US-based vaccine manufacturer Moderna has received limited emergency use approval in India for their vaccine trial. The approval came from the Drug Controller General of India (DCGI), according to the government.
In addition, Cipla has been granted a license to import and commercialize Moderna’s vaccine in India. Moderna is the fourth Covid-19 vaccine to be introduced used in India’s vaccination drive.
India is now using the vaccines are:
– Covishield, produced by Oxford University, and AstraZeneca. It is manufactured by the Pune-based Serum Institute of India.
– Covaxin: It is manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
– Sputnik V: It is manufactured by Gamaleya Research Institute of Epidemiology and Microbiology in Russia.
“An application was received from Moderna through their Indian partner Cipla following which Moderna’s Covid-19 vaccine has been granted restricted emergency use authorization by the drug authorizations new permission for restricted emergency use potentially opens up a clear possibility of this vaccine being imported to India in the near future” Dr. V K Paul of NITI Aayog’s Health Committee, stated.
Moderna has also announced that the US government has agreed to contribute the Moderna Covid-19 vaccine to India via COVAX. It has sought approval from the Central Drugs Standard Control Organization (CDSCO) for these vaccines.
Dr. Paul said that the government is still working and obtaining other internationally developed vaccines, notably from Pfizer and J&J.
“Those processes are on. We are also looking at increasing the production of availability of vaccines that are being manufactured in our country.”
Cipla submitted an application to import and distribute Moderna’s Covid vaccine. Cipla cited DCGI letters dated April 15 and June 1 in support of their application, which stated that if a vaccine is approved by the USFDA for EUA, it can be granted marketing authorization in India without a bridging trial.
According to WHO Moderna vaccine has an efficacy rate of 94.1% starting 14 days after 1st dose. It also says that the vaccine is also effective for new variants.
