Government gives nod for Cipla to import Moderna’s COVID-19 vaccine

DCGI grants emergency use approval for ready-to-use injectable jab

A vial of the Moderna COVID-19 vaccine is seen at a local clinic as the spread of the coronavirus disease continues in Aschaffenburg, Germany. File

The Drugs Controller General of India (DCGI), on Tuesday, granted permission to Mumbai-based pharmaceutical firm Cipla to import Moderna’s COVID-19 vaccine, making it the fourth vaccine in the country to be given the Emergency Use Authorisation (EUA).

Announcing this at the Health Ministry press conference on Tuesday, NITI Aayog’s member (Health) V. K. Paul said the finer modalities are being worked out for the import of the vaccine and added that India is also in conversation with Pfizer and JJ to add to the basket of vaccines available in India.

 

Currently India has made available three COVID vaccines — Covaxin, Covishield and Sputnik. Dr. Paul added that the Moderna vaccine will be brought in as a ready-to-use injectable vaccine which can be stored for a period of seven months at prescribed temperature and that normal storage after vial is opened is 30 days.

“We are working to ensure that India is able to manufacture this vaccine here. We are also looking at increasing the production of vaccines that are being manufactured in our country to boost availability. The permission for restricted use in emergency situations has been granted for the Moderna vaccine keeping in mind the public interest. The firm has to submit a safety assessment of the vaccine in the first 100 beneficiaries before rolling out the vaccine for further immunisation programmes, according to the approval order. It, however, does not need any bridging study,” explained Dr. Paul.

He added that an application was received from Moderna through their Indian partner Cipla following which the vaccine has been granted restricted emergency use authorisation by the drug regulator.

“This new permission for restricted emergency use potentially opens up a clear possibility of this vaccine being imported to India in the near future,” explained Dr. Paul.

Cipla while applying for the license referred to DCGI notices dated 15 April and 1 June, which noted that if a vaccine is approved by the U.S. Food and Drug Administration (USFDA) for EUA, then it may be made available without a post-approval bridging trial and the testing of every batch of the vaccine by Central Drugs Laboratory.

According to the World Health Organisation (WHO), the Moderna vaccine has shown to have an efficacy of approximately 94.1% in protecting against COVID-19, starting 14 days after the first dose. The WHO adds that based on evidence collected so far, the new variants of SARS-CoV-2, do not alter the effectiveness of the Moderna mRNA vaccine.

Meanwhile, responding to a question about the spread of the Delta Plus variant in India, Dr. Paul said 51 cases of Delta Plus variant have been reported from 11 States and one Union Territory — MP, Maharashtra, Punjab, Gujarat, Kerala, Andhra Pradesh, Tamil Nadu, Odisha, Rajasthan, Karnataka, Haryana and Jammu (as of June 28).