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The makers of the Oxford/AstraZeneca coronavirus vaccine and UK government agencies have defended the vaccine’s efficacy after German authorities recommended it should not be used on people aged 65 or above, citing a lack of data.
A committee at 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. In all other respects the AstraZeneca vaccine was as “equally suitable” as those manufactured by Pfizer/BioNTech and Moderna, it said.
The recommendation came on the eve of a ruling by the European Medicines Agency (EMA) on the vaccine made by AstraZeneca.
The British-Swedish pharmaceutical company, which has consistently said its vaccine is safe for use on older adults, said on Thursday: “Reports that the AstraZeneca/Oxford vaccine efficacy is low in adults over 65 years are not an accurate reflection of the totality of the data. The latest analyses support efficacy in this age group, which we expect to be published by the EMA in the coming days.”
Dr June Raine, the chief executive of the UK Medicines and Healthcare products Regulatory Agency (MHRA), said: “Current evidence does not suggest any lack of protection against Covid-19 in people aged 65 or over. The data we have shows that the vaccine produces a strong immune response in the over-65s.”
Boris Johnson, the UK prime minister, echoed the MHRA. “This is a local German decision and the EMA will, as I understand it, be approving it for general use,” he said. “I think that’s 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.
A spokesperson for the University of Oxford, which developed the vaccine, said this week that 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 Public Health England, said on Thursday that while there “were too few cases in older people in the AstraZeneca trials to observe precise levels of protection in this group … 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 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 an interview with the Italian newspaper la Repubblica, the AstraZeneca chief executive, Pascal Soriot, defended the low number of older participants in the Oxford trials, saying: “They didn’t want to vaccinate older people until they had accumulated a lot of safety data in the 18 to 55 group.”
Prof Stephen Evans, of 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.”
Jim Naismith, a professor of structural biology at the University of Oxford, said: “It is really important to read what has been said. German scientists conclude that the Oxford/AstraZeneca 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.
“Scientists often disagree about how much evidence is needed for any new advance and there is always more data to be secured. Normally this all happens out of sight of the glare of the media and not in a pandemic.”
In a separate development on Thursday, the EMA said it advised medics inject a second dose of the Pfizer/BioNTech vaccine three weeks after the first, amid a debate over how much time to leave between the two jabs. “Previously, the product information stated that the interval should be ‘at least 21 days’,” the EMA said.
Source: The Guardian
Keyword: UK defends Oxford vaccine as Germany advises against use on over-65s | World news