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

A sobering lesson for Indian pharma and vaccine companies is to secure their production facilities to the level of lsquoStar Warsrsquo say microbiologists and virologists days after a fire killed five workers at the Serum Institute of India But the fire wonrsquot raise concerns about vaccine confidence globally they sayDr Subhash Hira Professor of Global Health at the University of WashingtonSeattle 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 COVID19He explained ldquoA vaccine facility normally consists of the following component areas secure storage of COVID19 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 sectionrdquo He said the smoke could disrupt the vaccine assembly line as carbon monoxide may have entered the area through ducts Dr Hira said ldquoThis disruption will be over and above the likely biological leaks of highly infectious COVID19 and adeno vectorvirus stocksrdquoThe expert threw more light on the biological safety levels BSL for biologic labs and vaccine facilities ldquoFor example simple aerosol of insecticides or even perfume in a virus tissue culture BSL3 lab can cause toxic death of cell lines in incubators The BSL4 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 vaccinesrdquo He cited the examples of microbes that include Ebola and COVID19 virusesVaccine 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 BSL4 COVID vaccine lab and vaccine assembly line said Dr Hira SII estimated the loss due to the blaze at R1000 crore and said its BCG vaccine lab was affectedDr Hira added ldquoA sobering lesson for Indian pharma and vaccine companies is to secure their production facilities to the level of lsquoStar Warsrsquo 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 interestrdquoRenowned virologist Dr Jacob John said it is always a matter of concern when a fire breaks out at a stateoftheart setup like the Serum Institute of India ldquoIt 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 guidelinesrdquoldquoThough 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 mindrdquo said Jacob JohnProfessor Nirmal K Ganguly former DirectorGeneral of ICMR sought to allay concerns over the fire He said the facility is GMP Good Manufacturing Practices certified and WHO prequalified with ISO10000 certificationsldquoThese 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 culturesrdquo he saidGanguly said the fire wonrsquot have any adverse impact ldquoPlants of international standard like Serum institute will have 24x7 setups which can immediately tap any untoward happeningsrdquo As the Covishiled manufacturing plant is not affected he said it would be better to wait till the exact reason for the fire is knownRs 1000 crEstimated loss suffered by Serum Insititute in the fire