Despite Lack Of Efficacy In Older People, E.U. Authorizes AstraZeneca Covid Vaccine For All Adults


The European Union’s regulator recommended authorization of the Oxford-AstraZeneca coronavirus vaccine for use in the 27-country bloc on Friday, despite a lack of data about efficacy in older people.

European officials had raised concern about the limited knowledge of the vaccine’s effectiveness in older people, who represented only 6 percent of clinical trial participants, though they account for the majority of coronavirus deaths and are high on most countries’ vaccination priority lists.

But the European Medicines Agency said, “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines.”

Germany announced on Thursday that it would recommend that the vaccine only be used in people under 65. The United States is waiting for further trial data before authorization, whereas Britain and India have authorized it for all adults.

Europe’s regulatory decision comes amid a furious fight between the E.U. and the British-Swedish company. AstraZeneca has said its vaccine deliveries to the E.U. would fall short by as much as 60 percent this quarter, after problems at a manufacturing site in Belgium. The E.U. has responded with threats of legal action and export controls while demanding to visit the site in question.

European governments are under pressure as they face a surging coronavirus outbreak, increasingly driven by the more contagious variant of the virus first identified in Britain.

The E.U. had sought to hedge its bets by preordering multiple vaccines — some say, not enough. It has authorized two others at this point: the offerings by Pfizer-BioNTech and by Moderna.

But limited supply has meant that, while strict lockdown orders remain in effect in many countries, inoculation campaigns have ground to a halt in certain regions. Less than 2 percent of the E.U.’s 450 million inhabitants have received a shot — and many in that group have only gotten the first of two doses.

In a news conference Friday, German Health Minister Jens Spahn said Germany is facing “a few hard weeks” of vaccine shortages.

“We are living in and with the biggest crisis since World War II,” he said but added a note of optimism. “This crisis is a challenge for each of us, for science, for politics, for society. Many people are suffering from the current situation and yes, many are also frustrated, frustrated because the vaccine is very scarce.”

AstraZeneca’s chief executive officer Pascal Soriot has said that the company is not legally obligated to supply the expected amount to Europe and only committed to making its “best effort” in the contract.

But Brussels wants the company to share supply from British production sites, publishing its contract with the pharmaceutical firm on Friday to argue that it was obliged to. The contract says the company should make efforts to manufacture E.U. vaccines at sites within the European Union and the United Kingdom and can use other sites if it accelerates supply.

So far, AstraZeneca’s supplies to Britain have not been disrupted.

“There’s clearly an obligation on the company. There’s not a shadow of a doubt about that,” an E.U. official said, briefing reporters about the contract under ground rules of anonymity.

The E.U.’s contract with AstraZeneca is for 300 million doses, with the option for 100 million more. The vaccine was expected to make up the bulk of E.U. supplies in the first quarter of the year.

The bloc has purchased 160 million doses of Moderna, enough to vaccinate 80 million people. Brussels has also recently boosted its initial order with Pfizer and BioNTech to allow it to buy up to 600 million doses.

Europe’s medical authority has given a conditional marketing approval for its vaccines, rather than the speedier emergency authorization given by Britain. Its officials say that involves a deeper look at the data.

According to a breakdown of the trial data released by Germany’s vaccination committee, one person among the 341 people over 65 that received the AstraZeneca vaccination was infected with the coronavirus. There was also just one person infected in the control group of 319 people over 65 that was not given the vaccine.

Due to the “small number” of study participants above the age of 65, “no statement can be made about the efficacy and safety for older people,” it said.

AstraZeneca has said it deems the vaccine to be effective in older people, as all those involved in the trial showed antibodies after the second dose.

Given the restrictions on its use in Germany, Berlin has said that it will use the 3 million doses of AstraZeneca it expects to get next month to inoculate younger people within high priority groups, such as medical workers.

Brussels released further details of its new export controls on Friday, which it says is designed to improve “transparency” over where vaccines being produced in the European Union are being exported. Europe is particularly irked given investments in both the Pfizer and AstraZeneca vaccines, with officials insisting they see a “fair” return.

Pfizer and BioNTech said earlier this month that deliveries in the first three months of the year would be disrupted as they expand the capacity at a site in Belgium. Israel, which paid a higher price for its Pfizer vaccines than the European Union but also agreed to provide the company with medical data, has not had similar delays despite their vaccines being produced in Belgium.

“Our goal at the moment is for all European countries to receive, at the same moment, vaccines in proportion to their population. Transparency is necessary, not that there’s a vaccine war,” Didier Reynders, the top E.U. official for legal affairs, told Belgium’s RTBF broadcaster on Friday. “Perhaps Britain wants to start a vaccine war, but we, we have set up vaccines for European countries and our partners.”

The regulations will mean that pharmaceutical companies will have to fill in a customs form detailing the amount they want to export, which will be reviewed by customs authorities in the country of production.

Some analysts have raised concerns that the controls could impact developing countries, that are banking on the cheaper and more easily distributed AstraZeneca vaccine. It is currently unclear how much the reduction in yields at AstraZeneca’s plant in Belgium will impact countries such as Brazil and Indonesia, who have also put in orders.

There were some indications that the dispute between Europe and AstraZeneca over supplies might be easing on Friday, as Spahn said that a new offer from the company to supply extra doses despite the production issues “creates trust.”

However, Reuters reported that some E.U. officials are still dissatisfied with the figure, which falls short of the promised supply.

“What I think is important to see,” said Spahn, is “the way out of the pandemic of the century has begun.”

He pointed that the fact that three vaccines are available in Europe only a year after the outbreak began is a “unique success story in medicine.”