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The one-component Sputnik Light vaccine has been authorized in India; over 2.5 billion people live in countries that approved Sputnik Light as a standalone vaccine and a universal booster

MOSCOW, Feb. 6, 2022 /PRNewswire=KYODO JBN/ --

- Sputnik Light will be an important part of India's vaccination program and

the fight against mutations of COVID, including Omicron.

- Sputnik Light has been authorized in more than 30 countries with total

population of over 2.5 billion people.

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund)

announces the Russian one-shot Sputnik Light vaccine against coronavirus has

been authorized by the Drug Controller General of India (DCGI).

Thus Sputnik Light has been registered in more than 30 countries with total

population of over 2.5 billion people. A number of countries, including

Argentina, Bahrain, UAE, San Marino and Philippines, have already authorized

Sputnik Light as a universal booster.

A preliminary study of the Gamaleya Center has found that Sputnik Light as a

booster significantly increases virus-neutralizing activity against Omicron,

which is comparable to titers observed after Sputnik V against wild-type virus,

associated with high levels of protection.

A unique comparative study[1] conducted at Lazzaro Spallanzani National

Institute for Infectious Diseases in Italy by a team of 12 Italian and 9

Russian scientists led by Francesco Vaia, Director of the Spallanzani Institute

and Alexander Gintsburg, Director of the Gamaleya Center has shown that Sputnik

V vaccine demonstrates more than 2 times higher titers of virus neutralizing

antibodies to Omicron (B.1.1.529) variant than 2 doses of Pfizer vaccine (2.1

times higher in total and 2.6 times higher 3 months after vaccination).

The study was conducted in the equal laboratory conditions on comparable sera

samples from individuals vaccinated with Sputnik V and Pfizer with a similar

level of IgG antibodies and virus neutralizing activity against Wuhan variant.

Sputnik V showed significantly smaller (2.6 times) reduction of virus

neutralizing activity against Omicron as compared to reference Wuhan variant

than Pfizer vaccine (8.1-fold reduction for Sputnik V in contrast to 21.4-fold

reduction for Pfizer vaccine).

Based on the data collected by the Spallanzani Institute and results of

previous studies, heterologous ("mix & match") boosting with Sputnik Light is

the best solution to increase other vaccines' efficacy and extend the booster

protection period as optimal adenoviral platform configuration provides better

protection against Omicron and other mutations.

Sputnik Light is based on recombinant human adenovirus serotype number 26 (the

first component of Sputnik V). A one-shot vaccination regimen of Sputnik Light

provides for ease of administration and helps to increase efficacy and duration

of other vaccines when used as a booster shot.

Dr. Reddy's Laboratories, a major partner of RDIF in India, has conducted local

clinical trials of Sputnik Light in India. Positive data from these trials have

been presented to India's regulator and contributed to the positive decision by

DCGI.

Clinical studies and the real-world data in many countries have demonstrated

Sputnik Light is a safe and effective vaccine when used both on a standalone

basis and as a booster.

A study in Argentina on heterogeneous regimens combining Sputnik Light and

vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino has

demonstrated that each "vaccine cocktail" combination with Sputnik Light

provided higher antibody titer on 14th day after administering the second dose

as compared to original homogenous (same vaccine as first and second dose)

regimens of each of the vaccines.

Sputnik Light will add to India's national vaccine portfolio and join Sputnik

V, which was approved in the country in April 2021. India is the leading

production hub for Sputnik V.

Sputnik V and Sputnik Light are based on a safe and effective human adenoviral

vector platform and have not been associated with rare serious adverse events

following vaccination, such as myocarditis or pericarditis. The highest safety

and efficacy of Sputnik V and Sputnik Light was demonstrated in more than 30

studies and real-world data from more than 60 countries.

Sputnik V has been authorized in 71 countries with total population of over 4

bn people. To facilitate the necessary production capacities, RDIF has reached

agreements with the leading Indian pharmaceutical companies, including Serum

Institute of India - the world's largest vaccine producer, as well as Gland

Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and

Morepen.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said:

"Authorization of Sputnik Light in India is another major step in successful

cooperation between Russia and India in the fight against COVID. Sputnik Light

has proven to be safe and effective both as a standalone vaccine and a

universal booster shot to vaccines of other producers, helping to induce

stronger immune response as compared to two shots of the same vaccine. The

heterologous boosting approach using Sputnik Light is the solution to increase

efficacy and duration of other vaccines, including against Omicron variant."

[1] https://www.medrxiv.org/content/10.1101/2022.01.15.22269335v1

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Source: The Russian Direct Invest Fund (RDIF)