Russian authorities approved the use of the one-dose coronavirus vaccine Sputnik Light, after carrying out studies that showed that it has an efficacy of 79.4% and that the protection also extends to the new variants. The announcement could have important implications in the development of the vaccination campaign in Argentina.
As you already know, the Sputnik light consists of the first component of the Sputnik V and the calculation of 79.4% effectiveness was made on the basis of data from the Russian population that received only one dose as part of the massive civil vaccination program and did not receive a second injection for various reasons, between 5 December 2020 and April 15, 2021.
In Argentina, after March, the accent was placed on applying the first doses to as many people as possible rather than dedicating the available vaccines to completing the immunization of those who had already received the first dose.
This decision was supported by the successful experience of Great Britain, which was successful in reaching the majority of its population, and was validated by studies of demonstrated efficacy with the application of just one dose of the AstraZeneca vaccine. Those studies even showed that the effectiveness increased as the two injections were spaced.
The approval in Russia of the Sputnik light vaccine, with the corresponding scientific studies that support it, shows that the vaccination campaign in Argentina with Russian vaccines could concentrate on continuing to cover as many people as possible without stopping for now to complete the immunization schedule in the approximately three million who have already received the first dose and not yet the second.
Some officials consider that this could be considered as a “break” of the “tacit contract” with these people, but they do not rule out applying the criterion in the future, especially in the immunization of those under 60 years of age.
Of course, for this to be possible, it should have the approval of the Anmat. The Russian authorities have already said that they will present all the information necessary to obtain it shortly.
“This announcement is very important to us because a single dose vaccine that is close to 80% effective will save many lives and it is key for many countries, “said Kirill Dmitriev, CEO of RDIF during the announcement press conference.
In the statement released by the RDIF, it was also indicated that Sputnik Light “is effective” against all new variants of coronavirus, according to the results of the laboratory studies of the Gamaleya Research Center, the developer of the vaccines.
“Sputnik V could be used for people over 60 years old while Sputnik Light could generate almost 80% coverage in those under 60,” said Dmitriev, adding that “in this way, more people could be reached faster. “plus the cost would be cut in half.
Sputnik Light is the first component of the Sputnik V coronavirus vaccine, a recombinant human adenoviral vector of serotype 26 (rAd26) that has already been applied to more than 20 million people worldwide.
“This allows us to show that it is a safe vaccine, since no serious cases have been registered in any of the countries that were inoculated,” Dmitriev described.
The CEO of the RDIF indicated that “all countries will receive the proposal of the two vaccines and each one will choose the one they prefer, surely depending on the moment they are in relation to the pandemic.”
Regarding the production of Sputnik Light, he explained that “it will be carried out in countries where Sputnik V is already being produced”, and said that “surely next week it will begin to be registered in all countries that already have Sputnik V authorized “.
In this regard, he added: “We are confident that the process will be very fast as this component is being applied and each country has its own evidence (on efficacy and safety).”
According to the RDIF statement, the phase I / II safety and immunogenicity studies of Sputnik Light, which began in January and yielded the first results on March 10, showed that immunization with this vaccine allows the development of specific IgG antibodies in the 96.9% of people vaccinated on day 28 after injection; while 91.67% developed neutralizing antibodies against the virus in that period.
“The cellular immune response to the S protein of SARS-CoV-2 is induced already on the 10th day in 100% of vaccinated people,” the statement described.
He also indicated that “immunization with Sputnik Light of people who have pre-existing immunity to SARS-CoV-2, allows the level of specific IgG antibodies to be increased more than 40 times in 100% of vaccinated people already on the tenth day” .
Regarding safety, the statement noted that no serious adverse effects were recorded after immunization.
In parallel, the Gamaleya, together with the Russian Investment Fund, launched a global study on the effectiveness of Sputnik Light on February 21, 2021, which is already in phase III of a clinical trial, in which they participate 7,000 people from the Russian Federation, the United Arab Emirates, Ghana and other countries, whose provisional data is expected in May.
The cost of Sputnik Light in foreign markets will be less than 10 dollars, as it requires standard requirements for the temperature regime of its storage (between two and eight degrees Celsius).
Finally, Dmitriev indicated that this single-dose vaccine could be used as a “booster” vaccine for any other.
“We are testing AstraZeneca and have made it available to any laboratory that wants to do studies to combine,” he concluded.