The Indian Vaccine Manufacturers Association (IVMA) has assured that all COVID-19 vaccines in India were approved for emergency use authorisation based on extensive evaluation in preclinical studies and human clinical trials.
“Patient safety and product quality are always prioritised during the vaccine development and its manufacture,” Dr G V J A Harshavardhan, Director General, IVMA, said in a statement released on Thursday. The statement sought to reassure the public on the safety and efficacy of COVID-19 vaccines.
“All COVID-19 vaccines in India were approved for emergency use authorisation [restricted use in emergency situations as per World Health Organization guidelines], he said, adding, “These approvals were based on extensive evaluation in preclinical studies and human clinical trials, with positive results on safety, efficacy, and immunogenicity of these vaccines.”
The IVMA statement comes in the backdrop of the Union health ministry saying on Wednesday that extensive studies by several agencies have “conclusively established no linkages” between COVID-19 vaccines and sudden deaths.
The Serum Institute of India also posted on X that the COVID-19 vaccines were safe and scientifically validated. “Two large-scale studies by ICMR [Indian Council of Medical Research] and AIIMS [All India Institute of Medical Sciences], as cited by the Ministry of Health have found no link between Covid-19 vaccines and sudden deaths,” SII said.
The IVMA statement also noted that prior to their release, all COVID-19 vaccines were tested extensively for safety by the manufacturers and were also provided Batch Release Certification by the Central Drugs Laboratory in Kasauli, Himachal Pradesh, under the Ministry of Health and Family Welfare.
“The strengths of innovation and large-scale, high-quality manufacturing are the hallmarks of the Indian vaccine ecosystem. COVID-19 vaccines manufactured in India were largely responsible for not only controlling the COVID-19 pandemic and restricting its impact on lives, livelihoods, but most importantly, enabling India’s economic activity and GDP to rebound and grow to new heights globally,” Dr Harshavardhan said.
“This positive impact of COVID-19 vaccination was not only limited to India, but also to several countries worldwide, under the Government of India’s Vaccine Maitri programme…,” he added.
