Pharmacy News

Not many equipped to make Covaxin, Health News, ET HealthWorld

HYDERABAD: After the loud chorus for vaccine maker Bharat Biotech to share its Covaxin `formula’ prompted a top NITI Aayog official to invite interested vaccine makers to come forward, experts say very few players in the country are equipped to handle the process required to make the inactivated virus vaccine.

That’s perhaps what also prompted Biocon’s founder chairperson Kiran Mazumdar-Shaw to tweet: “Vaccine Makers Invited To Produce Covaxin To Address Shortage – interested to see how many takers there are.”

“Basically nobody actually wants to deal with or work with live viruses. In the rest of the world, nobody would dare to do it, that’s why most manufacturers go for protein-based vaccines. But in terms of the pandemic, the quickest way to develop a vaccine is to take the live virus and inactivate it,” says the top honcho of a leading vaccine company, hitting the nail on the head.

Adds vaccine pioneer and Shantha Biotech founder KI Varaprasad Reddy: “Firstly, in a vaccine, there is no formula, its a process and technology. Even if others get it, they will take at least 6-8 months to a year to get acclimatised and start production as validation of a high containment Bio-Safety Level-3 (BSL-3) facility alone would take 3-6 months. Also, training people to handle live viruses would require at least six months. It’s not a joke.”

Sources point out that even Indian Immunologicals Ltd, which will be manufacturing the Covaxin drug substance, will take at least three months to repurpose its BSL-2+ rabies facility and full-fledged production would begin only after October. Others like Bharat Immunologicals & Biologicals as well as Haffkine Institute, roped in by the Indian government to make Covaxin, too would take a few months to set up BSL-3 facilities.

Explaining the need for a BSL-3 facility to make Covaxin, Dr Rakesh K Mishra, former director and now advisor of Centre for Cellular and Molecular Biology (CCMB), points out that Covaxin requires a large-scale culture facility in a BSL-3 setup for growing the live SARS-CoV-2 virus.

“Apart from a BSL-3 facility, the process also requires inactivation of the virus to prevent its replication. The manufacturer would also need the capability to manufacture the modified adjuvant that Covaxin uses,” points out former CCMB director and CSIR distinguished scientist Dr Ch Mohan Rao.

“So, you need not just a facility but also the technology, the method and the skilled manpower to do it. I am not saying nobody can do it. They can, but the issue is safety and trained manpower,” he adds.

Experts point out that it might be easier to manufacture the AstraZeneca-Oxford vaccine Covishield or even mRNA vaccines like Pfizer BioNTech or Moderna in India as they don’t require BSL-3 facilities.

“The mRNA vaccines are the easiest and fastest to make as they don’t require growing a large quantity of infectious virus. The virus is already modified and once cloned, can be produced in large quantities. The only hitch is the platform is currently not available in the country and can be set up if their developers agree to share the IP,” explains Mishra of CCMB.

Sources also point out that any existing BSL-3 animal vaccine facilities too would require a few months for repurposing and validation as well as regulatory approvals. Among other things, the new manufacturer would have to take up further studies like a human bridging clinical trials as transfer of technology is involved.

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