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Explained: Is Russia's COVID-19 vaccine Sputnik V ready and safe?

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Explained: Is Russia's COVID-19 vaccine Sputnik V ready and safe?

Explained: Is Russia's COVID-19 vaccine Sputnik V ready and safe?
Of the 166 COVID-19 vaccine programs globally, 24 of which are in clinical trials and 6 in late-stage human trials, Russia surprised the world with its announcement that it has cleared the world’s first COVID-19 vaccine for public use.
But more than a sense of relief, the announcement has been greeted with scepticism about the vaccine's effectiveness and safety. That is because the vaccine has been tested on humans for less than two months and no data has yet been disclosed.
Here’s what we know and what we don’t. And yes, we don’t yet know if the vaccine is safe. Read on.
First, what Russia said:
On August 11, Russia cleared the world’s first COVID-19 vaccine for public use. Russian President Vladimir Putin said the vaccine showed "stable immunity" against the new coronavirus and had "passed all the necessary checks". He added that one of his adult daughters has already taken it.
The vaccine, developed by Moscow’s Gamaleya Institute and Russian Defence Ministry has been named Sputnik V after the world’s first satellite Sputnik launched by the Soviet Union during the Cold War in 1957.
The vaccine has to be given in two doses, with a gap of 21 days.
Russia can start using the vaccine after this approval; however, the Russian Health Ministry said that large scale global supplies will start only by end of 2020 or early 2021.
What type of vaccine is Sputnik V?
The Sputnik V vaccine is based on human adenoviral vector. Human adenoviruses that cause the common cold are weakened and genetically modified to insert protein codes from Sars-Cov2 to stimulate an immune response in the body. The Russian vaccine uses two different strains of human adenoviruses (rAd26 and rAd5) for the first and second vaccination dose, to boost the effect of the vaccine.
Adenoviruses have become a popular vaccine vector considering the ease to modify them and several potential COVID-19 vaccines are now using this vector, including the Oxford University-AstraZeneca vaccine, China’s CanSino Biologics and Johnson & Johnson among others. However, till now not a single vaccine has been approved for commercial use involving this vector, not for COVID-19 or for any other disease.
How did Russia manage to develop a COVID-19 vaccine faster than the others?
Russia said its existing work on developing a vaccine for Ebola and Middle East Respiratory Syndrome (MERS) based on the same adenovirus vector, helped create a vaccine against COVID-19.
“We were just fortunate that the coronavirus was very close to MERS, so we pretty much had a ready-to-go vaccine on MERS, studied for two years on MERS (and) slightly modified to be the coronavirus vaccine, and that is the real story, no politics ... Russia has always been at the forefront of vaccine research,” Kirill Dmitriev, CEO of Russia’s sovereign wealth fund RDIF, which is backing the vaccine, told CNBC.
Additionally, in April 2020 Russia had passed a law that did not mandate a Phase 3 vaccine trial before approval. This means the vaccine can be publicly distributed even when Phase 3 trials are underway.
The Russian Health Ministry on August 12 announced that a Phase 3 trial involving more than 2,000 people in Russia and several Middle Eastern and Latin American countries had begun, even as it laid out plans for a “massive release” to the public.
Why the skepticism then?
Experts say this argument does not hold ground as other leading candidates like Oxford-Astrazeneca, Moderna and Pfizer are all using platforms earlier developed for MERS, Ebola. “I don’t think the other late-stage vaccine programs are far behind,” said vaccine expert Dr Davinder Gill.
Besides, Russia has yet not completed the globally accepted vaccine trials and hence the vaccine cannot be called a proven one. Oxford-Astrazeneca, US drug firms Pfizer, Moderna, are all starting late-stage trials for potential COVID-19 vaccines, on nearly 30,000 participants in multicenter trials. Even by the most liberal approach, these large-scale trials are expected to end by December 2020, same time as Russia’s.
How effective is the Russian vaccine against Sars-Cov2?
A Russian government press release said the vaccine showed “high efficacy and safety” and that there were no serious side effects. The release also suggested that the vaccine would confer “2 years of immunity to SARS-CoV-2,” the novel coronavirus responsible for causing COVID-19.
For the scientific community and global health agencies, the pace of development and lack of transparency is disconcerting. No one has a clear answer or can vouch for the efficacy or safety. “Where is the data?” ask experts.
Sputnik V has been studied in humans for just 54 days of clinical trials, divided into Phase 1 and Phase 2 trials, conducted on 76 participants. However, so far Russia has not disclosed any data, preliminary or published, from the trials conducted. Even animal study data has not been released.
Lack of transparency aside, the vaccine has been approved for mass public use without the Phase 3 trials, considered the most crucial to test the vaccine on a wide-scale and in diverse sets of participants.
Dr. Scott Gottlieb, former commissioner of the USFDA was quoted by CNN as saying, "It's not clear how efficacious the Russian vaccine is going to be and whether or not people have some prior immunity to the adenovirus that they're using to deliver the coronavirus gene sequence.”
