BERLIN (AP) – Regulators may use AstraZeneca’s coronavirus vaccine for adults across the European Union on Friday, amid criticism that the bloc is not moving fast enough to vaccinate the population.
The European Medicines Agency’s expert committee has unanimously recommended that the vaccine be used in people aged 18 and over, although concerns have been expressed this week that there is not enough data to prove that it works in older people. not, and some countries have indicated that they may not give it to the elderly.
The shot is the third COVID-19 vaccine to be given the green light by the European Medicines Agency, followed by Pfizer and Moderna. The EMA’s decision requires final approval from the European Commission, a process that took place rapidly with the other vaccines.
Hours later, the EU gave its support to the use of the vaccine in its 27 countries.
‘I expect the company to deliver the 400 million doses as agreed. We will continue to do everything in our power to secure vaccines for Europeans, our neighbors and partners worldwide, ”tweeted Ursula von der Leyen, President of the European Commission.
With trials showing about 60% efficacy, it appears that the vaccine offers less protection than has already been granted, but experts have said that any vaccine with an efficacy rate of more than 50% can help prevent outbreaks.
The agency recommended the use of the vaccine by older people, despite limited data regarding its efficacy in people over 55, citing the immune responses seen and the experience with other vaccines.
“At least some protection is expected,” Bruno Sepodes, an EMA expert committee, told a news conference on 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 shot would help speed things up at a time when countries are in a pandemic with serious cases. took the lives of more than 400,000 people in the block.
The EU has risked a lot 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.
“None of them are a magic wand in themselves, but together they offer tools and options to prevent various aspects of the disease,” said Emer Cooke, head of the EMA.
The AstraZeneca vaccine was approved for use in all adults in other countries, although only 12% of research participants were over 55 and enrolled later, so there was not enough time to get results.
According to the EMA’s decision, AstraZeneca’s vaccine could be used across the block, but individual countries could still decide how and to whom they would give the doses.
According to the Baltic News Service, Lithuania, for example, says the vaccine is not available to older people, the country’s deputy minister Zivile Simonaityte said. However, it was not clear which age groups would get the chance, but Simonaityte noted that trials in people aged 55 and older were not ‘comprehensive’.
Germany can follow a similar path. The country’s independent vaccination advisory committee recommended on Friday that the shot be given to people under 65 only. The final decision rests with the government, but it will probably be followed.
Thomas Mertens, head of the German advisory committee, said that 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 further information herein. appear.
Mertens stressed that the German experts are particularly concerned about the clinical data the company has provided so far.
“The AstraZeneca study was generally a little more messy,” 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 meant that older people would be vulnerable to COVID-19 and that some would die unnecessarily.
“It involves huge costs,” he said. “It means you have an extra vaccine that can be used to protect people who are unused and that more people will be at risk.”
Tang described the EMA’s authorization on Friday as “the best decision in the current situation, where the EU urgently needs a useful vaccine.”
The agency evaluated four trials in the UK, Brazil and South Africa and said the research showed that the vaccine was about 60% effective by reducing the number of people getting 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 ongoing.
As the EU struggled to export the vaccine, politicians blamed the supply problems, but other factors, such as heavy paperwork and poor planning, also played a role. The EU in particular has struggled with AstraZeneca after the drugmaker said it would initially deliver less vaccine than originally expected. Moderna has told countries, including Italy and Denmark, that the company will deliver fewer vaccines than originally expected.
Spahn, the German health minister, said he understood that many were impatiently waiting for the vaccine, but warned that some difficult weeks with a shortage of vaccines were still ahead of us. ‘
Two more vaccine manufacturers also recently announced results, and Novavax said this week that its shot looks 89% effective based on early findings and Johnson & Johnson says its long-awaited single-shot vaccine was 66% effective in preventing moderate to severe diseases. If these vaccines are finally licensed, it could ease the pressure on the worldwide huge demand for the limited shots currently available.
The authorization of the AstraZeneca vaccine comes amid a bitter dispute between the drug manufacturer and the bloc after the company said the initial deliveries would be sharply reduced from 80 million doses to 31 million. The EU has also introduced stricter rules on the export of COVID-19 vaccines that can be shipped to countries such as the United Kingdom.
The AstraZeneca vaccine has already been approved in more than 40 countries, including Britain, India, Argentina and Mexico. The World Health Organization is also reviewing it; a recommendation from the UN’s health agency will make it possible to buy and distribute it to developing countries from a global program known as COVAX.
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Cheng reported from Toronto. Associated Press authors 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.
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Follow AP’s pandemic coverage at: https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus- vaccination and https://apnews.com/UnderstandingtheOutbreak.
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