Results from two early‐phase vaccine trials for Sputnik V found that two formulations of a two‐part vaccine had a good safety profile
Most adverse events were mild, and no serious adverse events were detected within 42 days of vaccination, the Lancet said
Close to Russian Direct Investment Fund (RDIF) announcing to partner with Dr. Reddy’s Laboratories Ltd for distribution of Russia’s covid-19 vaccine --Sputnik V in India, the Soviet nation's health minister, Mikhail Murashko, in a statement to Moscow Times said that nearly 14% of patients who have been administrated the vaccine reported suffering from side-effects.
One in seven volunteers have complained of side effects including weakness and muscle pain after taking Russia’s highly touted coronavirus vaccine, Russia’s health minister said Tuesday as quoted in Moscow Times. Murashko said the symptoms “level off" by the next day. The complications are described in the instructions and are predictable," he said as quoted in the newspaper.
The preliminary results of the human clinical trial were published in the Lancet Journal on September 4. 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, the preliminary results published in the Lancet also listed the adverse effects of the vaccine. “The most common adverse events were pain at the injection site (44/76 participants – 58%), hyperthermia (high temperature – 38/76 – 50%), headache (32/76 – 42%), asthenia (weakness or lack of energy – 21/76 – 28%), and muscle and joint pain (18/76 – 24%)," said the Lancet.
Most adverse events were mild, and no serious adverse events were detected within 42 days of vaccination, the Lancet said. The authors note that these adverse effects are characteristic of those seen with other vaccines, particularly those based on recombinant viral vectors, the Lancet said.
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.
India and Russia are in talks about the vaccine to be made available for Indian population. Upon regulatory approval in India, RDIF, Russia’s sovereign wealth fund will supply 100 million doses of the vaccine to Dr. Reddy’s, it said in a statement on Wednesday. “Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India," the RDIF said in a statement. India will also conduct clinical trials on its own population before approving the vaccine administration. “The Phase I and II results have shown promise, and we will be conducting Phase-III trials in India to meet the requirements of the Indian regulators," G V Prasad, Co-Chairman and Managing Director of Dr. Reddy’s Laboratories said.
On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of
Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against covid-19 based on the human adenoviral vectors platform.