Any vaccine maker, including Pfizer, which seeks emergency-use authorization for its COVID-19 vaccine in India, has to conduct a local bridging safety and immunogenicity study to be considered for the countrys immunization program, stated a senior government official.

Serum Institute of India, which is the local manufacturer of the AstraZeneca and Oxford University vaccine, has conducted a similar study on over 1,500 people over months prior to seeking and receiving emergency approval in the country. As per reports, Pfizer had sought an exception when last month it sought emergency-use approval in India for its vaccine which was already being used overseas. According to Dr Vinod K Paul, heading a government panel on vaccine strategy, "As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial." (ET Healthworld – Reuters, January 14, 2021)