Make in India Vaccines: A True Story of Atmanirbhar Bharat—Journey of COVID-19 Vaccines at Serum Institute of India
摘要
Serum Institute of India Pvt. Ltd. (SIIPL) is the world’s largest vaccine manufacturer by the number of doses distributed globally (more than 1.5 billion doses every year), which includes vaccines against Polio, Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, Rubella, Pneumococcus, and COVID-19. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by SIIPL. Most of the SIIPL vaccines are prequalified by the World Health Organization (WHO) and are being used in around 170 countries across the globe, thus saving millions of lives. Covid-19 pandemic caused by the novel SARS-CoV-2 virus was a global crisis and like many other organizations, SIIPL rose to the occasion to fight the virus. The pandemic had devastating effects in terms of out-patient visits, hospitalizations, ICU admissions, medicine availability, and deaths. Vaccine development against this disease was an uphill task as there was little knowledge about the virus. After target identification, Covid-19 vaccine development was done with extraordinary speed. Until global roll-out of effective Covid-19 vaccines, it seemed that pandemic was unlikely to end though we could actually deliver the vaccines. It was also important that once the vaccines become available, there should be an equal vaccine access throughout the globe. After development of the vaccines targeted against the ancestral strain, the clinical trials began. During the trials themselves, new variants of virus started emerging, having more infectious nature and disease severity. clinical trials showed excellent safety, efficacy and immunogenicity of the vaccine after primary immunization though waning immune response was a concern. There were many other techno-commercial challenges in terms of process development, raw material support, quality release, clinical evaluation and distribution that are required for large scale manufacturing. With a collaborative approach, we could overcome these challenges and successfully delivered the vaccines to the world.