Two Arab nations have become the first countries to approve a Chinese COVID-19 vaccine, a significant boost for China’s plans to roll out its vaccines worldwide. The United Arab Emirates (UAE) approved a vaccine developed by Chinese state-owned Sinopharm on 9 December, and Bahrain followed days later. But researchers say a lack of public data on the safety and efficacy of the vaccine could hinder the company’s plans to distribute the vaccine in a range of other countries.
The Sinopharm vaccine is probably safe and effective and could be a great help in fighting the pandemic, says Jin Dong-Yan, a virologist at the University of Hong Kong. But he notes a lack of available clinical-trial data, and adds that confidence in the vaccine’s safety and efficacy will be key to its successful international distribution.
“Chinese state-run companies, like Sinopharm, can produce billions of doses. They have the capacity and expertise,” he says. “They need to have an open and transparent system, but they are not good at doing that,” he adds.
The UAE and Bahrain are also the first countries to grant full approval to sell a COVID-19 vaccine. Russian officials have licensed two vaccines, but the approvals are conditional and subject to the results of ongoing phase III trials. In China, Sinopharm’s vaccine has been widely deployed under emergency-use authorization, but full approval is expected very soon. The United States and the United Kingdom have issued emergency authorizations for a COVID-19 vaccine made by Pfizer of New York City and BioNTech of Mainz, Germany.
UAE regulators said in a press release that they had approved an inactivated vaccine developed by Sinopharm’s Beijing Institute of Biological Products. The approval was based on company data stating that the efficacy of the two-dose vaccine was 86% in final-stage testing, including a trial in 31,000 people in the UAE, according to the press release. The vaccine had been granted emergency-use authorization in September. Bahrain officials did not state whether they approved the same Sinopharm vaccine, but it is thought to be the same jab, because they, too, reported 86% efficacy. Some 7,700 people participated in Sinopharm trials there.
The UAE press release also states that 99% of those vaccinated developed neutralizing antibodies to SARS-CoV-2 and that the vaccine prevented moderate and severe disease in everyone vaccinated.
But scientists not involved in developing and approving the Chinese vaccines are finding it hard to make sense of the data behind the latest announcements. The UAE reported the phase III efficacy data before Sinopharm did, and the company has yet to confirm that they are correct. Neither the UAE, Bahrain nor Sinopharm have released the data used to make the 86% efficacy claims. “They give no real data. That’s a bit weird,” says Zhengming Chen, an epidemiologist at the University of Oxford, UK. “It’s difficult to tell how well the vaccine works. I hope it is real.”
Sinopharm did not respond to Nature’s request for more detail on its trial results.
Scientists would like to see data on the number of infections in the groups that received the vaccine and in those that were given a placebo. Such data are used to calculate a vaccine’s effectiveness — and have been released by the makers of several other leading coronavirus vaccines, including that developed by Pfizer and BioNTech. They released some detailed data in a press release in November, before the UK authorization, and published the phase III trial results on 10 December in the New England Journal of Medicine1.
Chinese state media have reported that Sinopharm has vaccine orders from more than 100 countries, including many in Africa, but few details of such deals have been reported. Sinopharm’s vaccine is also undergoing phase III testing in Egypt, Jordan, Argentina and other countries, so they are likely to be among the next to consider approving it.
Other countries are probably also planning to rely on China for vaccines, because the United States and European nations have pre-purchased billions of doses of the vaccines being developed there, says Jin. Sinopharm’s jab is also appealing because it uses inactivated virus and — unlike the Pfizer–BioNTech vaccine — does not need to be stored at extremely cold temperatures, making it easier to transport and distribute.
Chen thinks that there will be some resistance to Chinese vaccines if the companies do not allow independent analysis of the safety and efficacy data. “I don’t think other countries will follow suit unless there is really convincing, robust data. You need really strong scientific evidence that can be scrutinized to convince people,” says Chen. In the United States, the Food and Drug Administration has an independent committee that evaluates vaccine trial data and makes its findings public, which then makes a recommendation to the regulator.
Jin worries that countries might have to choose between accepting the vaccine without independent analysis or not using the vaccine.
Whether vaccine approvals will allow life in the UAE and Bahrain to return to normal is unclear. The UAE will need approximately 20 million doses — two per person — to vaccinate the entire country, but securing and administering that many doses will take time, says Ben Cowling an epidemiologist at the University of Hong Kong.
Scientists think that around 70% of the population will need to get the vaccine to achieve herd immunity — when enough people are immune to a virus that spread becomes unlikely, says Cowling.
When Sinopharm will have capacity to meet the UAE’s and Bahrain’s requirements is unclear. The company says it has 500 million doses, but scientists have previously told Nature that most of those will probably be distributed in China.