NEW DELHI: 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.
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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.
Meanwhile, More than 1.84 crore COVID-19 vaccine doses are still available with states and UTs and they will receive over 11 lakh doses within the next three days, the Union Health Ministry said on Thursday.
The Centre has so far provided, both through the free of cost category and through direct state procurement category, more than 22 crore vaccine doses (22,16,11,940) to states and UTs.
Of this, the total consumption, including wastages is 20,17,59,768 doses, the ministry said.
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As part of the nationwide vaccination drive, the Centre has been supporting the states and UTs by providing them COVID-19 vaccines free of cost.
The Centre has also been facilitating direct procurement of vaccines by states and UTs.
Implementation of the Liberalized and Accelerated Phase-3 Strategy of COVID-19 Vaccination has started from May 1.
Under the strategy, every month 50 per cent of the total Central Drugs Laboratory (CDL) cleared vaccine doses of any manufacturer would be procured by the Centre.
It would continue to make these doses available to state governments free of cost as was being done earlier, the ministry said.
“More than 1.84 crore COVID-19 vaccine doses (1,84,90,522) are still available with states and UTs to be administered.”
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“Furthermore, 11,42,630 vaccine doses are in the pipeline and will be received by states and UTs within the next three days,” the ministry added.
The cumulative number of COVID-19 vaccine doses administered in the country has exceeded 20.25 crore, the Union health ministry said on Wednesday.
It said 8,31,500 beneficiaries in the 18-44 age group received the first dose of Covid vaccine on Wednesday and cumulatively 1,38,62,428 people across 37 states and union territories have received it since the start of Phase-3 of the vaccination drive on May 1.
Bihar, Gujarat, Rajasthan and Uttar Pradesh have administered the first dose of Covid vaccine to more than 10 lakh beneficiaries in the 18-44 age group, the ministry said.
According to provisional data, the total number of COVID-19 vaccine doses administered across the country so far stands at 20,25,29,884, it said.
The beneficiaries include 98,08,901 healthcare workers (HCWs) who have taken the first dose and 67,37,679 HCWs who have taken the second dose; 1,52,42,964 frontline workers (FLWs) who have received the first dose and 84,00,950 FLWs who have taken the second dose; and 1,38,62,428 individuals in the 18-44 age group who have taken the first dose.
Besides, 6,26,09,143 and 1,01,11,128 beneficiaries in the 45-60 age group have been administered the first and second dose respectively while 5,73,45,128 and 1,84,11,563 beneficiaries aged above 60 have taken the first and second dose.
As many as 17,19,931 vaccine doses were administered on Wednesday, the 131st day of the vaccination drive.
According to provisional data, 15,76,982 beneficiaries were administered the first dose and 1,42,949 received the second dose, the ministry said, adding that final reports for the day would be completed by late night.
The vaccination exercise, as a tool to protect the most vulnerable population groups in the country against COVID-19, continues to be regularly reviewed and monitored at the highest level, it said.