The World Health Organization has added a Sinopharm vaccine to its list of approved Covid-19 jabs, boosting the credentials of the China-made dose amid doubts over its efficacy.
The emergency use listing for the shot, developed in partnership with the Beijing Institute of Biological Products, is for a two-dose regimen for all adults aged 18 and over, said Tedros Adhanom Ghebreyesus, the WHO’s director-general.
It is the first vaccine of any kind made in China to receive emergency use authorisation from the WHO. The approval is a signal to countries that the Sinopharm vaccine is safe to use and means that the jab will be added to the WHO’s vaccine procurement programme Covax.
Alejandro Cravioto, chair of the WHO’s strategic advisory group of experts on immunisation, said the panel had made “a thorough assessment” of the vaccine, and that there was “enough evidence” it was safe and reduced cases of severe or symptomatic disease by at least 79 per cent.
Early-stage studies for the vaccine were mainly conducted in China, where coronavirus has already been contained. Final stage, or phase 3, studies were held in other countries. Sinopharm has a second two-dose coronavirus vaccine, which it developed with the Wuhan Institute of Biological Products, that has not yet been approved by the WHO.
The WHO authorisation is a victory for Sinopharm, which is the dominant producer of vaccines for China’s domestic market and supplies the majority of jabs for state-run immunisation programmes but has yet to establish itself as an exporter of vaccines.
The company did not immediately respond to a request for comment.
China has pledged Covid vaccines across the developing world but the international rollout has been hampered by lingering concerns about its efficacy, as Chinese manufacturers have been slower than western candidates to release detailed trial data.
The WHO noted a relative lack of data in older patients, recommending surveillance studies be undertaken in countries where the shot is administered to elderly people.The approval of the jab means it could be used in countries suffering from devastating Covid waves, such as India and Brazil, the WHO said. Mohga Kamal-Yanni, a health policy expert at the People’s Vaccine Alliance, said the approval was “great news for people in developing countries who, for months, have been watching people in rich countries being vaccinated while they have been left at the back of the queue”.Mariângela Simão, the WHO assistant director-general for access to medicines, said the approval had the potential to “rapidly accelerate” access for countries looking to protect health workers and those most at risk.