Graffiti on a street in Mumbai, March 30, 2021. Photo: Reuters/Francis Mascarenhas/Files
- How did India’s indigenous COVID-19 vaccine become an also-ran when it had been touted as one of the two mainstays of the ‘world’s largest’ vaccination drive?
- The answer matters because the Centre has amply supported Bharat Biotech, and showcased its preference for this ‘Made in India’ product on many an occasion.
- The Centre has cut a sorry figure since the company’s deliveries have fallen far short of its claims, while the vaccine is not at all the unalloyed success it could have been.
Even as India has administered close to 240 million doses of COVID-19 vaccines in September 2021, at an average of 80 million doses a day – which is double that of July – its Covaxin conundrum lingers.
Covaxin accounts for only 102 million doses, which is merely 11% of the total of almost 900 million COVID-19 vaccine doses administered in the country up to September. About 36 million doses were administered in five months up to June and 66 million from July to September, which is an average of just 22.3 million doses per month in the last three months.
Covishield, the AstraZeneca/Oxford University vaccine manufactured by Serum Institute of India, makes up the bulk of doses. Sputnik V, developed by the Gamaleya Institute in Russia, accounts for a minuscule 4.4 million doses.
The question is why and how India’s first indigenously developed vaccine became an also-ran when in fact it had been touted as one of India’s two mainstays of the ‘world’s largest’ vaccination drive (the other being Covishield).
This is especially pertinent as the Centre has consistently provided ample support to Bharat Biotech, which co-developed and manufactured the vaccine, and showcased its pride in and preference for this completely ‘Made in India’ product on every occasion. Prime Minister Narendra Modi, many senior ministers and bureaucrats have personally taken Covaxin shots and encouraged others to do so.
The supply conundrum
Bharat Biotech developed Covaxin from a viral strain it received from the National Institute of Virology (NIV), Pune. Both NIV and the Indian Council of Medical Research (ICMR), its parent body, collaborated with the company in conducting animal studies and clinical trials, giving the Centre a stake in the product.
The Centre however handed the rights to manufacture Covaxin over to just Bharat Biotech, even when it was no secret that this company had a low production capacity relative to the demand. One explanation is that the Centre underestimated demand and overestimated capacity, and woke up to reality only after the second wave barrelled into India in April this year.
On May 14, under pressure from the Supreme Court, the Centre announced a new plan to procure 2,160 million COVID-19 vaccine doses from different manufacturers between August and December. Of this, Covaxin would constitute 550 million doses, at 110 million doses a month. Then, about six weeks later, it sharply cut the total projection to 1,350 million doses and Covaxin to 400 million doses for the same period, at 80 million doses a month, in an affidavit to the Supreme Court. Finally, the Centre said it expected only 30 million Covaxin doses in August, marking another large reduction. But even this was not met.
Bharat Biotech has not often declared its capacities or committed supplies. In January 2021, its managing director Krishna Ella announced that the company would produce 700 million doses in 2021 through multiple facilities. That works out to 65 million doses a month, on average. But at the time, it was capable of producing just about 5 million doses a month.
The company’s new facility at Malur, Karnataka, should reportedly have churned out 40-50 million doses by August end. In May, the company shared a plan to produce around 200 million Covaxin doses at a subsidiary based in Ankleshwar, Gujarat.
Since then, information from the company has been sketchy and not much progress seems to have been made in procuring doses from the new facilities.
The first batch from the Ankleshwar factory was approved for sale sometime in August. But the company hasn’t announced any commitments on how many doses we can expect from these locations in the coming months.
Biovet, an associate of Bharat Biotech that was expected to begin production at its plant near Pune by end-August, has just started production of engineering batches. This implies manufacturing of commercial batches is a few weeks away.
So much for Bharat Biotech’s plans to augment its capacity. Amidst great fanfare, the Centre also announced its plans to upgrade three public sector plants – Haffkine Biopharmaceutical Corporation, Ltd., Mumbai; Bharat Immunologicals and Biologicals, Ltd., Bulandshahr; and Indian Immunologicals, Ltd., Hyderabad – to manufacture 40-50 million Covaxin doses per month, under its ‘Covid Suraksha’ mission.
None of these plants are operational as of now – not an unexpected outcome since facility upgradation and validation, technology transfer, production and testing require more than a few months. And in any case, the Centre’s initiative to extend Covaxin production came too late and was restricted to only PSU sites. Its expectation that manufacturing could begin at these sites within a few months was unreasonable and unscientific.
Now, Ella says that the company is planning to ramp up production from 35 million in September to 55 million in October. This just underlines that there is no accountability for supplies from both the company and the Centre so far – even though the gap between promise and actual delivery continues to be really wide.
