The independent commission advising the German government on vaccination policy has recommended that the Oxford / AstraZeneca vaccine should not be used for people over the age of 65, which may complicate the acrimonious rollout of the vaccine in the EU.
A statement from the Standing Committee on Vaccines at the Robert Koch Institute, Germany’s leading public health agency, said there was “currently not enough data available to determine the effectiveness of immunization in the country. over 65 ”.
For this reason, the commission said it recommends that the vaccine be used only on people between the ages of 18 and 64. She added that the two injections already approved by the European Medicines Agency – of BioNTech / Pfizer and Moderna – were deemed to be “equivalent in terms of safety and efficacy.” The EMA is expected to reach an expected decision on Friday. long overdue approval of the Oxford / AstraZeneca vaccine for use in the EU.
According to a test data set released by the German Vaccine Commission, only two of the 660 trial participants over the age of 65 contracted Covid-19 – one in the vaccinated group and one in the control group – this which is far less than the number needed to draw statistical conclusions. This test data set showed an overall efficiency of 70.4%.
AstraZeneca rejected the German recommendation, saying the latest analysis of clinical trial data for the vaccine supported efficacy in the over 65 age group.
“We are awaiting a regulatory decision on the vaccine from the EMA in the coming days,” he said.
The drugmaker’s London-listed shares fell 2.4% after the news broke.
The German recommendation came with the EU and AstraZeneca locked in a crisis on vaccine supply, after Brussels attacked the company’s “continuing lack of clarity” on its delivery schedule.
While the EU and AstraZeneca have said the high-level emergency talks held on Wednesday evening were “constructive”, they have done little to resolve the dispute over whether the company should deliver tens of millions of doses more to the EU than expected in the first three months of the year.
France and Italy both said they would wait for the EMA’s decision on Friday, before deciding whether to recommend the vaccine to the elderly.
Emer Cooke, head of the EMA, said on Wednesday that there was no indication that jab use should be restricted based on age, but said she did not want to prejudge any results.
The EMA declined to comment on the German recommendation, instead pointing to a statement it made earlier on Thursday, saying it is still evaluating the vaccine.
“We are awaiting the recommendation of the commission on the authorization of this vaccine tomorrow, January 29, and we will communicate the evaluation and its results shortly after the adoption of the opinion,” he said.
Germany’s move could raise questions in the UK, where the vaccine is approved for all people aged 18 and over. When the UK regulator, the Medicines and Health Products Regulatory Agency (MHRA), approved it for emergency use last month, health authorities acknowledged there was a small amount of data on older populations, but that other results would be available this year.
The MHRA did not immediately respond to a request for comment.
Additional reporting by Miles Johnson in Rome and Leila Abboud in Paris