The European Union’s drugs regulator said the benefits of AstraZeneca PLC’s COVID-19 vaccine continue to outweigh its risks, and the shot can still be administered while investigations of possible blood clots are ongoing.
The European Medicines Agency reiterated that there is currently no indication that the Astra vaccine caused these conditions, which aren’t listed as side effects. The EMA issued the statement as Denmark, Italy and Norway joined other European countries in temporarily suspending use of some or all of their Astra COVID-19 shots. The regulator is investigating the concerns.
It’s the latest setback for AstraZeneca’s European rollout, which has already encountered a number of bumps along the way. Delayed deliveries fueled a dispute between the EU and the U.K., where AstraZeneca is based, and there were questions over its efficacy for people over 65. Several EU countries have since reversed course on earlier restrictions after new data showed the vaccine’s benefits for the elderly.
Further negative perceptions among the public could affect take-up of the Astra vaccine in the EU, which is relying on the shot as it races to catch up with the rest of the developed world in inoculating its population.
Even before the latest questions arose, perceptions of the shot’s safety in Europe were lower compared with the one from Pfizer Inc. and partner BioNTech SE, and the vaccine produced by Moderna Inc., according to a March 7 YouGov survey. In Britain, by contrast, Astra’s was viewed as the safest of the three.
Denmark said it wants more research conducted before resuming inoculations with the company’s vaccine. Danish Health Minister Magnus Heunicke called the decision a precautionary move, following “signals of a possible serious side effect in the form of deadly blood clots” stemming from a batch of the vaccine.
AstraZeneca said the safety of its vaccine was demonstrated in clinical trials. An analysis of more than 10 million records has shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any age group, gender, batch or country using the shot, the company said in a statement.
“In fact, the observed number of these types of events are significantly lower in those vaccinated than would be expected among the general population,” AstraZeneca said.
The U.K. government also sprang to Astra’s defense, with Prime Minister Boris Johnson’s spokesman, Jamie Davies, calling it “safe” and “effective,” in response to reporters’ questions about Denmark’s decision.
News of the risk of clotting drew different reactions across the EU. In Sweden, health authorities said they saw no reason to stop using Astra. Italy said on Thursday it has blocked use of the Astra batch in question, pending a review.
The development follows news from Austria, where authorities last weekend suspended use of the Astra batch after reports of a death and an illness among recipients.
Phil Bryan of the U.K. Medicines & Healthcare Products Regulatory Agency issued a statement to underline that “it has not been confirmed that the report of a blood clot, in Denmark, was caused by the COVID-19 Vaccine AstraZeneca.”
“We continually monitor the safety of vaccines to ensure that the benefits outweigh any potential risks,” he said. He also said the reports of blood clots received so far “are not greater than the number that would have occurred naturally in the vaccinated population,” and he urged people to continue seeking inoculation.
In the Philippines, health authorities concurred with European regulators, saying there was no reason to stop the rollout of Astra’s shot and that they were closely monitoring the situation.
Meanwhile, Estonia, Lithuania, Luxembourg and Latvia have all suspended use of shots from the Astra batch, according to the EMA. Iceland has since said it will also put its Astra program on hold until more is known about the side effects.
Vaccines from the lot, totaling 1 million shots, have also been delivered to France, Bulgaria, Cyprus, Greece, Ireland, Malta, the Netherlands, Poland, Spain and Sweden, the EMA said.
The EMA’s list of side effects referred to one Danish fatality, identified by local authorities as a 60-year-old woman. Health authorities are stressing that it’s currently not possible to establish a link between her death and AstraZeneca’s vaccine. Denmark will pause its Astra shots for two weeks, with a new assessment due in the week starting March 22.
“It’s important to underline that we haven’t abandoned the AstraZeneca vaccine,” the Danish Health Authority said in a statement. “But we’re pausing its use. There’s good documentation that the vaccine is both safe and effective.”
Denmark said the development could delay its immunization program by about a month.
The country’s decision represents a “super-cautious approach based on some isolated reports in Europe,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. “The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence.”
Denmark has given more than 142,000 inoculations with the AstraZeneca vaccine, accounting for about one-quarter of all Danes who have received a first COVID-19 shot.
A year ago, Denmark became one of the first EU nations to go into a lockdown and shut its borders, and it has stood out for its cautious approach to fighting the pandemic. That includes forcing its fur industry to cull the entire Danish mink population amid concerns the animals were spreading the virus.
Denmark has also been one of the EU leaders in vaccinations, giving 13 shots per 100 people, according to Bloomberg’s vaccine tracker.
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