Vaccine manufacturing is a complex and time-consuming process, more so when it involves multiple facilities in different cities. Availability of trained personnel and materials can pose serious obstacles to scaling up production. Nonetheless, a company that has been in the business of vaccines for over three decades and has aspirations to market its product around the world could have done better. At the least, it should have been more forthcoming about its constraints and supplies.
On its part, the Centre added to the lack of clarity by floating new numbers often without any explanation. The goalposts shifted with such frequency that it became hard to just keep track of the latest commitments. In the beginning, the Centre didn’t place any orders with the company and didn’t tie it down on deliverables. Later, it placed large orders that were out of sync with the actual capacity, thus raising public expectations that it knew would be let down.
The quality conundrum
On the quality front, too, all is not well. Bharat Biotech has hardly been transparent about the conduct of Covaxin clinical trials and how it handled adverse side effects reported there. Neither the company nor India’s regulatory authorities have addressed the many doubts raised on these issues.
Credible questions from concerned experts have been met by incredible claims describing the vaccine as “200% safe” compared to others in the world, sans any apparent basis. Even the Drugs Controller General of India said at the time he approved the shot that it was “110% safe”.
Such self-serving propaganda tends to fuel scepticism and sometimes vaccine hesitancy. Though Covaxin has been in use in India since January 2021, and the results of the phase 3 trials demonstrated a 78% efficacy, it has not been able to gain international acceptance.
This is also because the company’s foray into the international COVID-19 vaccine market has been marred by allegations of corruption and unethical business practices. Brazil’s regulatory body, Anvisa, raised doubts about Covaxin’s quality in May, and the South American country suspended orders in July. The US Food and Drug Administration rejected the company’s application for emergency use authorisation in June. The WHO approval of Covaxin is yet to materialise.
Many Indians, especially students, who intend to study abroad and have taken two shots of Covaxin are considered unvaccinated for all practical purposes by most foreign countries.
In recent times, the development and launch of Covaxin provides a good example of the truism that politics is ubiquitous.
The first signs surfaced as early as July last year, when ICMR chief Dr Balram Bhargava directed sites involved in clinical trials of Covaxin to to accelerate the trials so that the vaccine could be launched by August 15, 2020. This ludicrous demand was quickly withdrawn after the press and public health experts raised a hue and cry.
In November 2020, Bharat Biotech confirmed that phase 3 results would be available only by March or April 2021, while ICMR was confident the vaccine would be available by February 2021. This time politics won. Following a high-profile visit by the Prime Minister to the company’s plant later that month, Bharat Biotech applied for emergency use approval.
In spite of misgivings expressed in many quarters, the regulator approved Covaxin for “restricted use in emergency situation in public interest as an abundant precaution in clinical trial mode” – a phrase that the government couldn’t explain satisfactorily.
This haste actually made for a botched rollout of the vaccine, with rampant shortage and failed expectations. Covaxin became and has since remained a minor player in India’s COVID-19 vaccination drive.
For unknown reasons, the Centre allowed all rights to manufacture a vaccine developed in collaboration with government institutions to a private company that had little capacity. It is incomprehensible that the government did this even as it was arguing with the World Trade Organisation to suspend intellectual property rights for all COVID-19 vaccines and technologies developed by companies around the world.
Malini Aisola, co-convenor of the All India Drug Action Network, a public health group, said that the government has helped create a monopoly. She considers it highly problematic that other private firms that, at various stages, expressed interest in making this vaccine haven’t been granted licenses, and thinks that the government has exercised a deep control over Bharat Biotech and the vaccine.
As if its support of the company when it was failing to meet expectations was not enough, the Centre allowed Bharat Biotech a substantial price hike from Rs 200 per dose to Rs 600 per dose for supplies to state governments and Rs 1,200 per dose for private hospitals, exactly double the price at which Covishield was being sold to private hospitals.
While the differential pricing between supplies to the Centre and the states no longer holds, the price for private hospitals has been left unchanged. Ella has conveniently forgotten his own claims in November 2020 that his vaccine would cost less than a bottle of water.
Unfortunately, the Centre-company association on Covaxin has been detrimental for all stakeholders. The Centre has cut a sorry figure since the company’s deliveries have fallen far short of all its tall claims. Its celebrated ‘Made in India’ vaccine is not at all the unalloyed success it could have been. Bharat Biotech has undermined its own reputation, and the pharmaceutical industry of India has lost some credibility as a reliable supplier of low-cost, good-quality vaccines.
Ultimately, of course, the people have been the losers, as they have been deprived of vaccines in time and have been repeatedly misled by both Bharat Biotech and the Centre.
While time may provide some redemption, for now, an iconic line from lyricist Anand Bakshi comes to mind:
Majhi jo naav duboye, usse kaun bachaye?
‘Who can save the boat that the boatman himself capsizes?’
Neeta Sanghi has over three decades’ experience in managing pharmaceutical supply chains. She is currently working on a book about the industry.