Moderna's COVID-19 vaccine has received authorisation from the Drugs Controller General of India (DCGI) for emergency use for India. According to news agency PTI, Indian pharmaceutical company Cipla has received permission from the DCGI to import Moderna’s COVID-19 vaccine for restricted emergency use in India. Moderna's vaccine is the fourth COVID-19 vaccine to be approved in India after Covishield, Covaxin and Sputnik V.
"Our efforts to invite and have other internationally developed vaccines, specifically Pfizer and Johnson and Johnson, also continue. Those processes are on. We are also looking forward to increasing the production and availability of our own vaccines that are already being manufactured. We look forward to the vaccination programme gaining further momentum towards coverage of the larger population in every part of the country," said Dr VK Paul, NITI Aayog (Health), addressing the media on Tuesday. Moderna vaccine will be given in two doses, 28 days apart, he added.
The World Health Organisation has said that the Moderna vaccine has been shown to have an efficacy of approximately 94.1% in protecting against COVID-19, starting 14 days after the first dose. The WHO Strategic Advisory Group of Experts (SAGE) has recommended the use of the Moderna mRNA-1273 vaccine at a schedule of two doses (100 µg, 0.5 ml each) 28 days apart. If necessary, the interval between the doses may be extended to 42 days. WHO has also added that based on the evidence so far, the new variants of coronavirus, including the Alpha and Beta variants, do not alter the effectiveness of the Moderna mRNA vaccine.
#Moderna, the first international vaccine in India
— PIB India (@PIB_India) June 29, 2021
No bridging trials in India for #MODERNA vaccine
Storage at -25 to -15, for 7 months
Normal storage after vial is opened is 30 days
Dr VK Paul, Member-Health, @NITIAayog pic.twitter.com/ZROgatnhEn
Moderna on June 27 informed DCGI that the US government has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to India and sought an approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines. On Monday, June 28, Cipla, on behalf of the US pharma major, requested the drug regulator for import and marketing authorisation of these jabs.
"This permission is for restricted use in emergency situations in public interest. The firm has to submit seven days’ safety assessment of the vaccine in the first 100 beneficiaries before rolling out of the vaccine for further immunisation programme, according to the approval order," an official said.
Cipla filed its application referring to DCGI's notices dated April 15 and June 1 according to which if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunisation programme.
Also, the requirement of testing of every batch by Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin, however summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release according to standard procedures, Cipla said referring to the DCGI's new revised rules.
On June 1, in a bid to expedite the rollout of vaccines, the DCGI decided to waive testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK's MHRA or the WHO. The Union government in April issued detailed guidelines and proactively eased entry of foreign made COVID-19 vaccines approved by US FDA, EMA, UK's MHRA and Japan's PMDA, and WHO's Emergency Use Listing into India.
According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.
With inputs from PTI