Dirk Waem / BELGA MAG / AFP via Getty Images
Denmark will stop using the AstraZeneca COVID-19 vaccine, health authorities announced on Wednesday.
In a statement, the Danish health authority stressed that the benefits of the shot outweigh the risks to those who received it, but said they had decided to discontinue its use due to its possible link to rare cases of blood clotting and “the fact that the COVID-19 epidemic in Denmark is currently under control and other vaccines are available. “
“Based on scientific findings, our overall assessment is that there is a real risk of severe side effects associated with the use of the COVID-19 vaccine by AstraZeneca,” said Søren Brostrøm, Director General of the Danish Health Authority. “That’s why we decided to remove the vaccine from our vaccination [program]. “
All vaccination appointments against AstraZeneca will be canceled and those who have already received their first dose will receive their second in the form of another vaccine, officials said. Those who had canceled upcoming meetings will be able to reschedule “based on an assessment of the current epidemic situation.”
“The consequence of this decision is that anyone over the age of 16 can expect to receive a vaccination offer at the end of June,” officials said. “That way, anyone who accepts the offer will be fully vaccinated about five weeks later – in early August.”
COVID-19 cases and deaths have dropped significantly in Denmark after a winter wave. The country has reported 4,552 new cases and 14 deaths in the past week, according to data from Johns Hopkins University.
Just under 8% of the population is fully vaccinated, according to John Hopkins. Of this group, Reuters reported that 77% had received the Pfizer vaccine, 7.8% had Moderna and 15.3% had received AstraZeneca.
Denmark was one of several European countries to suspend the use of AstraZeneca in mid-March to investigate reports of rare clotting events in some recipients.
The European Medicines Agency and the World Health Organization continued to recommend its use, and many of these countries resumed vaccinations within days of a preliminary EMA investigation, which concluded that the benefits outweighed the risks.
Wednesday’s announcement comes exactly one week after the EMA said rare blood clotting events should be listed as a possible side effect of the AstraZeneca vaccine, but stressed that it has been shown to prevent serious illness, hospitalization and death from COVID-19. Such clotting events are rare, officials said, and appear to be more common in women under the age of 60.
Several countries, including France, Germany and South Korea, have reintroduced age-restricted vaccines, while others, including Australia, Greece and the United Kingdom, are now recommending alternatives for young people.
Also Wednesday, the EMA announced that it continues to monitor the phenomenon of “very rare blood clots with low blood platelets” that occur after vaccination, and will review more data at the request of the European Commissioner for Health and Food Safety.
The review will give more context to the benefits of ongoing vaccination campaigns, he said, and will consider updating the second dose recommendations for those who have already received their first dose of AstraZeneca vaccine. Public health experts are very hesitant about the idea of mixing and comparing vaccines without further data, and a new extended study in the UK is working to assess the potential benefits.
“The EMA believes that the overall benefits of the vaccine continue to outweigh the risks to people being vaccinated,” the statement said, adding that the review “will support ongoing national vaccination campaigns in their decisions to make the best use of the vaccine.”
The EMA said last week that the use of the vaccine in member states’ vaccination campaigns would vary depending on the severity of the pandemic and the availability of vaccines in each country, the Danish authorities said.
And in the case of Denmark, they said, the country has already made progress in vaccinating older age groups at the highest risk of becoming seriously ill and has vaccines produced by Pfizer-BioNTech and Moderna.
The Danish authorities said that research and research in Denmark revealed a “higher-than-expected frequency” in the number of blood clots, especially in the veins in the brain, after vaccination.
Brostrom described the situation as “a certain risk of severe adverse effects from AstraZeneca vaccination, even if the risk is absolutely low.”
Brostrøm emphasized that the AstraZeneca vaccine was still approved. He also said the country could introduce it later if the situation changes.
“If Denmark was in a completely different situation and in the midst of a third outbreak, for example, and a health system under pressure – and if we had not reached such an advanced point in the spread of vaccines – then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with its use, “Brostrom said.
The AstraZeneca vaccine is not currently used in the United States, although the company has said it will seek authorization for emergency use from the Food and Drug Administration.
Meanwhile, the United States is reviewing its own reports of rare cases of blood clotting – six out of nearly 7 million doses – in the single-dose Johnson & Johnson vaccine. The FDA on Tuesday recommended that its use be paused “due to a great deal of caution” while reviewing the data.
The same day, the company announced that it would “actively delay” the release of its vaccine in Europe. On the issue of Johnson and Johnson, Danish health officials said they were closely monitoring risk assessments initiated by US and European authorities and would cooperate with research on the safety and efficacy of this and all vaccines against COVID-19.