Russia’s announcement of the world’s first COVID-19 vaccine has opened a Pandora’s Box, with experts questioning the safety and efficacy of its human clinical trials. Currently, six vaccine candidates from around the globe are in phase III of human trials.

On August 11, Russia announced the world’s first registered vaccine against COVID-19. ‘Sputnik V’ is named after the world’s first satellite launched by the Soviet Union. Developed jointly by Moscow’s Gamaleya Research Institute and the Russian Defence Ministry, medical experts worldwide have raised concerns regarding the vaccine’s approval for civilian use before the Phase III trial, which is usually a vital precursor to regulatory approval.

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The assertion

Russian President Vladimir Putin has said that the vaccine was given to his daughter and the only side-effect she had was a temperature of 38 degrees Celsius for one day. “I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the necessary checks,” the President declared in a recent government meeting.
The vaccine is administered in two doses. It is based on the DNA of a SARS-CoV-2 type adenovirus, a common cold virus. It enters human cells to stimulate an immune response. “The two-stage injection plan helps form lasting immunity. The experience with vector vaccines and the two-stage scheme shows that immunity lasts for up to two years,” the Russian Health Ministry said.

As per Russian government officials, the medical personnel and teachers will be vaccinated first by the end of this month or early September. A mass vaccination programme in Russia is expected to launch in October. Russia claims it has already received foreign requests for one billion doses.

The reservations

The World Health Organization (WHO) has said that it doesn’t have enough information on whether the Russian vaccine has completed all three stages of clinical trials. The phase I human trials started in June with 76 volunteers. A Russian news agency had reported that the Gamaleya Institute had entered phase II of clinical trials on July 13. In this phase, the vaccine is tested for its ability to trigger an immune response in human beings, which usually takes a few months to be completed.

Phase III trials are usually carried out on several thousand volunteers to assess whether it offers protection to the people against the disease for which it is being developed. But Russia had earlier indicated that Phase III human trials will be completed after the shot received an approval.

Companies including Oxford-AstraZeneca Plc and Moderna Inc. are still conducting final-stage trials of their vaccines in studies that are expected to soon yield results. Additionally, a vaccine developed by Germany’s BioNTech and US pharma giant Pfizer entered the third phase last month, with the companies planning to test it on 30,000 young volunteers. India’s vaccine candidate, being developed by Bharat Biotech, is in second and third trial phases simultaneously.

Russia’s COVID-19 vaccine raises more questions than the solutions that it claims to provide. Why is there so much ambiguity about the trials? How did they manage such superfast speed? Have the health risks been adequately addressed?