NEW DELHI: The Covid vaccine by the US-based Moderna on Tuesday became the first vaccine to receive the emergency use authorisation in India under the changed regulatory norms that allow coronavirus vaccines approved in certain other nations to enter the country without bridging clinical trials.
Mumbai-based pharmaceutical major Cipla’s application to the Central Drugs Standard Control Organisation to import the vaccine, which had shown over 90% efficacy against preventing Covid infection in the efficacy trials, was accepted and approved the same day.
It is, however, yet to be understood exactly when will the messenger RNA-based vaccine be available in India and in what quantity. Cipla in a statement said that it is supporting Moderna with the regulatory approval and importation of vaccines to be donated to India, clarifying that at this stage, there is no definitive agreement on commercial supplies.
The vaccine can be stored at 2-8 degree centigrade for a month while the vial is unopened but needs to be stored at -20 to -25 degree centigrade for medium- and long-term storage—making the logistics requirement somewhat challenging. Its two doses have to be administered 28 days apart.
The development comes even as the Union government is yet to take a decision on the demand of indemnity put forth by Moderna, along with another company Pfizer whose coronavirus vaccine is also looking to enter the Indian market.
Sources in the apex drug regulator said that as per the modified rules, the Covid vaccine by Moderna, will still need to be administered to 100 people first for the safety assessment and the report will be examined after 7 days before mass vaccinations are carried out.
“We are pleased to inform that Moderna vaccine has been approved in India today through an Indian partner and it opens the pathways for the vaccine’s availability in the country soon,” said VK Paul, member health, Niti Aayog, in a press briefing on Tuesday, shortly after the CDSCO meeting in which the application by Cipla was cleared.
In April, while battling the devastating second wave of the pandemic, the Narendra Modi government had relaxed norms significantly to expedite the approval of foreign-made Covid vaccine in India.
Bending the rules, it had said that the vaccines approved by the US FDA, EMA (European Union Medical Authority), UK’s MHRA and Japan’s PMDA, and WHO’s emergency use listing will not need to undergo prior bridging trials.
It had, however, said that the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country,
Meanwhile, Paul added that while the Moderna vaccine, for now, will arrive in India in ready-to-use form, the government is hoping that the company will develop partnerships for its local production in the country.