A health ministry expert panel has rejected individual proposals from Serum Institute of India (SII) and Biological E on booster vaccine doses, stating that there is lack of robust data.

The subject expert committee (SEC) also turned down Biological E’s separate application for emergency approval of its COVID-19 vaccine, Corbevax. The committee asked for more data on safety and some other parameters.

While considering Biological E’s application on the use of Corbevax for booster doses, the committee asked the company to submit a revised clinical trial protocol, stating that safety and efficacy data from the phase 3 trials has to be assessed. The committee sought complete safety and immunogenicity data of the vaccine, justification for the age group proposed, timing of the booster dose and the sample size.

Serum Institute was asked to carry out local trials to establish Covishield’s efficacy as a booster jab before the application can be reviewed… (ET Healthworld – TNN, December 23, 2021)