India has authorized Russia’s Sputnik V COVID-19 vaccine.
The news was confirmed by the Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, announced that India approved the vaccine for use.
The RDIF says this means that Sputnik V is now authorized for use for 3 billion people, or 40% of the world’s population. India’s population is the second largest in the world, with about 1.4 billion people.
India is already using two vaccines: the Oxford/AstraZeneca vaccine and another made by Indian firm Bharat Biotech.
Interim analysis of phase-3 data published in The Lancet in February found that Russia’s vaccine is 91.6% effective. Russia has been giving it to its population since December.
India’s coronavirus cases have been reaching record highs, and the country is looking to increase its vaccination rate as it battles a surge.
However, Russia is also struggling with supply bottlenecks and according to information from an independent pollster reported by Reuters, over 60% of Russians are unwilling to be vaccinated with Sputnik V.
Biocad is a well-known and well-connected name in the pharmaceutical industry and has been producing drugs for HIV and cancer for years.
US-based Pfizer, which is producing its own vaccine together with BioNTech, was even interested in acquiring Biocad.
Morozov owns 30% of the company and, in September, the company established one of Russia’s most modern production facilities in Zelenograd, north of Moscow.
The company employs 2,500 employees and has 1,500 people working on Sputnik V alone.
The team is also developing a drug for COVID-19 lung disease.
A camera team from Spiegel TV got a rare glimpse into the production of the vaccine, which revealed high levels of security at the factory in St Petersburg.
Complexity inhibits production
According to Russian Prime Minister Mikhail Mishustin, 10 million doses of Sputnik V have been produced so far.
However, many more doses are needed to vaccinate Russia and meet global demand.
Unlike the Pfizer and Moderna vaccines, Sputnik V is a vector-based vaccine.
This means fragments of the genetic material of the coronavirus are placed in attenuated viruses like adenoviruses.
The adenoviruses deliver genetic information from the coronavirus into the human body.
The body’s cells then respond and produce the virus’s protein, which the immune system can recognize and for which it can produce the body’s required defense substances.
With Sputnik V, however, two different adenoviruses are found in each of the required two doses, administered three weeks apart.
While this makes the vaccine more effective, it also increases the complexity of production.
According to data published in The Lancet, Sputnik V is just under 92% effective and so is roughly as effective as the mRNA vaccines produced by Pfizer/BioNTech and Moderna.
Morozov finds the EU countries’ hesitation baffling and has spoken about vaccine nationalism and bureaucracy in the EU, according to World Today News.
In addition to Sputnik V, Russia has approved two other homemade vaccines, CoviVac and EpiVacCorona.
Russia’s Sputnik V vaccine is gaining ground in Latin America, Eastern Europe, Asia, and Africa.
More than 40 countries have reached deals with the makers of the vaccine, many of which have little ability to access the in-demand shots made by Western companies that are powering vaccination drives in the US and Europe.
Americas: Argentina, Bolivia, Venezuela, Paraguay, Mexico, Nicaragua, Guyana, Saint Vincent and the Grenadines, Honduras, Guatemala.
Africa and Middle East: Algeria, Angola, the Republic of the Congo, Djibouti, Republic of Guinea, Tunisia, United Arab Emirates, Iran, Bahrain, Lebanon, Gabon, Egypt, Ghana.
The vaccine is also approved by the Palestinian Authority and by an entity of Bosnia and Herzegovina called the Srpska Republic, the press release said.
Kirill Dmitriev, the CEO of the RDIF, told Insider on February 2 that he had little interest in seeing the vaccine used in the US and only a moderate interest in sending it to Europe.
Outside these markets, however, there is a wide field. Beyond the US and Western Europe, there are relatively few doses available from vaccine makers such as AstraZeneca, Moderna, Pfizer, and Johnson & Johnson.
Nations including the US, Canada, and the UK have ordered enough doses to vaccinate their populations several times over, prompting accusations of hoarding. They are also getting their doses sooner.
A mechanism intended to provide access to the poorest countries, the World Health Organization’s COVAX program, has been slow to deliver the vaccines. The first ones reached Africa on Monday.
