"Governments may be taking shortcuts."
There are worrying signs that governments—for a variety of reasons not always benign—are rushing COVID-19 vaccines toward mass use.
Russia, for example, has secured orders for 1 billion doses of the yet-unproven vaccine from 20 countries, including the Philippines, which will take part in Phase 3 clinical trials. The development shortcuts for the Russian vaccine have been well documented, yet countries battered by the pandemic are eager to get their hands on the drug.
These countries should bear in mind that Russia registered its vaccine before large-scale, late-stage trials, without publishing research data. Hoping to allay concerns about the safety and efficacy of the drug, Russian President Vladimir Putin says his own daughter has been given a dose of the vaccine. The statement proves nothing, however, except Putin’s confidence in the drug—which is not the same as its actual efficacy—or his willingness to take risks in search of a medical—and political—coup.
China, too, has sped up some of its development, with pharmaceutical companies saying that their senior executives have been given shots to “pre-test” their vaccine. Again, this is simply proof of their willingness to take risks. A vaccine being developed in cooperation with the People’s Liberation Army, was approved for use on military personnel in June, even before late stage Phase 3 trials had started.
In the United States, there are signs that President Donald Trump, who has failed miserably to control the spread of COVID-19 in his country and facing elections in November, is pressuring federal agencies to take shortcuts in the approval of therapeutics and vaccines.
For example, the US Food and Drug Administration’s Commissioner Dr. Steven Han said his agency could consider an emergency use authorization for a COVID-19 vaccine before late-stage clinical trials are complete if the data show strong enough evidence it would protect people.
The FDA had done the same thing with hydroxychloroquine, a drug much praised by Trump, but the emergency use authorization was yanked when studies showed it was not effective and could cause serious heart problems.
Dr. Howard Markel, director of the Center for the History of Medicine at the University of Michigan, says people’s distrust of vaccines makes the FDA’s option to rush the process before late stage clinical trials are complete a “colossally stupid” move.
"This is one of the most ridiculous things I've heard this administration say," Markel told CNN. "All it takes is one bad side effect to basically botch a vaccine program that we desperately need against this virus. It's a prescription for disaster."
The Philippines, of course, has had its own unfortunate experience in rushing an untested vaccine to the mass market, thanks to the indecent haste shown by the previous administration. Given the high public distrust in the wake of the Dengvaxia scandal, the government ought to think twice before jumping in with eyes closed with yet more untested vaccines.