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China has promised coronavirus vaccines to parts of the world struggling to accede to Western coups, even as concerns arise about Beijing’s deviation from international standards of transparency during drug development.
This month, separate announcements from Bahrain and the United Arab Emirates that they had approved a vaccine developed by Chinese state pharmaceutical group Sinopharm raised further questions about inoculation.
In both cases, the Gulf states issued only brief statements stating that initial testing of the Sinopharm vaccines had shown them to be 86% effective. The underlying data and details of the analysis by Sinopharm or regulatory bodies were not released.
International experts worry that the opaque process and allegations of shortcuts taken by China risk undermining global immunization efforts.
“I think this is a mistake and may backfire,” said Suerie Moon, co-director of the Center for Global Health at the Graduate Institute for International and Development Studies in Geneva.
“If any of the vaccines turn out to have safety problems, or not to be as effective as expected or expected, this will be a major blow to the public will to vaccinate and efforts to control the pandemic.
As part of an offensive of diplomatic charm, China has pledged to deliver its four major Covid-19 vaccines, two developed by Sinopharm, one by Beijing-based Sinovac and one by CanSino Biologics, to nations across the developing world.
Western pioneers, such as Pfizer / BioNTech, AstraZeneca-Oxford, and Moderna, have already completed phase 3 testing and released data that has been reviewed by regulators in Europe, the UK and the US.
But many of China’s low- and middle-income customers will have a hard time securing Western vaccines.
“The production capacity of European and American companies has basically been bought by developed countries,” which means Asian, African and Latin American countries will have to order from China, said Zhang Tong, an analyst at Kaifeng Investment in Shanghai.
Covax, the World Health Organization-backed program that tries to ensure access to vaccines for poor countries, has suffered setbacks and revisions after very few high-income countries joined.
China signed up for Covax in October, but has yet to announce any details about financial support or vaccine provision for the program. Instead, Beijing has favored bilateral agreements with partners for the supply of vaccines and has offered loans, including a commitment of one billion dollars to countries in Latin America and the Caribbean, to support purchases.
China’s success in eradicating much of the virus at home has given its developers greater scope to export a significant portion of their vaccines.
The government has also used an expanding “emergency use” program to administer the blows to more than 1 million Chinese citizens, giving manufacturers an advantage in meeting domestic demand.
Sinovac’s local partner in Brazil will announce the results of initial phase 3 this week © AP
Nations are already stocking up on blows. Indonesia received 1.2 million doses of the Sinovac vaccine, while the Philippines has said it is close to closing a deal to buy 25 million doses from the group.
Even at this last stage, however, impediments continue to hamper China’s quest to vaccinate the developing world. Last weekend, Peru suspended testing of the Sinopharm vaccine after one of the volunteers involved in the program suffered a “serious adverse event” before resuming testing this week after talking with the company.
In Brazil, where Sinovac’s local partner is scheduled to announce the initial results of phase 3 on Wednesday, health regulator Anvisa has criticized China for failing to explain its decision to approve the jab for emergency use at home.
The WHO and international experts have warned that expedited approval may be appropriate during a pandemic, as long as regulators and companies are rigorous in analyzing vaccine data.
Some experts argue that the risks of the China approach are acceptable if the companies’ initial phase 3 test results meet basic standards for safety and efficacy.
“The major Chinese vaccines are using relatively established technology, so it adds to the comfort level about how much to know before they are introduced,” said Calvin Ho, a bioethicist at the University of Hong Kong.
Others, however, caution against overly aggressive cuts. China is a relatively newcomer to world vaccine markets and many of its partners are not considered “strict” regulators by the WHO.
Jerome Kim, director general of the International Vaccine Institute, a multilateral organization based in Seoul, said that regulatory authorities in countries such as the United Arab Emirates or Bahrain may not carry out the analysis of data submitted by Chinese developers with the same degree of scrutiny as in Europe or North America.
To allay concerns, Kim suggested that Chinese vaccines undergo review by the WHO or a joint panel of experts for tougher regulatory regimes.
“In the absence of multilateral approval, China will simply turn 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 information from Wang Xueqiao in Shanghai
