“Chinese producer seeks early approval from countries over Covid-19 vaccine”, 28 August 2020

… Early distribution by CanSino Biologics Inc. would give the company a head start over rivals by making its vaccine the first to go into public use internationally outside of clinical trials…

The effort shows the intensity of the race to become the first to develop a vaccine, though public-health experts say immunizing people widely before large-scale tests are completed could present serious health risks.

China’s military has already approved the use of CanSino’s vaccine before the completion of large-scale final testing, usually known as Phase 3 trials, according to a filing the company made with the Hong Kong stock exchange.

Pierre Morgon, senior vice president for international business at CanSino, said getting the vaccine out to millions of people now, before its clinical trials are complete, would broaden the base of knowledge about the drug’s safety and effectiveness… Such early distribution would require the countries to authorize the drug for emergency usage…

The vaccine has been shown to promote an immune response, and no serious safety concerns have emerged in early human trials involving smaller groups, according to the company and trial results published in the Lancet, a prestigious international medical journal.

Mr Morgon declined to name all of the countries the company is talking to, citing the discussions’ confidentiality. He said they include Pakistan and countries in Latin America as well as some developed nations. So far, no countries have agreed to approve the drug on an emergency basis, Mr Morgon said…

But vaccines, intended for large numbers of healthy people who don’t have the disease, are virtually never approved for widespread use before the completion of large-scale trials.

“It’s breaking all the global conventions around science and ethics. It’s a huge gamble,” Lawrence Gostin, professor of global health law at Georgetown University, said of any country authorizing emergency use of a vaccine before it completes tests.

Most medications that pass early phases of testing for safety and effectiveness—as CanSino’s vaccine has—don’t succeed in the larger final-stage trials, he said.

“You might end up rolling out a vaccine that causes enormous hazards in the population or is ineffective. If it’s ineffective, then the public is going to assume they’re immune and go about their business and spread Covid-19 like mad,” said Prof. Gostin…

[Also referred to Petrovax]