Kerala’s attempts to manufacture COVID-19 vaccine in the state have enthused health experts, but the state will have to overcome several challenges that lie ahead to achieve the production capability.
The state will have to set up world-class infrastructure besides inking deals with other vaccine manufacturers. Globally, manufacturers have already shifted to robotics engineering to produce the vaccine, currently in high demand.
India is now using three vaccines to inoculate its population against COVID-19. Of the three, Kerala is unlikely to partner with the Serum Institute for the production of Covishield vaccine, developed by AstraZeneca, since there are several impediments.
However, Kerala has hope in producing Bharat Biotech-developed Covaxin and Russian Gamaleya Research Institute’s Sputnik V. The Indian Council for Medical Research (ICMR) has been collaborating in the production of Covaxin.
Meanwhile, seven Indian private firms have already signed contracts for producing Sputnik. Efforts are also on to manufacture Covaxin by public sector units.
Different vaccines, separate methods
Setting up a plant itself will be a challenge since no two vaccines follow the same production procedure. While Covaxin makes the coronavirus inactive (but their proteins, including spikes, remain intact), Sputnik uses two different adenoviruses (which causes the common cold) as viral vectors to elicit an immune response. Both vaccines require different infrastructure and methods for their production.
The government alone cannot manufacture the vaccine without the cooperation of expert firms. Additionally, shortage of workers with desired expertise, too, will pose a challenge.
From research to production
Chemistry has an upper hand in the development and production of a normal medicine or drug, while manufacturing vaccines calls for the application of biotechnology.
Vaccine manufacturing units also need research wings, more importantly, biosafety labs. Such production units also require microbiology and chemical laboratories, besides animal houses for pre-clinical trials.
The expenses for the setting up a plant may vary according to the facilities it may offer. The Serum Institute of India spent Rs 4,000 crore for developing facilities in 2019, much before the world clamoured for COVID-19 vaccines.
Production plant: Requisites
Research and Development Block: Research and development (R&D) play an important role in the production of a vaccine. The R&D comprises cell culture lab, cell culture reactors, virus handling lab, centrifuge and purification facilities, and spectrophotometer (an instrument to measure the photons absorbed by a solution, determining the amount of a known chemical substance present in it).
Additionally, a high-security biosafety level-III lab is also required in plants that produce vaccines, like Covaxin, by making deadly viruses inactive.
Antigen Production Lab: Rapidly multiplying an inactive virus or genetic material is a major stage in the production of a vaccine. It requires fermenters (to contain an internal environment for the efficient reproduction of microorganisms), bioreactors (device or system supporting a biologically active environment), etc.
Fill-Finish Block: The vaccine is filled in this block. Automation technology is employed to ensure the safety of vaccines during the production stage.
High-Pressure Water Jetting Facility: The unit requires special pipes that could withstand a temperature of 200 degrees and facilities for filling the vaccine.
Quality Check: This is the facility to screen the quality of the product, which needs a wide array of sophisticated equipment.
Packing and Storage Area: Packets of the vaccine, after quality check, are shifted to the cold storage centre. The centre needs freezers to store huge quantities of the vaccine.