NEW DELHI: India got off the blocks slowly to make Bharat Biotech’s Covaxin an open source vaccine within the country for its mass production, as any company that participates in it would need at least six months for the assembly line to start rolling.
For, jabs such as Covaxin need highly sophisticated Biosafety Level 3 (BSL-3) labs, which is only available with Bharat Biotech at the moment. BSL-3 labs work with agents that could cause serious or potentially lethal disease through inhalation to the personnel, and may contaminate the environment, hence the high safety parameters.
While India has just over a dozen such labs at present, most of them are with academic institutions for testing and research. Upgrading existing BSL-3 labs to produce Covaxin is a long term process, says a senior Bharat Biotech official.
Sudhanshu Vrati, a virologist, told The New Indian Express, “The government laboratories we have at present across India is only meant for research and are not designed for production. Even if a pharma company starts work to set up a BSL-3 lab, it will take at least three to six months to do so, after which it will require certification.”
“Even if we assume that government does the certification in a week’s time, vaccine production and hitting the market will take more than 6 months.” Eminent virologist Dr Jacob John concurred.
He said even if the Centre ropes in additional labs to produce vaccines, it may take from three to six months for the vaccine to be produced.“By that time, the pandemic itself would be over. We must have done this by October 2020, so that there was enough vaccine by January this year,” Dr John said.
Call to hold talks with vax makers to ramp up production
“By that time, the pandemic itself would be over. We must have done this by October 2020, so that there was enough vaccine by January this year,” Dr John said. Criticising the Centre for not acting with foresight even now, K Sujatha Rao, former secretary in the Union health ministry, said: “It has to act immediately for the results to kick in at least four to five months from now. It is high time the government called all vaccine manufacturing companies, discussed with them the challenges the country is facing and help them with funds and the wherewithal to produce the vaccine in the required quantities, at least four to six months from now.”
R amping up vaccine production is easier said than done, she said, since extreme care has to be taken while producing it as the vaccine involves using the attenuated strain of the Covid-19 virus to generate antibodies in the host, the human being, when administered.
“Though we have about 15 BSL-3 labs, all of them cannot produce vaccine overnight. They have to be custom-built for Covid-19. This throws up another challenge. If the companies make an investment, and make the vaccine, then the price might be high like Sputnik-V. If the government wants to control the price, then it should fund the necessary changes that had to be made to BSL-3 labs,” Sujatha Rao added. Last week, the Department of Biotechnology said it has provided financial support to Maharashtra’s state-owned company Haffkine Institute for manufacturing Covaxin.
Haffkine does not have BSL-3, but the state government said it will provide Rs 94 crore for upgrading the plant. It is expected to start production of 20 million doses per month from November. While Haffkine said it needed 12 months to complete the ramp up, it was asked to cut duration by half. It is now is expected to start production of 20 million doses per month from November. Two other PSUs, too, will make Covaxin. Besides, Bharat Biotech is reportedly in talks with another company, Panacea Biotec, for contract manufacturing Covaxin.
Gujarat-based Hester Biosciences, too, has shown interest in its production. A suggesting to set up an experts’ committee to examine the status of existing labs came from Dr Tribhuban Mohan Mohapatra, chairman of the multi-disciplinary research unit and head of the Covid testing lab at Banaras Hindu University. He urged the Centre to immediately set up the panel to inspect the existing labs and approve those that fulfil the criteria for vaccine manufacturing instead of wasting time in setting up new labs.
However, Dr Jacob John said the Centre has no role to play on vaccines anymore as the private companies are directly handling production. Although Odisha does not have a BSL-3 lab for manufacturing vaccine, Bharat Biotech has recently started construction of its new production unit at Andharua on the outskirts of Bhubaneswar. If everything goes as per plan, vaccine production will commence by June 2022.