The Russian President Vladimir Putin announced in a virtual government meeting aired on the state television on Tuesday that his country is the first in the world to grant regulatory approval to the coronavirus vaccine, paving the way for mass production and deployment till the end of the year. He said that the vaccine has lived up to the criteria of efficacy and safety and that it has also been administered to one of his daughters. The officials say that they plan for mass vaccination in October.
The vaccine – “Sputnik-V” – was approved after only two months of human trials, a remarkably short period considering that efficacious and widely approved vaccines have taken no less than years for mass deployment in the past. This regulatory approval betokens the start of the third trial, known as Phase III, which will include thousands of participants. Putin hailed this achievement as the testimony of Moscow’s scientific prowess, but it has raised the alarms in the scientific community. Experts surmise that in its determination to outstrip other countries in producing an effective vaccine, Russia might be prioritizing its prestige over the safety of its citizens.
Immunologists and infectious disease experts argue that intent on topping the global race for a coronavirus vaccine, Russia is taking a “reckless” step in prematurely approving a vaccine, without large-scale clinical trials. Such exhaustive trials produce data by the truckload which helps in determining whether the vaccine works or not. Experts say that in the absence of peer-reviewed scientific papers, they cannot ascertain whether the vaccine is truly efficacious or not.
The World Health Organization echoed similar concerns, saying that it has not received enough information to evaluate the vaccine. Jarbas Barbosa, the head of WHO’s regional branch, the Pan American Health Organization. At least 100 vaccines are being developed around the world at a cost of roughly $10 billion, four of which are in the final phase, Phase III, of human trials, according to WHO data.
The vaccine – developed by Russia’s Gamaleya Institute – has been deemed as a “population-level experiment” by some, indicating that the scientific community is highly sceptical of Moscow’s announcement. In many cases, preliminary vaccine candidates can trigger potentially adverse effects that are not detected immediately but might take weeks or months to show up. Two months, in this scenario, is an alarmingly short period to approve mass vaccination. Russian president, however, seemed confident when he said: “I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks.”