Russia’s COVID-19 vaccine Sputnik V on Monday received approval of Centre’s expert panel for emergency use in India with certain conditions. The Drugs Controller General of India (DCGI) will take a final call on the recommendation of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO), which took up the application of Dr Reddy’s Laboratories seeking emergency use authorisation for Sputnik V.
If approved, the vaccine would be imported from Russia for emergency use in the country. It will be the third COVID-19 vaccine to be available in India. The DCGI has given the emergency use authorisation for two COVID-19 vaccines — Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by Serum Institute of India in Pune.
Efficacy of Sputnik V:
Sputnik V vaccine against COVID-19 has shown 91.6 per cent efficacy in the phase 3 trial without any serious side effects, according to an interim analysis of data published in The Lancet journal on February 2, 2021. The findings are based on analysis of data from nearly 20,000 participants, three-quarters of whom received the two-dose regimen of the adenovirus-based vaccine, Gam-COVID-Vac, and one quarter received a placebo.
Rare Serious Adverse Events:
Serious adverse events or those requiring hospital admission were rare in both the placebo and vaccine groups and none were considered associated with vaccination, the researchers said. Four deaths were reported in the trial, none of which were considered related to the vaccine, they said, adding most reported adverse events were mild, including flu-like symptoms, pain at injection site and weakness or low energy.
How Sputnik V Vaccine Works:
The Gam-COVID-Vac, called Sputnik V, is a two-part vaccine that includes two adenovirus vectors recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S). These vectors have been modified to express the SARS-CoV-2 spike protein, which the virus uses to enter human cells. The adenoviruses are also weakened so that they cannot replicate in human cells and cannot cause disease.
In the trial, participants were given one dose of rAd26-S, followed by a booster dose of rAd5-S 21 days later. The researchers explained that using a different adenovirus vector for the booster vaccination may help create a more powerful immune response, compared with using the same vector twice, as it minimises the risk of the immune system developing resistance to the initial vector.
“Stopping the COVID-19 pandemic requires the introduction of different vaccines based on different mechanisms of action to cover diverse global health demands. Our vaccine, along with other SARS-CoV-2 vaccines, helps to diversify the world SARS-CoV-2 vaccine pipeline,” said study co-lead author, Denis Logunov, from Gamaleya National Research Centre for Epidemiology and Microbiology, Russia.
Key Advantages of Sputnik V:
Sputnik V is one of only three vaccines in the world with efficacy of over 90%. It provides full protection against severe cases of COVID-19. Further, more than 250 clinical studies conducted over two decades have proved the safety, efficacy and lack of negative long-term effects of adenoviral vaccines. There are no strong allergies caused by Sputnik V.
The developers of the Sputnik V vaccine and AstraZeneca are working on a joint clinical trial to improve the efficacy of Oxford-AstraZeneca’s Covishield vaccine.
With the storage temperature ranging between 2-8 degree Celsius, the Sputnik V vaccine can be stored in a conventional refrigerator and thus saves the need to invest in additional cold-chain infrastructure. The vaccine is priced at an affordable cost of less than $10 per shot.
Need for Bridging Trials:
India is conducting ‘bridging trail’ of the Sputnik V vaccine as it has been produced outside the country. “The data has required has been provided, but any vaccine produced abroad requires ‘bridging trial' in India, this trial is being carried out by 8 laboratories. Hopefully, by this month-end the data will be released and submitted to the drug regulatory authorities – that is where it stands.” a CNBC-TV18 report quoted Dr V Ravi, member of the scientific advisory board for Sputnik vaccine.
On the need to conduct ‘bridging trails’ in India in future, he said, “Initially it will be imported and distributed through these agencies, but Reddy laboratories is getting their vaccine manufactured facility and probably there will be the first ones to produce the vaccine in India itself.”
However, questions have been raised on the need for ‘bridging trials’ as a few states complain of vaccine shortage. Several inoculation centres in Maharashtra had to shut down as they ran out of vaccine doses. On Sunday, at least 900 session sites in Odisha remained shut owing to shortage of COVID-19 vaccines. Meanwhile, Andhra Pradesh, Rajasthan and Punjab have claimed that their vaccine stock is about to get over.
Further opposing the step, Dr Arvinder Singh Soin, Chairman of the Institute of Liver Transplantation and Regenerative Medicine, Medanta-The Medicity, Gurgaon, said, “Insistence on bridging trials data for the first three is hardly relevant anymore, given the desperate and dire situation. Millions (including Indians and others of Asian origin) have had these all over the world, and enough scientific data is available to justify their use in India.
RDIF’s Deals With Indian Firms to Make Sputnik V:
Dr Reddy's has partnered with the Russia Direct Investment Fund (RDIF) to bring the Sputnik V vaccine to India. India has been pledged 125 million doses of the vaccine by Russia. The RDIF has also made deals with Indian pharma firms such as Panacea Biotec, Hetero, Gland Pharma and Stelis Biopharma to produce millions of Sputnik V vaccine in India.
India, the world's largest vaccine maker, has become one of the biggest producers of the Sputnik V shot outside Russia. Other countries producing it include Brazil, China and South Korea.
Sputnik V Approved in 59 Countries:
Sputnik V has been approved for use in 59 countries across the world with the total population of over 1.5 billion people. Following this, Sputnik V has recieved the second-highest number of approvals issued by government regulators globally.
Sputnik V has also been approved in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon, San-Marino, Ghana, Syria, Kyrgyzstan, Guyana, Egypt, Honduras, Guatemala, Moldova, Slovakia, Angola, Republic of the Congo, Djibouti, Sri Lanka, Laos, Iraq, North Macedonia, Kenya, Morocco, Jordan, Namibia, Azerbaijan, Philippines, Cameroon, Seychelles, Mauritius, Vietnam, Antigua and Barbuda and Mali.