Germany expects limited EU approval for AstraZeneca vaccine


BERLIN (AP) — Germany’s health minister says he expects the European Union’s drug regulator to authorize a further coronavirus vaccine made by AstraZeneca on Friday, but that currently available data may mean it is not recommended for older adults.

Jens Spahn said authorities are waiting to see what advice the European Medicines Agency issues with regard to vaccinations for people over 65, and Germany would then adjust its own guidance for doctors in the country.

“We don’t expect an unrestricted approval,” Spahn told reporters in Berlin.

Questions remain about how well the AstraZeneca vaccine protects older people. Only 12% of the participants in the AstraZeneca research were over 55 and they were enrolled later, so there hasn’t been enough time to get results.


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.

A separate study testing the AstraZeneca vaccine in the U.S. is still underway.

The shot would be the third COVID-19 vaccine given the greenlight by the EMA, after ones made by Pfizer and Moderna. Those were authorized for all adults.

Spahn’s comments come amid a bitter dispute between AstraZeneca and the 27-nation bloc over delayed supplies.

Earlier this week, the EU lashed out at AstraZeneca after the British-Swedish drugmaker said it would sharply reduce initial deliveries from 80 million doses to 31 million, blaming manufacturing problems. The EU has threatened to stop any vaccines made in Europe from leaving its borders.

Many countries on the continent have been struggling to vaccinate people as quickly as Britain, Israel, the U.S. and elsewhere. While politicians have blamed supplies for the slow rollout, other factors, like onerous paperwork and poor planning, have also played a role.

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.

Separately, the EMA said Friday that no new side effects linked to the coronavirus vaccine made by Pfizer and its German partner BioNTech were identified in the regulator’s first safety update.

Its expert committee assessed reports of people who died after getting the vaccine and said their review “did not suggest a safety concern.” Earlier this month, Norwegian officials amended their vaccination advice to say that doctors should assess frail and severely ill elderly people to decide if they should be immunized.

The EMA concluded that safety data collected on the Pfizer vaccine are “consistent with the known safety profile of the vaccine” and noted that severe allergic reactions are a known, rare side effect.

The EMA authorized the Pfizer vaccine on Dec. 21 and granted it a conditional license; Pfizer and BioNTech must submit safety reports every month in line with a heightened monitoring process. The agency said “there are no recommended changes regarding the use of the vaccine.”


Cheng reported from Toronto.


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