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Human trials for Russia’s COVID-19 vaccine going on: Volunteers experience side effects

Human trials for Russia’s COVID-19 vaccine going on: Volunteers experience side effects
The Sputnik V is among several vaccine candidates being considered by Indian authorities for the country.

One in seven volunteers complained of side effects after being injected with Sputnik V, Russia's experimental vaccine against COVID-19.

Written by Jahnavi Sarma |Updated : September 18, 2020 11:51 AM IST

The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia in early August. This became the world's first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Russian authorities approved this vaccine even before phase 3 trials were initiated to test its efficacy. This raised some safety concerns among the scientific community. According to the World Health Organisation, at the time of approval, this vaccine was in Phase I clinical trial. But the Russian government said that Phase I and Phase II of clinical trials were completed before the vaccine approval was given. In late August, phase III trials, involving at least 40,000 people, were launched in Russia. The preliminary results of the human clinical trial were published in the Lancet Journal on September 4.

Side effects include high temperature, headache, fatigue

Results from two early phase non randomised vaccine trials for Sputnik V in a total of 76 people found that two formulations of a two part vaccine had a good safety profile with no serious adverse events detected over 42 days, and induce antibody responses in all participants within 21 days. However, these preliminary results also listed the adverse effects of the vaccine. The most common adverse events were pain at the injection site (44/76 participants 58 per cent), hyperthermia (high temperature 38/76 50 per cent), headache (32/76 42 per cent ), asthenia (weakness or lack of energy 21/76 28 per cent ), and muscle and joint pain (18/76 24 per cent).

Reactions are mild, not life-threatening, say experts

Most adverse events were mild, and no serious adverse events were detected within 42 days of vaccination. Researchers say that these adverse effects are characteristic of those seen with other vaccines, particularly those based on recombinant viral vectors. The two part vaccine includes two adenovirus vectors recombinant human adenovirus type 26 (rAd26 S) and recombinant human adenovirus type 5 (rAd5 S) which have been modified to express the SARS CoV 2 spike protein.

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1 in 7 volunteers experienced side-effects

One in seven volunteers complained of side effects after being injected with Sputnik V, Russia's experimental vaccine against the coronavirus disease (COVID-19), according to Mikhail Murashko, the Russian health minister. He also added that more than 300 out of the announced 40,000 volunteers have been vaccinated with Sputnik V so far. Approximately 14 per cent have small complaints of weakness, muscle pain for 24 hours and an occasional increase in body temperature. According to Murashko, symptoms after being injected with the anti-coronavirus vaccine "level off" by the next day. The complications are described in the instructions and are predictable. Volunteers are expected to receive a second shot of the adenovirus-based viral vector vaccine within 21 days of the first.

Vaccine safe, says RDIF

However, the Russian Direct Investment Fund (RDIF) reiterated that the vaccine is safe. "The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic," a statement said. The Sputnik V is among several vaccine candidates being considered by Indian authorities for the country. Dr Balram Bhargava, the director general of the Indian Council of Medical Research (ICMR), earlier said that a high-level government committee was looking into the data coming from Russia on its COVID-19 vaccine.

(With inputs from Agencies)