse consequences are declared,” French Health Minister Olivier Véran said in his weekly briefing on Thursday. “But what are we talking about? About 30 people out of more than five million Europeans have received an injection.”
The British MHRA, which administered 11 million doses of the vaccine, said blood clots “can occur naturally and are not uncommon.” Phil Bryan, leader for vaccine safety, added that the reports of blood clots “do not exceed the number that would occur naturally in the vaccinated population.”
And Germany confirmed on Thursday that it will stick to its deployment plans. “We plan to continue with AstraZeneca, just like an overall majority of other European countries,” said German Health Minister Jens Spahn.
‘No evidence’ of coagulation compound
AstraZeneca said on Friday that its analysis not only shows “no evidence of an increased risk” of blood clots in vaccines, but that it 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 thrombosis in deep veins in any defined age group, gender, group or in any 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 who are vaccinated than would be expected among the general population,” he added.
Denmark’s health leaders have stressed that the decision to announce a two-week break in vaccine use was a precautionary measure and reminded people that there is ‘good evidence that the vaccine is safe and effective’, but says that they will ‘act early’ to investigate the reports of coagulation.
Spain has delayed giving those between 55 and 65 years old until a review is done, but Dutch health minister Hugo de Jonge said on Thursday there was “no cause for concern” and no reason to step up. do not agree with the use of the AstraZeneca vaccine.
Earlier this week, a number of EU countries suspended the use of doses coming from a specific group of AstraZeneca vaccines after a 49-year-old woman in Austria died on Sunday from multiple thrombosis. The EMA said Wednesday there is “no indication” that vaccination was behind the cases of coagulation or death.
And on Thursday, the Italian Medicines Agency AIFA also banned the use of another group of AstraZeneca vaccines. The agency said it was responding to some serious adverse events that took place around the time of vaccinations from one specific group. It did not say what the events were, saying no causal link between the events and the vaccine had been established.
Actual data also showed that the vaccine had a significant impact on reducing Covid-19 hospitalizations.
Concerns about the safety of the vaccine nevertheless come at an awkward time for AstraZeneca, while disputes over its delivery to the EU have not yet been resolved. After announcing that it would discontinue the vaccine, Denmark’s health authority said on Thursday that the country would now receive about 900,000 fewer doses.
“The fact that AstraZeneca is again downgrading the amount of doses delivered to the EU and thus downgrading Denmark is obviously unsatisfactory and a serious challenge,” said Ole Jensen, deputy director at the Statens Serum Institut.
Polish officials also announced on Friday that AstraZeneca will reduce the number of doses administered against coronavirus.
CNN’s Antonia Mortensen, Schams Elwazer, Arnaud Siad and Vee Intarakatug reported.