EU regulator authorizes AstraZeneca vaccine for all adults

Coronavirus Vaccine

FILE – In this Jan. 2, 2021 file photo a vial of the COVID-19 vaccine developed by Oxford University and U.K.-based drugmaker AstraZeneca is checked as they arrive at the Princess Royal Hospital in Haywards Heath, England. (Gareth Fuller/Pool via AP, File)

BERLIN (NewsNation Now) — Regulators authorized AstraZeneca’s coronavirus vaccine for use in adults 18 and over throughout the European Union on Friday.

The AstraZeneca vaccine demonstrated an efficacy rate of around 60% in the trials on which the decision was based, the European Medicines Agency (EMA) said in a statement. The EMA licensed the vaccine to be used for all adults, although concerns had been raised this week that not enough data exist to prove it works in older people.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA.

The European Medicines Agency has already approved vaccines made by Pfizer and Moderna, both authorized for all adults with trials showing they provided more protection, with roughly 95% efficacy rates.

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 U.S. 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 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.

Concerns over its value for the elderly were raised on Thursday when Germany’s vaccine committee said it should be given only to people aged between 18 and 64, due to a lack of data about how effective it is in older people.

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% effective by reducing the number of people who got sick. The trials have not yet shown whether the vaccine can stop disease transmission.

AstraZeneca CEO Pascal Soriot welcomed the decision.

“Today’s recommendation underscores the value of AstraZeneca’s COVID-19 vaccine which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations,” he said in a statement.

The AstraZeneca vaccine is administered via two injections into the arm, the second between 4 and 12 weeks after the first.

The European Union last year agreed to buy up to 400 million doses of the vaccine, which is cheaper and easier to handle than some other vaccines. 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.

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.

In France, some elderly citizens getting a COVID-19 shot said younger people should be prioritized instead.

“Are we looking at this wrong way round?” asked Pierre-Antoine Lafortune, an 86-year-old who got a dose of a vaccine in Paris on Friday. “I’m getting vaccinated, but I think of our youths and how they can catch the virus, and it’s a pity that people in the prime of life can’t get immunity like us.”

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.

The Associated Press and Reuters contributed to this article: Frank Jordans and Maria Cheng reporting for the AP. Pushkala Aripaka reporting for Reuters

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