AMSTERDAM / LONDON (Reuters) – Germany, France and other European countries announced plans to resume use of AstraZeneca’s COVID-19 vaccine on Thursday after European and UK regulators decided to boost confidence in the shot, claiming that its benefits outweighed the risks.
Reports of rare brain blood clots had prompted more than a dozen countries to suspend use of the vaccine, the latest challenge for AstraZeneca’s ambition to produce a “vaccine for the world” as the global death toll due to the coronavirus exceeds 2.8 million.
The “clear” conclusion from the European Medicines Agency (EMA) following an investigation of 30 cases of unusual blood disorders was that the vaccine’s benefits in protecting people from coronavirus-related death or hospitalization outweigh the possible risks, although it indicates a link between blood clots in the brain and stroke could not be definitively ruled out.
“It’s a safe and effective vaccine,” EMA director Emer Cooke said in a briefing. “If it was me, I would be vaccinated tomorrow.”
In a few hours, Germany announced that it would resume administration of the AstraZeneca vaccine from Friday morning. Health Minister Jens Spahn said suspending the vaccine out of caution had been the right decision “until the clustering of this very rare type of thrombosis has been reviewed.”
France has also said it will resume use of the vaccine, with Prime Minister Jean Castex saying he will receive the vaccine himself on Friday afternoon.
Italian Prime Minister Mario Draghi said Italy will follow suit and his government’s priority remains to vaccinate as many people as possible as quickly as possible.
Spain said it was evaluating a possible recovery, while Cyprus, Latvia and Lithuania said they would resume administering the vaccine.
Many governments have said the decision to withhold vaccinations was due to great caution. But experts have warned that political interference could undermine public confidence in vaccinations as governments struggle to tame more variants of the infectious virus.
“We are confident that following careful regulatory decisions, vaccinations can resume across Europe again,” Ann Taylor, AstraZeneca medical director, said in a statement.
EUROPE LAGS BRITAIN, UNITED STATES
The EMA review covered 20 million people after shooting AstraZeneca in the UK and the European Economic Area (EEA), which connects 30 European countries.
Safety concerns had led at least 13 European countries to stop administering the vaccine, slowing an already hesitant inoculation campaign in the EU, which is lagging behind Britain and the United States.
The UK Medicines and Health Products Regulatory Agency (MHRA) said earlier it was investigating five cases of rare cerebral blood clots that had been reported out of 11 million vaccines given in the UK.
He said he would investigate reports of clots in the cerebral veins (sinus vein thrombosis or CSVT) occurring with low platelets soon after vaccination. But the agency said use of the vaccine is expected to continue and an official said Britain’s deployment will likely continue even if a link is proven.
The AstraZeneca vaccine was among the first and cheapest of the COVID-19 vaccines to be developed and launched in volume and is expected to be the mainstay of immunization programs in most developing countries.
“The (verdict) of the EMA now clarifies the safety of this vaccine, which should now be vaccinated at a high rate after this safety shutdown in order to effectively prevent the real risk, i.e. medical damage sometimes serious due to Covid-19, ”said Clemens Wendtner, head of infectious diseases at the Munich Schwabing clinic.
The drugmaker’s own review of more than 17 million people who received his injection in the EU and Britain found no evidence of an increased risk of blood clots.
The World Health Organization also reaffirmed its support for shooting this week.
The EMA said it will update its AstraZeneca vaccine guidelines to include an explanation for patients about the potential risks and information for healthcare professionals.
The agency said it was in contact with regulators around the world to keep tabs on possible side effects of all COVID-19 vaccines.