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BERLIN: Regulators authorized AstraZeneca’s coronavirus vaccine for use in adults throughout the European Union on Friday, amid criticism the bloc is not moving fast enough to vaccinate its population.
The European Medicines Agency’s expert committee unanimously recommended the vaccine to be used in people 18 and over, though concerns had been raised this week that not enough data exist to prove it works in older people.
The shot is the third Covid-19 vaccine given the greenlight by the European Medicines Agency, after ones made by Pfizer and Moderna. Both were authorized for all adults. The decision requires final approval from the European Commission, a process that occurred swiftly with the other vaccines.
“There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group,” the regulator said, but added that “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines.
“EMA’s scientific experts considered that the vaccine can be used in older adults,” the agency said.
Many countries on the continent have been struggling to vaccinate people as quickly as Britain, Israel, the US and elsewhere, and it was long hoped that the AstraZeneca shot would help speed things up at a time when countries face surging cases in a pandemic that has taken the lives of more than 400,000 people in the 27-nation bloc.
The EU bet heavily on the shot, which is cheaper and easier to handle than some other vaccines, with orders for 300 million doses to be delivered after authorization and options for another 100 million doses.
Emer Cooke, the head of the EMA, said it was “a real pleasure” to authorize the vaccine.
“None of them is a magic wand on its own, but together they provide tools and options to prevent different aspects of the disease,” she said.
While the AstraZeneca vaccine has been authorized for all adults in other countries, only 12% of the participants in its research were over 55 and they were enrolled later, so there hasn’t been enough time to get results. But some doctors warned that restricting the vaccine’s use in older people might worsen the pandemic’s impact, since older people have suffered more severe disease and died at a higher rate from the coronavirus.
In its decision on Friday, the EMA assessed four trials in the UK, Brazil and South Africa. The agency said the research showed the vaccine proved to be about 60% effective by reducing the number of people who got sick. The trials have not yet shown whether the vaccine can stop disease transmission.
A separate study testing the AstraZeneca vaccine in the US is still underway.
Professor Andrew Pollard, director of the Oxford Vaccine Group that developed the shot together with AstraZeneca, welcomed the decision.
“The recommendation by the European Medicines Agency is an important milestone in extending access to the Oxford/ AstraZeneca vaccine in our region and providing further endorsement that, after the rigorous scrutiny of regulators, the vaccine can be used to help protect populations from the coronavirus pandemic,” he said in a statement.
While politicians have blamed supply problems for the EU’s slow rollout, other factors, like onerous paperwork and poor planning, have also played a role. The EU has particularly lashed out at AstraZeneca after the drugmaker said it would initially supply less vaccine than originally anticipated. Exacerbating concerns about supplies to the bloc, which is home to some 450 million people, Moderna told countries including Italy and Denmark the company would be delivering fewer vaccines than originally expected.
Jens Spahn, the German health minister, said Friday he understood many were waiting impatiently for the vaccine, but cautioned that “several hard weeks of vaccine shortage still lie before us.”
Before the EMA announcement, Spahn had said Germany would use the regulator’s recommendation to decide whether the AstraZeneca vaccine should only be given to people aged 18-64 for now, as suggested in a draft recommendation by the country’s independent vaccine advisory committee. Britain’s medicines regulatory agency also acknowledged the limited data in older people but still cleared the shot last month for all adults, with some caution for pregnant women.
Julian Tang, a virologist at the University of Leicester, said he thought any recommendation to limit the vaccine’s use to people under 65 was understandable, but “overly cautious.”
The AstraZeneca shot appears to offer less protection than the other two vaccines given the greenlight by the EMA, the Pfizer and Moderna shots, which showed roughly 95% efficacy rates.
Two more vaccine makers also recently announced results, with Novavax saying this week that its shot appears 89% effective based on early findings and Johnson & Johnson saying its long-awaited single-shot vaccine was 66% effective at preventing moderate to severe illness. If those vaccines are eventually licensed, that could help alleviate the pressure on the world’s huge demand for the limited shots currently available.
The authorization of the AstraZeneca vaccine comes amid a bitter dispute between the drugmaker and the bloc after the company said it would sharply reduce initial deliveries from 80 million doses to 31 million.
Amid fears doses from AstraZeneca could be diverted outside the bloc, EU officials are expected to propose measures Friday that could be used to block vaccine shipments to non-EU countries.
The AstraZeneca vaccine has already been authorized in several countries, including Britain, India, Argentina and Mexico. The World Health Organization is also reviewing it; a recommendation from the UN health agency would allow its purchase and distribution to developing countries from a global program known as COVAX.
