China strays from official paths in race for vaccine.
The offer to employees at the state-owned oil giant was compelling: Be among the first in China to take a coronavirus vaccine.
The employees at PetroChina could use one of two vaccines “for emergency use” to protect themselves when working overseas as part of China’s ambitious infrastructure program, according to a copy of the notice, which was reviewed by the New York
Times. They would effectively be guinea pigs for testing the unproven vaccines outside of the official clinical trials.
The offer was backed by the government. It stressed that data from clinical trials showed the products, both made by Sinopharm, were safe. It did not mention the possible side effects or warn against the false sense of security from taking a vaccine that regulators had not approved.
“I don’t think this is right, ethically,” said Joan Shen, Shanghai-based CEO of pharmaceutical firm I-Mab Biopharma.
The unorthodox move to test people separately from the normal regulatory approval process reflects the formidable challenge facing China as it races to develop the world’s first coronavirus vaccine.
Chinese companies are rushing to get as much data as possible on their vaccines to prove they are safe and effective. In China, they are selectively testing their vaccines on small pools of people like the PetroChina employees — an approach that does not count toward the regulatory process but could bolster their own confidence in the vaccines. In Brazil and other countries, they are conducting clinical trials, going through the normal regulatory channels.
The dual strategy, though, is risking scientific setbacks and political backlash, potentially undercutting China’s efforts.
Such “emergency use” is rare, and the taking of unapproved vaccines is typically reserved for health care professionals. Although the government has stressed that taking the vaccine is voluntary, the state-owned workers and soldiers could feel pressure to participate.
As Chinese companies also look beyond their borders to test the vaccine, they are running into mistrust and skepticism. Health experts have questioned why the Canadian government is allowing CanSino Biologics, which has teamed up with the People’s Liberation Army, to run human trials in the country. Rumors have spread about the authenticity of a Chinese-made vaccine that is being tested in Brazil as supporters of President Jair Bolsonaro cast doubt.