Why the “world’s first” Covid-19 vaccine spurred global scepticism

President Vladimir Putin on Tuesday announced Russia as the first country to grant regulatory approval to Covid-19 vaccine named 'Sputnik V', raising concern among vaccine experts who felt the government has cut corners and may put citizens at risk.

Putin claims that the vaccine offers “sustainable immunity” against Covid-19 and also mentioned that one of his daughters had received the inoculation and felt better.

Based on the DNA of a SARS-CoV-2 type adenovirus, the vaccine has been developed by Moscow's Gamaleya Research Institute in collaboration with the Russian defence ministry.

The global scepticism over the safety and effectiveness of Russia’s rapid vaccine is because of the fact that it has been cleared without phase-3 human trials which are normally considered an essential precursor to regulatory approval, and even rushed phase-1 and phase-2 trials, all of it being completed within two months.

Lawrence Gostin, a global public health law expert at Georgetown University, told AP, “I’m worried that Russia is cutting corners so the vaccine that will come out may be not just ineffective, but also unsafe. It doesn’t work that way… Trials come first”.

Importance of human clinical trial for vaccine development
Clinical trials are critical for a vaccine's approval as it demonstrates its safety, efficacy, helps calculate dosage to achieve immunization against a pathogen and to assess the best route of administration, number of boosters required at vaccination intervals and the duration of immunity.

Clinical development is a three-phase process:
During phase-1, small groups of people receive the trial vaccine.
In phase-2, the clinical study is expanded and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended.
In phase-3, the vaccine is given to thousands of people and tested for efficacy and safety.

The testing, manufacturing and approval of a vaccine are usually a long and laborious process which takes 10-15 years normally. Considering the prevailing emergency, vaccine trials are being fast-tracked across the world. This acceleration, however, does not mean compromising on safety by jumping the phases of clinical trials.

Commenting on the importance of phase-3 clinical trials, Arun Bhatt, consultant, clinical research and therapy development, said, “One cannot talk of vaccine approval for masses without studying the long term safety and efficacy of the vaccine on a large number of patients.”

The Sputnik V human clinical trials
According to news reports, the phase-1 human trials started on June 17.

Phase-2 trials were started on July 13, usually, these take few months to be completed.

Gamaleya Institute announced it completed clinical trials on August 2.

Till now Russia has only made public the results of phase-I of the clinical trials. There is no information on whether all the three phases of clinical trials were completed or only phase-2.

Russia claimed the superfast vaccine was made possible due to the fact that its Covid-19 vaccine candidate closely resembled a vaccine for Middle East Respiratory Syndrome (MERS) disease, caused by another coronavirus, that had already been tested extensively.

Earlier Dr Anthony Fauci, the top US infectious disease specialist, questioned the fast-track approach during his testimony to a panel of US lawmakers. “I do hope that the Chinese and the Russians are actually testing the vaccines before they are administering the vaccine to anyone. Because claims of having a vaccine ready to distribute before you do testing is problematic at the very least,” Fauci said.

Last week, the World Health Organisation also cautioned Russia against rushing through with its novel Coronavirus vaccine.

Surprisingly, Russia earlier indicated that phase-3 human trials will be completed after the shot received regulatory approval.

Russian officials have said that the country plans to start mass vaccination in October.

The World Health Organization (WHO) has responded to Russia's claim by saying that a rigorous review of the vaccine's safety data needs to be submitted if the country wants the WHO's stamp of approval.

Human trial data is crucial to understand the safety, efficacy and long term impact of the vaccine on humans. While adverse side-effects are rare in vaccines majorly because it undergoes the protocols of observation and approval before releasing a vaccine for the general population.

The novel coronavirus disease continues to spread globally, with more than 2 crore cases and over 7 lakh people losing their lives. Currently, the frontrunners in the global race for Covid-19 vaccine include Oxford-AstraZeneca, Moderna and Pfizer.