As the virus continues to play a game of whack-a-mole with the healthcare system worldwide, the vaccine supply crunch is universal and yet infinitely particular to India. From 3-9 April, a total of 24.7 million doses of vaccine were administered, the highest ever, but the numbers dropped drastically due to vaccines being in short supply. Between 15-21 May, only 9.2 million doses were given.
Indian policy makers, the Covid Taskforce, specifically, have been playing their own game of whack-a-mole with vaccine registration, procurement, pricing, and now total availability by the end of the year. It appears the Taskforce put numbers in a spreadsheet—which seem to have multiplied faster than the virus—and shared it with the media on 13 May. With Niti Aayog’s member (health) Vinod Paul announcing that 2.1 billion doses would be procured, the Taskforce assumed their job during the pandemic peak was done.
Then, as if as a bonus or even a safety net, the government asked three public sector units (PSUs)—Haffkine Biopharma in Mumbai, Indian Immunologicals Ltd in Hyderabad, and BIBCOL in Bulandshahar, to step up and produce Bharat Biotech’s Covaxin.
This spreadsheet math doesn’t add up, neither for immediate needs, nor for future-proofing.
The company at the top of this list, Serum Institute of India, hasn’t commented on these numbers. However, The Ken has reliably learnt that producing 150 million doses per month between August and December—as mentioned in the above chart—is simply not possible. Serum hasn’t scaled manufacturing to that level yet even though it has diverted other production lines for Covid vaccines.
Purported to produce 550 million doses over the next five months, Bharat Biotech has committed only 80 million doses till date. The company has further commissioned its animal vaccine facilities in Malur in Karnataka and Ankleshwar in Gujarat to produce its inactivated vaccine, Covaxin. The Hyderabad-based company now says it can manufacture 1 billion doses by December. But can it, really?
Even if Malur and Ankleshwar plants are GMP GMP Good Manufacturing Practices A system put in place by drug regulators for ensuring that products adhere to quality standards consistently, every time they are manufactured compliant, industry experts say, the qualification process itself can take up to six months. The latter plant uses the same platform—vero cell. At Malur, The Ken has learnt, the company uses a different platform—submerged cell culture—for producing a foot and mouth disease vaccine. Repurposing it for Covaxin will take more time than the company has indicated.
“The regulatory processes require carrying out limited comparability studies with the vaccine produced in Hyderabad. Then, if the regulators are satisfied with the results of three consistency batches instead of human studies of safety and immunogenicity, it can get expedited approval in about a month’s time thereafter,” says a vaccine manufacturing expert in Hyderabad.