Denmark has become the first country to stop all use of AstraZeneca’s COVID-19 vaccine after recent reports of rare but serious side effects in a small minority of vaccine recipients.
The move will postpone the planned conclusion of the Scandinavian country’s vaccination program to early August from July 25.
It comes despite recommendations from the World Health Organization and the European Medicines Agency (EMA) – the European Union’s medicines regulator – to continue using the AstraZeneca vaccine.
Both organizations have repeatedly said that the benefits of the shot outweigh the potential risks associated with its use after its use has been linked to several cases of serious blood clots, some of which have been shown to be fatal.
But the Danish health authority said in a statement on Wednesday that the results of its own investigations showed there was a “real risk of serious side effects associated with the use of AstraZeneca’s COVID-19 vaccine.”
Agency chief Soren Brostrom said the investigation indicated that one in 40,000 recipients of the shot would develop serious side effects.
“Based on a global consideration, we therefore chose to continue the vaccination program for all target groups without this vaccine,” he added.
The Danish Health Authority said the availability of other vaccines, combined with pandemic control in the Scandinavian country at the moment, meant the inoculation campaign could continue without the AstraZeneca vaccine.
AstraZeneca said it respects Denmark’s choice and will continue to provide it with data to inform future decisions.
“The implementation and deployment of the vaccination program is up to each country to decide, depending on local conditions,” said the Anglo-Swedish company.
Almost one million of Denmark’s 5.8 million people have so far received a first dose of a COVID-19 vaccine.
Almost four-fifths of recipients have received a dose of the vaccine produced by Pfizer-BioNTech. The Scandinavian country has also used the vaccine developed by Moderna in its vaccination campaign.
EU member Denmark was the first country to initially suspend all use of the AstraZeneca vaccine for safety reasons last month, after reports of rare but serious cases of blood clots developing in some people who have received the vaccine appeared for the first time. More than a dozen countries then followed suit.
All but a few have since resumed use of the vaccine, which was developed by the company in partnership with the University of Oxford in the UK, following a review by the EMA which has deemed the vaccine “safe and effective”.
The EU’s medicines watchdog said last week it found a possible link between AstraZeneca’s jab and cerebral venous sinus thrombosis (CVST), a brain blood clot, but said the risk of dying from COVID-19 was “much greater” than the risk of death from rare side effects.
As of April 4, the EMA had received reports of 169 cases of CVST after 34 million doses of Astrazeneca had been administered in the European Economic Area, he said.
The EU regulator, however, has left it up to each state to make its own risk assessments and decide how to administer the vaccine.
Although many countries in Europe and elsewhere have since resumed administration of the vaccine, some have limited its use to certain age groups, often those over the age of 50 or over 60.
Johnson & Johnson delays vaccine deployment in Europe
In another blow to Europe’s failing mass vaccination campaign, U.S. pharmaceutical giant Johnson & Johnson (J&J) has delayed the rollout of its own COVID-19 vaccine across Europe over concerns over the risk of blood clotting in some vaccine recipients.
The EMA said it plans to release a vaccine recommendation next week, but continues to believe that the benefits of the vaccine outweigh the risks of side effects.
U.S. federal health agencies have recommended stopping use of the vaccine for at least a few days after six women under the age of 50 develop rare blood clots after receiving it.
Deliveries had already started in some European countries, but authorities have taken different approaches on whether to restrict the use of the vaccine, with Belgium and France saying they will continue while Greece and Italy suspend them. .
The EMA said J&J was in contact with national authorities and recommended storing doses already received until the safety committee issues an expedited recommendation.
This delay will do little to allay concerns across Europe over the jerky rollout of the vaccine in the EU, which has been plagued by issues ranging from poor coordination between national and regional authorities to supply difficulties. and a damaging contractual dispute with AstraZeneca.
In what appeared to be a scathing rebuke to Anglo-Swedish society, the 27-member bloc on Wednesday announced its intention to negotiate a massive contract extension for Pfizer-BioNTech’s COVID-19 vaccine, insisting it had to go with companies that had shown their worth from the pandemic.
“We need to focus on proven technologies,” said European Commission President Ursula von der Leyen.