Russia’s coronavirus vaccine: An announcement by Russia on Tuesday that it will approve a COVID-19 vaccine after less than two months of human testing prompted alarm among global health experts, who said that with no full trial data, the vaccine is hard to trust.
Intent on being first within the international race to develop a vaccine in opposition to the pandemic illness, Russia has but to conduct large-scale trials of the shot that might produce information to indicate whether or not it really works – one thing immunologists and infectious illness consultants say might be a “reckless” step. “Russia is essentially conducting a large population-level experiment,” mentioned Ayfer Ali, a specialist in drug analysis at Britain’s Warwick Business School. She mentioned such a super-fast approval might imply that potential antagonistic results of a vaccine may not be picked up. These, whereas prone to be uncommon, might be severe, she warned.
His comments were echoed by Danny Altmann, a professor of Immunology at Imperial College London, who said the “collateral damage” from deploying any vaccine that is not yet known to be safe and effective “would exacerbate our current problems insurmountably”.
Even as Russia declared victory, more than half a dozen drugmakers around the world are in the process of conducting large-scale, advanced human trials of their potential COVID-19 vaccines, each with tens of thousands of volunteer participants.
Several of these frontrunners, including Moderna, Pfizer, and AstraZeneca, say they hope to know if their vaccines work and are safe by the end of this year.
All are expected to publish their trial results and safety data and submit them to regulators in the United States, Europe, and elsewhere for scrutiny before any license could be granted.
The Russian vaccine’s approval by the Health Ministry comes before trials that would normally involve thousands of participants, commonly known as a Phase III trial. Such trials are usually considered essential precursors for a vaccine to secure regulatory approval.
Peter Kremsner, an expert at Germany’s University Hospital in Tuebingen who is working on clinical trials of a vaccine candidate from CureVac, said Russia’s move was “reckless”.
“Normally you need a large number of people to be tested before you approve a vaccine,” he said. “I think it’s reckless to do that if lots of people haven’t already been tested.”
Experts said the lack of published data on Russia’s vaccine – including how it is made and details on safety, immune response, and whether it can prevent COVID-19 infection – leaves scientists, health authorities, and the public in the dark.
“It is not possible to know if the Russian vaccine has been shown to be effective without submission of scientific papers for analysis,” said Keith Neal, a specialist in the epidemiology of infectious diseases at Britain’s Nottingham University.