Mumbai: The Panel of the Ministry of Health has rejected a separate proposal from the Indian Serum Institute (SII) and Biological E in the Jab Booster, quoting a lack of strong trial data.
The subject administration committee (SEC), which suggested drug regulators on the vaccine and new drugs, also did not delete other biological E applications that seek emergency approval from Covid vaccine, Corbevax.
It has been looking for more data about safety and other parameters, which can delay the launch of the vaccine.
India has not received a call about Booster Shots after the spread of the Omicron strain.
While taking the biological application E using Corbevax which was accidentally developed for booster shots, this second recommends that it sends a revised clinical test protocol, noting that the safety and efficacy data from phase 3 trials have not been evaluated.
It asks for complete safety and immunogenicity data from the vaccine, justification for the proposed age group, time booster shots and sample size.
SEC asked SII to conduct a local trial to prove the efficacy of the covishield as a booster dose before the application can be reviewed.
In accordance with official sources, the panel said the company did not present any data from India and that demand for Booster approval was based on immunogenicity data only 75 subjects from the UK study.