The decision by a WHO technical advisory group on Friday, a first for a Chinese vaccine, opens the possibility that Sinopharm’s offer will be included in the UN-backed COVAX program in the coming weeks or months, and distributed through the United Nations Children’s Agency, UNICEF and the Americas of WHO. regional office.
Efficacy figures aside, the Chinese manufacturer has released very little public data on its two vaccines – one developed by its Beijing Biologics Institute and the other by the Wuhan Biologics Institute.
The Sinopharm vaccine made in Beijing is one of the WHO advisory groups being considered for the list of emergency uses.
“This afternoon, WHO gave an emergency use list to approve Beijing’s COVID-19 vaccine, making it the sixth vaccine to receive WHO validation for its safety, efficacy and its quality, ”said WHO Director-General Tedros Adhahom Ghebreyesus.
The Sinopharm vaccine will join those manufactured by Pfizer-BioNTech, Johnson & Johnson, Moderna, AstraZeneca and a version of the AstraZeneca vaccine manufactured by the Serum Institute of India, receiving coveted clearance from the United Nations health agency.
“This expands the list of vaccines that COVAX can purchase and gives countries the confidence to expedite their own regulatory approval and to import and administer a vaccine,” Tedros said at a press conference in Geneva.
Previously, a separate group advising the WHO on vaccines said it was “very confident” that the Sinopharm vaccine will protect people between the ages of 18 and 59.
The group said they had a “low level of confidence” in the vaccine’s effectiveness for people 60 years and older.
Its members said they had “very low confidence” in the data available on serious side effects in this age group.
Sinopharm has not published its late-stage test results in scientific journals, so the WHO has requested a breakdown of its data, which mainly comes from the United Arab Emirates.
A summary published online by the WHO suggests the vaccine is around 78% effective, with the caveat that all but a few hundred of the study volunteers were under the age of 60.
Gavi, the Vaccine Alliance, which co-leads COVAX, has welcomed WHO’s approval of emergency use.
“This means the world has yet another safe and effective tool in the fight against this pandemic,” the alliance said.
The public-private partnership said it was in discussions with several manufacturers, including Sinopharm, “to further expand and diversify the portfolio and secure access to additional doses” for the COVAX program countries.
COVAX aims to send vaccines free of charge to 92 low-income countries and help 99 other countries and territories obtain them.
It was not immediately clear when the Chinese vaccine could be made available to the COVAX portfolio.
WHO senior adviser Bruce Aylward said it would be up to Sinopharm to say how many doses of its vaccine it can provide to the program, but added: “They are looking to try to provide substantial support, to make substantial doses available all at the same time. of course, trying to serve the Chinese people.
“Its easy storage requirements make it ideally suited for low-resource environments,” said a statement from the WHO.
Tedros said that following the approval, its Strategic Expert Advisory Group (SAGE) recommended that adults over 18 receive two doses of the Sinopharm vaccine.
“Based on all the available evidence, the WHO recommends the vaccine for adults 18 years of age and older, in a two-dose schedule with three to four week intervals,” the WHO statement said.
The WHO has said it may make a decision on China’s other main COVID-19 vaccine, made by Sinovac Biotech, next week. Technical experts examined it on Wednesday.
Arnaud Didierlaurent, chairman of the WHO technical advisory group, told the press conference: “We have started to look at the Sinovac report. We actually requested additional information from the manufacturer… which we hope to receive very soon to make a decision.
China has deployed around 65 million doses of the Sinopharm vaccine and more than 200 million doses of the Sinovac vaccine.
Both have been exported to many countries, especially Latin America, Asia and Africa, many of which have had difficulty in sourcing vaccines developed in the West.