Covaxin output cycle may hit Centre’s deadline

Each batch takes 4 months, says Covaxin manufacturer Bharat Biotech.

May 28, 2021 11:20 pm | Updated May 29, 2021 07:03 am IST - NEW DELHI

A staff nurse displays vials COVAXIN at the vaccination centre in District Hospital King Koti, Hyderabad on May 28, 2021.

A staff nurse displays vials COVAXIN at the vaccination centre in District Hospital King Koti, Hyderabad on May 28, 2021.

Amid claims by the Centre that “all Indians” would be vaccinated by the year end, Bharat Biotech, the manufacturer of Covaxin, has disclosed that it takes 120 days — or about four months — for a manufactured batch of vaccines to be released for supply. “Thus, production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June,” the company said in a statement on Friday.

So far about between 2-2.5 crore doses of Covaxin have reportedly been supplied.

Also read | WHO nod for Covaxin likely in July-September: Bharat Biotech

Earlier this month, V.K. Paul, who heads India’s National Empowered Group on Vaccines stated that 216 crore doses of vaccine would be available by December.

Nearly 60%, or about 130 crore and enough to inoculate every Indian once, is premised on quantum jumps in the supply of the two vaccines Covishield and Covaxin, with 50-55 crore of the latter.

According to a statement from the Department of Biotechnology on April 15, Bharat Biotech is to scale up production to 6-7 crore doses a month from July-August and 10 crore doses, a month from September. This works out to at least 52 crore doses from July-Dec, of which 40 crore is marked out from September-December.

Also read | India to push for Covaxin recognition by WHO and EU

However, from what Bharat Biotech has stated about the time lag between production and supply, it appears this tranche may have to be excluded for this calendar year.

The Centre has administered 2.1 crore doses as of Friday and, including doses of Covaxin in the pipeline, has got 3.1 crore doses from Bharat Biotech since the vaccine drive began in January. It had got a committment for another 1 crore by June end, the Health Ministry said on Friday.

The government has placed an order for 7.5 crore doses so far of Covaxin, according to a Right To Information request response from the Health Ministry to activist Kanhaiya Kumar on Friday. If the requirement of about 4 crore is fulfilled by June, that still leaves a gap of about 3.5 crore doses.

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Thus if the expanded production of July-August (12 crore) numbers (to be available in November and December) are clubbed, that works out to 15.5 crore being available for the year, which is about 30% of Dr Paul’s estimate.

“The manufacturing, testing, release and distribution of vaccines is a complex and multifactorial process with hundreds of steps, requiring a diverse pool of human resources. 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,” the company said.

All vaccines supplied in India are to be submitted for testing and release to the Central Drugs Laboratory, Government of India. It takes two days for vaccine supplies to reach the depots of the State and Central governments from Bharat Biotech’s facilities and from there, they are further distributed by the State governments to various districts. This requires additional number of days. From here on, vaccines are administered at the designated vaccination centres.

Also read | Bharat Biotech commences direct supply of COVID-19 vaccine Covaxin to 14 States

Secretary, Department of Biotechnology Renu Swarup said that while it could take nearly four months for a batch of vaccine to be prepared, the government prepared its estimate based on what the manufacturer had committed to supply to the government.

“Vaccine manufacturing is time consuming and complex. But if, as Dr. Paul has said, a certain number of doses would be available in a particular month, it accounts for the time taken to produce it,” she told . “However we have to be optimistic about production and musn't forget that these are companies with long experience in vaccine production.”

India is currently grappling with a shortage of vaccines and only about 11% of the population has got at least one dose. India has relaxed regulations to allow any established COVID-vaccine maker to supply vaccines, though few such deals have materialised. As of Friday, more than 22.46 crore vaccine doses had been supplied to States and Union Territories. Of this, the total consumption, including wastages was 20.46 crore doses as per Health Ministry data. More than 1.84 crore COVID vaccine doses remained with States to be administered.

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