News Analysis India

Tag: Russian vaccine

  • No tie-ups with anyone for supply of Sputnik V Covid vaccine, clarifies Dr Reddy’s

    By Express News Service
    NEW DELHI: Pharma major Dr Reddy’s laboratories on Friday said it has initiated legal action against “unscrupulous elements” committing fraud in the name of the Covid vaccine Sputnik V in India, while announcing that the vaccine will be fully launched in the country only by mid-June.

    In the last few days, there have been several reports from various quarters in India on alleged tie-ups for the Sputnik V vaccine with residents’ associations, the company said.

    This vaccine, whose 2 lakh doses have been imported thus far in India, had been soft launched in Hyderabad about two weeks back but is available for vaccination so far only in limited quantities in a few cities.

    Dr Reddy’s along with the Russian Direct Investment Fund, the sponsor of the Russian vaccine, in a joint statement said that the firm is the brand custodian of the Sputnik V vaccine in India and hasthe sole distribution rights of the first 250 million doses.

    ALSO READ | ‘Covaxin has a production cycle of 120 days’: Bharat Biotech on delayed availability of vaccine

    “We wish to clarify that Dr Reddy’s has not entered into any partnership or collaboration with any party to supply the Sputnik V vaccine to residential associations, nor has the company authorised any third party or intermediary to supply the vaccine on its behalf in India,” said the statement.

    It warned people against unauthorised individuals offering fake deals or procurement of the Sputnik V vaccine posing as its representatives in India and asked them to alert the authorities immediately, if approached.

    Importantly, the company also said that it has fully put in place cold storage logistics as well as track-and-trace arrangements for the vaccine.

    “These arrangements are absolutely imperative to ensure the safety and quality of the vaccine, and for pharmacovigilance.”

    Ahead of the commercial launch of the vaccine in mid-June, Dr Reddy’s continues to engage in direct talks with the government and the private sector to explore partnerships, as per the statement.

  • First batch of Russia’s Sputnik V Covid vaccine to arrive in India on May 1

    Express News Service
    NEW DELHI: The first batch of Sputnik V, the Covid vaccine developed by Russia, is set to arrive in India on May 1, the Russian embassy in the country confirmed to The New Indian Express on Wednesday.

    “…According to Mr Kirill Dmitriev, CEO of the RDIF, the first batch of Sputnik V will be delivered to India on May 1, 2021,” said the Russian embassy in response to a query.

    “That is what we are proceeding from. Yet, don’t have any details on the number of doses,” it also said and added that the details on the stock of vaccine doses for India will be updated later.

    Sputnik V, based on human adenoviral vectors, is one of only three vaccines in the world, along with those by Pfizer and Moderna, with an efficacy of over 90% against SARS CoV 2 infection and was given regulatory approval or restricted use authorisation in India on April 12.

    The vaccine has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology and is supported by Russia’s sovereign wealth fund, RDIF.

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    The two-dose vaccine, which has to be administered 21 days apart, costs about $10 or Rs 750 per dose in the international market but sources said that talks are on between RDIF, its distribution partner in India, Dr Reddy’s Laboratories, and the Indian government on its pricing in the country.

    The Centre has hinted that this vaccine, apart from other foreign vaccines that get available in India in the future, may be available only in private hospitals where people will have to pay directly for them as per the new liberalised Covid vaccination policy under which all adults qualify for Covid vaccines. 

    Though no official response could be elicited from Dr Reddy’s on the development, its management has earlier said that the initial quantity of Sputnik V that will be supplied in India is set to be limited as they will be imported from Russia.

    However, RDIF’s manufacturing partners in India — at least four other companies apart from Dr Reddy’s — will start producing the jabs locally by July, after which the supplies are likely to be scaled up.

    The news on Sputnik V comes amid concerns that despite a frightening expansion of the Covid pandemic in India, the vaccination, mainly due to the shortage of Covishield and Covaxin, has not picked up the pace required to arrest the pace of the infectious disease.

    Health economist Rijo M John pointed out that daily average jabs continue to decline from 3.7 million per day to 2.5 million over the past 20 days.

    “There has been a 31% fall in the daily vaccination rate from its peak,” he said. “The country needs to administer at least 7.5 million jabs per day to fully vaccinate all eligible adult population by the end of this year.”

    As per the government figures, 16 crore vaccine doses of the two available vaccines have been supplied to the states so far, while 57,000 more doses are set to be dispatched within the next 3 days but those can be used only for vaccinating those above 45 years of age.  

  • India gets third Covid vaccine as experts approve Russia’s Sputnik V

    Express News Service
    NEW DELHI: As India faces an avalanche of Covid cases, the expert panel of the apex drug regulator on Monday recommended the use of Russia’s Covid vaccine Sputnik V in the country’s vaccination drive.