Lawrence Gostin, a professor of medicine at Georgetown University who is director of the WHO Collaborating Center on National and Global Health Law, told Insider in an interview that the distribution of doses was obviously unfair.
“What should be a politically neutral scientific lifesaving medical resource is being divvied up around the world, according to political and geostrategic spheres of influence,” he said.
This has created a vacuum in poorer countries.
The RDIF makes no secret of its intentions. “Our priority is the Middle East, Latin America, Asia, Africa, those countries who are very eager to procure Sputnik,” Dmitriev told the Saudi-backed outlet Arab News in an interview on January 18.
“Russia is selling to desperate people,” Gostin said. “Governments realize that people are dying, that [COVID-19] is absolutely shattering their economies, and that they’re losing public trust.”
“If it was an informed and competitive market, countries could choose between a number of equally effective or more effective vaccines,” Gostin said. “They probably wouldn’t take the Russian one.”
The shot has been shown to be highly effective in clinical trials, with 91.6% efficacy. But by then, the shot was mired in mistrust because the Russian government decided to start using the shot on its population months before the trials were finished.
“Once a country has blatantly violated all of the scientific and ethical rules about deploying a vaccine, it’s hard to regain trust, at least in people who have a choice,” Gostin said.
“They’ve got a choice between doing nothing or giving their country some hope. And the Russian vaccine represents hope.”
The country has vaccinated about 1.5 million of its people with a combination of the Pfizer-BioNTech shot, China’s Sinovac shot, and Sputnik V. Within that figure it was not clear how many were Sputnik jabs.
The small European nations of San Marino and Montenegro have also received a couple of thousand doses each of Sputnik V.
Some European countries have expressed interest in the vaccine but appear to be waiting for the influential European Medicines Agency to give its approval. Countries can move without EMA approval but tend not to.
Frustrated with the delays, some of the EU member states have decided not to wait for the EMA. Hungary was the first member state to splinter from the bloc.
“Every day that we would spend waiting for Brussels, we would lose a hundred Hungarian lives,” Prime Minister Viktor Orban told Hungarian radio, The Irish Times reported on February 14. “I don’t trust a [vaccine] analysis in Brussels more than I do in a Hungarian one.”
“It is right to buy the Russian vaccine, as COVID-19 does not know anything about geopolitics,” Slovakian Prime Minister Igor Matovic said, The Moscow Times reported on Monday.
The former Soviet countries Turkmenistan and Kazakhstan have also started administering Sputnik V.
Russia has proved eager to capitalize on the publicity opportunities that its vaccine distribution offers, often with some theatrics.
The scene is practically the same in several countries. Journalists are invited to airport runways to witness the offloading of crates of vaccine, stamped with the Sputnik V and the RDIF logo or draped with a Russian flag.
They will come at a price. The RDIF had announced that the vaccine would be “two or more times cheaper” than mRNA vaccines such as Pfizer’s. But the price, at just under $10 a shot, ended up being far more than what the AU is paying for shots from AstraZeneca ($3) or Pfizer ($6.75), the Financial Times reported last week.
The United Arab Emirates gave emergency approval to the vaccine on January 21, before the late-stage trial results were published.
The Palestinian Authority has also administered some doses of the shot, after Russia sent 1,000 doses of Sputnik V and the UAE a further 20,000 doses of Sputnik V.
For Gostin, the health expert, geopolitical advantage is not the only driver of Russia’s strategy.
“This is kind of a way of demonstrating that Russia’s technology prowess is the equal to that of the West,” Gostin told Insider.
“It’s no accident that it was called Sputnik, because it’s really is very reminiscent of the race to the moon with the United States.
“The truth is that you’ve got Russia playing politics with vaccines, trying to get a geostrategic advantage and bolstering their image abroad. Then you’ve got Europe, the US, the UK, and Canada that are hoarding vaccines and robbing lower-income countries.
“I don’t know that leaders of Europe and the US can look themselves in the mirror and feel any kind of ethical superiority.”
