Denmark will no longer offer the AstraZeneca vaccine as part of its immunisation programme, becoming the first country to drop the vaccine over suspected rare but serious side-effects.
The move comes in spite of strong recommendations from the World Health Organization and European medicines watchdog to continue using the inoculation, as the benefits far outweigh any potential risk.
“Denmark’s vaccination campaign will go ahead without the AstraZeneca vaccine,” the director of the Danish health authority, Søren Brostrøm, told a press conference.
Neighbouring Sweden has said it plans to pause its own roll-out of a second vaccine, produced by Johnson & Johnson, which has also been linked to rare blood clots.
Finland also announced that it would continue to limit the AstraZeneca vaccine to people aged 65 and over, adding that it was possible to give a second dose from another manufacturer and that it was drafting a plan on how to continue with its vaccinations.
Denmark’s decision comes amid a continuing focus on rare side-effects that has seen the US-produced Johnson & Johnson vaccine paused in the US over similar concerns, potentially putting back the EU’s vaccination effort by several months as it waits for supplies.
An advisory committee to the US Centers for Disease Control and Prevention was due to meet on Wednesday to review the six clotting cases and vote on recommendations for future use of the shot. The Food and Drug Administration will review the analysis.
All six cases involved women between the ages of 18 and 48, with symptoms occurring six to 13 days after vaccination. The FDA said patients should watch for up to three weeks for symptoms including severe headache, abdominal pain, leg pain or shortness of breath.
Experts said clotting risks for both vaccines remained extremely low and that vaccines were highly effective in providing protection against Covid-19. There are concerns that reports of rare side-effects could deter people from getting their shots.
The European Medicines Agency (EMA) is due to issue guidance on Johnson & Johnson next week after US federal health agencies recommended pausing use of the vaccine for at least a few days after six women under age of 50 developed blood clots following their inoculations.
Regarding AstraZeneca the European regulator found the benefits of vaccination outweighed the risks and left it to individual states to make their own assessments and decide how administer the vaccine based on local conditions, which vary widely across the bloc.
Brostrøm said last month that Denmark had “followed a precautionary principle” with regards to the AstraZeneca vaccine before this week’s decision not to use it.
Denmark was the first country in Europe to suspend the use of the AstraZeneca jab in its vaccination rollout, after reports of rare but serious cases of blood clots among those that had received the vaccine.
More than a dozen countries followed suit, but all but a few have since resumed its use after the EMA emphasised the benefits of the vaccine and deemed it “safe and effective”. As of April 4, the European Medicines Agency had received reports of 169 cases of cerebral venous sinus thrombosis (CVST) after 34m AstraZeneca doses had been administered in the European Economic Area.
In Denmark, two cases of thrombosis, one of which was fatal, were linked to vaccinations after more than 140,000 people received the jab made by the Anglo-Swedish drugmaker. In the country of 5.8 million inhabitants, 8 percent have been fully vaccinated against Covid-19, and 17 percent have received the first dose.
Although deliveries of the Johnson & Johnson shot had barely begun in Europe, questions about the two vaccines threaten to undermine public confidence in the low-cost jabs, which authorities had been counting on as a central weapon in fighting the pandemic.
The potential risk of blood clots from some vaccines has prompted different responses across Europe: French government spokesman Gabriel Attal told a news conference on Wednesday that Paris retained confidence in the AstraZeneca shot and would deploy the first doses of the newly arrived Johnson & Johnson shot.
The suspension of Johnson & Johnson’s coronavirus vaccine could delay efforts to inoculate most people in the European Union by more than two months, scientific information and analytics company Airfinity said. “If the EU can’t use the J&J vaccine indefinitely, it could push the timeline for vaccinating 75% of the population back into December,” Airfinity said in a forecast update.
