Bulgarian Prime Minister Boyko Borissov suspended on Friday (12 March) the use of AstraZeneca’s COVID-19 vaccine, following similar steps in Denmark, Iceland and Norway over safety concerns.
“Until we don’t receive an accurate and clearly confirmed position in writing from the European Medicines Agency whether we can or cannot administer the AstraZeneca vaccine, we will stop it,” Borissov said.
Health Minister Kostadin Angelov said that the reason for Bulgaria’s measure was the death of a 57-year-old woman from Plovdiv, who lost her life after vaccination with the AstraZeneca jab.
The EMA announced on Thursday that countries can keep using AstraZeneca’s vaccine while it probes cases of blood clots that prompted suspension of particular batches of the vaccine or all jabs with it in several countries.
Bulgaria falls last among EU countries in terms of its vaccination rate with only 270,000 people or 3.9% of the population receiving at least one dose so far. The country is holding general elections on 4 April and election officials have been vaccinated already, according to reports.
Bulgaria has ordered far more AstraZeneca vaccines than Pfizer/BioNtech and Moderna doses. It was using primarily the AstraZenica vacccine in recent weeks after deciding to scrap prioritisation lists and offer jabs to anyone willing to take them.
So even if it remained unclear on Friday how long the suspension could last, it was expected to severely disrupt vaccination plans.
Health officials already confirmed on Thursday that the country had already used up almost completely 31,200 shots from a batch of the vaccine that was suspended in Austria earier this week after the death of a 49-year-old nurse from “severe blood coagulation problems,” days after receiving the shot.
Health Minister Angelov had previously tried to dismiss any fears over the use of the vaccine saying that there was “no clear and precise conclusion that this batch is the cause of the adverse drug reaction associated with the lethal outcome.”
Angelov is a candidate from Borissov’s GERB party for the general elections. On Thursday, he created controversy by saying that Bulgaria, which currently experiences a surge in COVID-19 cases, would not introduce new restrictions “because people won’t accept them”.
The World Health Organisation said on Friday there was no reason to stop using AstraZeneca’s COVID-19 vaccine after several countries suspended the rollout over blood clot fears.
The WHO, which said its vaccines advisory committee was examining the safety data coming in, stressed that no causal link had been established between the vaccine and clotting.
The UN health agency also said that after the injection of more than 260 million coronavirus vaccine doses so far around the world, no deaths had yet been attributed to a COVID-19 jab.
Denmark, Norway and Iceland paused the use of the AstraZeneca jab as a precaution after isolated reports of recipients developing blood clots.
A range of health authorities around the world have insisted the jab is safe, including the European Medicines Agency (EMA) and the WHO.
“AstraZeneca is an excellent vaccine, as are the other vaccines that are being used,” WHO spokeswoman Margaret Harris told reporters at a briefing in Geneva.
“Yes, we should continue using the AstraZeneca vaccine,” she added, stressing though that any concerns over safety must be investigated.
“We must always ensure that we look for any safety signals when we roll out vaccines, and we must review them,” she said.
“But there is no indication to not use it.”
No causal link found
The EMA said Thursday that there had been 30 cases of so-called thromboembolic events among five million people who had received the jab in Europe.
But European countries could still keep using the vaccine, the EU’s drug regulator said.
Harris said that while a few countries had, as a precaution, suspended the use of a specific batch of AstraZeneca vaccine distributed in Europe, based on reports of blood coagulation disorders, “a causal relationship has not been shown”.
“Vaccination against COVID-19 doesn’t reduce deaths from any other causes,” she said.
“As of March 9, there have been over 268 million doses of COVID-19 vaccines administered since the start of the pandemic.
“No causes of death have been found to have been caused by COVID-19 vaccines to date.”
Harris said the WHO’s advisory committee on vaccine safety, which meets at least every two weeks, systematically reviews any safety reports coming in.
“They’re currently assessing the reports on AstraZeneca,” she said.