The Danish health authority said on Wednesday that, following its own review, the country’s vaccine rollout would continue without the AstraZeneca shot, as it warned of a “real risk of severe side effects.”
“Based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the COVID-19 vaccine from AstraZeneca,” said DHA director general Søren Brostrøm. “We have, therefore, decided to remove the vaccine from our vaccination program,” he added.
The health agency said it agreed with the European Union drug regulator’s assessment that the benefits of the vaccine outweigh the risks, but noted that the watchdog urged individual countries to consider their own situations and vaccine availability when making a judgment.
Brostrøm said the epidemic was currently under control in Denmark, with a large proportion of the older population vaccinated and those yet to be inoculated at less of a risk.
“We must weigh this against the fact that we now have a known risk of severe adverse effects from vaccination with AstraZeneca, even if the risk in absolute terms is slight,” he added.
Those who have already received the first dose of AstraZeneca will be invited to have a different vaccine second time around, the health authority said.
It added that Denmark could reintroduce use of the U.K.-Swedish drug company’s vaccine at a later date if the country’s situation changes.
Last week, the U.K. government’s vaccination advisory committee said people under the age of 30 would be offered an alternative vaccine. It came after the U.K.’s drug regulator — the Medicines and Healthcare products Regulatory Agency (MHRA) — said the benefits outweighed the risks for most people, but MHRA Chief Executive Dr. June Raine said for young people it was more “finely balanced.”
Denmark’s move is another set back to the EU’s already sluggish vaccination campaign, which was exacerbated on Tuesday after U.S. pharmaceutical Johnson & Johnson said it would delay the planned rollout of its COVID-19 shot across the 27-member bloc due to reports of blood clotting.
J&J made the decision after U.S. health agencies called for an immediate pause of the vaccine’s use while they examine six severe cases of rare blood clots that have been reported in people who have received the shot. J&J was due to supply 55 million doses of its single-shot vaccine to the EU in the second quarter.
The J&J vaccine has currently only been delayed, but analytics company Airfinity warned the EU’s vaccination rollout would take two months longer than expected if the bloc was unable to use the shot at all.
However, there was some good news for Europe as the EU reached an agreement to speed up delivery of 50 million more doses of the vaccine developed jointly by German biotech BioNTech and U.S. drug company Pfizer to boost the rollout program.
Denmark’s decision could delay the country’s vaccine rollout by up to four weeks, based on previous statements by health bodies, a report by Reuters noted.
The country was the first to initially suspend use of the AstraZeneca vaccine in March, over safety concerns. Last week, the EU drug regulator said that “unusual blood clots” should be listed as a “very rare” side effect of the AstraZeneca vaccine, but insisted the benefits of the shot still outweighed the risks.
The majority of EU countries have since restarted using the AstraZeneca vaccine, but some countries, including Spain and Italy, have limited the use of the shot to people aged over 60. Last month, French and German health officials restricted the use of the AstraZeneca shot for the over-55s and over-60s, respectively, following concerns over unusual blood clotting in some recipients.
Shares in AstraZeneca were trading 1.31% higher in London on Wednesday.
AstraZeneca has acknowledged the findings from the EMA, as well as a separate review from the U.K.’s MHRA, noting that they “reaffirmed the vaccine offers a high-level of protection against all severities of COVID-19 and that these benefits continue to far outweigh the risks.”
The drug company said it was working with global regulators to better understand the individual cases, epidemiology and possible mechanisms that could explain these extremely rare events.