AMSTERDAM / LONDON (Reuters) – Germany, France and other European countries announced plans to resume AstraZeneca’s COVID-19 vaccine on Thursday after EU and British regulators moved to boost confidence in the shooting, saying that its benefits outweigh the risks.
Reports of rare blood clots had caused more than a dozen countries to stop using the shot, the latest challenge to AstraZeneca’s ambition to produce a “vaccine for the world,” as the number overall coronavirus deaths exceed 2.8 million.
The “clear” conclusion of the European Medicines Agency (EMA) after an investigation into 30 cases of unusual blood disorders was that the benefits of the vaccine in protecting people from coronavirus-related death or hospitalization outweigh the possible risks, although it is said that there is a link between blood clots in the brain and the shot could not be ruled out definitively.
“This is a safe and effective vaccine,” EMA Director Emer Cooke said in a briefing. “If it were me, I’d be vaccinated tomorrow.”
Within hours, Germany said it would resume administration of the AstraZeneca vaccine starting Friday morning. Health Minister Jens Spahn said suspending the vaccine as a precaution had been the right call “until the grouping of this rare type of thrombosis had been examined”.
France also said it would resume use of the vaccine, and Prime Minister Jean Castex said he would receive the shot himself on Friday afternoon.
Italian Prime Minister Mario Draghi said Italy would do the same and that his government’s priority was to vaccinate as many people as possible as soon as possible.
Spain said it was evaluating a possible resumption, while Cyprus, Latvia and Lithuania said they would re-administer the vaccine.
Many governments had said the decision to pause inoculations was a great precaution. But experts have warned that political interference could undermine public confidence in vaccines as governments struggle to domesticate more infectious virus variants.
“We are confident that, following careful decisions by regulators, vaccinations can resume throughout Europe,” Ann Taylor, AstraZeneca’s medical director, said in a statement.
EUROPE LAGS BRITTANY, USA
The EMA review covered 20 million people who received the AstraZeneca shot in the UK and the European Economic Area (EEA), which unites 30 European countries.
Security concerns had led at least 13 European countries to stop administering the firing, slowing an already faltering inoculation campaign in the EU, which is being delayed in Britain and the United States.
The UK Medicines and Health Products Regulatory Agency (MHRA) previously said it was investigating five cases of the rare-brain blood clot that had been reported from the 11 million shots administered in the UK.
He said he would investigate reports of clots in the cerebral veins (sinus vein thrombosis or CSVT) that occurred along with lowered platelets shortly after vaccination. But the agency said vaccine use should continue and an official said the UK launch would likely continue even if a link was demonstrated.
The AstraZeneca shot was one of the first and cheapest COVID-19 vaccines to be developed and launched at high volume and is considered to be the mainstay of vaccination programs in much of the developing world.
“The EMA (verdict) now provides clarity on the safety of this vaccine, which should now be vaccinated at a high rate after this safety stop to effectively prevent the real risk, i.e. serious medical damage. caused by Covid-19, ”he said. Clemens Wendtner, head of infectious diseases at the Schwabing Clinic in Munich.
The drug maker’s own review, which covered more than 17 million people who have been shot in the EU and Britain, found no evidence of an increased risk of blood clots.
This week the World Health Organization also reaffirmed its support for the shooting.
The EMA said it would update its guidelines on the AstraZeneca vaccine to include an explanation for patients about possible risks and information for healthcare professionals.
The agency said it is in contact with regulators around the world to monitor the possible side effects of all COVID-19 vaccines.
Reports by Anthony Deutsch and Toby Sterling in Amsterdam, Ludwig Burger in Frankfurt, Kate Kelland and Alistair Smout in London and Caroline Copley in Berlin; Written by Josephine Mason, Elaine Hardcastle and Nick Tattersall; Edited by Bill Berkrot