translated from Spanish: Russia asks Cofepris for authorization to conduct Sputnik V vaccine studies

The Russian COVID vaccine ‘Sputnik V’ could be the second option for Mexico. Its manufacturers have submitted to the Federal Commission for the Protection of Health Risks (Cofepris) an application for clinical studies in our country.
According to the results of the latest tests, corresponding to phase 3, this vaccine is 91.4% effective.
Foreign Secretary Marcelo Ebrard announced that it was the government of Mexico that invited Russian manufacturers to submit the necessary application and documentation to cofepris.

I share that at the invitation of Mexico, Russian manufacturers of the Sputnik V vaccine have submitted an application and documentation necessary to COFEPRIS to conduct clinical studies in our country and obtain the corresponding authorization. Good week!!!
— Marcelo Ebrard C. (@m_ebrard) December 14, 2020

The National Research Centre on Epidemiology and Microbiology Gamaleya of the Ministry of Health of the Russian Federation (Gamaleya Center) and the Russian Direct Investment Fund (RDIF, Russia’s sovereign investment fund) announced the calculation of dose effectiveness, which was based on tests administered to more than 22,000 volunteers.
Read also: Oxford-AstraZeneca will do trials combining its vaccine with Russian Sputnik V
The evaluation of the effectiveness of the ‘Sputnik V’ vaccine was carried out to participants 21 days after receiving the vaccine and, so far, none have reported unexpected side effects.
However, some of those vaccinated had short-lived symptoms, such as injection site pain and pseudo-flu symptoms, including fever, weakness, fatigue and headache.
Compared to severe cases of COVID-19, Sputnik V was 100% effective.
The executive director of the Russian Direct Investment Fund – the one funding the vaccine – Kirill Dmitriev, announced that the data obtained would serve as the basis for continuing applications for accelerated registration of the vaccine in other countries.
«We also see great interest from international pharmaceutical companies in the Gamaleya Center vaccine, as the use of Sputnik V components in combination with other vaccines can significantly increase their effectiveness,» he added.
To understand: Vaccines that use adenovirus, such as Sputnik V, won’t integrate into your genetics
One of the biggest advantages of the vaccine, reported by the Gamaleya Center and the RDIF, is the safety, efficacy and absence of long-term negative effects provided by its «proven and well-structured platform of human adenoviral vectors».
The safety of human adenovirus-based vaccines has been confirmed in more than 75 international publications and more than 250 clinical trials over the past two decades. 
The cost of a dose is less than $10 in international markets, while the production of the dry form of the vaccine, which is stored at a temperature between +2 and +8 degrees Celsius, allows easier distribution in international markets.
Countries with Sputnik
To this day, phase three clinical trials are already approved and ongoing in countries such as Belarus, the United Arab Emirates and Venezuela. In India they are in phase II-III.
Previously, Russia had reached an agreement with Mexico to supply it with 31 million doses of Sputnik V, while in Argentina it would send 10 million before the end of the year and also made a pact with Paraná, a Brazilian state, for an unconfirmed number of doses.
It was planned to be included in the export list to South Korea, Egypt and possibly Hungary, which would make way for it in the European Union Square.
According to Dmitrev, quoted in El País, the drug has been supplied to «several EU ambassadors to Russia»; on the other hand, it stated that a delegation from France and a producer in Germany had shown interest.
«The Russian vaccine is safe; its price is less than $10 for each of the two doses, three times cheaper than Pfizer and Moderna,» the manager added.
With information from El País.
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Original source in Spanish

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