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Lancet: Sputnik V vaccine seems 91.6% safe and effective

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phase III

Already approved in 16 countries, the two doses are well tolerated and also work in the elderly and new strains of the virus. Soon the use for children will also be studied and coupled with that of Oxford / AstraZeneca

by Francesca Cerati

(AFP)

Already approved in 16 countries, the two doses are well tolerated and also work in the elderly and new strains of the virus. Soon the use for children will also be studied and coupled with that of Oxford / AstraZeneca

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Criticized for the haste with which it was used and the lack of transparency, the Russian Sputnik V vaccine takes its revenge with a second publication in the prestigious medical journal Lancet, after that of September 2020. From the study, an interim analysis, just published in phase III clinical trials involving nearly 20,000 participants, the vaccine is 91.6% effective against the symptomatic forms of Covid-19, validating the claims of the developers from last year. The vaccine was well tolerated and also worked in the elderly and against new strains of the virus. Now they are preparing to study its use for children as well.

‘The reported results are clear and the scientific principle of this vaccination is proven,’ said two British experts involved in the study, Ian Jones and Polly Roy, in a comment attached to the Lancet study – This means that an additional vaccine can now join the fight to reduce the incidence of Covid-19 ».

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Also known as Gam-Covid-Vac, the vaccine uses two adenoviruses (Ad26 and Ad5) as vectors, administered 21 days apart. The recombinant adenovirus approach is shared with the Oxford-AstraZeneca vaccine, which however uses a chimpanzee adenovirus (ChAdOx), the Johnson & Johnson vaccine that only uses Ad26
(detailed results are expected shortly), and China’s CanSino Ad5-based vaccine, whose phase 3 trial began in September 2020.

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Recombinant adenoviruses have been widely used as vaccine vectors because they can ‘harbor’ genetic material and, although unable to replicate, activate the ‘sensors’ of innate immunity sufficiently to ensure a strong immune response.
As a result, they do not need an adjuvant and provide immunity after a single dose. Already in the phase 1/2 trials published in September 2020, the developers had shown evidence of responses also of T lymphocytes, consistent with an immune response that is not expected to decline rapidly over time. The immunity required to prevent the disease occurs within 18 days of the first dose, protection that occurs in all age groups, including those over 65.

“It differs from the others in that the two doses respond to two different viral vectors, which gives it an advantage against the new strains,” said Kirill Dmitriev, head of the Russian Direct Investment Fund (Rdif) which co-finances the vaccine. We have no doubt that the vaccine will be approved by the World Health Organization: not only is it highly effective but it is also one of the most accessible thanks to its low price and ease of logistics and storage ». Storage must take place at temperatures around –18 ° C. The disadvantage of recombinant adenovirus vaccines is that high doses are required, which requires large production and quantification capacities for global launch.

Dmitriev added that tests of the AstraZeneca-Sputnik V combo will start next week in Azerbaijan and the United Arab Emirates. The vaccine mix could prove more effective against the new variants, he said. Rdif also plans to offer the vaccine as a second dose to companies that have vaccines less than 90 percent effective.

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