News Analysis India

Tag: Sputnik Light

  • DCGI grants emergency use permission to single-dose Sputnik Light COVID vaccine

    By PTI

    NEW DELHI: The Drugs Controller General of India has granted emergency use permission to single-dose Sputnik Light Covid vaccine in the country, Union Health Minister Mansukh Mandaviya said on Sunday.

    This comes following recommendations of an expert panel of India’s central drug authority to grant restricted emergency use authorisation to Sputnik Light subject to various regulatory provisions.

    Sputnik-Light is the same as component-1 of Sputnik V.

    “DCGI has granted emergency use permission to single-dose Sputnik Light COVID-19 vaccine in India. This is the ninth COVID-19 vaccine in the country. This will further strengthen the nation’s collective fight against the pandemic,” Mandaviya tweeted.

    An official source said in light of recommendations of Subject Expert Committee (SEC) following a meeting on January 31, Dr Reddy’s Laboratories presented its proposal for grant of permission to import Sputnik Light for restricted emergency use and booster dose vaccination along with analysis of safety and efficacy data including its benefit against Omicron.

    The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.

    “The SEC on COVID-19 of the CDSCO, which deliberated on the application by Dr Reddy’s Laboratories, noted the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the ongoing Phase-3 clinical trial interim data from Russia,” the source said.

    The interim data of efficacy trial from Russia has shown 65.4 per cent efficacy, 21 days after immunization.

    “After detailed deliberation, the SEC had recommended grant of permission for restricted use in emergency situation subject to various regulatory provisions including,” the source said.

  • Govt allows export of Russian COVID vaccine Sputnik Light manufactured in India by Hetero Biopharma

    By PTI

    NEW DELHI: The government has permitted the export of Russia’s single-dose COVID-19 vaccine Sputnik Light domestically produced here as the jab has not yet been approved for emergency use in India, sources said on Sunday.

    Indian drug firm Hetero Biopharma Limited has been allowed to export 40 lakh doses of Sputnik Light to Russia, sources in the know of the developments told PTI.

    Sputnik Light is the same as component-1 of the Russian vaccine Sputnik V which is being used in India’s anti-COVID inoculation programme after getting emergency use authorisation from India’s Drug Regulator in April.

    The Russian ambassador had urged the Indian government to allow the export of Sputnik Light produced by Hetero Biopharma, one of the partners of the Russian Direct Investment Fund (RDIF) in the production of the jab, to his country till the vaccine gets emergency use authorisation from India’s drug regulator.

    In a communication to the Centre, Russian Ambassador Nicholay Kudashev had stated that Hetero Biopharma Limited already has manufactured one million doses of Component 1 of the Sputnik V and two million doses of the Sputnik Light but the six-month shelf life of the vaccine may expire before its registration which will result in the wastage of vaccine doses, sources said.

    “The government has permitted Indian drug firm Hetero Biopharma to export 40 lakh doses of Sputnik Light to Russia. The decision was taken this week following detailed deliberations,” a source said.

    Over the past months, the RDIF has been working closely with Indian pharmaceutical companies to ramp up the production of Sputnik vaccine in India that could be used in the local and global markets, the ambassador had stated in his communication last month.

    At the moment RDIF together with Dr Reddy’s Laboratories is working with authorities concerned on the registration of the Sputnik Light in India.

    “We would like to note that Indian manufacturers of the Russian vaccine are discouraged by the current ban that prevents the use of the produced Sputnik Light vaccine in India and its export to other countries,” stated the communication from the ambassador to V K Paul, chair of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).

    If permanent or time-to-time permission could be granted to Hetero Biophar Limited to export the produced Sputnik Light vaccine by selling it to RDIF until its registration in India, this could encourage the company to scale up the production of the vaccine and provide the Indian market with more supplies of the Sputnik Light by the moment of its regulatory approval, it said.

    The Drugs Controller General of India (DCGI) had in September given permission to Dr Reddy’s Laboratory Limited to conduct phase-3 bridging trials of Sputnik Light in India.

    The DCGI’s permission was based on the recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which held its meeting on August 5.

