Denmark has become the first country to permanently halt the use of AstraZeneca’s COVID-19 vaccine following its possible link to very rare cases of blood clots.
The Danish Health Authority said on Wednesday that following its own review the country’s vaccine rollout would continue without the AstraZeneca jab, 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,” DHA director general Søren Brostrøm said. “We have, therefore, decided to remove the vaccine from our vaccination programme,” he added.
The health agency said it agreed with the EU 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 re-introduce use of the British drugmaker’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. regulator — the Medicines and Healthcare products Regulatory Agency (MHRA) — said the benefits outweighed the risks for the vast majority of people but chief executive Dr. June Raine said for young people it was more “finely balanced.”
Denmark’s move is another set back to the European Union’s already sluggish vaccination campaign which was exacerbated on Tuesday after Johnson & Johnson
said it would delay the planned rollout of its coronavirus 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 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 jab 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 BioNTech
to boost its 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 became the first country to initially suspend use of the AstraZeneca vaccine in March, over safety concerns. Last week, the European Union 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 Anglo-Swedish 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.