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Sinopharm Vaccinates Hundreds of Thousands as Late-Stage COVID Vaccine Trials Continue

September 15, 2020

China’s state-owned pharmaceutical company, Sinopharm, said that it has already vaccinated hundreds of thousands in the country with its COVID-19 vaccine candidates, even though its phase 3 trials have not yet wrapped up.

A Sinopharm official said on national radio that hundreds of thousands of Chinese citizens have already been given one of two of its COVID-19 vaccine candidates under Emergency Use Authorizations that the government granted in July.

Tens of thousands of individuals traveled to high-risk countries and regions after vaccination and were not infected, “which proved the effectiveness of the vaccine,” said Zhou Song, an official with the China National Biotec Group (CNBG), a Sinopharm subsidiary.

The company, however, has not yet completed phase 3 trials or assembled the needed data to make definitive conclusions about the safety and efficacy of its vaccine candidates.

The head of China’s COVID-19 vaccine development task force, Zheng Zhongwei, recently acknowledged that the government granted authorizations for the temporary use of coronavirus vaccines among high-risk populations, such as medical staff and pandemic workers on the frontlines (DID, Aug. 31). But the country appears to have moved beyond those groups.

Global health experts have stressed the importance of allowing phase 3 trials to run their course before vaccinating large numbers of patients so that conclusive data on safety and effectiveness can be evaluated. Russia was strongly criticized for approving the Gamaleya Institute’s Sputnik V candidate based on early-stage trial data (DID, Aug. 12).

Researchers have since reported data from two phase 1/2 trials showing the Russian vaccine was safe and effective in 76 total participants. By comparison, phase 3 COVID-19 vaccine trials, which nine leading drugmakers have pledged to finish before filing for approvals, have been enrolling tens of thousands of patients (DID, Sept. 8).

In a televised interview Sunday, former FDA Commissioner Scott Gottlieb predicted that a vaccine will not be available for use on a mass scale in the U.S. until 2021, though he said high-risk individuals could possibly be vaccinated before the end of this year.

“This is likely to be a very staged market entry. I think that’s what people should expect,” he said. “For most people, they will not have access to a vaccine until 2021, I think maybe the first quarter of 2021, probably the first half. That’s assuming these vaccines have demonstrated to be safe and effective in these large trials.” — James Miessler