While older adults have been at the front of the vaccination queue in many countries because of their increased vulnerability to Covid-19, this has not been the case in China – until now.
This month some cities, including Beijing and Shanghai, officially opened enrolment to adults over 60 and in good physical health as the country rapidly scaled up its vaccination programme. China aims to have 40 per cent of its population inoculated by June and is expanding from its original priority group of people in so-called high-risk jobs at a rapid clip.
But health officials are proceeding with caution, citing a shortfall in data, as some of China’s vaccine makers appear to have included fewer elderly people in large-scale final phase trials compared to their Western counterparts.
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“Research and development units are speeding up their work, once there is sufficient safety and efficacy clinical trial data, we will carry out large-scale vaccinations of people over 60 years of age,” National Health Commission (NHC) spokesman Mi Feng said on March 21.
China’s delay in vaccinating its elderly sets it apart from much of the rest of the world, including countries like Brazil, Turkey and the United Arab Emirates which are using vaccines from Chinese developers Sinopharm or Sinovac BioTech. In these countries, regulators have looked at the same data - including early phase studies - and weighed it up against the risks of a deadly disease that preys on older adults, and decided to vaccinate.
Experts say there is no sign so far that either of these choices is wrong. China has no ongoing local spread of Covid-19, while early evidence out of Brazil and Turkey has shown reductions in severe cases of the disease following Sinovac vaccinations, according to scientists involved with clinical trials there.
There has been no indication these vaccines, which rely on a tried and true technology, are unsafe in older adults. But some experts still lament what they see as a lack of safety and efficacy data.
“There is no reason to believe these inactivated vaccines cannot be used [in the elderly], but the concern is that they have not done the trials properly,” said virologist Jin Dong-yan, a professor at the University of Hong Kong’s medical school. “The policymakers who are guiding the vaccine manufacturers should have provided better instruction to the manufacturers.”
The key issue, according to experts, is that without this data, health authorities will be vaccinating a vulnerable group without knowing whether the vaccine works well to protect them.
“There is a greatly increased risk of death from Covid-19, almost a 10 times higher risk of mortality, for people over 75,” said John Donnelly of Vaccinology Consulting in the US. “You want to know how well the vaccine works in older people.” However, he said, given that older adults typically had fewer side effects compared with younger adults, once there was solid phase 3 data on the younger group it might be “better to use what you have” in this crisis, and closely monitor the effects. It is a view shared by many experts.
It remains unclear exactly what clinical trial results China’s health authorities are waiting on before they expand mass roll-outs to the elderly and those with underlying conditions. The NHC and the makers of China’s four vaccines with market approval did not respond to requests for comment about the elderly in trials.
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Yang Xiaoming, chairman of Sinopharm subsidiary China National Biotec Group, earlier this month told state broadcaster CCTV that each stage of his company’s clinical trials were first conducted on people aged 18-59, before they were expanded to the over-60s and under-18s. Trials run with its partners in the United Arab Emirates involving 31,000 people in interim data were restricted to those aged 18-60.
Chinese state media reported in February that Moroccan health authorities had found the Sinopharm vaccine to be well tolerated by peopled aged over 60 in a phase 3 trial which partly took place in Morocco. The clinical data appears to refer to the second of two vaccines Sinopharm vaccines to be approved in China. The company has not said what clinical data has been collected on the older age group overall.
According to clinical trial registry data, global trials for the Sinovac vaccine enrolled more than 29,000 participants. Two of these trials aimed to include around 1,000 participants each. But the Brazilian trial, powered with 1,260 older participants, was not designed to measure efficacy by age group, the lead investigator told the South China Morning Post.
Another vaccine maker, CanSino Biologics did not specify an age cap in global trials, according to its registration, but it is not clear if people over 60 were ultimately enrolled.
Only China’s latest vaccine to win emergency use authorisation, developed by Anhui Zhifei Longcom Biologic Pharmacy, appeared to have large-scale elderly enrolment. Records show a phase 3 trial that began in December intended to include 7,000 older adults outside China.
