EU regulator authorizes AstraZeneca vaccine for all adults

Regulators authorized AstraZeneca’s coronavirus vaccine for use in adults throughout the European Union on Friday, 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 exists to prove it works in older people.

The shot is the third COVID-19 vaccine given the green light by the European Medicines Agency, after those 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.

Authorized elsewhere

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 U.N. health agency would allow its purchase and distribution to developing countries from a global program known as COVAX.

Many countries in Europe have been struggling to vaccinate people as quickly as Britain, Israel and the U.S., 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 for all adults.

While the AstraZeneca vaccine has been authorized for all adults in other countries, only 12 per cent 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 U.K., Brazil and South Africa. The agency said the research showed the vaccine proved to be about 60 per cent effective by reducing the number of people who got sick. The trials have not yet shown whether the vaccine can stop disease transmission.

Cheaper, easier to handle

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. The pandemic 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 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.

Julian Tang, a virologist at the University of Leicester, said he thought any recommendation to limit the vaccine’s use to people under 65 was understandable but “overly cautious.”

He said that although data on the vaccine’s effectiveness in older populations was limited, it was reasonable to extrapolate that it would help protect older people against COVID-19.

“The vaccine clearly offers some protection and since the older 65’s are your most vulnerable population, I’d think you want to get some vaccine into them sooner rather than later,” he said. “If Europe and the Germans want to be nitpicky, they can restrict its use, but I think giving older people this vaccine is better than nothing.”

3rd shot approved by EMA

Although the AstraZeneca shot has been given the green light by the EMA, the trials for Pfizer and Moderna’s vaccines showed they provided more protection, with roughly 95 per cent efficacy rates.

Two more vaccine makers also recently announced results, with Novavax saying this week that its shot appears 89 per cent effective based on early findings and Johnson & Johnson saying its long-awaited single-shot vaccine was 66 per cent effective at preventing moderate to severe illness.

If those vaccines are 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.

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