Russia’s Sputnik V is the third coronavirus vaccine approved for use in India amid a deadly second wave of infections.
The Russian vaccine has been deemed to be safe, and works in a way similar to the Oxford-AstraZeneca vaccine which is being made in India as Covishield.
Sputnik V gives around 92% protection against Covid-19, late stage trial results published in The Lancet reveal.
India has so far given more than 100 million doses of two approved vaccines – Covishield and Covaxin.
Sputnik V’s approval came on a day when India overtook Brazil to become the country with the second-highest number of cases globally.
With the total case tally of more than 13.5 million cases, India is now only behind the US which has reported more than 31 million cases. With 13.4 million cases, Brazil is now at number three.
The Indian government aims to vaccinate 250 million “priority people” by the end of July. But experts say that the pace of vaccination has been slow and unless the drive is scaled up, the target could be missed.
Sputnik V, developed by Moscow’s Gamaleya Institute, initially generated some controversy after being rolled out before the final trial data had been released.
But scientists say its benefits have now been demonstrated.
The vaccine uses a cold-type virus, engineered to be harmless, as a carrier to deliver a small fragment of the coronavirus to the body.
Safely exposing the body to a part of the virus’s genetic code in this way allows it to recognize the threat and learn to fight it off, without the risk of becoming ill.
After being vaccinated, the body starts to produce antibodies especially tailored to the coronavirus.
This means that the immune system is primed to fight coronavirus when it encounters it for real.
Sputnik V can be stored at temperatures of between 2 and 8C degrees (a standard fridge is roughly 3-5C degrees) making it easier to transport and store.
The Russian Direct Investment Fund (RDIF), which is marketing the vaccine, has signed deals to produce more than 750 million doses of Sputnik V in India with six domestic vaccine makers, according to reports.
Unlike other similar vaccines, the Sputnik shot uses two slightly different versions of the vaccine for the first and the second dose – given 21 days apart.
They both target the coronavirus’s distinctive “spike”, but use different vectors – the neutralized virus that carries the spike to the body.
The idea is that using two different formulas boosts the immune system even more than using the same version twice – and may give longer-lasting protection.
As well as proving effective, it was also safe with no serious reactions linked to the vaccine during the trial.
Some side-effects to a vaccine are expected, but these are usually mild, including a sore arm, tiredness and a bit of a temperature. There were no deaths or serious illnesses in the vaccinated group linked to the jab.
As well as Russia, Sputnik V is being used in a number of other places, including Argentina, Palestinian territories, Venezuela, Hungary, UAE and Iran.
It will be weeks before Sputnik will be rolled out in India and until then, the country has to make do with Covaxin and Covishield.
Covaxin is an inactivated vaccine which means that it is made up of killed coronaviruses, making it safe to be injected into the body.
Bharat Biotech, a 24-year-old vaccine maker with a portfolio of 16 vaccines and exports to 123 countries, used a sample of the coronavirus, isolated by India’s National Institute of Virology.
When administered, immune cells can still recognize the dead virus, prompting the immune system to make antibodies against the pandemic virus.
The two doses are given four weeks apart. The vaccine can be stored at 2C to 8C.
The vaccine has an efficacy rate of 81%, preliminary data from its phase 3 trial shows.
India’s regulators gave the vaccine an emergency approval in January while the third phase of the trial was still underway, sparking skepticism and questions from experts.
Bharat Biotech says it has a stockpile of 20 million doses of Covaxin, and is aiming to make 700 million doses out of its four facilities in two cities by the end of the year.
The Oxford-AstraZeneca vaccine is being manufactured locally by the Serum Institute of India, the world’s largest vaccine manufacturer. It says it is producing more than 60 million doses a month.
The vaccine is made from a weakened version of a common cold virus (known as an adenovirus) from chimpanzees. It has been modified to look more like coronavirus – although it can’t cause illness.
When the vaccine is injected into a patient, it prompts the immune system to start making antibodies and primes it to attack any coronavirus infection.
The shot is administered in two doses given between four and 12 weeks apart. It can be safely stored at temperatures of 2C to 8C and can easily be delivered in existing health care settings such as doctors’ surgeries.
The vaccine developed by Pfizer-BioNTech, which is currently being administered in several countries, must be stored at -70C and can only be moved a limited number of times – a particular challenge in India, where summer temperatures can reach 50C.
International clinical trials of the Oxford-AstraZeneca vaccine showed that when people were given a half dose and then a full dose, effectiveness hit 90%.
But there was not enough clear data to approve the half-dose, full-dose idea.
However, unpublished data suggests that leaving a longer gap between the first and second doses increases the overall effectiveness of the jab – in a sub-group given the vaccine this way it was found to be 70% effective after the first dose.
