Can Bharat Biotech Deliver the Covaxin Doses It Promised?

As we crunch numbers, and look at the projections on Covaxin - it's clear that those goals are highly inflated.

What is Bharat Biotech's capacity to produce Covaxin? Can it scale up to deliver? 

(Photo: The Quint)

As per Government of India projections, Bharat Biotech will deliver 55 crore doses of its COVID-19 Covaxin between August to December.

But as we crunch numbers, and look at these projections - it's clear that those goals are highly inflated.

While the government has roped in some pharma Public Sector Undertakings (PSUs) to expand Covaxin's production, those timelines extend well beyond 2021.

But before we get into any more details, it's important to underline that Bharat Biotech has till date not released full phase 3 data of its vaccine, months after concluding the trials, and months since the vaccine has already been administered to millions of people.

Nor do we have any real-world effectiveness data on the vaccine produced in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

Claims, And Why They Don't Add Up

On 15 May, amid mounting criticism of its vaccine policy, the Government of India presented some optimistic projections. According to those projections, the country would have 216 crore vaccines by the end of 2021, enough to vaccinate its entire population.

Among those projections was a heavy dependence on two vaccines that have been approved for emergency use in India - Serum Institute's Covishield and Bharat Biotech's Covaxin.

They said between August and December 2021, Bharat Biotech would produce 55 crore doses of Covaxin. To achieve that goal, Bharat Biotech would have to produce 11-12 crore vaccines a month, a projection the GOI said Bharat Biotech will be able to achieve as soon as July. But it gave no breakup of how they will achieve their targets.

By the GOI's own admission in this Affidavit to the Supreme Court dated 9 May, the company was producing Covaxin at the capacity of only 1 crore doses a month, and will take another 8-10 months to scale up to 11 crore doses a month.

What Has Bharat Biotech Said?

Bharat Biotech has previously said that it has the capacity to make 50-70 crore doses a year. If one goes with 70 crore figure, that would come to around 5.8 crore doses a month.

The pharma major in a recent statement did say that they will be able to produce 100 crore annual doses - but the timeline for that is last quarter of 2021.

So how many vaccine doses has Bharat Biotech supplied so far? This is what we know according to a Health Ministry release:

India has placed a total order of 7 crore vaccines with Bharat Biotech. Of this, the order for 5 crore Covaxin was placed on April 28. To meet this order will take time till July. According to its own release on May 28, it taken 4 months from manufacturing to supply of vaccines. The release states:

Production scale-up of vaccines is a step-by-step process, involving several regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices). There is a four-month lag time for Covaxin to translate into actual vaccination.

Where All is Bharat Biotech Making Covaxin?

In a release on 20 May, Bharat Biotech said that in addition to the multiple Production lines at its Hyderabad & Bengaluru campuses, they plan to add Chiron Behring, in Ankleshwar Gujarat, a wholly owned subsidiary of Bharat Biotech.

The company plans to produce 20 crore annual doses of Covaxin here starting the last quarter of 2021. By including this facility, they say they will be in a position to produce 100 crore doses annually by last quarter of 2021.

What About Pharma PSUs?

In its affidavit to the SC, the GOI said that under Mission COVID Suraksha, the government is providing support to one private industry (BB) and three public sector manufacturing facilities, to augment vaccine production over the next 6-8 months. The pharma PSUs include Indian Immunologicals, Hyderabad; Haffkine Biopharmaceuticals, Mumbai; Bharat Immunologicals and Biologicals, Bulandshar.

On 2 June, in an interview to ANI, Sandeep Rathod, Managing Director of Haffkine said that they will be in the position to supply 22 crore vaccines annually once their Bio-safety lab for production of Covaxin is ready.

Currently, the formalities of technology transfer from Bharat Biotech are under process.

And how long with it take to get the Bio-Safety Lab (BSL)-III ready? 8 months, said Rathod. This takes us well into 2022.

There are similar upgrades that will have to be made at other PSUs before vaccines can be made there. Setting up BSL-III labs is a long drawn process, and one where you don't want to make any compromises.

Once India's golden goose, India's much celebrated indigenous vaccine has faced problems from day, often due to the government's own bungling - from premature approvals, delay in reporting clinical data, delay in placing orders and lack of planning and foresight in vaccinating a country the size of India.