China’s controversial emergency-use program for COVID vaccines is going global

On Monday, the United Arab Emirates (UAE) approved a Chinese vaccine candidate for emergency use, making China’s Sinopharm the first vaccine maker to receive approval to deploy a COVID-19 candidate in a foreign country.

“The UAE authorizes the emergency use of the COVID-19 vaccine for members of the first line of defense who are most at risk of catching COVID-19,” the UAE’s National Emergency Crisis and Disaster Management Authority said in a tweet on Monday.

Sinopharm is among several vaccine makers to receive similar emergency-use approval from government authorities in China, where vaccine companies have injected hundreds of thousands of frontline health care workers and other select population groups like members of the military, customs workers, and employees of vaccine makers.

The UAE’s decision makes it the first foreign country to follow China’s lead in deploying a vaccine ahead of completing final-stage clinical trials, underscoring China’s growing clout in the global vaccine race.

Sinopharm’s candidate

Sinopharm, a shortened name for the state-run company China National Pharmaceutical Group Corp., began its late-stage clinical trials in the UAE on July 16 and has already tested the COVID-19 vaccine candidate on some 31,000 volunteers.

Dr. Nawal Al Kaabi, the head of the UAE’s National Clinic Committee for COVID-19, told an Abu Dhabi–based news outlet that even though Sinopharm’s vaccine trials are ongoing in the country, initial results in the trials “showed that the vaccine is effective” and generated strong antibodies of the virus among volunteers. “Studies on the safety of the vaccination have been reviewed and showed that it is safe for use,” Al Kaabi said.

Experts, however, have cautioned against deploying an immunization before finishing clinical trials and receiving official approval that it’s safe and effective.

In late July, Anthony Fauci, the U.S.’s top infectious disease official and director of the National Institute of Allergy and Infectious Diseases, said in a congressional hearing that he hoped China would complete testing of any vaccine candidate before distributing it.

“Claims of having a vaccine ready to distribute before you do testing, I think, is problematic, at best,” Fauci said.

Sinopharm’s CEO Liu Jingzhen claimed in August that its candidate may reach market by December. He said that based on early trial results, he expects the vaccine to be 100% effective in producing an immune response after patients receive two doses of the vaccine. Sinopharm’s candidate is currently in Phase III clinical trials in the UAE, Bahrain, Peru, Morocco, Argentina, and Jordan.

China’s international vaccine

Wu Guizhen, China’s Centers for Disease Control top bio safety expert, said on Monday that she expects Chinese citizens to have official access to vaccine as early as November or December.

In a conversation with Fortune last week, Dr. Aimin Hui, vice president of Chinese vaccine maker Fosun, put forth a similar timeline for his company’s vaccine candidate, which is being developed in partnership with American pharmaceutical giant Pfizer and German vaccine maker BioNTech.

With one or several Chinese vaccines set to reach the market in coming months, a looming question is which countries will distribute a Chinese vaccine.

In the July hearing, Fauci said it was “unlikely” that the U.S. would turn to Chinese- or Russian-made vaccines if they beat American candidates to the market, given the countries’ questionable development processes and the U.S.’s own advanced candidates. “I do not believe that there will be vaccines so far ahead of us that we will have to depend on other countries to get us vaccines,” he said. 

But the UAE decision indicates that other countries are more willing to work with China on coronavirus vaccinations.

Including Sinopharm and Fosun, Chinese pharmaceutical firms are involved in five of the nine vaccine candidates currently in late-stage, Phase III trials. Sinopharm is behind two of the efforts, partnering with the Wuhan Institute of Biological Products and the Beijing Institute of Biological Products on separate candidates. Sinopharm has tested both of these vaccines in the UAE, but it is unclear if the UAE granted emergency approval to one or both candidates. Sinopharm did not immediately return a request for comment. Candidates being developed by Chinese biotech firm Cansino and private Chinese vaccine maker Sinovac are also in Phase III trials.

The five firms are testing their candidates in numerous countries around the world, including Saudi Arabia, Pakistan, Brazil, Indonesia, and Russia.

Beyond the trials, foreign governments are also engaged in talks with Chinese vaccine makers for supply of a potential vaccine after it’s approved.

In late August, Chinese vaccine maker Sinovac struck a deal with Indonesia to supply it with 40 million doses of its potential vaccine. Philippines president Rodrigo Duterte also said this week that he would prioritize buying vaccines from China or Russia over potential candidates from the U.S. or Europe.

The UAE may be the first country to approve a Chinese vaccine for domestic use, but as the global vaccine race heats up, it’s unlikely to be the last.