Moderna's vaccine already has been cleared for emergency use by the FDA and regulators in numerous other countries
New Delhi: American pharmaceutical company Moderna Inc on Tuesday sought approval from the Drugs Controller General of India (DGCI) for use of its Covid vaccine for emergency use in those aged 18 and above, news agency PTI reported.
Moderna's vaccine already has been cleared for emergency use by the FDA and regulators in numerous other countries. So far, more than 124 million doses have been administered in the United States.
Moderna has also informed that the US Government has agreed to donate a certain number of doses of the Moderna COVID-19 vaccine through COVAX to the Government of India for use and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines, news agency PTI reported.
The news agency, citing sources, said that the drugs controller is likely to approve the pharmaceutical's vaccine soon.
Meanwhile, Mumbai-based pharmaceutical firm Cipla has come forward and applied for the import, marketing and authorisation of Moderna vaccine's jabs.
Cipla filed an application on Monday seeking permission for import of Moderna COVID-19 vaccine referring to DCGI notices dated April 15 and June 1 stating that if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorization without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
Earlier this week, the Delhi government requested the Centre to approve international vaccines like Pfizer, Moderna, and Johnson&Johnson in order to protect the country against an anticipated 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 done away with specific trials of COVID-19 vaccines that have been approved by other international regulatory bodies - a big move likely to clear the way for foreign vaccines like Pfizer and Moderna for the country's urgent requirement.
In a letter, DCGI Chief VG Somani letter said that this will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.
"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 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.
Earlier in June, Moderna started the process to win full US regulatory approval for the use of its COVID-19 vaccine in adults. The pharma giant also announced that its vaccine appears safe and effective in kids as young as 12.
Moderna is the second COVID-19 vaccine maker to seek full approval, following Pfizer and German partner BioNTech.