The Moderna vaccine is to become available in India by July 15th, reports indicate.
Cipla, a pharmaceutical firm based in Mumbai, received the nod to import doses of the Moderna vaccine from the Drug Controller General of India (DCGI) last month. It became the fourth COVID-19 vaccine to receive emergency use authorisation from the Centre in India, following Covaxin (manufactured by Bharat Biotech); Covishield (the AstraZeneca vaccine, manufactured in India by the Serum Institute of India); and the Russian-manufactured Sputnik-V. Approval for the Pfizer/BioNTech vaccine is also on the cards, with arrangements said to be in the “final stages.”
The Moderna vaccine, considered to be 94.1 percent effective, will be administered in two doses, “New drug permission has been granted to Moderna, the first internationally developed vaccine. This new drug permission is for restricted use,” said Dr Vinod K. Paul, a member of government think tank Niti Aayog. Both Moderna and Pfizer have sought indemnity from liability should adverse effects arise from administering the vaccine, a concession made to no other drugmaker by India as of yet. The requirement for clinical trials in India, meanwhile, is waived for vaccines approved by certain international regulators including the World Health Organization (WHO) in order to accelerate the rollout of inoculations.
Clarifying the arrangement, an official stated “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 [programmes], according to the approval order.”
Following the approval of the Moderna vaccine, doses are expected to arrive this week and rollout in government hospitals from July 15th. To date, no confirmation has been given as to how many doses will be brought into the country. Vaccines are currently being rolled out in a more federalised system than previously explored, with “the Government of India itself…[buying] 75 percent of the total vaccine production from vaccine manufacturers and [giving] it for free to the state governments” as explained by Prime Minister Narendra Modi. Experts welcomed the policy shift.