Sputnik V: What we know about Russia’s coronavirus vaccine
Russia is set to roll out the world’s first approved coronavirus vaccine amid scepticism about its effectiveness and safety after less than two months of human testing.
President Vladimir Putin announced on Tuesday that Russia had become the first country to grant regulatory approval to a COVID-19 vaccine, which showed “stable immunity” against the new coronavirus and had “passed all the necessary checks”.
However, the vaccine, named “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union, has not yet completed its phase-three trial, which involves wide-scale testing with thousands of participants.
Across the globe, more than 200 vaccine candidates are being developed and trialled, with at least 24 in the human clinical trial phase, according to the World Health Organization (WHO).
Here is what we know so far about Russia’s vaccine:
The vaccine was developed by the Moscow-based Gamaleya Institute, using funding from the Russian Direct Investment Fund (RDIF). The vaccine is named Sputnik V — a reference to the 1957 Soviet Union satellite.
Scientists conducted months of human trials but are yet to publish data and did not begin the crucial Phase 3 stage, which usually precedes approval, before the announcement on Tuesday.
On Wednesday it was announced that a Phase 3 trial involving more than 2,000 people in Russia and several Middle Eastern and Latin American countries had begun. Typically this stage of trial involves testing on tens of thousands of people.
Dr. Scott Gottlieb
, former commissioner of the US Food and Drug Administration (FDA), said Tuesday that the number of people the vaccine had been tested on so far was the equivalent of a Phase 1 trial, which typically involves a small group and studies the safety of the vaccine.
The vaccine is expected to provide immunity from SARS-CoV-2, the virus that causes COVID-19, for up to two years, according to the Russian health ministry. But the results of the limited trials have yet to be made public.
The vaccine is administered in two doses and consists of two serotypes of human adenovirus, each carrying an S-antigen of the new coronavirus, which enter human cells and produce an immune response.
It is a so-called viral vector vaccine, meaning it employs another virus to carry the DNA encoding of the needed immune response into cells.
Is the Russian vaccine safe?
The short answer is that we don’t know. Russia has released no scientific data on its vaccine testing and Cohortias is unable to verify claims about its safety or effectiveness. But Russia says the vaccine has passed through Phase 1 and “Phase 2” trials which were completed on August 1.
A Phase 1 study typically focuses on whether a vaccine is safe and whether it elicits an immune response in a small number of people.
“We do not have any information whatsoever on whether this is safe,” Keith Neal
, Emeritus Professor of the Epidemiology of Infectious Diseases, University of Nottingham.
Russia claims that volunteers in the Phase 1 and 2 trials felt well after taking the vaccine, and exhibited no unforeseen or unwanted side effects.
Neal said that researchers were unlikely to have detected any rare side effectslinked to the Gamaleya vaccine.
“You won’t know about side effects without [widespread] testing, if they’re rare. That’s the point of a Phase 3 study,” Dr. Neal said.
Reactions from the USA
“I wouldn’t take it, certainly not outside of a clinical trial right now,” Dr. Gottlieb, former FDA commissioner
“I hope that the Russians have actually definitively proven that the vaccine is safe and effective,” “I seriously doubt that they’ve done that.” Dr. Fauci said to ABC News correspondent Deborah Roberts,