BERLIN (AP) – Regulators authorized AstraZeneca’s coronavirus vaccine for use in adults across 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 that the vaccine be used in people aged 18 or over, although concerns have been raised this week that there is insufficient data to prove that it works in older people, and some countries indicated that they may not give to the elderly.
The vaccine is the third COVID-19 vaccine to receive a green light from the European Medicines Agency, after those from Pfizer and Moderna. The EMA decision requires final approval by the European Commission, a process that occurred quickly with other vaccines.
Hours later, the EU supported its use of the vaccine in its 27 countries.
“I expect the company to deliver 400 million doses as agreed. We will continue to do everything in our power to guarantee vaccines for Europeans, our neighbors and partners around the world ”, tweeted EU Commission President Ursula von der Leyen.
With tests showing about 60% effectiveness, the vaccine appears to offer less protection than those already authorized, but experts say any vaccine with an effectiveness rate of more than 50% can help prevent outbreaks.
The agency recommended the use of the vaccine by older people, despite limited data on its effectiveness in people over 55, citing the immune responses seen and experience with other vaccines.
“At least some protection is expected,” Bruno Sepodes, of the EMA expert committee, said Friday at a news conference. He acknowledged that “the exact level of protection cannot be estimated at this time”.
Many countries on the continent have been struggling to vaccinate people as quickly as Britain, Israel, the USA and elsewhere, and the AstraZeneca injection has long been expected to help speed things up at a time when countries face growing cases of a pandemic that claimed the lives of more than 400,000 people in the bloc.
The EU is betting heavily on the vaccine, 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.
“None of them is a magic wand in its own right, but together they provide tools and options to prevent different aspects of the disease,” said Emer Cooke, head of the EMA.
The AstraZeneca vaccine was authorized for use in all adults in other countries, although only 12% of the participants in their research were over 55 and were enrolled later, so there was not enough time to get results.
The EMA decision authorizes the AstraZeneca vaccine to be used throughout the bloc, but individual countries can still decide how and to whom they will give the doses they receive.
Lithuania, for example, will not use the vaccine in elderly people, said the country’s deputy health minister, Zivile Simonaityte, according to the Baltic News Service. It was unclear, however, which age groups would receive the injection, but Simonaityte noted that the trials on people aged 55 and over were not “comprehensive”.
Germany can follow a similar path. The country’s independent vaccine advisory committee recommended on Friday that the vaccine should only be applied to people under 65. The final decision is up to the government, but it is likely to follow this advice.
Thomas Mertens, the head of the German advisory committee, said that EMA’s overall approval was “confusing” in light of the data provided by AstraZeneca, but that he and his colleagues would gladly update their recommendations if more data arrived.
Mertens pointed out that German experts are mainly concerned with the clinical data provided by the company so far.
“The AstraZeneca study was a little more confusing in general,” he said.
Julian Tang, a virologist at the University of Leicester, said that the German decision to restrict the use of the vaccine to younger people means that more older people will be vulnerable to COVID-19 and that some will die unnecessarily.
“There is a tremendous cost to this,” he said. “This means that you have an extra vaccine that can be used to protect people who are not used and that more people are at risk.”
Tang described the EMA authorization on Friday as “the best decision in the current situation, where the EU desperately needs a usable vaccine”.
The agency evaluated four tests in the UK, Brazil and South Africa and said the research showed that the vaccine proved to be about 60% effective in reducing the number of people who fell ill. Tests have not yet shown whether the vaccine can stop disease transmission.
A separate study testing the AstraZeneca vaccine in the USA is still ongoing.
As the EU has struggled to launch the vaccine, politicians blame supply problems, but other factors, such as costly paperwork and insufficient planning, also played a role. The EU particularly criticized AstraZeneca after the drugmaker said it would initially provide less vaccine than originally planned. Exacerbating concerns over supplies for the bloc, which is home to around 450 million people, Moderna told countries like Italy and Denmark that the company would deliver fewer vaccines than initially expected.
Spahn, the German health minister, said he understood that many were waiting impatiently for the vaccine, but warned that “several difficult weeks of vaccine shortages are still ahead of us”.
Two more vaccine manufacturers also announced results recently, with Novavax saying this week that its injection looks 89% effective based on early discoveries and Johnson & Johnson saying their long-awaited single injection vaccine it was 66% effective in preventing moderate to severe illness. If these vaccines are eventually licensed, it could help ease the pressure on the huge worldwide demand for the limited vaccines currently available.
The authorization of the AstraZeneca vaccine comes amid a fierce dispute between the pharmaceutical and the bloc after the company said it would drastically reduce initial deliveries from 80 million doses to 31 million. The EU has also introduced stricter rules on exports of COVID-19 vaccines that can reach shipments to countries like the United Kingdom.
The AstraZeneca vaccine has already been authorized in more than 40 countries, including Britain, India, Argentina and Mexico. The World Health Organization is also reviewing; a recommendation from the UN health agency would allow its purchase and distribution to developing countries of a global program known as COVAX.
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Cheng reported from Toronto. Associated Press writers Samuel Petrequin and Raf Casert in Brussels, Nicole Winfield in Rome, Danica Kirka in London, Angela Charlton and Alex Turnbull in Paris and Jan M. Olsen in Copenhagen, Denmark, contributed.
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