EU Drugs Regulator Approves Astrazeneca Covid-19 Vaccine

European Union regulators have authorized AstraZeneca’s coronavirus vaccine for use in adults, amid criticism the bloc is not moving fast enough to vaccinate its population.

The European Medicines Agency licensed the vaccine to be used in people 18 and over, although 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. On top of the recent news that the drugmaker would supply fewer doses in an initial batch, there were concerns that an age restriction would further hamper Europe’s vaccination program. Some doctors also feared 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.

But in its decision Friday, the European agency said the AstraZeneca vaccine, developed with Oxford University, would be recommended for use in all adults.

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.

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.

The EU bet heavily on the AstraZeneca 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. It’s especially critical given the bloc’s difficulties rolling out vaccinations 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.

While politicians have blamed supply problems for the 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 supply less vaccine in a first batch than originally anticipated. Further raising 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.”

On Thursday, a draft recommendation from Germany’s vaccination advisory committee said the AstraZeneca vaccine should only be given to people aged 18-64 for now.

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.

The AstraZeneca shot is the third Covid-19 vaccine to be given the greenlight by the EMA, after ones made by Pfizer and Moderna. Those were authorized for all adults and trials showed they provided more protection, with 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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