: EU regulator declares AstraZeneca vaccine ‘safe’ after blood clot investigation


Europe’s drug regulator has concluded that the AstraZeneca COVID-19 vaccine is “safe and effective,” following its investigation into reports of blood clots in people that had received the shot.

European Medicines Agency (EMA) executive director Emer Cooke said the benefits of the vaccine outweighed the possible risks, in a press briefing on Thursday. The watchdog said the vaccine is “not associated with an increase in the overall risk of blood clots,” in a separate statement.

However, the EMA’s safety committee said it would continue to study possible links between very rare blood clots and the vaccine.

“We still cannot rule out definitively a link between these cases and the vaccine,” Cooke said, adding that the regulator would raise awareness of the possible risks.

The EMA’s conclusion comes after a number of countries — including Germany, France, Spain and Sweden — temporarily paused their rollouts of the vaccine from drug company AstraZeneca

following the reports of blood clots.

Several countries — including Germany, Italy and France — have all said their decision to restart use of the AstraZeneca shot rests with the EMA’s conclusion.

Earlier this week, the EMA reiterated that there was “no indication” that AstraZeneca’s COVID-19 vaccine causes blood clots and said it remained “firmly convinced” that the benefits of the shot in preventing coronavirus disease outweighed the risks.

The World Health Organization has also backed the vaccine and urged countries to keep their inoculation campaigns going, pending its own full review.

Read: Amid vaccine hurdles, EU battles to save summer vacations with COVID travel pass

AstraZeneca said on Sunday a review of safety data of more than 17 million people vaccinated in the U.K. and European Union had shown no evidence of an increased risk of blood clots.

Shares in AstraZeneca
which have fallen by 2.2% so far this year, were 0.3% up in afternoon trading in London.

The U.K. drugs regulator reported five cases of a rare type of blood clot in people who had received the shot on Thursday but said the benefits far outweigh any risks. The Medicines and Healthcare products Regulatory Agency said the available evidence doesn’t suggest a causal link between the vaccine and the blood clots.

Several countries in Europe are currently experiencing a spike in coronavirus infections.

Read: Why Goldman says the AstraZeneca vaccine suspension won’t be a game changer for growth

On Thursday, the number of confirmed coronavirus cases in Germany rose by 17,504 to 2,612,268, the biggest daily rise since Jan. 22, according to data from the Robert Koch Institute for infectious diseases. 

Poland also reported its highest number of daily coronavirus infections this year for the second day in a row.

“We see the crest of a third wave forming in member states, and we know that we need to accelerate the vaccination rates,” said European Commission President Ursula von der Leyen earlier this week.

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