Sinopharm to Supply 1 Billion COVID-19 Vaccine Doses Next Year

China’s state-owned pharmaceutical company Sinopharm is gearing up to manufacture 1 billion doses of its two potential coronavirus vaccines in 2021.

Sinopharm Chairman Liu Jingzhen announced during a Tuesday press briefing that the company is setting up production lines in Beijing and Wuhan in order to meet the massive supply goal for its two vaccine candidates.

The company chairman said that testing of the two vaccine candidates is nearing completion, describing Sinopharm as being “in the last kilometer of a long march,” though he declined to provide a precise timeline for when trial results will be ready.

While the vaccines may be nearing a regulatory decision from the Chinese government, concerns persist that Sinopharm’s candidates and other hopeful vaccines are being held to standards that aren’t as strict as those imposed by the FDA and other regulatory agencies.

For example, a company official announced in September that hundreds of thousands of Chinese citizens have already been vaccinated with one of the two vaccine candidates under emergency clearance granted by the government (DID, Sept. 15). The vaccinations occurred despite the fact the company has not yet wrapped up phase 3 trials and collected enough data to conclusively determine if the two vaccine hopefuls are safe and effective.

Additionally, Russia’s Sputnik V vaccine was granted regulatory approval well before phase 3 vaccine trials began to fully assess the vaccine in a large number of patients.

Former FDA chief Scott Gottlieb previously criticized Sputnik V for being approved without that full phase 3 evaluation and said he would not take the vaccine himself, shrugging off the approval as essentially an authorization based on inconclusive phase 1 data (DID, Aug. 12).

Last week, National Institutes of Health (NIH) Director Francis Collins spoke out against China and Russia for administering or approving their COVID-19 vaccine candidates before late-stage trials and said the FDA would not accept their vaccines for use in the U.S. unless they meet the FDA’s safety thresholds.

“I’ve been not very reassured so far that in some of those countries, and I have to name both Russia and China, they’ve kind of skipped over this phase 3 trial thing and said, ‘okay, let’s just start putting needles in people’s arms cause it looked like the first couple of looks were alright’,” he said during an interview posted on the NIH website.

“That is not what we do in this country. And certainly if something is going to be administered in this country, our FDA, who are a very rigorous bunch of folks who demand to see all the data, would have to say, ‘this is good enough by our standards and not just somebody else’s hope that it might be okay’.” — James Miessler