Russia became the first country to authorize the use of a COVID-19 vaccine, but it has not yet been massively tested in humans
Vladimir Putin managed to make headlines around the world on Tuesday by announcing that Russia became the first country to authorize a vaccine against COVID-19.
Under the name of Sputnik V, in reference to the satellite with which the Soviet Union set out in the space race in the 1950s, the Russian president assured that the new vaccine had passed all the necessary verifications and that even had been tested by one of his daughters.
“I believe, in that sense, that she participated in the experiment. After the first injection her temperature rose to 38 degrees, the next day she was 37.5 and that was it. After a second injection, her temperature rose slightly, and then returned to normal, “explained the Russian president on Tuesday.
The vaccine, developed by the Gamalei National Center for Epidemiological Research and Microbiology, was celebrated by Moscow as proof of Russia’s scientific development.
Russian Health Minister Mikhail Murashko said the vaccine had “proven to be highly effective and safe,” calling it a great step forward towards a “victory for humanity” over COVID-19.
Putin assured that mass production would begin shortly and that it would begin to be available to doctors and teachers in the first place towards the end of August or the beginning of September, while the rest of the citizens could access it in January 2021.
Moscow’s announcement of its progress in the race to defeat the coronavirus has raised great expectations in many parts of the world, to the point that the President of the Philippines, Rodrigo Duterte, said he was willing to test it personally.
At the same time, however, it has been met with great doubts and skepticism by the scientific community, including the World Health Organization (WHO) itself.
Around the world, more than 150 vaccines against COVID-19 are being developed and tested.
According to WHO data, there are 28 that are undergoing clinical trials, among which there are six that are in what is known as phase 3, the last of the stages of the process.
Neither of these is Sputnik V.
According to a statement issued this Tuesday by the Russian Ministry of Health, this vaccine “Passed all the necessary safety and efficacy tests in different types of animals (rodents and primates) ”before being tested in two groups made up of 38 volunteers each.
But, according to international standards, a vaccine to demonstrate its effectiveness and that it is not dangerous must be tested in thousands of people, phase 3. And the Russian has not undergone that scrutiny.
This led the WHO to receive the news with caution and insisted that, like all others, it go through the prequalification and review procedures set by the agency.
“Accelerating progress should not mean compromising security,” WHO spokesman Tarik Jasarevic said at a press conference.
What’s more, the WHO had already asked Russia last week to adhere to international standards for the production of the vaccine against COVID-19.
“Sometimes there are researchers who say they have found something, which – of course – is good news as such. But between discovering a key to maybe getting a vaccine that works and having gone through all the stages there is a big difference, “Christian Lindmeier, a WHO spokesman, told reporters last week.
This week, the Association of Clinical Trials Organizations, which brings together the main pharmaceutical companies present in that Russia, asked the health authorities of that country to postpone the approval of the vaccine until the final tests were successfully completed.
In a letter addressed to the Ministry of Health, they warned that approving the vaccine before these trials conclude is very risky.
“It is during this phase that the most important evidence on the efficacy of a vaccine is collected, as well as information on adverse effects. that could arise in a certain group of patients: people with weak immune systems, people with pre-existing diseases and so on, ”they pointed out.
Overall, it is estimated that only 10% of clinical trials are successful.
Trial and error
Despite objections, Moscow’s plans focus on conducting phase 3 clinical trials, which usually span months, in parallel with the vaccination process.
Alexander Gintsburg, director of the Gamalei Institute, said that initially there will only be doses for vaccinations in 10 or 15 of the 85 regions of Russia, according to the Interfax agency.
Gintsburg had surprised the scientific community by announcing last May that he and other researchers had tested the vaccine on themselves.
By then, the researcher had advanced his plans to carry out tests in humans in a single phase that would conclude during the summer.
The Russian Health Minister, Mikhail Murashko, has assured that the vaccine is safe, effective and that it produced among the volunteers who tested it high levels of antibodies, which can confer immunity for up to two years.
Faced with his claims, however, the scientific community faces an additional problem, since the Gamalei Institute has notbía disclosed until this Tuesday specific information on safety and immunity that he obtained from his tests, making it impossible for independent scientists to verify his claims.
In that sense, the WHO announced on Tuesday that it has been in talks with Moscow to carry out an evaluation of the vaccine.
Experts are also concerned that the use of vaccines that have not been properly tested may cause more harm than good, by generate a false sense of immunity that leads to abandoning effective prevention measures or that their failures end up giving strength to the anti-vaccine movement.
Brazil, Cuba, Nicaragua
Despite the doubts of the scientific community, Kirill Dmitriev, head of the Russian sovereign wealth fund, said that already have international agreements to produce 500 million doses and requests for more than 1 billion doses from about 20 countries.
Dmitriev assures that in some of those countries, such as the United Arab Emirates and the Philippines, they will also carry out clinical trials.
Sputnik V production will also take place in other countries, including some in Latin America.
João Pedro Schonarth, spokesman for the Paraná Institute of Technology, reported on Tuesday that there are ongoing talks with the Russian authorities to produce the vaccine in Brazil and that the governor of that state, Ratinho Júnior, plans to meet this Wednesday with the ambassador of Russia in the country.
The Cuban agency Prensa Latina said on Tuesday also – quoting Dmitriev – that the production of the vaccine “could” take place on the island.
Even anticipating Putin’s announcement, Daniel Ortega’s government in Nicaragua had advanced on Monday its willingness to produce the Russian vaccine in Managua at the Mechnikov Latin American Institute of Biotechnology and even distribute it among Central American countries.