schema:articleBody
| - Germany expects EU regulator EMA to impose restrictions when it authorises the use of the AstraZeneca vaccine in the bloc as efficacy data for older people are insufficient, Health Minister Jens Spahn said Friday. "We're not expecting an authorisation without limits," he told a press conference, adding that the approval could possibly carry specific indications with regards to usage in elderly people. How strongly the warning would be worded remains to be seen, Spahn added. The EMA is on Friday due to approve the AstraZeneca vaccine developed with the University of Oxford. Germany's vaccine commission has said it could not recommend the use of the jabs on people aged 65 years and older because efficacy data for the group were lacking. Klaus Cichutek, who heads Germany's medical regulatory body Paul Ehrlich Institut, said the "foundations have essentially been laid for an approval with no restrictions for age groups" but that it would possibly be "pointed out that the data is weaker for older people". "As you know, the basis for approval, especially for vaccines, must be that the benefits far outweigh the risks," said Cichutek. AstraZeneca and British Prime Minister Boris Johnson have defended the jabs, which have already been widely used in Britain on older people. hmn/dlc/mjs
|