News Coronavirus EU drugs agency says AstraZeneca ‘safe and effective’ after review of 5 million people

EU drugs agency says AstraZeneca ‘safe and effective’ after review of 5 million people

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The European Union’s drug watchdog has concluded the AstraZeneca vaccine is “safe and effective” after a review of five million people found the benefits far outweighed any risk.

About 30 cases of rare blood clotting were investigated and the European Medicines Agency expert committee found the vaccine was not associated with an increased risk.

Britain’s medicines regulator also said the evidence did not suggest the vaccine caused blood clots.

Italy has indicated it will resume its AstraZeneca rollout after more than a dozen European countries, including Germany and France, suspended use of the vaccine as a precaution.

The safety declaration came as Australia’s booking system for the GP rollout of the AstraZeneca vaccine was labelled “chaos” by Labor after a website set up by the government for people to check their eligibility was inundated.

More than 100 federally funded clinics will start taking bookings for COVID-19 vaccines from Friday to ease pressure on GPs and state-run health services.

The clinics, which will delivering their first shots on Monday, don’t require a patient being a member of a practice.

More than 17 million AstraZeneca doses have been issued in Europe and Britain, with only a handful of reported cases of blood clots.

The EMA’s focus and primary concern was cases of blood clots in the head, a rare condition called cerebral venous thrombosis or a subform known as cerebral venous sinus thrombosis.

EMA director Emer Cooke said the clear conclusion of the review was that the vaccine “benefits in protecting people from COVID-19 with the associated risk of death or hospitalisation outweighs the possible risks”.

“This is a safe and effective vaccine,” she said.

However, she said the EMA could not completely rule out a link between the vaccine and a “small number of cases of rare and unusual but very serious clotting disorders”.

The agency has been under mounting pressure to clear up safety concerns after reports in recent weeks of bleeding, blood clots and low platelet counts in people who have received the shot.

Despite backing the vaccine, Britain’s medicines regulator MHRA said it was still investigating links to rare blood clots in the head.

“A further, detailed review into five UK reports of a very rare and specific type of blood clot in the cerebral veins (sinus vein thrombosis) occurring together with lowered platelets (thrombocytopenia) is ongoing.”

AstraZeneca has found no evidence of an increased risk of blood clots and the World Health Organisation is urging countries to resume their vaccination schedules.

WHO European director Hans Kluge said “the benefits of the AstraZeneca vaccine far outweigh its risks – and its use should continue, to save lives”.

Mr 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.

“Basically we do this by transparency, so communication from day one is very important.

“No.2 is showing empathy with the people. And No.3 is to be competent.”

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The federal government is sticking by its plan to give most Australians the AstraZeneca shot.

Australia’s GP rollout

About 1000 doses a week will be available through federally funded clinics set up to ease pressure on GPs and state-run health services.

Some of the larger facilities will have up to 2000 doses.

More than 1000 GP clinics will start administering the vaccine next week, using their own booking systems.

Health Minister Greg Hunt said it was “an important step forward”.

Earlier, Prime Minister Scott Morrison sought to reassure Australians the vaccine rollout would be “tough” to deliver but was being managed.

Meanwhile, Queensland’s vaccination program is back on track after concerns were raised about the AstraZeneca vaccine and anaphylaxis but the state accepted the findings of the review by the national medicines regulator.

By Friday it is expected more than 250,000 people will have been vaccinated using either the Pfizer or AstraZeneca products.

Over the next week it is expected states will receive 150,000 doses, GPs 200,000, commonwealth clinics 50,000. A further100,000 doses will go to frontline workers and aged care.

The next phase of the program, known as 1B, includes six million Australians – those aged over 70, health care workers, Indigenous people aged over 55, adults with a specific medical condition or disability and high risk workers in defence, police, fire, emergency services and meat processing.

-with AAP