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Domestic vaccine makers remain unconvinced about the government’s claim that India will have 2.16 billion doses by the year-end as the country grinds through the second wave of the coronavirus pandemic amid severe vaccine shortage.

Senior industry executives said the health ministry’s assumptions on raising vaccine production took them by surprise, given continuing uncertainties about raw material supplies and approvals and the fate of upcoming vaccine candidates winding through clinical trials.

“It appears that the government’s projections are based on the assumption that everything will go smoothly and right on time. It has not been smooth for any manufacturer," an executive with a leading vaccine maker said on condition of anonymity.

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In a presentation last week, NITI Aayog member (health) V.K. Paul projected production estimates of various domestic vaccine makers, citing provisional data. “About 75 crore (750 million) doses of Covishield and 55 crore (550 million) of Covaxin will be produced in that period," Paul said, adding Covaxin will be made by Bharat Biotech and three public sector units through a technology transfer.

However, these numbers may be overly optimistic, given the pace of expanding vaccine production.

Covishield maker Serum Institute, which currently makes 60-70 million doses a month, said in the past that this will go up to 100 million once its capacity expansion is completed in July. This means in the remaining five months of the year, it can make a maximum of 500 million doses, provided everything goes smoothly.

Last month, the department of biotechnology said Covaxin production, which is currently at 10 million doses a month, will be scaled up to 60-70 million by August and 100 million by September. If this proceeds smoothly, up to 470 million doses can be produced by year-end. In both instances, the potential number of doses falls short of the government’s estimates.

Mint sent emailed queries to the Union health ministry and Paul on Tuesday, along with messages to both, seeking to understand the basis of the estimates. No reply was received from either till the time of publishing.

The government’s blueprint estimates Covaxin production boost via three PSUs—Indian Immunologicals, Bharat Immunologicals and Biologicals, and Haffkine Biopharmaceutical Corp. “All three companies either have to repurpose or set up new plants to produce Covaxin, and Bharat Biotech itself has taken over six months to scale up its manufacturing," another top industry executive said on condition of anonymity.

On Sputnik V, Paul on Thursday claimed about 156 million doses will be supplied by Dr Reddy’s Laboratories. A day later, when the vaccine was launched in India, the company said its domestic production will be scaled up by July-September, after which 20-25 million doses are expected to be supplied every month. Going by that projection, the best-case scenario would be 125 million doses in the last five months, over 30 million short of Paul’s numbers. An executive at one of Sputnik V’s India manufacturers said even the July-September target looks challenging since Sputnik’s first and second doses are different and need to be separately manufactured, involving more challenges.

Paul’s presentation also included a total of over 700 million doses of various other experimental vaccines, including Serum Institute’s Covovax, Zydus Cadila’s ZyCoV-D, Biological E’s yet-to-be-branded protein subunit vaccine, as well as Bharat Biotech’s intranasal vaccine and Gennova Biopharmaceuticals’ messenger RNA vaccine.

All these are yet to complete their clinical trials. Experts have questioned their inclusion in estimates, saying it assumes the vaccine will pass muster.

“What has been projected is the best case scenario. While hoping for it, we should plan for other scenarios, too. In case some of the candidate vaccines currently in trials do not pass the regulatory test, or if the currently licensed vaccines cannot scale up speedily to the projected level, we may fall short of our estimates," said K. Srinath Reddy, president of Public Health Foundation of India, adding that the government should be ready to improvize by trying to get international vaccines in such cases.

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