Dr Gill told CNBC TV18 that Russia’s claims on the 2-year long immunity could be estimates derived from their previous animal studies or trials against MERS.
Is the Russian vaccine safe?
Short answer: Don’t know yet.
Medical experts say that without a large-scale phase 3 clinical trial, it’s really unknown whether the vaccine works and what potential side effects it could have on the general public.
Why are Phase 3 trials so important?
Phase 3 clinical trials are important because the vaccine’s efficacy and safety can differ on different populations and racial groups. Besides, there is a chance that the impact of adverse events and side effects seen in smaller groups in Phase 1 or 2, may amplify when the vaccine is tested in a larger population. This poses a threat as vaccines are meant to be administered to large number of healthy populations.
WHO's view
The World Health Organization has maintained that the Russian vaccine is not in the list of 9 vaccines in advanced stages of human trials. Dr. Bruce Aylward, a Senior Adviser to WHO's Director-General has said, “We don't have sufficient information at this point to make a judgment. We're currently in conversation with Russia to get additional information to understand the status of that product, the trials that have been undertaken, and then what the next steps might be.”
Ideally, developing, testing, and reviewing any potential vaccine may take years as the process is long, complex, and expensive. Owing to the pandemic regulators across the globe have shortened timelines.
Even as medical experts globally debate about the ethics of Russia’s vaccine development, Russia’s own senior pulmonologist Professor Alexander Chuchalin has quit the health ministry, citing ‘gross violations’ of medical ethics concerning ‘Sputnik V’ approval. The Daily Mail reported that Professor Alexander said he tried to block the registration, and the newspaper has criticised the two scientists at Gamaleya Institute involved in the development of ‘Sputnik V’ for ‘flouting medical ethics’ by rushing the vaccine into production.
The Wall Street Journal reported that the Russia’s Association of Clinical Trials Organizations, a non-governmental agency, has raised safety concerns and asked the health minister in an open letter to delay registering the vaccine until all trials have been completed. “It hasn’t even completed testing with participation of even 100 people,” WSJ reported quoting the letter.
Is the Russian vaccine available publicly?
The approval allows the vaccine to be given to a small number of vulnerable citizens in Russia, including healthcare workers. Mass production in Russia will begin September 2020.  However, the vaccine will be available for widespread use in foreign markets by 1 January 2021, which is most likely after the phase 3 clinical trials will be over.
The vaccine is supposed to be manufactured at Gamaleya Institute’s own facility and also at a plant owned by Russia’s largest business group Sistema. Sistema says it can produce up to 1.5 million doses per year and is expanding capacities.
In a statement, Russia Development Investment Fund (RDIF) said Russia, along with foreign partners is prepared to manufacture over 500 million doses of vaccine per year in five countries and a ramp-up is planned. RDIF also said there was strong global interest with enquiries from 20 countries, including from India. Phase 3 clinical trials are planned in different countries and mass production will be started in partnership with local sovereign wealth funds, including in India, South Korea and Brazil, as well as, in Saudi Arabia, Turkey and Cuba, the statement said.
When will the Russian vaccine reach Indian shores?
The Indian government has yet not disclosed its interest in the Russian vaccine. A recently set up National Expert Group on COVID-19 Vaccine Administration, chaired by Niti Aayog’s V K Paul, is working on a strategy for vaccine availability and delivery. Even if India assesses the Russian vaccine, the Drug Controller general of India might need Russia to conduct late-stage (Phase 2 and 3) human trials on Indian population. A similar criterion has been placed for the Oxford-Astrazeneca vaccine candidate, who will be conducting phase 2/3 trials in 1600 volunteers in India.
Is early vaccine approval political posturing by Russia?
Russia claims to be the first country to approve a COVID-19 vaccine, although it was technically China, which had cleared its vaccine for ‘limited use’ much earlier. The difference being China’s vaccine was approved to be administered only on soldiers of the People’s Liberation Army and was seen as Phase 3 trials.
Dr Gill says the bigger worry is if Russia’s approval forces or pressurises political establishments of other countries to skip crucial trials or cut corners on safety and effectiveness.
Would leave you with the statement that Dr Peter Piot, Director of the London School of Hygiene & Tropical Medicine made during a recent vaccine symposium organised by Indian Council of Medical Research that might provide an alternate perspective.
“This is not only a scientific and public health challenge but will be one of the biggest geopolitical issues of our times. The country that has first access to the vaccine and can protect its people from this epidemic will have a major advantage economically. They can reboot the economy. They will have advantage politically and strategically. So important to have dialogue on equitable distribution and access to vaccine.”
 
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