The European Medicines Agency’s expert committee unanimously recommended the vaccine to be used in people 18 and over, though concerns had been raised this week that not enough data exist to prove it works in older people.
The shot is the third Covid-19 vaccine given the greenlight by the European Medicines Agency, after ones made by Pfizer and Moderna. Both were authorized for all adults. The decision requires final approval from the European Commission, a process that occurred swiftly with the other vaccines.
“There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group,” the regulator said, but added that “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines.
“EMA’s scientific experts considered that the vaccine can be used in older adults,” the agency said.
Many countries on the continent have been struggling to vaccinate people as quickly as Britain, Israel, the US and elsewhere, and it was long hoped that the AstraZeneca shot would help speed things up at a time when countries face surging cases in a pandemic that has taken the lives of more than 400,000 people in the 27-nation bloc.
The EU bet heavily on the shot, which is cheaper and easier to handle than some other vaccines, with orders for 300 million doses to be delivered after authorization and options for another 100 million doses.
Emer Cooke, the head of the EMA, said it was “a real pleasure” to authorize the vaccine.
“None of them is a magic wand on its own, but together they provide tools and options to prevent different aspects of the disease,” she said.
While the AstraZeneca vaccine has been authorized for all adults in other countries, only 12% of the participants in its research were over 55 and they were enrolled later, so there hasn’t been enough time to get results. But some doctors warned that restricting the vaccine’s use in older people might worsen the pandemic’s impact, since older people have suffered more severe disease and died at a higher rate from the coronavirus.
In its decision on Friday, the EMA assessed four trials in the UK, Brazil and South Africa. The agency said the research showed the vaccine proved to be about 60% effective by reducing the number of people who got sick. The trials have not yet shown whether the vaccine can stop disease transmission.
A separate study testing the AstraZeneca vaccine in the US is still underway.
Professor Andrew Pollard, director of the Oxford Vaccine Group that developed the shot together with AstraZeneca, welcomed the decision.
“The recommendation by the European Medicines Agency is an important milestone in extending access to the Oxford/ AstraZeneca vaccine in our region and providing further endorsement that, after the rigorous scrutiny of regulators, the vaccine can be used to help protect populations from the coronavirus pandemic,” he said in a statement.
While politicians have blamed supply problems for the EU’s slow rollout, other factors, like onerous paperwork and poor planning, have also played a role. The EU has particularly lashed out at AstraZeneca after the drugmaker said it would initially supply less vaccine than originally anticipated. Exacerbating concerns about supplies to the bloc, which is home to some 450 million people, Moderna told countries including Italy and Denmark the company would be delivering fewer vaccines than originally expected.
Jens Spahn, the German health minister, said Friday he understood many were waiting impatiently for the vaccine, but cautioned that “several hard weeks of vaccine shortage still lie before us.”
Before the EMA announcement, Spahn had said Germany would use the regulator’s recommendation to decide whether the AstraZeneca vaccine should only be given to people aged 18-64 for now, as suggested in a draft recommendation by the country’s independent vaccine advisory committee. Britain’s medicines regulatory agency also acknowledged the limited data in older people but still cleared the shot last month for all adults, with some caution for pregnant women.
Julian Tang, a virologist at the University of Leicester, said he thought any recommendation to limit the vaccine’s use to people under 65 was understandable, but “overly cautious.”
The AstraZeneca shot appears to offer less protection than the other two vaccines given the greenlight by the EMA, the Pfizer and Moderna shots, which showed roughly 95% efficacy rates.
Two more vaccine makers also recently announced results, with Novavax saying this week that its shot appears 89% effective based on early findings and Johnson & Johnson saying its long-awaited single-shot vaccine was 66% effective at preventing moderate to severe illness. If those vaccines are eventually licensed, that could help alleviate the pressure on the world’s huge demand for the limited shots currently available.
The authorization of the AstraZeneca vaccine comes amid a bitter dispute between the drugmaker and the bloc after the company said it would sharply reduce initial deliveries from 80 million doses to 31 million.
Amid fears doses from AstraZeneca could be diverted outside the bloc, EU officials are expected to propose measures Friday that could be used to block vaccine shipments to non-EU countries.
The AstraZeneca vaccine has already been authorized in several countries, including Britain, India, Argentina and Mexico. The World Health Organization is also reviewing it; a recommendation from the UN health agency would allow its purchase and distribution to developing countries from a global program known as COVAX.
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