China has promised coronavirus vaccines to parts of the world struggling to access western jabs, even as concerns emerge over Beijing’s deviation from international standards for transparency during drug development.
This month, Bahrain and the United Arab Emirates’ separate announcements that they had approved a vaccine developed by Chinese state-owned pharmaceutical group Sinopharm raised further questions about the inoculation.
In both instances, the Gulf states released only brief statements declaring that initial analysis of Sinopharm’s vaccines had shown them to be 86 per cent effective. Neither underlying data nor details of analysis carried out by Sinopharm or the regulatory bodies were released.
International experts worry that the opacity of the process and allegations of short-cuts taken by China risk undermining global immunisation efforts.
“I think this is a mistake and can easily backfire,” said Suerie Moon, co-director of the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva.
“If any of the vaccines turn out to have safety problems, or not to be as efficacious as hoped or expected, this will be a big blow to public willingness to be vaccinated and efforts to control the pandemic.”
As part of a diplomatic charm offensive, China has pledged deliveries of its four leading Covid-19 vaccines — two developed by Sinopharm, one by Beijing-based Sinovac and another from CanSino Biologics — to nations across the developing world.
Western frontrunners, such as Pfizer/BioNTech, AstraZeneca-Oxford and Moderna, have already completed phase 3 trials and publicly released data that has been reviewed by regulators in Europe, the UK and the US.
But many of China’s low or middle-income customers will struggle to secure western vaccines.
“The production capacity of European and US companies has basically been bought out by developed countries,” which means that Asian, African and Latin American countries will have to place orders with China, said Zhang Tong, an analyst at Kaifeng Investment in Shanghai.
Covax, the World Health Organization-backed programme trying to ensure vaccine access for poor countries, has suffered setbacks and revisions after too few high-income countries joined.
China signed up to Covax in October but it has yet to announce any details of financial support or vaccine provision for the programme. Instead, Beijing has favoured reaching bilateral agreements with partners to supply vaccines and has offered loans, including a $1bn pledge to Latin American and Caribbean countries, to support purchases.
China’s success in largely eradicating the virus at home has given its developers greater leeway to export a sizeable portion of their vaccines.
The government has also used an expanding “emergency use” programme to administer the jabs to more than 1m Chinese citizens, giving manufacturers a head start in fulfilling domestic demand.
Nations are already stocking up on the jabs. Indonesia received 1.2m doses of Sinovac’s vaccine while the Philippines has said it is close to finalising a deal to buy 25m doses from the group.
Even at this late stage, however, impediments continue to hamper China’s quest to vaccinate the developing world. Last weekend, Peru suspended trials of Sinopharm’s vaccine after one of the volunteers involved in the programme suffered a “serious adverse event” before resuming tests this week following talks with the company.
In Brazil, where Sinovac’s local partner is set to announce initial phase 3 results on Wednesday, the health regulator Anvisa has criticised China for not explaining its decision to approve the jab for emergency use at home.
The WHO and international experts have advised that accelerated approval can be appropriate during a pandemic, so long as regulators and companies are rigorous in analysing vaccine data.
Some experts argue that the risks of China’s approach are acceptable if the companies’ initial phase 3 trial results meet basic standards for safety and efficacy.
“The leading Chinese vaccines are using relatively established technology, so that adds to the comfort level about how much should be known before it is introduced,” Calvin Ho, a bioethicist at the University of Hong Kong, said.
Others, however, warn against cutting corners too aggressively. China is a relative newcomer to global vaccine markets and many of its partners are not considered “stringent” regulators by the WHO.
Jerome Kim, director-general of International Vaccine Institute, a Seoul-based multilateral organisation, said that regulatory authorities of countries such as the UAE or Bahrain may fail to carry out analysis of data presented by Chinese developers with the same degree of scrutiny as in Europe or North America.
To allay concerns, Mr Kim suggested Chinese vaccines submit to a review by the WHO or a joint panel of experts from more demanding regulatory regimes.
“In the absence of multilateral approval, will China just go to various national regulators and say: ‘[China’s regulatory authority] has approved this for marketing. Do you want the vaccine or not?’ ” he said.
Additional reporting by Wang Xueqiao in Shanghai
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