He is reportedly so confident of the vaccine’s efficacy that he has already inoculated one of his children with it.
“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” NIAID Director Dr.
Rather than wait for the results from tens of thousands of study cases, it appears that the Russians may have engaged in a form of intensive human challenge trial, starting with members of the research team themselves, then expanding to military service members and eventually the VIP cohort that Putin’s daughter was a part of. .
“I hope that the Russians have actually definitively proven that the vaccine is safe and effective,” Fauci told ABC News correspondent Deborah Roberts this week, during the taping of an upcoming NatGeo keynote event.
These “are trials in which participants are intentionally challenged (whether or not they have been vaccinated) with an infectious disease organism,” the WHO explains in its 2016 publication, Human Challenge Trials for Vaccine Development: regulatory considerations.
The tradition continues today with organizations like 1DaySooner advocating for coronavirus human challenge trials
“Human challenge studies are generally contemplated only when rescue with a lifesaving treatment or intervention is available should a vaccine candidate not protect a volunteer from the disease,” Michael Rosenblatt, Chief Medical Officer for Flagship Pioneering, argues in a June StatNews op-ed
“But there is no cure or treatment against the SARS-CoV-2 virus that can be deployed with confidence, making viral challenges particularly risky and ethically questionable.”
Russia’s methodology has also drawn concern from the World Health Organization, which has requested that the Russian Federation adhere to international norms and regulations regarding vaccine development.