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‘Benefits outweigh risks’: European watchdog defends AstraZeneca vaccine

Europe’s medicines watchdog says it is “firmly convinced” the benefits of the AstraZeneca shot outweigh the risks after a multitude of countries suspended the vaccine’s use following reports of blood clots.

The cases of blood clots that reportedly developed following an injection of the drug were “not unexpected”, European Medicines Agency executive director Emer Cooke said.

At least 17 countries have suspended or delayed using the AstraZeneca vaccine, with Cyprus, Latvia, Luxembourg, Sweden and Venezuela the latest to join the list.

Governments say they have acted out of an abundance of caution but Ms Cooke said it seemed “unlikely” that specific batches of the vaccine might have caused the blood clots.

“When you vaccinate millions of people, it’s inevitable that you have rare or serious incidences of illnesses that occur after vaccination,” she said.

The EMA will soon release the results of its “very rigorous analysis” to determine whether the vaccines might have caused the events.

“We are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19 with its associated risk of hospitalisation and death outweigh the risk of these side effects,” Ms Cooke said.

The rate of reported blood clots amongst vaccinated people seemed to broadly mirror the rate in the general population, she said.

The agency had also received similar numbers from other vaccines from across the world, she said.

The WHO had earlier said there is no proven link, but some experts said rare cases of cerebral thrombosis in younger people appeared to indicate a causal link to the AstraZenica shot.

“Unfortunately, the … brain thrombosis is likely due to the AstraZeneca vaccine. And it affects younger people without risk factors,” said Karl Lauterbach, health spokesman for Germany’s Social Democratic Party.

“But because the risk is only about one in 250,000, the benefits predominate,” he added in a tweet.

Australia remains ‘confident’ in the vaccine

AstraZeneca will be Australia’s main coronavirus vaccine, with CSL’s Melbourne plant expected to start its rolling supply from next week, gearing up to produce one million doses a week.

Health Minister Greg Hunt has told parliament the government “clearly, unequivocally, absolutely supports the AstraZeneca roll out”.

The TGA said in a statement on Tuesday it was aware of the European decisions and reiterated: “It has not been confirmed that the reports of blood clots were caused by the AstraZeneca COVID-19 vaccine. People should still go and get their COVID-19 vaccine when asked to do so.”

“The TGA has not received any reports of blood clots following administration of the AstraZeneca COVID-19 vaccine in Australia … (or) have any evidence of a biologically plausible relationship that could suggest a cause and effect relationship between vaccination and blood clots.”

The federal government’s renewed backing of the shot came after LNP senator Matt Canavan urged Australia to follow other nations and pause its use amid the reports of blood clots.

Chief medical officer Paul Kelly said Australia had 17,000 blood clot cases every year and it was expected they could occur around the time of vaccinations.

“This does not mean an event that happens after a vaccine has been given is due to that vaccine,” Dr Kelly said.

“I can absolutely say I remain confident in the AstraZeneca vaccine. It is safe and at this point there is no evidence that it causes blood clots.”

Prime Minister Scott Morrison told parliament “it is incumbent on all of us in this place to support the vaccination program”.

On Tuesday morning, NSW Premier Gladys Berejiklian confirmed a new hotel quarantine infection of the virus. It followed a security guard, who worked at a the same Sydney hotel, being diagnosed with the virus at the weekend.

Meanwhile, there are still no reports of coronavirus spreading in Brisbane six days after a doctor became infected.

The woman tested positive on Friday after working at Princess Alexandra Hospital.

The state government has tested about 230 of the 400 people who may have come into contact with her, but all have come back negative.

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