The Russian president stated on Tuesday, August 11 that the locally developed vaccine had passed all required checks and received approval, according to BBC News. Yet, questions were later raised surrounding the safety of the drug.
The Daily Mail reported documents submitted at the point of registration stated “no clinical studies have been conducted to study the epidemiological effectiveness” of the vaccine.
Of the 38 healthy human volunteers who tested the treatment, there were 144 separate adverse events (AEs) recorded, the publication noted.
While most of these side effects passed “without consequences,” 31 were still ongoing on the 42nd day of the study, according to the news source. The outcome of 27 of these adverse events were believed still to be unknown.
The Gamaleya Research Institute, which produced the vaccine, claimed it is not possible to “more accurately determine the incidence of AEs due to the limited sample of study participants.”
The reported side effects — which, according to the newspaper occurred “frequently and very often” — included swelling, pain, hyperthermia, and itching at the site of injection. Physical weakness, malaise, fever, decreased appetite, headaches, nasal congestion, sort throat, and runny nose were also named as common manifestations.
Tests performed on the 42nd day after vaccination appeared to show that volunteers had antibodies at below average levels, the source stated.
In his announcement, Putin revealed his daughter had been given the vaccine in the early stage of its development and that she had suffered no side effects worse than a high temperature.
“She’s feeling well and has a high number of antibodies,” he said.
Putin described the vaccine — which he has called Sputnik V after the former Soviet satellites — as a world first and claimed the product offered “sustainable immunity” against COVID-19.
The BBC News report noted officials plan to start mass rollout of the vaccine in October.
Globally, more than 100 vaccines are currently in early development, the publication underlined, but most experts agree that none will be widely available until mid-2021.
As The Inquisitr covered, President Donald Trump recently told Fox News’ Geraldo Rivera that a coronavirus vaccine could be ready for distribution in the U.S. by the time the November election rolls around. This suggestion, which he made in an interview on August 6, came just days after Vice President Mike Pence said a vaccine could be ready by the end of 2020.