    According to the recommendations of the SEC meeting held last month, Dr Reddy’s, which has tied up with the RDIF to market the jab in India, presented updated safety, immunogenicity and efficacy data of Phase III clinical trial of Sputnik Light vaccine conducted in Russia, along with the proposal to conduct the clinical trial in India.

    “After detailed deliberation, the committee recommended for grant of permission for conduct of Phase III immune-bridging clinical trial in Indian population subject to the condition”, the SEC recommendation had said.

    The Committee noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies, which gives a measure of the persistence of antibodies in the participants.

    In July, the subject expert committee of the Central Drugs Standard Control Organisation had refused to grant emergency-use authorisation for Sputnik Light.

    The single-dose Sputnik Light vaccine demonstrated 79.4 percent efficacy according to analysed data taken from 28 days after the injection was administered as part of Russia’s mass vaccination program between December 5, 2020 and April 15, 2021.

    An efficacy level of almost 80 percent is higher than that of many two-dose vaccines.

    Sputnik Light has proven effective against all new strains of coronavirus, as demonstrated by the Gamaleya Center during laboratory tests, a press release from RDIF had said on May 6.

  • Russia’s COVID-19 single dose vaccine Sputnik Light gets SEC node for Phase III trials

    By PTI

    HYDERABAD: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation has recommended the conduct of Phase III clinical trials of Russia’s single dose COVID-19 vaccine Sputnik Light.

    According to the recommendations of the SEC meeting held last month, Dr Reddy’s, which has tied up with Russian Direct Investment Fund to market the jab in India, presented updated safety, immunogenicity and efficacy data of Phase III clinical trial of Sputnik Light vaccine conducted in Russia, along with the proposal to conduct the clinical trial in India.

    “After detailed deliberation, the committee recommended for grant of permission for conduct of Phase III immune-bridging clinical trial in Indian population subject to the condition”, the SEC recommendation said.

    The Committee noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies, which gives a measure of persistence of antibodies in the participants.

    The primary endpoint of the trials should be assessed at day 42, 90 and 180 and interim analysis can be conducted at the 42nd as this data was not generated during the Sputnik V trial in India after the first dose, which was stated to be available up to day 21 only, the SEC said.

    The single dose Sputnik Light vaccine demonstrated 79.4 per cent efficacy according to analyzed data taken from 28 days after the injection was administered as part of Russia’s mass vaccination program between December 5, 2020 and April 15, 2021.

    An efficacy level of almost 80 per cent is higher than that of many two-dose vaccines.

    Sputnik Light has proven effective against all new strains of coronavirus, as demonstrated by the Gamaleya Center during laboratory tests, a press release from RDIF had said on May 6.

  • DCGI refuses to grant emergency-use authorisation to single-dose COVID jab Sputnik-Light

    By PTI
    NEW DELHI: India’s drug regulator has refused to grant emergency-use authorisation to single-dose COVID-19 vaccine Sputnik-Light, while ruling out the need for the conduct of the phase-3 trial of the Russian vaccine in the country.

    According to the recommendations of the Subject Expert Committee (SEC) meeting held on July 30, which have been approved by the Drugs Controller General of India (DCGI), Sputnik-Light is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial.

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    According to the SEC recommendations, which were uploaded on the Central Drugs Standard Control Organisation (CDSCO) website on Thursday, Dr Reddy’s Laboratories had submitted a proposal to the DCGI seeking market authorisation of Sputnik-Light, along with the interim safety and efficacy data generated from the phase 1/2 clinical trials in Russia, and presented the protocol for conducting the phase-3 clinical trial of the vaccine in India before the committee.

    The SEC of the CDSCO, which deliberated on the application, noted that Sputnik-Light is the same as the component-1 of Sputnik V.

    Furthermore, the firm has already generated the safety and immunogenicity data of the component-1 in the country.

    The committee also noted that the phase-3 efficacy trial is ongoing in Russia and the efficacy data is yet to be generated, read the recommendations of the SEC.

    “After detailed deliberation, the committee recommended that the firm should present the safety, immunogenicity and efficacy data of the phase-3 clinical trial of Sputnik-Light that is being carried out in Russia for considering the proposal for the grant of MA (market authorisation) in the country.

