India’s Covid-19 vaccination drive is unlikely to get much help from public sector institutions roped in to push up production of the indigenous vaccine, Covaxin, if one goes by the progress reported by these organisations.

Barring Indian Immunologicals Limited (IIL), the Hyderabad-based subsidiary of the National Dairy Development Board, no other unit is likely to be in a position to commence vaccine production before December.

Vaccine makers are expected to supply over 51 crore vaccine doses by end July and another 135 crore doses between August and December to help vaccinate 93 crore Indians, according to a Government affidavit in the Supreme Court.

Two PSUs — Bharat Immunologicals and Biologicals Corporation (BIBCOL) under the Department of Biotechnology (DBT) and Haffkine Biopharmaceutical Corporation (under the Maharashtra Government) — have said they would start Covaxin production only next year. The Gujarat Biotechnology Research Centre (GBRC) may start producing earlier but not before November-December.

“We are moving as per the plan. We have started with the manufacturing and the first batch is already under testing,” said IIL Managing Director Anand Kumar. IIL is first off the block because it has a Biosafety Level-3 (BSL-3) facility, a must for handling deadly pathogens.

Kumar said IIL will make about 2-3 million doses a month initially in the first phase, and in the second phase, starting November-December, it would add another five million doses a month.

“By December we will be able to make a total of about 8 million doses a month. We are building a new facility at the same site, and it will be ready by December,” said Kumar.

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Officials with BIBCOL, the Bulandshahr-based state-owned firm, specialising mainly in polio vaccine-making, said, it may need another five months to roll out Covaxin from its facility. “Currently we are in the process of setting up a BSL-3 facility, which is essential for handling the virus. We expect to start Covaxin production by early next year,” said YK Gupta, Chairman of Board of Directors, BIBCOL. Initially, the production would be 3 million doses a month, which would be ramped up to 7 million in three to four months and later beyond 10 million, Gupta said.

GBRC, which along with Ahmedabad-based animal vaccines maker, Hester Biosciences Limited, and OmniBRx Biotechnologies Private Limited, said it has already signed an MoU with Bharat Biotech for production of necessary drug substances for the vaccine production in Gujarat.

Rajiv Gandhi, MD, Hester Biosciences, said the term-sheet has already been signed and all the documentation has been finalised. "Construction is going on towards creating the required BSL-3 facility. We believe we would be able to go into production in the month of November or December," said Gandhi.

"The initial plan was to go for the production starting August 2021. But it seems that the process will take a little longer than that," said a source without divulging further details.

Haffkine Biopharma, which also received grants like others from the Centre for preparing themselves to produce Covaxin, said in June that it would be take at least eight months before this 125-year-old vaccine making facility becomes ready for producing Covaxin.

Even though Bharat Biotech has commited four plants to produce Covaxin, not all four have started producing the vaccine as yet. As a result, the current production capacity of the firm is around 25 million doses a month whereas it needs to ramp up the production to at least 80 million doses a month if it has to meet the target of 400 million (or 40 crore) by December. In addition, it has to clear a backlog of around 6 crore doses by end of July.

A Bharat Biotech source said, uncertainty had back the ramp-up. Now that phase 3 trials results are encouraging, the management will not hesitate to speed up the work.

(With inputs from Jyothi Datta PT)

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