China Drug Regulator says COVID-19 vaccines must have 50 percent efficiency rate to be approved for use


China’s drug regulator has said COVID – 19 vaccine candidates should have a 50 percent effectiveness rate and users can be provided with at least six moths’ immunity to the virus if they are to be approved in the country.

A draft document released by the Chinese Drug Evaluation Center (CCDE) outlined the guidelines, stating that although 50 percent effectiveness is the minimum, the goal is for vaccines to be effective for 70 percent of the population.

Emergency use of vaccines that have reached the minimum effectiveness level but have not yet completed their final phase of clinical trials could also be approved, according to the CCDE document. The final phases of these trials may take up to a year to complete, but state leaders would like to unpack a successful vaccine as soon as possible.

The effectiveness figures described follow guidelines issued by the World Health Organization (WHO) and the US Food and Drug Administration (FDA), the South China Morning Post report. The CCDE said it was developing its standards after looking at the WHO advice and consulting with more than 50 experts and 37 teams of science.

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

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

Fax test
A laboratory sorts blood samples for COVID-19 vaccination study at the American Research Center in Hollywood, Florida on August 13, 2020.
CHANDAN KHANNA / AFP / Getty

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

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Russia’s Ministry of Public Health on Tuesday approved the first vaccine for use, titled 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 Ministry of Health.

“I find it really scary. It’s really risky,” said Dr. Daniel Salmon, the director of the Institute for Vaccine Safety at Johns Hopkins University, The New York Times after the announcement of Russia.

Operation Warp Speed, the White House’s initiative to produce a viable vaccine, has selected three candidates to receive federal funding for their Phase 3 studies. Dr. Anthony Fauci, the leading expert on American infectious disease, has stated that the country will have a safe vaccine by the end of 2020 or the beginning of next year.

Paul Mango, a senior official in 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 hope is that every American not only gets a free vaccine that is distributed to many different stores, but also does not have to pay for the administration of that vaccine.”