Some side effects to a vaccine are expected but these are usually mild, including a sore arm, tiredness and a bit of a temperature.
There were no deaths or serious illness in the vaccinated group linked to the Russian vaccine.
As well as Russia, Sputnik V is being used in a number of other places, including: Argentina, Venezuela, Hungary, UAE, Iran, Palestinian territories.
The authors of the Lancet paper pointed out the analysis only included symptomatic cases of Covid, and more work would need to be done to understand whether it stops even asymptomatic cases, and prevents the virus from being passed on by vaccinated people.
Hungary is the first country in the EU to give preliminary approval to the Russian coronavirus vaccine, Sputnik V.
On January 21, PM Viktor Orban’s chief of staff confirmed both the Russian vaccine and the Oxford-AstraZeneca vaccine had been given the green light by the health authorities.
Foreign Minister Peter Szijjarto is travelling to Russia for further talks, where he is expected to discuss a shipment and distribution deal.
Early results from trials of the Russian vaccine have shown promising results.
Hungarian health officials are also in Beijing for talks with the Chinese authorities over the approval and immediate delivery of one million doses of the Sinopharm vaccine, which is already being used in neighboring Serbia.
Sinopharm, a Chinese state-owned company, announced last month that phase three trials of its vaccine showed that it was 79% effective – lower than that of Pfizer and Moderna.
However, PM Viktor Orban has said the only way Hungary can satisfy the demand for vaccination, given the “frustratingly” slow delivery of the Pfizer-BioNTech vaccine, is by buying from Russia and China.
At least 140,000 Hungarians have already been vaccinated. But government efforts to popularize the Russian and Chinese vaccines have already run into opposition.
The skepticism and suspicion among Hungarians is, in the public imagination at least, related to the Communist domination of the country from 1948 to 1989.
The move has also drawn criticism from the EU, which is wary of yet another example of Viktor Orban’s government going its own way and undermining EU solidarity.
Katalin Kariko, a Hungarian biochemist who left the country for the United States in 1985, played a key role in developing the Pfizer-BioNTech vaccine.
Some polls suggest only seven percent of Hungarians would accept the Sputnik V vaccine, while acceptance of the Chinese version has been measured as low as one percent by some surveys.
Russia is funding and building a major expansion of Hungary’s nuclear power station at Paks. The Chinese Fudan University is also due to open a campus in Budapest in 2024, and plans are advancing for a high-speed Chinese railway that would link Budapest to Thessaloniki and bring Chinese goods to Europe.
According to recent reports, 6,000 doses of the Sputnik V vaccine will be administered to 3,000 paid Hungarian volunteers in phase three of a clinical trial in the coming weeks.
The first report on the Russian coronavirus vaccine, named Sputnik-V, says early tests showed signs of an immune response.
The report published by medical journal The Lancet said every participant developed antibodies to fight the virus and had no serious side effects.
Russia licensed the vaccine for local use in August, the first country to do so and before data had been published.
However, experts say the trials were too small to prove effectiveness and safety.
But Moscow has hailed the results as an answer to critics. Some Western experts have raised concerns about the speed of Russia’s work, suggesting that researchers might be cutting corners.
Last month, President Vladimir Putin said the vaccine had passed all the required checks and that one of his own daughters had been given it.
Two trials were conducted between June and July, The Lancet paper said. Each involved 38 healthy volunteers who were given a dose of the vaccine and then a booster vaccine three weeks later.
The participants – aged between 18 and 60 – were monitored for 42 days and all of them developed antibodies within three weeks. Among the most common side effects were headaches and joint pain.
The trials were open label and not randomized, meaning there was no placebo and the volunteers were aware they were receiving the vaccine.
According to the report: “Large, long-term trials including a placebo comparison, and further monitoring are needed to establish the long-term safety and effectiveness of the vaccine for preventing Covid-19 infection.”
A third phase of trials will involve 40,000 volunteers from “different age and risk groups,” according to the paper.
Russia’s vaccine uses adapted strains of the adenovirus, a virus that usually causes the common cold, to trigger an immune response.
Kirill Dmitriev, head of a Russian investment fund behind the vaccine, said during a news conference that the report was “a powerful response to the skeptics who unreasonably criticized the Russian vaccine”.
He said that 3,000 people had already been recruited for the next phase of trials.
Health Minister Mikhail Murashko said Russia would start vaccinations from November or December, with a focus on high-risk groups.
However, experts warned that there was still a long way to go until a vaccine could enter the market.
According to the WHO, there are 176 potential vaccines currently being developed worldwide. Of those, 34 are currently being tested on people. Among those, eight are at stage three, the most advanced.
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