BERLIN (AP) – Regulators approved AstraZeneca’s coronavirus vaccine Friday for use in adults across the European Union amid criticism that 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 18 years and older, although concerns had been raised this week that there is not enough data to prove it works in the elderly, and some countries indicated that they may not be elderly.
The shot is the third COVID-19 vaccine to get the green light from the European Medicines Agency, after the vaccine from Pfizer and Moderna. EMA’s decision requires final approval from the European Commission, a process that was swift with the other vaccines.
Hours later, the EU supported the use of the vaccine in all 27 countries.
“I expect the company to deliver the 400 million doses as agreed. We will continue to do everything we can to secure vaccines for Europeans, our neighbors and partners worldwide, ”tweeted Ursula von der Leyen, President of the European Commission.
With studies showing about 60% efficacy, the vaccine appears to offer less protection than already approved vaccines, but experts have said any vaccine with greater than 50% efficacy can help stop outbreaks.
The agency recommended the use of the vaccine in older people, despite limited data on its efficacy in people over 55, citing observed immune responses and experience with other vaccines.
“At least some protection is expected,” Bruno Sepodes, of the EMA’s expert committee, said during a briefing Friday. He acknowledged that “the exact level of protection cannot be estimated for the time being”.
Many countries on the continent are struggling to vaccinate people as quickly as Britain, Israel, the US and elsewhere, and it has long been hoped that the AstraZeneca injection would help speed things up at a time when countries are facing rising pandemic cases took the lives of more than 400,000 people in the bloc.
The EU is strongly committed to 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 an additional 100 million doses.
“Neither of them is a magic wand in and of itself, but together they provide tools and options to prevent different aspects of the disease,” said Emer Cooke, the head of the EMA.
The AstraZeneca vaccine is approved for use in all adults in other countries, even though only 12% of the study participants were over 55 and enrolled later, so there was not enough time to get results.
The EMA decision allows the AstraZeneca vaccine to be used throughout the block, 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 the elderly, Deputy Health Minister Zivile Simonaityte said, according to the Baltic News Service. However, it was not clear which age groups would receive the injection, but Simonaityte noted that trials in people 55 years and older were not ‘comprehensive’.
Germany can follow a similar path. The country’s independent vaccine advisory committee on Friday recommended that the shot should only be given to people under the age of 65. The final decision rests with the government, but it is likely to follow this advice.
Thomas Mertens, the head of the German advisory committee, said the general approval by EMA was “confusing” in light of the data provided by AstraZeneca, but that he and his colleagues would be happy to update their recommendation as more data comes in.
Mertens emphasized that so far the German experts were mainly concerned about the clinical data provided by the company.
“The AstraZeneca study was generally a bit messier,” he said.
Julian Tang, a virologist at the University of Leicester, said Germany’s decision to limit use of the vaccine to younger people meant more elderly people would be vulnerable to COVID-19 and some would die unnecessarily.
“There are enormous costs involved,” he said. “It means you have an extra vaccine that can be used to protect people that goes unused and puts more people at risk.”
Tang described the EMA’s approval on Friday as “the best decision in the current situation, where the EU urgently needs a viable vaccine.”
The agency reviewed four studies in the UK, Brazil and South Africa and said the study showed that the vaccine was found to be about 60% effective by reducing the number of people who became ill. The studies have not yet shown whether the vaccine can stop disease transmission.
A separate investigation of the AstraZeneca vaccine in the US is ongoing.
While the EU struggles to roll out the vaccine, politicians have blamed supply problems, but other factors, such as cumbersome paperwork and poor planning, have also played a role. In particular, the EU has lashed out at AstraZeneca after the drug manufacturer said it would initially deliver less vaccine than initially expected. Concerns about deliveries to the block, home to some 450 million people, exacerbate Moderna to countries like Italy and Denmark that the company would deliver fewer vaccines than originally expected.
Spahn, Germany’s health minister, said he understood that many were impatiently awaiting the vaccine, but warned that “we still have some difficult weeks of vaccine shortage ahead”.
Two other vaccine makers also recently announced results, with Novavax saying this week that its injection appears to be 89% effective based on early findings and Johnson & Johnson says its highly anticipated one-time vaccination 66% was effective in preventing moderate to severe disease. If those vaccines are eventually licensed, it could help ease the pressure on the huge demand for the limited available injections in the world.
The AstraZeneca vaccine approval comes amid a bitter dispute between the drug manufacturer and the bloc after the company said it would sharply reduce initial deliveries from 80 million doses to 31 million. The EU has also introduced stricter rules for the export of COVID-19 vaccines that could affect shipments to countries such as the United Kingdom.
The AstraZeneca vaccine has already been approved in more than 40 countries, including Great 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 through 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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Follow AP’s pandemic coverage at: https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak.
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