Under the license for restricted use by India’s drug regulator DCGI, Cipla will facilitate the import of COVID-19 vaccines donated by US biotech major Moderna

Cipla is pursuing a separate tie-up with the US firm to accept large-scale fill-and-finish, distribution, and commercialization of Moderna’s messenger (mRNA) vaccines. Moderna’s vaccine is the 4th to get emergency authorization use (EAU) in India after Covishield, Covaxin, and Sputnik V.

V K Paul, Niti Aayog member (health) said that an application is received from Moderna via their Indian partner Cipla and has been granted new drug permission for restricted use. Their efforts to invite other internationally developed vaccines, such as Pfizer and J&J, also continue. 

Cipla’s global CEO Umang Vohra said that they are supporting Moderna Inc with the regulatory approval and with the importation of vaccines to be donated to India.

In May, the Biden administration had announced the donation of COVID-19 vaccines through the COVAX scheme for low-income and developing countries, including India too. A total of 20 million doses of Moderna are expected from India.

Pfizer and Johnson & Johnson vaccines are expected by month-end to low-income and developing countries, with more than 60 million Astra-Zeneca vaccines.

No need to conduct bridging studies on local people before import, according to the Centre’s policy given in April for these fast-track foreign-made vaccines. The company has to submit safety assessment data of the first 100 recipients before mass rollout starts.

Moderna CEO Stéphane Bancel had thanked the Indian government for this authorization, marking an important step towards the global fight against the coronavirus pandemic. They are committed to making the COVID-19 vaccine available throughout the world.

Source: ET Healthworld