It’s ironic that the government’s main drug regulator gave Russia’s Sputnik V vaccine, already approved and used in more than 60 countries, emergency use approval (EUA) on the same day it upset its vaccine approval process.
Together with Dr. Reddy’s labs, Sputnik V had undergone phase 2-3 trials in the country. The approval process, overseen by the Comptroller General of Medicines of India’s Expert Committee on the subject, had seen weeks of back-and-forth with a focus on the immunogenicity and safety data of these. testing.
Well, the need for these local pre-approval trials is gone. Any vaccine, which has received approvals from more stringent regulators such as those in the United States, United Kingdom, European Union and Japan or those that have been approved by the World Health Organization, may be used. in India.
Remember how Pfizer finally withdrew its emergency use authorization application in India in February 2021, when regulators insisted on transition trials?
They could come in now – but the bigger question is whether they will?
What also happens to vaccines like the Johnson & Johnson “one and done” boost, which was blocked after deployment by the United States Food and Drug Administration (US FDA)?