    This approval comes amidst the clamour to approve other Covid vaccines in India irrespective of their bridging trial status in the country. 

    The authorities too concede that while bridging trial data from the country is required to authorize the use of any vaccines in the country under the existing norms, it may be exempted under the present clinical trial norms. 

    Sputnik V, based on human adenoviral vectors, is one of only three vaccines in the world, along with those by Pfizer and Moderna, with an efficacy of over 90%.

    The two-dose vaccine which has to be administered 21 days apart, costs about $10 or Rs 750 per dose in the international market.

    The decision in India comes after the Central Drug Standards Control Organization’s subject expert committee on Covid met on Monday to consider the Sputnik V application for Emergency Use Authorization in India.

    The vaccine developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology which has shown nearly 91.6% efficacy against infection and 100% efficacy against severe disease had become the world’s first registered vaccine against Covid-19 in August last year.  

    The adenovirus-based vaccine can be stored at a comfortable 2-8 degree Celsius and is also being produced in the lyophilized (dry) form which makes it easier for distribution purposes.

    ALSO READ | COVID-19: RDIF collabs with Panacea Biotec to produce 100 million doses of Sputnik V vaccine in India

    Dr Reddy’s Laboratories, along with at least four other companies, have tied up with the Russian Direct Investment Fund — the codeveloper of Sputnik V, for the vaccine’s production in India.

    Top sources in the drug regulator said that the Drug Controller General of India will now consider SEC recommendation for the third Covid vaccine to be available in India amid reports of vaccine shortage in many states.

    The first two are Serum Institute of India’s locally-made AstraZeneca- Oxford University Covid-19 vaccine Covishield and Bharat Biotech’s indigenously manufactured Covaxin.

    Sputnik V is likely to be imported from Russia initially for emergency use in the country, government sources said.

    India is currently in the third phase of its mega Covid-19 vaccination drive which began on 16 January 2021. So far, nearly 10.5 crore vaccine doses have been administered through 15,56,361 sessions, as per the provisional report till Monday morning.

    Last Friday, CDSCO’s expert panel had sought additional data from drugmaker Dr.Reddy’s Laboratories on its Sputnik V Covid vaccine trial, in its second such request after an initial evaluation in February.

    The committee had earlier also asked the firm to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported to date.

  • India gets third Covid vaccine as experts approve Russia’s Sputnik V

    Express News Service
    NEW DELHI: As India faces an avalanche of Covid cases, the expert panel of the apex drug regulator on Monday recommended the use of Russia’s Covid vaccine Sputnik V in the country’s vaccination drive.

    Sputnik V, based on human adenoviral vectors, is one of only three vaccines in the world, along with those by Pfizer and Moderna, with an efficacy of over 90%.

    The two-dose vaccine which has to be administered 21 days apart, costs about $10 or Rs 750 per dose in the international market.

    The decision in India meanwhile comes after the Central Drug Standards Control Organization’s subject expert committee on Covid19 met on Monday to consider the Sputnik V application for Emergency Use Authorization in India.

    The vaccine developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology which has shown nearly 91.6% efficacy against infection and 100% efficacy against severe disease had become the world’s first registered vaccine against Covid-19 in August last year.  

    The adenovirus-based vaccine can be stored at a comfortable 2-8 degree Celsius and is also being produced in the lyophilized (dry) form which makes it easier for distribution purposes.

    ALSO READ | COVID-19: RDIF collabs with Panacea Biotec to produce 100 million doses of Sputnik V vaccine in India

    Dr Reddy’s Laboratories, along with at least four other companies, have tied up with the Russian Direct Investment Fund — the codeveloper of Sputnik V, for the vaccine’s production in India.

    Top sources in the drug regulator said that the Drug Controller General of India will now consider SEC recommendation for the third Covid vaccine to be available in India amid reports of vaccine shortage in many states.

    The first two are Serum Institute of India’s locally-made AstraZeneca- Oxford University Covid-19 vaccine Covishield and Bharat Biotech’s indigenously manufactured Covaxin.

    Sputnik V is likely to be imported from Russia initially for emergency use in the country, government sources said.

    India is currently in the third phase of its mega Covid-19 vaccination drive which began on 16 January 2021. So far, nearly 10.5 crore vaccine doses have been administered through 15,56,361 sessions, as per the provisional report till Monday morning.

    Last Friday, CDSCO’s expert panel had sought additional data from drugmaker Dr.Reddy’s Laboratories on its Sputnik V Covid vaccine trial, in its second such request after an initial evaluation in February.

    The committee had earlier also asked the firm to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported to date.