China Approves Sinopharm’s COVID-19 Vaccine, but Questions Remain

China announced that it has granted conditional authorization for one of Sinopharm’s inactivated COVID-19 vaccines, a shot that the state-owned pharma company claimed is 79.3 percent effective according to an interim analysis of its phase 3 trial. Questions remain, however, due to a lack of details from the company.

The authorization clears the vaccine for public use, but China will begin with vaccinations of senior citizens and people with underlying conditions before giving it to the general public, a National Health Commission official said. 

The official added that the vaccine, which will be provided for free, has already been given to more than 3 million people in priority groups in the past two weeks, including medical staff and supply-chain workers. 

The two-dose regimen of the vaccine proved to be safe and generated a high level of antibodies in response to the virus in a late-stage trial, according to Beijing Biological Products Institute, the Sinopharm subsidiary that developed the vaccine.

The company, however, declined to disclose critical details, such as how many participants were involved in the interim analysis, how many were given the vaccine or placebo, what side effects were seen, if any, and what specific data were evaluated, leaving uncertainty about the results. The company also didn’t offer any information on any logistical requirements for the vaccine, providing no insight on how it might best be distributed.

“The data results reached the relevant technical standards of the [World Health Organization] and [China],” the company claimed in its brief statement.

The Chinese trial’s 79.3 percent efficacy result was lower than findings from a phase 3 trial of the vaccine in the United Arab Emirates (UAE), where it had shown 86 percent effectiveness. While the vaccine candidate appears to meet the 50 percent effectiveness requirement set by the FDA, it appears to have a lower efficacy than the Pfizer/BioNTech and Moderna vaccines, which are 95 percent and 94.1 percent effective, respectively.

Sinopharm is developing a second inactivated coronavirus vaccine with the Wuhan Institute of Biological Products that has also made it to late-stage trials. The company previously announced that it intends to produce 1 billion doses of its two candidates this year from manufacturing plants in Beijing and Wuhan (DID, Oct. 21, 2020).

The UAE and Bahrain have also granted emergency clearance for the Beijing Biological Products Institute candidate. The authorizations came despite a lack of the clinical data that regulators in the West will require to truly assess the vaccines’ safety and effectiveness. — James Miessler