According to sources, though the process of transfer of technology by J&J to Indian vaccine maker Biological E has been initiated, it could take another 4-5 months for all the required processes to be completed and full-fledged manufacturing of the vaccines to begin in India.
The `Made in India’ J&J vaccine is expected to be available for use only after September, sources said, adding that the export restrictions imposed by the US government on critical vaccine raw materials was one of the key reasons that set back the entire process by nearly a couple of months.
While officials of both, J&J and Biological E, declined to comment on the issue, a top department of biotechnology (DBT) official is reported to have recently said that imports of the J&J vaccine for `fill-finish’ in India could happen as early as June-July this year.
Last month the Indian government waived the requirement to conduct bridging trial studies before granting emergency use authorisation to foreign-made vaccines that have been approved by regulatory bodies of United States, Europe, Japan or United Kingdom, considered among the most stringent globally.
As per the new norms, these vaccines can be imported into the country in ready-to-use vials or `fill and use’ form. However, such vaccines would have to be subjected to post-approval parallel studies in the Indian population, with the first 100 beneficiaries being assessed for seven days for safety before being allowed a full-fledged rollout under the immunisation programme.
J&J had, in August 2020, inked a pact with the Hyderabad-based vaccine maker to manufacture around 500 to 600 million doses per annum of its single-dose Covid-19 vaccine called Ad26.COV2.S, which will be manufactured at the Genome Valley facility of Biological E.
The vaccine has also been identified as a key weapon in the Quad’s (Quadrilateral Security Dialogue) arsenal to counter China’s influence in the Indo-Pacific region, as part of which the US International Development Finance Corporation (DFC) will be extending financial support to Bio E to help it ramp up capacities to manufacture at least 1 billion doses of Covid-19 vaccines by 2022.