Why Everybody With The 'Formula' Cannot Just Start Producing Covaxin

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This vaccine is currently developed inside Bharat Biotech's BSL-3 labs (Bio-Safety Level 3).

BSL-3 labs are used in the case of clinical or diagnostic research where the personnel work with agents that may cause a serious or potentially lethal disease through inhalation and/or where the agent being worked on has the potential to contaminate the environment.

Those companies which will manufacture Covaxin in India need to have such labs to begin with.

The Hyderabad-based Bharat Biotech, which developed the Covid-19 jab Covaxin, is willing to share the formula of its vaccine with other manufacturers to increase production, said NITI Aayog member Dr VK Paul on 13 May.

Amid the reports of Covid-19 vaccine shortage from several states in India, the Government of India and Bharat Biotech are willing to invite other manufacturers said Dr Paul, reported ANI.

"People say that Covaxin be given to other companies for manufacturing. I am happy to say that Covaxin manufacturing company (Bharat Biotech) has welcomed this when we discussed it with them,” he said.

According to him, it is an open invitation to companies who want to manufacture the vaccine.

“Companies that want to manufacture Covaxin, should do it together. Govt will assist so that capacity is increased," he concluded.

During the announcement, Dr Paul also noted that one-third of the population aged 45 and above are now protected.

“The age group 45 and above contribute to 88 per cent of deaths. So you can imagine, how many dents it would make to reduce the risk of death of this population,” he added.

The announcement was made at a time when many state governments urged central to increase the production of the vaccines.

Earlier on the same day, Delhi Health Minister Satyendar Jain stated that he has discussed with Union Health Minister Harsh Vardhan that the vaccine formula can be shared with other companies to ramp up production.

Even Andhra Pradesh Chief Minister YS Jaganmohan Reddy this week wrote to Prime Minister Narendra Modi to share manufacturing technology of the vaccine with other firms.

India has so far inoculated almost 18 crore doses of Covid-19 vaccines, while in the United States the number is nearly 26 crores.

Even though in the overall vaccination tally, India sits in the third position in the world, more vaccination is required at a crucial time like this when the country is suffering from a deadly coronavirus second wave.

On 13 May, the Covaxin makers, Bharat Biotech submitted its production plan for the vaccine for the next four months.

The pharmaceutical company also told the Union Health Ministry and the Drugs Controller General of India (DCGI) that the production of this jab can be raised to 3.32 crore in July, followed by 7.82 crores in August and it will also be maintained in September.

Meanwhile, the Pune-based vaccine manufacturer Serum Institute of India (SII) said that it can scale up the production of Oxford-AstraZeneca’s Covid-19 vaccine—Covishield—to 10 crore doses.

Dr Paul also stated that over 2 billion Covid-19 vaccines will likely be available in the country between August to December 2021.

This will include 750 million Covishield doses and 55- million doses of Covaxin, he added.

Covaxin Manufacture

This vaccine is India’s first home-grown vaccine which is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

It is developed using Whole-Virion Inactivated Vero Cell-derived platform technology.

This vaccine contains a dead virus. It is incapable of infecting people but can still instruct the body's immune system to initiate a defensive reaction.

Covaxin is included with immune-potentiators, known as vaccine adjuvants, which are added to the jab to boost its immunogenicity.

This vaccine is developed inside Bharat Biotech's BSL-3 labs (Bio-Safety Level 3).

BSL-3 labs are used in the case of clinical or diagnostic research where the personnel work with agents that may cause a serious or potentially lethal disease through inhalation and/or where the agent being worked on has the potential to contaminate the environment.

Those companies which will manufacture Covaxin in India need to have such labs, as the manufacturing process requires culturing of large batches of the highly infectious SARS-CoV-2 virus before killing them with an inactivating agent before finally bottling the vaccine.

But not many companies have such labs in India—which means that any company willing to manufacture Covaxin needs to set up such highly sophisticated plants if they don’t have it.

Bharat Biotech is reportedly in an initial discussion with another company, Panacea Biotec—which is the other company apart from the Hyderabad-based firm with BSL-3 facility—for contract manufacturing Covaxin.

As per early reports, Maharashtra state-owned company Haffkine Institute has already received the Centre’s approval to manufacture Covaxin.

However, Haffkine does not have a bio-safety level 3 facility.

But as reported, the state government said that it will provide ₹94 crores for setting up the plant.

While Haffkine said it needs 12 months to complete the setting up the facility, the Central asked the company to complete the task within six months.

It is expected to start production of Covaxin jabs from November 2021, with a capacity of producing 20 million doses per month.

Two Central Public-Sector Enterprises (PSEs), Hyderabad’s Indian Immunologicals Limited (IIL), as well as Bharat Immunologicals and Biologicals Corporation (BIBCOL) in Uttar Pradesh have entered into technology transfer pacts with Bharat Biotech to develop Covaxin locally in a major boost to India's vaccination drive.

These two enterprises would provide 10 to 15 million doses per month by August-September this year.

As reported, the Department of Biotechnology (DBT) earlier said that it has provided financial support to Haffkine, IIL and BIBCOL.

While Bharat Biotech and Haffkine are getting Rs 65 crores each, IIL and BIBCOL will also receive an undisclosed amount from DBT to double the total Covaxin manufacturing capacity.

The capacity is expected to grow to around 60 to 70 million Covaxin doses per month by August and then about 100 million by September.

For IIL and BIBCOL, the task to manufacture Covaxin would be challenging as they have to set up or restructure existing manufacturing facilities at breakneck speed to start producing the vaccine—that would take at least four months.

The other option is building a whole new plant. But that would take more time.