China Drug Regulator Says COVID-19 Vaccines Must Have 50 Percent Efficacy Rate to Be Approved for Use

China's drug regulator has said COVID-19 vaccine candidates must have a 50 percent efficacy rate and be able to provide users with at least six moths' immunity from the virus if they are to be approved in the country.

A draft document released by the Chinese Centre for Drug Evaluation (CCDE) laid out the guidelines, stipulating that while 50 percent efficacy is the minimum, the target is that vaccines should be effective for 70 percent of the population.

Emergency use of vaccines that have achieved the minimum efficacy rate but haven't yet completed their final phase of clinical trials could also be approved, according to the CCDE document. The final phases of these trials can take up to a year to complete, but state leaders are eager to roll out a successful vaccine as soon as possible.

The outlined efficacy rates follow guidelines put out by the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA), the South China Morning Post reported. The CCDE said it developed its standards after looking at the WHO's advice and consulting with more than 50 experts and 37 teams of science.

The news comes as four Chinese vaccine candidates are in the final testing phase in the United Arab Emirates, Brazil, Saudi Arabia and Indonesia.

Newsweek contacted China's National Medical Products Administration, of which the CCDE is an affiliated institution, for comment, but did not hear back in time for publication.

Vaccine Trial
A lab technician sorts blood samples for COVID-19 vaccination study at the Research Centers of America in Hollywood, Florida on August 13, 2020. CHANDAN KHANNA / AFP/Getty

China is among several countries, including the U.S. and Russia, leading the race to produce the first effective coronavirus vaccine. According to draft data released by the WHO Thursday, there are currently 29 vaccine candidates in clinical evaluation.

Russia's Ministry of Health on Tuesday approved the first vaccine for use, titled the Sputnik V, despite the fact that it has not yet entered the final phase of clinical trials. Production of the vaccine began Saturday, according to the health ministry.

"I think it's really scary. It's really risky," Dr. Daniel Salmon, the director of the Institute for Vaccine Safety at Johns Hopkins University, told The New York Times following Russia's announcement.

Operation Warp Speed, the White House-backed initiative to produce a viable vaccine, has chosen three candidates to receive federal funding for its Phase 3 trials. Dr. Anthony Fauci, the U.S.' leading infectious diseases expert, has maintained that the country will have a safe vaccine available by the end of 2020 or the beginning of next year.

Paul Mango, a senior official at the Department of Health and Human Services, told reporters Thursday that Americans could expect doses to be ready in about five months.

"We are on track to deliver hundreds of millions of doses by January 2021," Mango said, adding that the vaccine would be free of cost to all Americans. "What we're hoping is that every American will not only get a free vaccine distributed to many different outlets but also will not have to pay for the administration of that vaccine."