The World Health Organisation (WHO) on Friday gave the green light to China’s Sinopharm Covid-19 vaccine for emergency use, approving the vaccine to be rolled out globally.
It is the first vaccine developed by a non-Western country to get the UN health agency’s backing though China has already vaccinated millions of people at home, since last year, and in dozens of other countries with it.
“On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalised disease was estimated to be 79%, all age groups combined,” the WHO said.
“Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.”
Until now, the WHO had only approved the vaccines made by Pfizer, AstraZeneca, Johnson & Johnson and Moderna to be used during the ongoing Covid-19 pandemic.
“This afternoon, the WHO gave emergency use listing to Sinopharm, Beijing’s Covid-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy, and quality,” WHO DG Tedros Ghebreyesus said at a twice-weekly webinar on Covid-19.
“The Strategic Advisory Group of Experts on Immunization, or SAGE, has also reviewed the available data, and recommends the vaccine for adults aged 18 and older, with a two-dose schedule,” he said.
“This expands the list of vaccines that COVAX combined, and gives countries confidence to expedite their own regulatory approval,” he was quoted as saying by the official Chinese news agency, Xinhua.
The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group.
“The addition of this vaccine has the potential to rapidly accelerate Covid-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr Mariangela Simao, WHO assistant-director general for Access to Health Products.
“We urge the manufacturer to participate in the COVAX facility and contribute to the goal of more equitable vaccine distribution,” Simao was quoted as saying.
The WHO emergency use listing (EUL) is a prerequisite for COVAX facility vaccine supply, also allowing countries to expedite their regulatory approval to import and administer Covid-19 vaccines in the population.
The listing assesses the quality, safety, and efficacy of Covid-19 vaccines, and risk management plans and programmatic suitability, such as cold chain requirements.
The EUL, according to the WHO, assesses the quality, safety and efficacy of Covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements.
The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions, the WHO said.
Feng Duojia, president of the China Vaccine Industry Association, told Global Times that the WHO approval will allow Chinese vaccines to reach more developing countries through international purchase or donations, and it will also be helpful for some EU members’ emergency use of Chinese vaccines.
“The Sinopharm product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). Its easy storage requirements make it highly suitable for low-resource settings,” said the WHO.
