The World Health Organization has officially recommended the Oxford/AstraZeneca vaccine for people over the age of 65 and said it should be used ‘without upper age limit’.
WHO experts have reviewed all the evidence from studies of the jab and said there is ‘no reason’ it shouldn’t be used against the South African variant because it should still prevent severe illness and death.
There are concerns that the vaccine won’t work against that mutated strain of the virus after a study in South Africa found it offered only ‘minimal protection’ against mild disease in young people – but WHO scientists called that paper ‘inconclusive’.
And they backed up the UK’s strategy of spacing the first and second dose by three months, saying between eight and 12 weeks was ideal for maximum protection.
The over-65s ruling is a hit back against European countries that criticised the jab and refused to use it among their older populations, claiming there was not enough proof it worked.
Countries including Germany, France, Denmark, Sweden, Norway, Spain, Poland, Hungary and Italy decided not to roll out the vaccine to older people.
News reports from Germany in January sensationally claimed that the vaccine was only eight per cent effective among over-65s, but it later emerged that ministers had put an inaccurate percentage on clinical data that was so vague it was meaningless.
However today, Dr Alejandro Cravioto, a director at the WHO, said in a briefing that the jab could be given ‘without an upper age limit’.
Dr Cravioto also said there was ‘no reason’ that places with the South African variant of the virus should not use the vaccine to keep down hospital admissions and deaths with the virus.
The Oxford/AstraZeneca vaccine has been the most controversial of all the jabs so far, with claims that it might give less protection among people over 65. But the World Health Organization today put some of the concerns to bed, recommending the jab for people ‘without an upper age limit’ (Pictured: A pharmacist in Hertfordshire loads a syringe with the vaccine)
Dr Alejandro Cravioto, a director at the WHO, said in a briefing that there was ‘no reason’ that places with the South African variant of the virus should not use the vaccine to keep down hospital admissions and deaths with the virus, in the wake of a study suggesting it may be less effective against it
The WHO said in a report published this afternoon that the Oxford/AstraZeneca was, overall, 63 per cent effective at preventing Covid-19 symptoms.
The efficacy is expected to be higher at preventing severe illness and close to 100 per cent for death, but it is not known how well it will stop the virus spreading.
Those parts of the WHO’s report were already expected – the big move was the confirmation that it should be used for people over the age of 65.
Britain is using the jab as one of its key components of the NHS vaccine rollout among elderly people, which has so far immunised more than 12.7million people.
WHY IS EUROPE REJECTING THE JAB?
The reason European countries are turning down the AstraZeneca vaccine for people over the age of 65 seems to be that there isn’t enough proof that it will work.
A German analysis of the clinical trial of the vaccine, published on Twitter by a Berlin correspondent for The Times, showed that officials there estimated the efficacy of the vaccine to be just 6.3 per cent in over-65s.
This figure was close to an eight per cent claim touted in German newspapers Handelsblatt and Bild in January, which sparked outrage among scientists and fierce rebuttals from Oxford University and AstraZeneca, who said it was ‘completely incorrect’.
The issue with the study is that the vaccine was only trialled on 660 people over the age of 65 in results that have been published so far.
In the breakdown shown in the German report, it shows that one out of 341 people who got the jab later tested positive for coronavirus. Meanwhile one in 319 people who got a fake jab, called a placebo, tested positive.
The whole point of a clinical trial is to compare the number of positive cases in the vaccine group to the number of positives in the non-vaccine group, to work out how well the jab works.
With the exact same number of cases in both groups and an almost identical number of participants, this is impossible to do.
To illustrate how unreliable the 6.3 per cent estimate is, the researchers included their confidence interval, which is a range of numbers they are almost certain the true number falls within. The confidence interval suggests that scientists thought the true effectiveness of the vaccine in over-65s was somewhere between -1,405% and 94.5%. This means the estimate is wildly unreliable and a true figure cannot be calculated.
The data is the same that was used by the UK Government to approve the jab, and regulators in Britain admitted there was not enough data to give a percentage estimate of its efficacy – while the Germans attempted to do it anyway.
But they were satisfied by the fact that the vaccine was well-tolerated and safe in the older people who did receive it, and the fact that their immune response appeared in lab tests to be the same as those in younger people, who featured more heavily in the trial.
In short, the Medicines and Healthcare products Regulatory Agency (MHRA) said they would not expect the vaccine to work any differently in older people than in other age groups.
They said: ‘Efficacy and safety data are currently limited in individuals ≥65 years of age. No dosage adjustment is required.’
The study has enrolled more older people since it first reported results and continues to gather data on how the vaccine functions in that group.
The jab appears to be between 62 and 90 per cent effective in the adult population in general, according to Oxford University researchers.
It is being given to people of all ages but some European countries were sceptical about this, despite the thumbs-up from the European Medicines Agency.
France’s President Macron ruffled feathers by calling it ‘quasi-ineffective’ for elderly people.
But the WHO’s Dr Joachim Hombach said today that ‘the immune response in people over 65 is almost the same as in younger people, and this makes us confident that this vaccine is protective.’
Dr Katherine O’Brien, the WHO’s director for vaccines, said that even if the vaccine was less effective than billed, it should still be used.
She told a news conference: ‘Even with a hypothetical drop in efficacy, it’s still the right thing to do to vaccinate adults with a low efficacy vaccine because of the high risk of severe disease in that age group.
‘Even if the efficacy was substantially lower than what was measured, it’s still the right thing to do.’
In its report the World Health Organization said: ‘Because a relatively small number of participants aged 65 years or over were recruited into the clinical trials, there were few cases of Covid-19 in either the vaccine or the control group in this age category, and thus the confidence interval on the efficacy estimate is very wide.
‘More precise efficacy estimates for this age group are expected soon, from both ongoing trials and vaccine effectiveness studies in countries that are using this vaccine.
‘Immune responses induced by the vaccine in older persons are well documented and similar to those in other age groups.
‘This suggests it is likely that the vaccine will be found to be efficacious in older persons. The trial data indicate that the vaccine is safe for this age group.
‘The risk of severe disease and death due to Covid-19 increases steeply with age. Older adults are identified as a priority group in the WHO SAGE Prioritization Roadmap.
‘This prioritization is supported by vaccine impact modelling work, even for vaccine efficacy that is substantially below that observed among younger adults administered AZD1222 [Oxford/AstraZeneca vaccine].
‘Taking the totality of available evidence into account, WHO recommends the vaccine for use in persons aged 65 years and older.’
The WHO’s report comes after a senior scientist in the UK said last week that more evidence coming from the Oxford trials that the jab will be effective for older people.
Sir Munir Pirmohamed, boss of the Commission on Human Medicines, said on Friday that regulators had received extra information from Oxford University and AstraZeneca scientists to prove their jab was safe and effective for over-65s.
The data, which is not yet publicly available, is coming now from same clinical trials in the UK and around the world that got it approved in the first place.
They enrolled thousands more older people after the jab was green-lighted.
Sir Munir said in a briefing: ‘There was no evidence that those people over 65 were not getting evidence of efficacy.
‘Since then we’ve seen more data coming through from AstraZeneca as more people are completing the trial, which highlights again that efficacy in the elderly is seen, and there’s no evidence of lack of efficacy.’
The data Sir Munir refers to is not yet publicly available and has been sent directly to the MHRA, the UK’s vaccines regulator.
He added that elderly people were generating strong immune responses and said the most important thing was that both AstraZeneca’s vaccine and a jab developed by Pfizer and BioNTech were preventing serious disease and deaths.