A Chinese pharmaceutical company engaged in the global scramble to develop a COVID-19 vaccine has begun human testing on groups of volunteers without waiting for regulatory approval, raising questions not only of safety, but of ethics and efficacy.
Countries like the U.S., U.K., Singapore, and New Zealand took an early lead in the race to develop a vaccine that prevents COVID-19, announcing potential collaborative efforts back in May to begin medical tests and trials. But China, where the COVID-19 pandemic originated, may be overtaking other contenders, with eight potential vaccines in development, including the ones already undertaking unapproved human tests, the AP reports.
“Give a helping hand in forging the sword of victory. Be among the first in China to take a coronavirus vaccine,” read an online post from state-run Chinese pharmaceutical company SinoPharm showing workers who had purportedly volunteered to take the vaccine.
Chinese President Xi Jinping has pledged that any Chinese-made vaccine would be “a global public good,” and if China does succeed in developing the first COVID-19 vaccine, it would be a much-needed win for the country on the global stage, not only scientifically, but politically.
Against that backdrop, Sinopharm revealed that it was entering the final stages of human testing after “30 special volunteers” stepped forward. PetroChina, a state-run oil company with numerous employees overseas, also has employees taking the unapproved vaccine “for emergency use,” the New York Times reports.
A first round of human testing generally requires permission from a country's drug regulators, who decide whether there is enough lab-based and animal evidence to justify the attempt. But China’s unorthodox approach of allowing “emergency use” of unapproved vaccines is typically limited to health care workers elsewhere in the world.
SinoPharm and CanSino, another company testing a vaccine in conjunction with the Chinese army, maintain that data indicates the vaccines are safe for people to use. However, they do not appear to have listed possible side effects, or to have warned trial participants not to rely too heavily on a vaccine that has not yet been proven effective.
The approach has raised concerns that it does not conform to standard ethical norms, and what’s more, that it may be an ineffective way of testing a vaccine’s efficacy.
Yang Zhanqiu, a virologist at Wuhan University, wondered how reliable any insights gleaned from the PetroChina cohort would be given the difficulty of monitoring and collating data from a group of people traveling to different countries for different periods of time.
Still, the stakes involved are exceedingly high.
“Getting a COVID-19 vaccine is the new Holy Grail,” public health law expert Lawrence Gostin, of Georgetown University, told the AP. “The political competition to be the first is no less consequential than the race for the moon between the U.S. and Russia.”