Health authorities in Denmark, Norway and Iceland on Thursday suspended the use of AstraZeneca’s Covid-19 vaccine shots following reports of the formation of blood clots in some people who had been vaccinated.
Austria earlier stopped using a batch of AstraZeneca shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism. Still, the European medicine regulator EMA said the vaccine's benefits outweighed its risks and could continue to be administered. Europe is struggling to speed up a vaccine rollout after delivery delays from Pfizer and AstraZeneca, even as a spike in cases amid a more contagious virus variant has triggered fresh lockdowns in countries such as Italy and France.
The Republic is administering the AstraZeneca vaccine only to those aged under 70, and has so far given roughly 100,000 doses.
The State’s medicines regulator said it had received a “small number” of reports associated with blood clots following inoculation with the AstraZeneca vaccine.
The Health Products Regulatory Authority (HPRA) said the nature of the reports did not raise a concern and that the reports were communicated to the European Medicines Agency to be included in an ongoing review into the matter.
“Whilst the number of thromboembolic (blood clot) events reported in vaccinated people is no higher than that seen in the general population, it is very important to scrutinise swiftly any reports of potential safety concerns, even if very rare, so that appropriate action if required can be taken,” a HPRA spokeswoman said.
“The HPRA is working closely with the EMA and with national bodies here in Ireland and will further communicate as the assessment progresses.”
Denmark suspended the shots for two weeks after a 60-year-old woman, who was given an AstraZeneca shot from the same batch used in Austria, formed a blood clot and died, Danish health authorities said. Their response was also prompted by reports “of possible serious side effects” from other European countries.
“It is currently not possible to conclude whether there is a link. We are acting early, it needs to be thoroughly investigated,” Danish health minister Magnus Heunicke said on Twitter. The vaccine would be suspended for 14 days in Denmark.
“This is a cautionary decision,” Geir Bukholm, director of infection prevention and control at the Norwegian Institute of Public Health (FHI), told a news conference. FHI did not say how long the suspension would last. “We ... await information to see if there is a link between the vaccination and this case with a blood clot,” Mr Bukholm said.
Iceland on Thursday suspended jabs with the vaccine as it awaited the results of an investigation by the EMA. Italy, also on Thursday, said it would suspend use of an AstraZeneca batch different to the one used in Austria.
Some health experts said there was little evidence to suggest the AstraZeneca vaccine should not be administered and that the cases of blood clots corresponded with the rate of such cases in the general population.
“The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence,” Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said. Mr Evans added that the Covid-19 disease was very strongly associated with blood clotting.
Phil Bryan, head of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) said reports of blood clots so far didn’t exceed what would have occurred naturally in the vaccinated population.
AstraZeneca told Reuters in a written statement the safety of its vaccine had been extensively studied in human trials and peer-reviewed data confirmed it was generally well tolerated. The drugmaker said this week there had been “no confirmed serious adverse events associated with the vaccine”. It said it was in contact with Austrian authorities and would fully support their investigation. The European Union’s drug regulator, the EMA, said on Wednesday there was no evidence so far linking AstraZeneca to the two cases in Austria. It said the number of thromboembolic events – marked by the formation of blood clots – in people who have received the AstraZeneca vaccine was no higher than that seen in the general population, with 22 cases reported among the 3 million people who have received the shot as of March 9th.
EMA said it understood the decision by Denmark and Norway was taken as a precaution. Four other countries – Estonia, Lithuania, Luxembourg and Latvia – have stopped inoculations from the batch while investigations continue, the EMA said. The batch of 1 million doses went to 17 EU countries including Ireland.
Swedish authorities said they did not find sufficient evidence to stop vaccination with AstraZeneca’s jab. – Reuters