The German government has challenged reports of a lower-than-expected efficacy rate of the Oxford/AstraZeneca vaccine for older people, while reiterating concerns about the British-Swedish pharmaceutical giant’s data reporting.
An article in German business daily Handelsblatt had reported that the German government was expecting the European Medicines Agency’s (EMA) assessment to show the AstraZeneca vaccine to be only 8% effective among the over-65s, describing it a “setback for Berlin’s vaccination strategy”.
AstraZeneca instantly dismissed the reports on Monday night, saying the 8% figure was “completely incorrect”.
The German health minister, Jens Spahn, on Tuesday morning described the report as “speculation” and declined to comment while EMA’s analysis of AstraZeneca’s trial data was ongoing.
A later statement by the German health ministry suggested the report had mixed up the efficacy rate for over-65s with the number of seniors involved in AstraZeneca’s trials.
“At first sight it appears that two things have been muddled in the reports,” said the statement. “Around 8% of participants in the AstraZeneca efficacy trials were aged between 56 and 69 years old, only 3- to 4% were over 70. This does not result in an efficacy of only 8% among seniors.”
But the German government also voiced concerns about AstraZeneca’s data reporting: “It has been known since the autumn that fewer seniors were included in the trials supplied by AstraZeneca than the trials of other manufacturers.”
In a statement, Handelsblatt said it stood by its report that there were ongoing concerns over the AstraZeneca vaccine’s low efficacy within the German government, although the newspaper did not repeat the specific 8% figure previously cited.
“According to information by Handelsblatt, the government’s doubts about the efficacy of the AstraZeneca vaccine among elder risk groups have not been dispelled. A high-ranking official within the health ministry told Handelsblatt: ‘A mix-up of the numbers is impossible. On the basis of the data made available to us so far, the efficacy among the over-60s lies below 10%.’”
Scientists have previously raised questions about the representative value of AstraZeneca’s trial design.
An article published by Austrian daily Der Standard last week cited an anonymous high-ranking expert involved in the EU’s vaccine roll-out who said AstraZeneca had “shortcomings regarding the ‘provable efficacy’ for people over 65”.
In an interview with broadcaster ZDF, Spahn suggested that the German government could make younger people with pre-existing health conditions its priority for the AstraZeneca vaccine, rather than the elderly.
“On the basis of scientific findings we will decide next week which age groups will be vaccinated with the vaccine first,” said Spahn. “One thing is clear, we have people with pre-existing illnesses in all age groups, people who desperately hope for a vaccine […]. We can certainly make good use of the vaccine.”
The report in Handelsblatt was published on the same day that the European commission accused AstraZeneca of failing to give a satisfactory explanation for a huge shortfall of promised doses to member states, leading to speculation that the article was part of a retaliation strategy against the British-Swedish manufacturer.
However, the Guardian understands that the original tip-off for the story in Handelsblatt came from a source within one of Germany‘s medical regulatory bodies rather than government circles.