Expert group says ‘quality’ data needed on adverse effects of jab, as vaccine rolled out from Brazil to Indonesia.
The World Health Organization has approved the emergency use of a COVID-19 vaccine manufactured by China’s Sinopharm.
Friday’s decision by a WHO technical advisory group, a first for a Chinese vaccine, opens the possibility that Sinopharm’s offering could be included in the United Nations-backed COVAX programme in coming weeks or months, and distributed through United Nations children’s agency UNICEF and WHO’s Americas regional office.
Aside from efficacy numbers, the Chinese manufacturer has released very little public data about its two vaccines – one developed by its Beijing Institute of Biological Products and the other by the Wuhan Institute of Biological Products.
The Beijing-made Sinopharm shot is one the WHO advisory group considered for the emergency use listing.
“This afternoon, WHO gave emergency use listing to sign off on Beijing’s COVID-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality,” WHO Director-General Tedros Adhahom Ghebreyesus said.
The Sinopharm vaccine will join ones made by Pfizer-BioNTech, Johnson & Johnson, Moderna, AstraZeneca, and a version of the AstraZeneca vaccine made by the Serum Institute of India, in receiving the coveted authorisation from the UN health agency.
“This expands the list of vaccines that COVAX can buy and gives countries confidence to expedite their own regulatory approval and to import and administer a vaccine,” Tedros said at a Geneva news conference.
Previously, a separate group advising WHO on vaccines said it was “very confident” the Sinopharm vaccine protects people aged 18-59.
The group said it had a “low level of confidence” in the vaccine’s efficacy for people 60 and over.
Its members said they had “very low confidence” in the available data about serious side effects in that age group.
Sinopharm has not published its late-stage test results in scientific journals, so the WHO requested a breakdown of its data, which come mostly from the United Arab Emirates.
A summary posted online by WHO suggests the vaccine is about 78 percent effective, with the caveat that all but a few hundred of the study volunteers were younger than 60.
Gavi, the Vaccine Alliance, which co-runs COVAX, 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 expand and diversify the portfolio further and secure access to additional doses” for countries in the COVAX programme.
COVAX aims to send vaccines for free to 92 lower-income countries and to help another 99 countries and territories procure them.
It was not immediately clear when the Chinese vaccine might be made available to the COVAX portfolio.
Senior WHO adviser Bruce Aylward said it would be up to Sinopharm to say how many doses of its vaccine it can provide to the programme, but added: “They are looking at trying to provide substantial support, make substantial doses available while at the same time of course trying to serve China’s population.”
“Its easy storage requirements make it highly suitable for low-resource settings,” a WHO statement said.
Tedros said that, following the approval, its separate Strategic Advisory Group of Experts (SAGE) had recommended that adults over 18 receive two doses of the Sinopharm vaccine.
“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,” the WHO statement said.
The WHO has said it could reach a decision on China’s other main COVID-19 vaccine, made by Sinovac Biotech, next week. The technical experts reviewed it on Wednesday.
Arnaud Didierlaurent, chair of WHO’s technical advisory group, told the press conference: “We have started to review the report from Sinovac. We actually requested additional information to 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 shot.
Both have been exported to many countries, particularly in Latin America, Asia and Africa, many of which have had difficulty securing supplies of vaccines developed in the West