“Sending Sputnik to Latin America is a chance to demonstrate that Russia can be a country that is not sending ideology or arms for a regime, but rather, is sending medicine that is necessary for surviving,” he said.
Historically, Soviet Russia was interested in exporting its ideology to like-minded governments, Jeifets said. But now, Russia wants to reach out to more conservative leaders, like those of Colombia and Paraguay, who are in talks to receive shipments, Jeifets said.
Even as some states have begun to give vaccines to the general population, many doctors and nurses in public hospitals haven’t gotten shots, and health workers in private facilities have been largely ignored.
“My perception is that the federal government is making an effort that should be recognized, but there has also been terrible discoordination,” López-Cervantes said.
Many in Mexico who’ve already received the Sputnik vaccine say it’s a huge relief.
Sofia Avila Velasco, 68, was one of the first people in Mexico to receive a dose of the Sputnik vaccine on February 24 at a school in Mexico City’s southern borough of Xochimilco, which started with people over 60.
Avila Velasco said she’s been stuck at home – gaining weight, getting older and becoming consumed by anxiety. So, the shot, she said, means a lot.
“I feel calm,” she said.
Susana Balcazar, 62, arrived at about midday to the same site and waited for about two hours under large tents. She was the 2,149th person in line, she said.
She was glad to get a shot, she said, but was fully aware that only a relative few in the country have had that opportunity.
“This isn’t an instant cure for the entire population,” she said. “But we have to do our part to prevent the virus from becoming more aggressive.”
Russia became the first country to approve a coronavirus vaccine in August and start distributing shots in early December. Now it has some reliable data that those vaccines may be about as effective as those authorized for emergency use in the US and UK.
Unlike the US or UK, Russia approved its vaccine – called Sputnik V – before conducting phase 3 trials. These late-stage trials typically evaluate a medical treatment in tens of thousands of people to determine how well it works, ensure that it’s safe, and uncover any side effects.
When Russia approved Sputnik V for distribution, only 38 people had received the vaccine in clinical trials. All of them produced antibodies, and side effects were mostly mild – including elevated temperatures and headaches. That research had not undergone peer review, though.
As Sputnik V was distributed to frontline healthcare workers in December, medical experts warned that the data was insufficient to determine whether the vaccine was safe and effective. Some scientists suggested that the vaccine approval may have been rushed for political reasons.
But Russia’s risk seems to be paying off. An interim analysis of phase 3 trials published in The Lancet on Tuesday suggests that Sputnik V is 91.6% effective at preventing symptomatic COVID-19.
“I think everything has been done perfectly and this moment is in some ways a vindication moment,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), told Insider in an exclusive interview on Tuesday. The RDIF is one of the world’s largest sovereign wealth funds, and has overseen and financed the development of Sputnik V.
Dr. Julian Tang, a consultant virologist at the UK’s University of Leicester, told Insider the nation’s risky approach “has been justified to some extent now.”
Russia plowed forward on vaccinations, despite blowback
Sputnik V is given in two doses. Each dose relies on a different adenovirus – relatively harmless viruses associated with the common cold – to deliver a gene that codes for the coronavirus’ spike protein, which helps it attach to and invade cells. In theory, this should train the immune system to produce antibodies that ward off symptomatic disease.
The Gamaleya Institute in Moscow and the Russian Ministry of Defence developed the vaccine in tandem.
Russian President Vladimir Putin announced on August 11 that the country’s health agency had approved the new vaccine following phase 1 and 2 clinical trials. Some virus experts feared that any severe side effects missed in those early trials could undermine public trust in other vaccines, too.
“This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population,” Francois Balloux, a geneticist at University College London, said in a statement distributed by the UK Science Media Centre.
Despite these concerns, Russia’s health ministry began producing batches of the vaccine in August. By December, the country was offering its first doses to essential workers like teachers and healthcare professionals.
“We registered it in August why? Because we know it’s a safe human adenoviral platform tested for decades. It’s very different from an mRNA vaccine that has not been tested long term at all,” Dmitriev said. “So we do it and we give it only to high risk personnel who wants to take it. And therefore already in September, we were able to save people, protect lives, and to create this basically safety net of some of the high risk personnel.”
