AMSTERDAM / LONDON (Reuters) – Germany, France and other European countries announced plans to resume AstraZeneca’s COVID-19 vaccine on Thursday after EU and UK regulators boosted confidence in the shot, saying the benefits outweigh the risks.
Reports of rare brain blood clots had prompted more than a dozen countries to suspend use of the shot, the latest challenge to AstraZeneca’s ambition to produce a ‘vaccine for the world’ as the global coronavirus death toll was 2 , Exceeds 8 million.
The ‘clear’ conclusion of the European Medicines Agency (EMA) after an investigation of 30 cases of unusual blood disorders was that the benefits of the vaccine in protecting people from coronavirus-related death or hospitalization outweigh its potential risks, although it said there were A link between the brain and the shot could not be definitively ruled out.
“This is a safe and effective vaccine,” EMA Director Emer Cooke told a briefing. “If it was me, I would be vaccinated tomorrow.”
Within hours, Germany said it would resume administration of the AstraZeneca vaccine from Friday morning. Health Minister Jens Spahn said that suspending the vaccine out of prudence was the right thing to do “until the clustering of this very rare type of thrombosis was investigated.”
France also said it would resume use of the vaccine, with Prime Minister Jean Castex saying he would get the injection himself Friday afternoon.
Italian Prime Minister Mario Draghi said Italy would do the same, and that his government’s priority remained 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 restart administering the vaccine.
Many governments had said the decision to interrupt the vaccinations was out of an excess of caution. But experts have warned that political interference could undermine public confidence in vaccinations as governments struggle to tame more contagious virus strains.
“We are confident that, following careful decisions by regulators, vaccinations can resume across Europe,” Ann Taylor, AstraZeneca’s Chief Medical Officer, said in a statement.
EUROPE LAGS BRITAIN, USA
The EMA’s assessment involved 20 million people, given the AstraZeneca admission in the UK and the European Economic Area (EEA), which links 30 European countries.
Due to safety concerns, at least 13 European countries have stopped administering the shot, delaying an already faltering vaccination campaign in the EU, which is lagging behind Britain and the United States.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) previously said it was investigating five cases of the rare brain blood clot reported from 11 million injections administered in the UK.
It said it would investigate reports of clots in the cerebral veins (sinus venous thrombosis or CSVT) occurring along with decreased platelets shortly after vaccination. But the agency said use of the vaccine should continue, and an official said Britain’s rollout was likely to continue, even if a link was proven.
The AstraZeneca Injection was one of the first and cheapest COVID-19 vaccines to be widely developed and launched and will become the mainstay of vaccination programs in much of the developing world.
“The EMAs (ruling) is now clarifying the safety of this vaccine, which now requires high levels of vaccination after this safety stop to efficiently prevent the actual risk, i.e. sometimes serious medical damage from Covid-19,” said Clemens Wendtner, Head of Infectious Diseases at Schwabing Clinic in Munich.
The drug company’s own assessment, which involves more than 17 million people who received its shot in the EU and Great Britain, found no evidence of an increased risk of blood clots.
The World Health Organization also confirmed its support for the shot this week.
The EMA said it would update its guidelines on the AstraZeneca vaccine with an explanation for patients about the potential risks and information for healthcare professionals.
The agency said it is in contact with regulators around the world to keep an eye out for potential side effects of all COVID-19 vaccines.
Reporting 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; Editing by Bill Berkrot