China’s Sinopharm COVID-19 vaccine will now be rolled out globally after it was approved for emergency use listing (EUL), the World Health Organization (WHO) said.
In an announcement, WHO director general Tedros Adhanom Ghebreyesus said the EUL granted for Sinopharm COVID-19 vaccine will expand the list of vaccines that the COVAX facility can provide to poor countries in need of vaccine supply.
“This expands the list of COVID-19 vaccines that COVAX can buy, and gives countries confidence to expedite their own regulatory approval, and to import and administer a vaccine,” Tedros said in a briefing on May 7.
WHO’s emergency use listing is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
“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,” Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products said in a separate statement.
The WHO said the EUL 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, it added.
In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility, the health body said.
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. It is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.
This is the first vaccine developed by a non-Western country to receive WHO backing. It is also the first time the WHO has given emergency use approval to a Chinese-made vaccine for any infectious disease.
The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a unit of Sinopharm subsidiary China National Biotec Group.
Following the approval, the WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks.
On the basis of all available evidence, the WHO said the vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79%, all age groups combined.
The WHO, however, noted that only 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,” it said.
“There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations. WHO therefore recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust,” it added.
Other COVID-19 vaccines included in WHO emergency use listing are those produced by Pfizer/BioNTech, AstraZeneca, Janssen (Johnson& Johnson) and Moderna.