Of the various candidates involved in Covid 19 vaccine development the three firms one after another applied for emergency use authorisation (EUA) of their respective vaccine candidates in the country. America’s Pfizer Inc was the first to apply on December 4, Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech International Limited applied EUA on December 6 and 7 respectively.
SII will manufacture in India the Oxford University-AstraZeneca vaccine candidate, Covishield, Bharat Biotech’s candidate, Covaxin, is the country’s first, and the only, indigenously developed vaccine candidate. The sources reported, the EUA applications of all three companies will be reviewed on Wednesday. EUA approval authority lies with the Central Drugs Standard Control Organisation (CDSCO) in India. There is no clear definition of process to obtain EUA in India as the India’s drug regulations has no provisions for EUA. However, CDSCO had granted permission for the use of drugs like remdesivir and favipiravir in June, and itolizumab in July.
As there is no fixed rules for EUA grant, the minimal requirement for approval is not yet known. For example, US Food and Drug Administration (FDA) consider a EUA application only if the vaccine candidate has shown at least 50% efficacy in phase 3 trials involving more than 3,000 participants. The duration of processing the application as explained by Dr VK Paul, NITI Aayog member, is 90 days for an EUA application to be reviewed and permission to be granted. Across the globe, Pfizer has filed for EUA in the United States and the application is likely to be reviewed this week. The United Kingdom on Tuesday initiated the use of Pfizer’s vaccine candidate in emergency cases. Bahrain, too, has granted EUA for the US firm’s vaccine.
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