Germany recommends Oxford Covid vaccine not be used on over-65s

German authorities have recommended that the Oxford/AstraZeneca coronavirus vaccine should not be used on people aged 65 or above, citing a lack of data.

AstraZeneca and the vaccine’s developers have consistently said it is safe for use on older adults, and Public Health England said on Thursday that the vaccine provided reassuring immune responses in older people even if data on the precise level of protection was patchy.

However, Germany’s disease control agency, the Robert Koch Institute, said there was insufficient data to judge how effective the vaccine was for people over 65, and as a result it could only recommend using the vaccine on people aged 18 to 64.

An RKI advisory committee said that in all other respects the AstraZeneca vaccine was as “equally suitable” as those manufactured by Pfizer/BioNTech and Moderna.

The recommendation came on the eve of a ruling by the European Medicines Agency (EMA) on the vaccine made by AstraZeneca, a British-Swedish pharmaceutical company.

Boris Johnson, the UK prime minister, said: “This is a local German decision and the EMA will, as I understand it, will be approving it for general use and I think that’s a very sensible of the EMA, because that is the vaccine our own MHRA has said produces an immune response in all age groups, as a good vaccine, so I’m confident about it.”

Germany’s health minister, Jens Spahn, had indicated earlier that he was considering adjusting the priority list for the AstraZeneca vaccine, starting with younger people with pre-existing conditions or medical staff rather than older people.

This week a spokesperson for the University of Oxford, which developed the vaccine, said clinical trials showed similar immune responses in younger and older adults, a good safety profile and high efficacy in younger adults.

While there was less data from older adults involved in the trials, the team said early figures were promising. “Preliminary efficacy data in older adults supports the importance of this vaccine for use in this population,” they said.

Mary Ramsay, the head of immunisations at PHE, said on Thursday: “Both the AstraZeneca and Pfizer/BioNTech vaccines are safe and provide high levels of protection against Covid-19, particularly against severe disease. There were too few cases in older people in the AstraZeneca trials to observe precise levels of protection in this group, but data on immune responses were very reassuring.”

Earlier in the week the German government was forced to distance itself from reports of a lower-than-expected efficacy of the Oxford/AstraZeneca vaccine among older people, after an article in the business daily Handelsblatt claimed the rate was only 8% in over-65s.

Germany’s health ministry suggested the report had mixed up the efficacy rate for over-65s with the proportion of older people involved in AstraZeneca’s trials. But even in his rebuttal, Spahn voiced some criticism of AstraZeneca’s trial data, saying: “It has been known since the autumn that fewer seniors were included in the trials supplied by AstraZeneca than the trials of other manufacturers.”

​Calculations in the German authorities’ draft recommendation show only 6% of participants in the trials were over 65, with 341 of them receiving a shot of the AstraZeneca vaccine and 319 receiving a placebo.

In the trial, one infection was recorded in the treatment group and one in the placebo group, creating a high confidence interval that the German authorities described in their report as “no longer statistically significant”. They said: “Any assessment about the efficacy of the vaccination among the highest age group (≥75 years) therefore comes with a high level of uncertainty.”

In an interview with the Italian newspaper la Repubblica, the AstraZeneca chief executive, Pascal Soriot, defended the low number of older participants in the trials carried out by Oxford University, saying: “They didn’t want to vaccinate older people until they had accumulated a lot of safety data in the 18 to 55 group.”

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said: “Every country is in a different situation. Advice on the use of a vaccine will depend on its availability and the availability of other vaccines.

“For the Oxford/AstraZeneca vaccine, in Germany and the rest of the EU there is a shortage, as is well known. It must be emphasised that this is not a regulatory decision but draft advice on usage. It is in a context where supplies of the Pfizer/BioNTech vaccine, for which data in older people shows similar efficacy as in younger people, are relatively plentiful. In such a situation it is reasonable to prioritise younger people with one and older people with the other vaccine.”

Jim Naismith, a professor of structural biology at the University of Oxford and director of the Rosalind Franklin Institute, said: “It is really important to read what has been said. German scientists conclude that the Oxford /AZ vaccine is safe and it is effective for under-65s. Their assessment is that effectiveness is not yet demonstrated for over-65s. They have not said the vaccine is ineffective for over-65s.”

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