BERLIN (PA) – Regulators on Friday approved the vaccine against AstraZeneca virus in adults across the European Union on Friday amid criticism that the bloc is not moving fast enough to vaccinate its population.
The Committee of Experts of the European Medicines Agency unanimously recommended that the vaccine be used in people over the age of 18, although concerns were expressed this week that there is not enough data to prove that it works in the elderly, and some countries indicated that they may not be given by the elderly.
The image is the third COVID-19 vaccine given the green light by the European Medicines Agency after Pfizer and Moderna. The EMA decision requires the final approval of the European Commission, a process that has taken place quickly with the other vaccines.
A few hours later, the EU supported the use of the vaccine in the 27 nations.
“I expect the company to deliver the 400 million doses as agreed. We will continue to do everything we can to ensure that vaccines are available to Europeans, our neighbors and our partners around the world, “European Commission President Ursula von der Leyen wrote on Twitter.
With studies showing an effectiveness of about 60%, the vaccine seems to offer less protection than those already authorized, but experts said that any vaccine with an effectiveness rate of over 50% could help stop outbreaks.
The agency recommended the use of the vaccine by the elderly, despite limited data on its effectiveness 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 in a briefing on Friday. He acknowledged that “the exact level of protection cannot be estimated at this time.”
Many countries on the continent have struggled to vaccinate people as quickly as Britain, Israel, the US and elsewhere, and it has long been hoped that the AstraZeneca shot will help speed things up at a time when countries are facing Rising cases in a pandemic took the lives of over 400,000 people in the block.
The EU has strongly bet 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 are a magic wand on their own, but together they provide tools and options for preventing various aspects of the disease,” said Emer Cooke, head of EMA.
The AstraZeneca vaccine has been approved for use in all adults in other countries, even though only 12% of its participants were over 55 years old and subsequently enrolled, so there was not enough time to get results.
The EMA decision authorizes the use of the AstraZeneca vaccine 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, said Zivile Simonaityte, the country’s deputy health minister, according to the Baltic News Service. However, it was not clear which age groups they would be given, but Simonaityte noted that studies in people aged 55 and over were not “comprehensive”.
Germany can follow a similar path. The country’s independent vaccine advisory committee on Friday recommended that the shot be given only to people under the age of 65. The final decision rests with the government, but it is likely to follow that advice.
Thomas Mertens, head of the German advisory committee, said that the general approval by the EMA is “confusing” in the light of the data provided by AstraZeneca, but that he and his colleagues will be happy to update their recommendation if additional data appear.
Mertens pointed out that German experts were mainly concerned with the clinical data provided by the company so far.
“The AstraZeneca study was a little more messy overall,” he said.
Julian Tang, a virologist at the University of Leicester, said the German decision to restrict the use of the vaccine to younger people means that more elderly people will be vulnerable to COVID-19 and that some will die unnecessarily.
“There is an extraordinary cost to it,” he said. “It means you have an additional vaccine that could be used to protect people who are no longer used and will be exposed to more people.”
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 studies in the UK, Brazil and South Africa and said the research showed that the vaccine was shown to be about 60% effective in reducing the number of people who became ill. Studies have not yet shown whether the vaccine can stop the transmission of the disease.
A separate study testing the AstraZeneca vaccine in the US is still ongoing.
As the EU struggles to launch the vaccine, politicians have blamed supply problems, but other factors such as paperwork and poor planning, also played a role. The EU specifically attacked AstraZeneca after the doctor said it would initially provide fewer vaccines than initially anticipated. Exacerbating concerns about the supply of the block, which houses about 450 million people, Moderna told some countries, including Italy and Denmark, that the company will deliver fewer vaccines than initially expected.
Spahn, the German health minister, said he understood that many were looking forward to the vaccine, but warned that “a few difficult weeks of lack of vaccines are still ahead of us.”
Also, two other vaccine manufacturers recently announced results, and Novavax said this week that its shot appears to be 89% effective. based on early findings and Johnson & Johnson saying the expected vaccine with a single shot was 66% effective in preventing moderate to severe disease. If these vaccines are eventually licensed, this could help ease the pressure on the world’s huge demand for the limited fires currently available.
The authorization of the AstraZeneca vaccine comes amid a bitter dispute between the drug manufacturer and the bloc after the company said it would suddenly reduce initial deliveries from 80 million doses to 31 million. The EU has also introduced stricter rules on exports of COVID-19 vaccines that could affect shipments to countries such as the United Kingdom.
The AstraZeneca vaccine has already been licensed in over 40 countries, including the United Kingdom, India, Argentina and Mexico. The World Health Organization is reviewing it; a recommendation from the UN health agency would allow its acquisition and distribution to developing countries from 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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