DGCI Approval For Moderna's Covid Vaccine in India for Emergency Use Likely

 - Sakshi Post

The FDA and regulators in a number of other countries have already approved Moderna's vaccine for emergency use.

Moderna began the process of obtaining full regulatory approval in the United States in June.

New Delhi: Moderna Inc, an American pharmaceutical firm, applied to the Drugs Controller General of India (DGCI) on Tuesday to utilise its Covid vaccine for emergency use in anyone aged 18 and up, according to a top news source.

The FDA and regulators in a number of other countries have already approved Moderna's vaccine for emergency use. In the United States, about 124 million doses have been delivered thus far.

According to a top news agency, Moderna has also informed the US government that it has agreed to donate a certain number of doses of the Moderna COVID-19 vaccine to the Government of India through COVAX and that it has sought approval from the Central Drugs Standard Control Organization (CDSCO) for these vaccines.

According to the news agency, the drug controller is expected to approve the pharmaceutical's vaccine shortly.

Meanwhile, Cipla, a Mumbai-based pharmaceutical company, has requested the import, marketing, and approval of Moderna vaccines.

Cipla filed an application on Monday seeking permission to import the Moderna COVID-19 vaccine, citing DCGI notices dated April 15 and June 1 that stated that if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorization without a bridging trial, and safety data of the first 100 vaccine recipients must be submitted for assessment before the vaccine is rolled out in immunization programmes.

The Delhi government recommended that the Centre authorize overseas vaccinations from Pfizer, Moderna, and Johnson & Johnson earlier this week in order to safeguard the country from a third wave of the covid pandemic.

"We request the Centre to approve Pfizer, Moderna and Johnson & Johnson at the earliest and make it available to the Indian public. The faster India is vaccinated, the sooner it will be safe from Covid," said AAP MLA Atishi.

Meanwhile, the DCGI has scrapped particular studies of COVID-19 vaccines that have already been authorised by other international regulatory organisations, paving the way for foreign vaccines from Pfizer and Moderna to meet the country's urgent needs.

DCGI Chief VG Somani said in a letter that this would apply to vaccinations that have previously been authorised for limited use by the US FDA, EMA, UK MHRA, PMDA Japan, or the World Health Organization's Emergency Use List.

"In light of the huge vaccination requirements and the need for increased availability of imported vaccines, it has been decided that for approval of COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use listing," he said.

"The scrutiny and review of their Summary Lot Protocol and Certificate of the analysis of Batch/Lot Shall be undertaken by CDL Kasauli for batch release as per standard procedures and the requirement of assessment of the first 100 beneficiaries for 7 days for safety outcomes before the vaccine is rolled out in further immunization programs, along with other procedures for filing of applications and timeline for processing of the applications, etc, as laid down in the notice dated 15.04.21 shall remain the same." Dr Somani said in the letter.

Moderna began the process of obtaining full US regulatory clearance for the use of its COVID-19 vaccine in adults earlier this month. In addition, the pharmaceutical behemoth revealed that its vaccinations appeared to be safe and effective for children as young as 12 years old.

Following Pfizer and German partner BioNTech, Moderna is the second COVID-19 vaccine manufacturer to seek full clearance.

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