Serum Institute fire a big lesson for vaccine makers, say experts

The fire at Serum Institute India`s Pune facility left 5 workers dead and affected its BCG lab

A sobering lesson for Indian pharma and vaccine companies is to secure their production facilities to the level of ‘Star Wars', say microbiologists and virologists, days after a fire killed five workers at the Serum Institute of India. But, the fire won't raise concerns about vaccine confidence globally, they say.

Dr Subhash Hira, Professor of Global Health at the University of Washington-Seattle and advisor to several UN and Indian health agencies, said the January 21 blaze is being seen by some scientists as a big setback in the global fight against COVID-19.

He explained, "A vaccine facility normally consists of the following component areas: secure storage of COVID-19 virus stock, the selected cell lines for virus culture growth, the cell line culture incubators, virus isolation and purification area, sterile preparation of vaccine diluents, sterile vaccine preparation assembly, research and monitoring biosafety cabinet area, and quality assurance testing section." He said the smoke could disrupt the vaccine assembly line as carbon monoxide may have entered the area through ducts. Dr Hira said, "This disruption will be over and above the likely biological leaks of highly infectious COVID-19 and adeno vector-virus stocks."

The expert threw more light on the biological safety levels (BSL) for biologic labs and vaccine facilities. "For example, simple aerosol of insecticides or even perfume in a virus tissue culture BSL-3 lab can cause toxic death of cell lines in incubators. The BSL-4 lab is the highest level of biologic safety and comprises working with highly dangerous and exotic microbes that is a requirement for licensing a vaccine manufacturing facility. Infections caused by these types of microbes are frequently fatal, and do not have treatments or vaccines." He cited the examples of microbes that include Ebola and COVID-19 viruses.

Vaccine facilities are built to protect them from fire, blast and earthquake and scientists hope the accident at SII has not damaged the physical setup of its BSL-4 COVID vaccine lab and vaccine assembly line, said Dr Hira. SII estimated the loss due to the blaze at R1,000 crore and said its BCG vaccine lab was affected.

Dr Hira added, "A sobering lesson for Indian pharma and vaccine companies is to secure their production facilities to the level of ‘Star Wars'. The world is desperate to receive these vaccines and any perceived loss of confidence in the quality control of these systems can hurt our national interest."

Renowned virologist Dr Jacob John said it is always a matter of concern when a fire breaks out at a state-of-the-art setup like the Serum Institute of India. "It seems at the plant where the accident happened, some construction was underway. When such outsourced work is in progress, it raises concerns about the poor quality of workmanship, which is different from those working inside the plant, who follow a certain set of guidelines."

"Though the Serum Institute fire was a shock to the entire world, this would not affect the confidence of masses on their vaccine production. But yes, a retrospective inspection of vaccine producing pharma companies should always be on top of the mind," said Jacob John.

Professor Nirmal K Ganguly, former Director-General of ICMR, sought to allay concerns over the fire. He said the facility is GMP (Good Manufacturing Practices) certified and WHO prequalified with ISO-10000 certifications.

"These plants have systems which not only block but even purify air before it is thrown out. The circulated air inside the plant is dust free and the master cultures are so well protected inside these laboratories that they have multiple backups and working cultures separated, so that even if a sample of culture is impacted, they have others to safeguarded cultures," he said.

Ganguly said the fire won't have any adverse impact. "Plants of international standard like Serum institute will have 24x7 setups which can immediately tap any untoward happenings." As the Covishiled manufacturing plant is not affected, he said, it would be better to wait till the exact reason for the fire is known.

Rs 1,000 cr
Estimated loss suffered by Serum Insititute in the fire