Johnson and Johnson's COVID-19 vaccine to be manufactured in India by Biological E cannot be directly channelled to the domestic market and will have to be handed over entirely to the US pharma giant as agreed by the firms but the government is looking at the possibility of securing a part of this production, sources said. Hyderabad-based Biological E has, however, proposed to manufacture about 30 crore doses of its indigenous vaccine exclusively for the Indian market by December and has sought "funding support" from the government. Its vaccine candidate is currently in phase 1/2 clinical trial phase.
According to the sources, there are limited prospects of J&J exporting its vaccine from the US to other countries in the near future and the "entire production" at the BE facilities in India, beginning July/August, will be handed over to the pharma giant under a contract between the companies. The Ministry of External Affairs (MEA), along with the Department of Biotechnology (DBT), has been asked to work on securing a part of the J&J vaccine to be manufactured by BE for the Indian market, the sources said. The government is exploring all avenues to boost vaccine supply urgently to inoculate the billion-plus population amid a devastating second wave of COVID-19, and the Cabinet Secretary chaired two rounds of high-level meetings last week on the availability of the shots in the global as well as domestic markets.
The heads of the Quad member-countries — the US, India, Japan and Australia — had decided at a virtual summit in March to launch a mega vaccine initiative. Under the agreement, coronavirus vaccines will be produced in India for the Indo-Pacific region with financial assistance from the US and Japan, while Australia will contribute in logistical aspects. Biological E is likely to start "fill and finish" of the J&J vaccine in July-August and manufacturing of the vaccine in the last quarter of the year. The Development Finance Corporation of the United States is supporting BE for setting up three additional fill and finish lines, exclusively for J&J vaccine, and they plan to manufacture about 1 billion doses by the end of 2022, the sources said.
The sources privy to the discussions said another US pharma company, Moderna, does not have surplus jabs to share in 2021, and is expected to launch a single-dose COVID-19 vaccine in India next year. Pfizer is ready to offer five crore shots in 2021 itself but it wants significant regulatory relaxations, including indemnification and waiving the requirement of testing its vaccines in Central Drugs Laboratory, sources said earlier. Many states have flagged shortage of vaccines and the gap between supply and requirement is widening amid the deadly second wave. India has administered over 20 crore doses since the launch of the vaccination drive in mid-January.
India is currently using two 'made-in India' jabs – Covishield manufactured by the Serum Institute and Covaxin of Bharat Biotech – and Russian-made Sputnik V to inoculate its population. A few more indigenous vaccines, including the ones made by Biological E, Zydus Cadila and Gennova, are in the pipeline. For its indigenously developed vaccine, Biological E has sought funding support from the government for at-risk manufacturing, essentially for the import of adjuvant which is in "high demand" in the international market.
A sub-committee has examined the funding proposal of Biological E and given its recommendation to the health ministry, the sources said. The health ministry has been asked to take immediate decision on the funding proposal of Biological E, they added.
In the high-level meetings chaired by the Cabinet secretary, officials from the MEA, NITI Aayog, Department of Biotechnology, and law health ministries were present.
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