Phase 3 trials were ongoing at the time, but it would be months before they produced reliable results.
‘Good news’ from phase 3
In November, Russia announced that preliminary data from phase 3 trials showed that its vaccine was 92% effective at preventing COVID-19. But the data was based on just 20 confirmed COVID-19 cases, split between the group of participants that had been vaccinated and the group that had received a placebo, according to a press release. It had not yet undergone peer review.
The peer-reviewed analysis published Tuesday, however, was based on a group of nearly 15,000 people who received the Sputnik V doses. Of that group, only 16 people had confirmed COVID-19 cases 21 days after their first dose, compared to 62 out of 4,902 people in the placebo group. None of the vaccinated people had moderate or severe symptoms.
The phase 3 trial relied on participants to self-report any symptoms in order to test and identify new cases post-vaccination. But researchers still don’t know how effective Sputnik V is at preventing asymptomatic infection or transmission. The US is missing the same data for both the Pfizer and Moderna vaccines.
“The development of the Sputnik V vaccine has been criticized for unseemly haste, corner cutting, and an absence of transparency,” British virologists Ian Jones and Polly Roy wrote in an editorial accompanying the new study on Tuesday. “But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19.”
Ashish Jha, dean of the Brown University School of Public Health, called the results “good news.”
“We need all the safe effective vaccines we can get,” he wrote on Twitter.
Sixteen foreign countries or sovereign states have already approved Russia’s shots: Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, United Arab Emirates, Iran, Guinea, and Tunisia.
Dmitriev said he expects Sputnik V to be registered in 25 nations by the end of next week, but applying for regulatory approval in the US and UK isn’t a priority.
Andrew Dunn, Dr. Catherine Schuster-Bruce, Sinéad Baker, and Susie Neilson contributed reporting.
The COVID-19 vaccine being developed by AstraZeneca and the University of Oxford will be combined with Russia’s Sputnik V shot, which the country has already authorized for emergency use.
In a press release on Friday, AstraZeneca said that it would “soon begin exploring” combining its shot with one made by Russia’s Gamaleya Research Institute, which developed Sputnik V.
It did not specifically say that it was combining its vaccine with the Russian shot — but Russia’s sovereign wealth fund, which is financing the country’s vaccine development, confirmed the vaccine in question is one of two vectors that make up Sputnik V.
Trials will start by the end of 2020, the wealth fund said.
Combining two different vaccines could improve their accessibility as well as providing better protection against COVID-19, AstraZeneca said.
AstraZeneca, the British drugmaker working with the University of Oxford to develop a COVID-19 vaccine, plans to work with the developers of Russia’s Sputnik V to explore a combined shot, it said.
AstraZeneca “will soon begin exploring with Gamaleya Research Institute in Russia to understand whether two adenovirus-based vaccines can be successfully combined,” the drugmaker said in a statement Friday, naming the developer of the Sputnik V vaccine, but not the specific shot.
The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, confirmed the vaccine in question was one of two vectors that make up Sputnik V.
Clinical trials are slated to begin by the end of December, the RDIF, which is financing the development of Sputnik V, added.
This is the second time AstraZeneca’s vaccine is being used in a “mix and match” trial. On Tuesday, the head of the UK’s vaccine taskforce said it would combine the shot with Pfizer’s vaccine to see if the two vaccines together produce a stronger immune response.
Combining different COVID-19 vaccines “may be helpful to improved protection and/or to improve vaccine accessibility,” AstraZeneca said Friday, adding that it “is also likely that combining vaccines may lead to improved immunity over a longer-period of time.”
The RDIF welcomed the cooperation between vaccine producers, its CEO Kirill Dmitriev said Friday, and said it hoped other vaccine producers will follow the example. The RDIF and the Gamaleya Institute approached AstraZeneca in November to suggest combining vaccines.
“The decision by AstraZeneca to carry out clinical trials using one of two vectors of Sputnik V in order to increase its own vaccine’s efficacy is an important step towards uniting efforts in the fight against the pandemic,” Dmitriev added.