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Oxford-AstraZeneca Covid-19 vaccine is ‘safe and effective,’ European Medicines Agency rules

LONDON — The Oxford-AstraZeneca Covid-19 vaccine is safe to use, the European Medicines Agency said Thursday after a number of countries, including Germany, France and Italy, suspended it over concerns about blood clots in some recipients.

Executive Director Emer Cooke told a news briefing that her agency’s expert committee on the safety of medicines has “come to a clear scientific conclusion” on the review of cases of blood clots in people vaccinated with the drug.

“This is a safe and effective vaccine,” she said. “Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalization, outweigh the possible risks.”

Cooke added that the vaccine was not associated with an increase in the overall risk of blood clots, but during the investigation the committee had seen a small number of “rare and unusual, but very serious clotting disorders,” which had triggered a more focused review.

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“Based on the evidence available and after days of in-depth analysis of lab results, clinical reports, autopsy reports and further information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine,” she said.

The committee had therefore recommended “to raise awareness of these possible risks, making sure that they are included in the product information.”

Cooke added that “drawing attention to these possible rare conditions and providing information to health care professionals and vaccinated people will help to spot and mitigate any possible side effects.”

More investigations will be conducted, she said.

Within hours of the announcement, French Prime Minister Jean Castex said his country would start using the vaccine again, adding he will receive it on Friday afternoon.

His comments came as his government imposed a month-long lockdown on Paris and several other regions, following what he said was a clear acceleration in the spread of the virus, with France now in the grip of a third wave.

However, the Swedish Medical Products Agency said Thursday that a previously healthy woman has died in Sweden about a week after being vaccinated with the AstraZeneca vaccine.

“This is a case of blood clots in the arteries and veins and major bleeding, ie the unusual disorder that is the focus of the EMA investigation,” Veronica Arthurson, the agency’s head of drug safety told a news conference.

The EMA findings came as the White House confirmed it will send 4 million doses of the AstraZeneca vaccine to Canada and Mexico, in its first export of shots.

The United States relies on vaccines from Pfizer, Moderna and Johnson & Johnson, while the vaccine developed by the British-Swedish drugmaker is yet to be authorized, although it has been by the World Health Organization.

Tens of millions of doses have been stockpiled in the U.S. should it receive emergency use authorization, sparking an international outcry that lifesaving doses could not be used overseas.

The European Medicines Agency finding came just two days after the regulator said it reviewed new information and found there was “no indication” that there was any link between AstraZeneca’s vaccine and blood clotting.

AstraZeneca also said Sunday that a review of safety data from more than 17 million people given its shot in the United Kingdom and the European Union had shown no evidence of an increased risk of blood clots.

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The European Union’s vaccination rollout has been hampered by shortages and ahead of Thursday’s announcement, France and Italy said they would restart vaccinations with the AstraZeneca vaccine should the regulator rule there were no concerns.

In a separate press briefing Thursday, Dr. Hans Kluge, the World Health Organization’s regional director for Europe, said that countries should continue to use AstraZeneca’s vaccine for the time being.

“As of now, we do not know whether some or all of the conditions have been caused by the vaccine or by other coincidental factors,” he said. “At this point in time, however, the benefits of the AstraZeneca vaccine far outweigh its risks – and its use should continue, to save lives.”

Kluge said gaining and maintaining public trust was “crucial.”

“We need to renew confidence, if it’s lost, to restore it – especially for AstraZeneca,” he said.

Source:

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