The Indian drug regulator is going to consider emergency use approval (EUA) for the COVID-19 vaccine for children above 12 years of age, which is developed by Zydus Cadila. The subject expert committee (SEC) will assess the data submitted by Zydus Cadila.

The vaccine has been tested on adults and children aged over 12 years. The regulatory panel will give their nod to the vaccine if the SEC is satisfied with the phase 3 data and records. An approval for the vaccine will speed up the opening of schools even though the vaccine supply is a concern. 

According to an official, the preliminary evaluation of the application that is submitted by the company is underway and the SEC will soon hold a meeting. The supply of the vaccine will likely start by August-September if the approval is granted.

The vaccine, named ZyCov-D, is a locally developed DNA vaccine candidate and it would be the 5th COVID-19 vaccine to get EUA in India. At present, Covaxin, Covishield, and Sputnik V are administered under the national COVID-19 immunization program, while Cipla has received a EUA to import Moderna COVID vaccine, but it is still not available in the country.

Zydus’ 3-dose, intradermal vaccine can be stored at 2-8 degrees Celsius. It has good stability at temperatures of 25 degrees Celsius for minimum of 3 months. 

Zydus Cadila will manufacture one crore doses per month initially and later will increase the production. The vaccine’s availability will offer a cover to children aged 12-18 years, especially amid concerns of a potential third wave arriving.

Source: ET Healthworld