AstraZeneca renames Covid-19 vaccine Vaxzevria amid new safety concerns

Germany limits use of AstraZeneca Covid-19 vaccine for people under 60

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AstraZeneca has renamed its Covid-19 vaccine in Europe as the pharmaceutical company struggles to reassure the public that the drug is safe.

The British-Swedish company said the drug would now be marketed under the new name Vaxzevria but the product itself remained unchanged.

The European medicines regulator approved the new name and has updated its guidance to reflect the change.

The new look comes as Germany stopped general use of AstraZeneca's product in people aged under 60 because of a risk of rare blood clots.

The German medicines regulator on Tuesday found 31 cases of a type of rare blood clot among the nearly 2.7 million people who had received the vaccine in Germany.

Chancellor Angela Merkel said the country took the regulator's findings seriously and would be recommending use of the shot in older people only.

"They are findings that (Germany's vaccine commission) and finally us, cannot ignore," she said.

German federal and state health ministers said under-60s could still decide to take the vaccine but only after "consultation with the doctor carrying out the vaccination ... and with an individual risk analysis".

The World Health Organisation and the EU's health watchdog have both deemed the AstraZeneca vaccine safe, but several countries have restricted its use after clotting reports.

Germany's vaccine commission recommended that use of the shots be halted for under-60s because of "currently available data on the occurrence of rare but very severe thromboembolic side effects" in younger vaccinated people.

It intends to make another recommendation by the end of April on how to proceed with people under 60 who have already received a first dose.

Ministers said people who are due for their second shot could choose to take it if cleared by their attending doctor, or wait for the commission to make its recommendation.

Health Minister Jens Spahn said Germany would be able to meet its goal of offering every adult a coronavirus vaccine by the end of the summer.

The latest restrictions are a new setback for the Anglo-Swedish pharmaceutical company, which is embroiled in a dispute with the EU over vaccine supplies.

AstraZeneca's drug first ran into trouble in Germany after authorities restricted the shot to under-65s because of insufficient data on its effectiveness in older people.

After clearing it for the elderly, Germany along with several EU nations suspended its use in mid-March because of clotting fears.

Only a week after allowing it again, German authorities halted its use among younger people.

The chancellor insisted that public confidence in the vaccine was maintained through careful consideration and transparency on the safety risks.

"Trust stems from the knowledge that every suspicion, every individual case, will be examined," she said.

Berlin had already suspended the use of AstraZeneca’s coronavirus vaccine for people under 60 due to reports of blood clots.

The city-state's top health official, Dilek Kalayci, said on Tuesday the decision was precautionary after the country’s medical regulator announced 31 cases of rare blood clots in people who recently received the vaccine, nine of whom died.

All but two of the cases involved women aged 20 to 63.

Earlier on Tuesday, two Berlin-based hospital groups, Charite and Vivantes, announced they would stop giving the AstraZeneca vaccine to female staff members under 55.

"From the Charite's point of view, this step is necessary because, in the meantime, further cerebral venous thromboses have become known in women in Germany," a spokeswoman said.

The suspension was precautionary pending final assessments, representatives for each hospital group said.

About 19,000 people work at the Charite hospitals and 17,000 at Vivantes, which operates clinics as well as care homes.

Two thirds of staff at Charite have been vaccinated and 70 per cent of those have received one shot of the AstraZeneca vaccine, German newspaper Tagesspiegel reported.

Many European countries suspended the use of AstraZeneca’s vaccine while investigating blood-clotting incidents earlier this month.

Nearly all have since resumed but, breaking with guidance from the European medical regulator, France is offering the drug only to people aged 55 or older. It said the decision was based on evidence that the clotting affected younger people.

Finland and Sweden resumed the use of AstraZeneca doses in people aged 65-plus, while Norway last week extended its suspension for three weeks.

Canadian health officials said on Monday they would stop offering AstraZeneca's shot to people under 55 and called for a new analysis of its benefits and risks, based on age and gender.