    “Further, as the safety and immunogenicity data of the component-1 in Indian population has already been generated in the country in another trial, there seems to be inadequate data and justification in conducting a separate, similar trial,” the recommendations read.

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  • Government expects speedy India launch of single-dose Sputnik Light to boost COVID-19 vaccination drive

    By PTI
    NEW DELHI: The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country’s vaccination drive, sources said on Thursday.

    An application seeking regulatory approval for Sputnik Light is expected to be filed in the next couple of weeks and it could become the first single-dose vaccine to be launched in India, sources said citing high-level discussions held among top government officials in the recent days to boost domestic availability of COVID-19 vaccines.

    At a meeting chaired by the Cabinet Secretary last week, it was suggested to immediately convene a meeting with all concerned stakeholders including the Department of Biotechnology Secretary, Drugs Controller General of India (DCGI), the Ministry of External Affairs representatives, the Union Health Ministry officials, RDIF (Russian Direct Investment Fund) and domestic manufacturers to expedite the regulatory approvals for Sputnik Light.

    Also, with the rollout of Sputnik’s one-dose jab, the issue of the criticality of recombinant Adenovirus Type-5 (rAd-5) component, which is used in the second dose of the presently-approved double-dose Sputnik V vaccine and for production of which manufacturers are not very comfortable, will also become redundant, sources privy to the discussions said.

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    On Sputnik Light, it was discussed in the meeting that Russia has already approved this vaccine and trials are ongoing in other countries.

    Drugs Controller General of India (DCGI) informed other participants that the application for regulatory approval of Sputnik Light is expected to be filed in the next 2-3 weeks.

    It was also highlighted during the meeting that six Lakh imported double-dose of Sputnik-V will be available in May 2021, one crore imported doses in June 2021 and 2.8 crore doses (2.4 Crore imported and 40 Lakh manufactured in India) in July 2021, sources said.

    August 2021 onwards, locally manufactured Sputnik V vaccine will be available in the domestic market and technology-transfer arrangement for manufacturing of Sputnik-V vaccine has been firmed up with six Indian manufacturers, sources added.

    The Department of Biotechnology and the Central Drugs Standard Control Organisation (CDSCO) are in touch with all these manufacturers to provide the necessary support to them in setting up their manufacturing facilities.

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    It was also flagged during one recent meeting that the domestic manufacturers are not very comfortable with the production of recombinant Adenovirus Type-5 (rAd-5) component, which is used in the second dose of vaccine, due to its low yield and their inability to fully absorb its production process.

    Another round of meeting with the manufacturers and RDIF is likely to be held soon to resolve this issue.

    At the same time, it was noted that the availability of single-dose Sputnik Light in the domestic market can significantly boost the country’s vaccination drive.

    “Besides, the issue of the criticality of rAd-5 component will also become redundant with its launch. It was, therefore, suggested that NITI Aayog may immediately convene a meeting inviting all relevant stakeholders including the DBT Secretary, DCGI, representative of MEA, representative of Health Ministry, RDIF and domestic manufacturers to expedite the regulatory approvals for Sputnik Light,” another source said.

    The two-dose Sputnik V had received the Indian drug regulator’s permission for restricted emergency use with certain conditions on April 12.

    Dr Reddy’s Laboratories is importing the vaccine for use in India.

    Dr Reddy’s Laboratories Ltd had applied for the grant of permission to import and market Gam-COVID-Vac combined vector vaccine, popularly called Sputnik-V, developed by Gamaleya Institute, Russia for Emergency Use Authorization.

    The Gam-COVID-Vac combined vector vaccine (Component I and Component II) has been developed by the National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and is approved in 30 countries across the world.

    DRL has collaborated with the Russian developer for obtaining regulatory approval for import for marketing in India.

    The interim results of safety immunogenicity and efficacy from the Russian phase-3 clinical trial have been published in the Lancet journal.

    With many states reporting shortage of vaccines, the government is trying to secure imported jabs, including of Russia’s Sputnik vaccines, while talks are also underway for COVID-19 vaccines developed by US majors Pfizer and Moderna.

    Besides, the government is also looking to ramp up domestic manufacturing of vaccines, including those made by Serum Institute and Bharat Biotech, among other Indian manufacturers currently in various stages of their vaccine production.