India’s expert committee on Covid-19 vaccines has sought more data from Hyderabad-based Biological E to review its request for marketing authorisation of its Covid-19 vaccine Corbevax for use in children aged 5 to 12 years, people in the know said. They said the DCGI’s subject expert committee reviewed Biological E’s application at a meeting on Monday and asked the company for updated safety data – which should be from 2-3 months after the second dose – immunogenicity data and virus neutralising antibody data against a variant of concern.
Biological E had presented interim safety and immunogenicity data of phase 2/3 clinical trials conducted on participants aged 5 to 18 years.
The company had also presented neutralising antibody titres in over 200 subjects in the 5 to 12 years age group along with comparison with the adult age group.
However, after deliberation the SEC asked the company to present additional data for further review, the people cited earlier said.
