‘Big edge’: Australia’s vaccine win
Europe's drug regulator has declared the AstraZeneca vaccine "safe and effective" after multiple countries paused the COVID-19 shots over fears it was having alarming side effects.
More than a dozen countries suspended their rollouts of the vaccine over concerns it could increase the risk of blood clots and may have been linked to some deaths in Spain and France.
The European Medicines Agency (EMA) has now shared the results of its investigation, saying the shot was not linked to an increased risk of blood clots or thromboembolic events.
The committee has come to a clear scientific conclusion: this is a safe and effective vaccine," EMA Executive Director Emer Cooke told an online press conference.
"Its benefits in protecting people from COVID-19 with the associated risks of death and hospitalisation outweigh the possible risk.
"If it was me I would be vaccinated tomorrow."
However, the organisation said it could not rule out a possible connection to a particularly rare type of blood disorder and further investigation was needed.
It was particularly looking at cases of cerebral venous thrombosis, or blood clots in the vessels draining blood from the brain.
"During the investigation and review we began to see a small number of cases of rare and unusual but very serious clotting disorder and this then triggered a more focused review," said Cooke.
"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."
The EMA had recommended adding a warning to product information with the AstraZeneca shot.
This would draw attention to the "possible rare conditions" to help patients and healthcare professionals "stop and mitigate any possible side effects," said Cooke.
There had been 469 reports of blood clotting among 20 million people who had been vaccinated in the European Economic Area.
Following these reports, multiple countries stopped the rollout of the AstraZeneca vaccine, with Germany, Italy, Denmark, the Netherlands, Norway, Iceland, France and Spain just some of the nations to do so.
Treasurer Josh Frydenberg said it was "good news" the AstraZeneca vaccine had been given the green light by European regulators.
"Here in Australia we'll be relying on the AstraZeneca vaccine, also the Pfizer vaccine but the fact that we'll be making the AstraZeneca convenience here under licence of CSL gives us a big edge because we have a manufacturing capability that so many other countries don't have," he told ABC News Breakfast.
Mr Frydenberg said some doses of the vaccine have already been distributed to GP clinics across the country, with more expected in the coming weeks.
AstraZeneca is the COVID-19 vaccine that will be administered to the majority of Aussies, with the situation overseas sparking calls from some of our own government officials to pause the rollout here.
Earlier this week, Queensland Senator Matt Canavan said he didn't understand how the rollout of the vaccine could continue when "basically the whole of Europe is worried" about it.
"I don't think all the capitals in Europe have been taken over by anti-vaccine zealots, there is obviously legitimate concerns here," he said.
However, the Prime Minister and Australian health authorities insisted they were confident in the safety of the vaccine.
Health Department secretary Brendan Murphy said he was "confident" the clotting reported in Europe was "not a significant issue".
"All the evidence we have seen suggests there is no increase above what you would expect in the population, in the vaccinated population," he said.
"We have not seen any issues to suggest there is any higher increase of stroke."
Therapeutic Goods Administration head Professor John Skerritt said 17,000 Australians suffered blood clots every year, and it was important to differentiate between "bad luck" and the "natural frequency of these things happening".
"We are waiting to see if there is any further information, but at this stage we do not believe there is conclusive evidence for cause-and-effect on the clotting issue," he said.
- With AFP
Originally published as 'Big edge': Australia's vaccine win