Traditionally, phase 3 clinical trials would not include elderly adults but that approach has been cast aside by several vaccine makers in response to the Covid-19 crisis.
More than 40 per cent of people included in a 44,000-person phase 3 trial of a vaccine developed by US company Pfizer and German firm BioNTech were between 56-85 years of age. Moderna had 7,000 adults aged over 65 in its trial of 30,000. Johnson and Johnson included more than 14,600 people over 60 in its trial of around 44,000.
Kwok Kin-on, a professor at the Chinese University of Hong Kong’s school of public health and primary care, said the Chinese government was “playing it safe” by waiting for more data.
“At this moment, the situation [in China] is quite good, the elderly are at low risk because the community spread is not very active,” he said, adding this group, covering 18 per cent of China’s population, would need to be included as the country aimed for herd immunity and to loosen border controls in the medium-term. Meanwhile, China is in a different situation from other areas with more active spread, Kwok said.
Hong Kong is among those places which have approved Sinovac for emergency use in the older age group, as a third wave of infections over the summer saw elderly care homes hit hard. There have been 10 deaths, mainly among older, chronically ill adults, following the vaccinations but health authorities have so far found no link to the vaccine.
In Shanghai, which last week began enrolling adults aged over 60-75 who were not suffering from acute chronic disease, some residents were aware that limitations would exclude them from the roll-out for now.
In one group of four neighbours, retirees from 60 to 75 years old, interviewed by the Post, two women said they would not be eligible due to poor health or immune disorders, but they had confidence in the vaccine and that it would be widely used. “We know it’s all for one and one for all, but unfortunately I will not be able to take the vaccine,” said one woman, who did not wish to give her name.
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Another 60-year-old Shanghai resident and cancer survivor said she would wait for more information to come out before deciding, because of her history of ill health. “Since it’s voluntary to get vaccinated, better to decide after making some inquiries whether I should take it,” she said.
China has not been alone in grappling with issues of whether enough data has been collected about this age group. Canada and Germany initially chose not to recommend a vaccine developed by British-Swedish company AstraZeneca for use in over 65s until more data became available, while Britain approved its use.
“The issue is not so much that corners are being cut, but we are seeing high death rates, and the vaccine is unlikely to not work, it just could work less well, [but] by rolling it out, you likely more rapidly achieve a real effect,” said Naor Bar-Zeev, deputy director at the International Vaccine Access Centre at Johns Hopkins University in the US. “It’s an ethical and policy issue.”
Other experts say that frail elderly people were not recruited even in those trials that have enrolled older adults, leaving questions about whether the vaccines would work as well or if this vulnerable group could suffer more from any adverse effects.
“It’s only now that the vaccine has been rolled out … that we are starting to see a signal that, thankfully, appears to show that the vaccines work,” said geriatrician Roy Soiza, an honorary clinical reader at the University of Aberdeen in Britain.
China’s regulators may be waiting for effectiveness data on Chinese-developed vaccines to come in from their use overseas, experts say. In Brazil, scientists at the Instituto Butantan, which ran phase 3 clinical trials of the Sinovac vaccine, are conducting community studies of vaccinated residents, including the elderly, according to the institute’s clinical research medical director Ricardo Palacios.
“Preliminary reports [from health authorities in several areas in Brazil also show] that cases are increasing in all age groups, but not in the 90 plus and 85-89 years old group … the first ones to get vaccinated,” he said in an emailed response to the Post.
In Turkey, where a phase 3 study of the Sinovac vaccine was conducted in adults aged between 18-59, trial coordinator Serhat Unal said there were no plans for additional placebo-controlled trials with the elderly. But this group – the first to receive jabs in Turkey’s mass roll-out – was being monitored, he said.
“Those over 65 are being followed [to track the] number of cases who became positive after the vaccine, as an efficacy study, and for any side effects,” said Unal, a professor of medicine at Hacettepe University. “Now, the data will come from real life.”
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This article Why China is finally including the elderly in its Covid-19 vaccine programme first appeared on South China Morning Post