Russia has manufactured the first batch of its new vaccine for Covid-19, the health ministry said on Saturday. It is called Sputnik V, named after the world’s first satellite launched by the Soviet Union.
The news comes days after renowned international scientists expressed fears that Moscow puts national prestige before safety as it has issued regulatory approval without sufficient testing.
Professionals argued that the regulatory approval comes typically after a series of clinical trials, involving thousands of participants, commonly known as Phase III. Those trials are considered essential precursors for a vaccine to get a firm regulatory nod.
Russian officials said that the vaccine is the first for the coronavirus to go into production and rolled out by the end of the month.
The US National Institutes of Health (NIH) was among the first international organizations to question the fast approval of the novel vaccine. According to its director, Dr. Francis Collins, Moscow gave it the green light while skipping “fundamental parts” of the approval procedure.
NIH is part of the US government program entitled Operation Warp Speed to accelerate the development, manufacturing, and commercialization of vaccines and treatments to combat the novel virus.
According to Collins, Russian experts have conducted only one out of three recommended trials, involving no more than 100 people. Based on such a small sample, they decided that it “was good enough” to go for mass production, Collins noted.
The NIH director concluded that the sample is also not big enough to determine potential side effects.
Russian President Vladimir Putin has refuted all the Western allegations about the safety of Sputnik V. He highlighted that the vaccine had passed all the necessary tests. Putin also emphasized that one of his daughters has already taken it.
Moscow’s Gamaleya Institute, which worked on the vaccine, previously confirmed it aimed to produce about five million doses a month by December-January.
Dr. Anthony Fauci, the nation’s most qualified expert on infectious diseases, also expressed “serious doubts” on whether the Russian vaccine is safe and effective.
He noted that having a vaccine and proving its safety and effectiveness are two completely different things.
The World Health Organization said it is in contact with Moscow to conduct a review of the Russian vaccine before recommending it to other nations.
What do you think? Do you agree or disagree with the US experts saying that the Russian vaccine might not be safe?