Russia's announcement on Tuesday that it has approved a vaccine against COVID-19, becoming the first country to do so, was met with mixed reactions and scepticism from the scientific community. Scientists have questioned the regulatory approval given by the country to the vaccine candidate without initiating Phase III trials.
Russia's vaccine dubbed 'Sputnik-V' COVID-19 produced by Gamaleya National Research Center for Epidemiology and Microbiology in Moscow was approved after initiating human trials in less than two months.
While other potential candiates by Oxford, Moderna, Pfizer, and CanSino are conducting large scale trials, the Russian vaccine has been approved before this much crucial stage of vaccine development. The World Health Organization still lists the vaccine candidate as a preliminary trial and is now entering into discussions with the country for pre-qualification, reported Reuters. The prequalification will require a rigorous review of the safety and efficacy data added a WHO spokesperson. Russia has not publicly shared the results of all the clinical trials.
Large scale Phase III trials for the vaccine are set to begin from Wednesday Kirill Dmitriev who heads the Russian Direct Investment Fund which financed the vaccine project, told Russia Today. The country aims to begin industrial production by September and mass production by October. Around 20 countries have expressed interest in the vaccine and are willing to preorder a billion doses, he further added stating that this included India. Britain, however, has announced that they would not use the Russian vaccine.
When asked whether India has expressed interest in the Russian vaccine at a press conference, Indian Health Secretary Rajesh Bhushan responded it was too premature to discuss any situation about a vaccine that was still being researched. He further added that a Vaccine Administration committee headed by Dr. Vinod Paul from the Niti Aayog will be meeting on Wednesday and is responsible for decision-making on vaccine procurement, selection and all the other logistics.
What Are The Concerns Of The Scientific Community
Many scientists across the world have expressed their concerns at the speed at which the vaccine has been fast-tracked and developed. In April, Putin had fast-tracked vaccine and medicine production to reduce the time taken for clinical trials including for COVID-19.
The vaccine first came into the public eye when the researchers at Gamaleya claimed to have inoculated themselves with the vaccine candidate as early as May.
Scientists from Russia have flagged the speed at which the vaccine has been approved. Phase I trials began on June 17 with 76 volunteers some primarily from the military, but neither Gamaleya nor the Russian health authorities has shared data on the animal and early human studies. Similarly, details of the Phase II trials that were initiated on July 13 have not been shared.
Officials from the Russian Clinical Trial Organization told AP that they were urging government officials to focus on conducting advanced clinical trial stages similar to other vaccine candidates. "Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger," they said.
Russia's domestically produced Covid-19 vaccine could be dangerous and even cause infection if improperly designed, said another Russian scientist Alexander Chepurnov, the former lab head at the Vector State Research Center of Virology and Biotechnology in a conversation with Russia Today.
While Oxford-AstraZeneca's vaccine is recruiting over 30,000 people in the US with large scale administration underway in UK, Brazil, and South Africa; US-based Moderna has also started Phase III trials with over 30,000 participants. China's CanSino also plans to initiate Phase III trials in Saudi Arabia.
Also Read:Explained: Are Human Challenge Trials For COVID-19 Ethical?
Western scientists from UK and US have expressed their doubts about the efficacy and safety of the vaccine. Anthony Fauci, infectious diseases expert from the US questioned the fast-tracking of the vaccine. "I do hope that the Chinese and the Russians are actually testing a vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing I think is problematic at best," he said to AP.
Other scientists substantiate Fauci's concern. "The collateral damage from release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably," Imperial College London immunology professor Danny Altmann said in a statement Tuesday.
These questions come at a time when researchers from US, UK and Canada alleged Russia to have hacked systems in these countries for vaccine data. Russia denied involvement in any of these incidents.
What Did Russia Announce?
Russian President Vladimir Putin announced on Tuesday that the country had registered and authorised the use of the 'Sputnik V' vaccine. Vouching for the safety of the vaccine, AP reported Putin saying that the vaccine was efficient with lasting immunity. "I would like to repeat that it has passed all the necessary tests", AP reported Putin as saying. This makes Russia the first country to officially approve the use of a vaccine for COVID-19. The Russian Health Ministry has stated that immunity against the virus is expected to last for a period of two years.
One of the President's daughters had already received two doses of the vaccine."She's feeling well and has high number of antibodies," he clarified after his daughter experienced an increase in body temperature after receiving the second dose. It is not clear if she was part of the studies conducted.
Undergoing vaccination for COVID-19 will not be mandated but will be a voluntary effort, Putin further added. The country's health minister Mikhail Murashko also told Russia Today that the vaccine will be first administered to medical workers, teachers, and other risk groups on priority.
What Does The Vaccine Do?
Sputnik V is an adenovirus vaccine that has been genetically engineered to carry a gene from SARS-CoV-2. Adenoviruses are other common-cold causing viruses that have been active in humans.
When administered these vaccines will stimulate an immune response against SARS-CoV-2.The Oxford vaccine and the CanSino vaccine follow the same principle of a non-replicating adenovirus carrying a SARS-CoV-2 gene.
