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  • J&J’s Janssen single-dose Covid Vaccine gets approval for Emergency Use in India

    Published on August 9, 2021

    In a bid to expand India’s vaccine basket, US-based pharmaceutical giant Johnson and Johnson (J&J) single-dose Covid-19 vaccine gets Emergency Use Approval (EUA) from the government of India. J&J becomes the fifth vaccine to get Emergency Use Approval in India by the government of India. The other four vaccines include Bharat Biotech’s Covaxin, Serum Institute of India’s Covishield, SputnikV by Gamaleya Research Institute and Moderna.

    Minister of Health and Family Welfare, Mansuk Mandaviya tweeted, “India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines.”

    J&J has joined hands with Biological E Limited, an Indian biotechnology and biopharmaceutical company based in Hyderabad, for the supplying and manufacturing of the vaccines. The international pharma company earlier in a statement issued on 5th August 2021 has stated that Biological E will be an important part of Johnson and Johnson’s global supply chain network, helping to supply its COVID-19 vaccine, named Janssen through extensive collaborations and partnerships with governments, health authorities and organisations such as Gavi and the COVAX Facility.

    What is Emergency Use Authorization?

    For medicines, vaccines, diagnostic tests, approval of regulatory authority is required before they can be administered to the public. In emergency situations, like the one posed by the Covid-19 pandemic, regulatory bodies around the globe have designed mechanisms in order to grant approvals when sufficient evidence is available to suggest a vaccine or medicine, or a product is safe and effective. Only after the completion of trials and tests, final approval is granted; until then, emergency use authorisation (EUA) allows the medicine or the vaccine to be used on the public. In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).

    Efficacy of J&J’s Janssen COVID-19 Vaccine

    The Delta variant is rapidly taking over in various countries including India and hence, vaccines are the best interventions to get protection against the deadly virus. In July, J&J declared that its vaccine Janssen has generated strong, persistent activity against Delta variants as well, against highly prevalent COVID variants. An eight-month-long study has been submitted to bioRxiv for review which indicated that the usage of a single-shot vaccine has the capability of neutralizing antibody activity against the rapidly spreading Delta Variant. In addition, persistent and particularly robust, the durable cellular immune response has been observed in the Janssen vaccine against the virus.

    The J&J vaccine has been authorised by WHO and is available in most nations on an emergency basis.

    Vaccination Drive in India

    Earlier in July, a statement was issued by Dr NK Arora, who heads the National Expert Group on Vaccine Administration, who hinted that the entire adult population in India will be vaccinated against Covid by December 2021. To date, a cumulative 50,27,98,223 persons have been inoculated whereas 11,05,31,743 of them have received the second dose of the vaccine too.