India approves use of Moderna vaccine
Cipla gets DCGI nod to import vaccine, which shows promise against Delta variant, for restricted use
NEW DELHI: India on Tuesday authorised the emergency use of Moderna’s Covid-19 vaccine in the country as it seeks to ramp up its vaccination drive in the wake of an anticipated third wave of the viral disease, officials said. However, other crucial details, including the granting of indemnity, were yet to be worked out.
Drug regulator Drugs Controller General of India (DCGI) granted permission to Mumbaibased Cipla to import Moderna’s shots for restricted emergency use in the country, Niti Aayog member (health) Dr VK Paul said at a press conference.
Moderna’s vaccine, which has shown promise against the Delta variant first identified in India, will be the fourth Covid-19 jab to be available in the country after Covishield, Covaxin and Sputnik.
“An application was received from Moderna through their Indian partner Cipla following which Moderna’s Covid-19 vaccine has been granted restricted emergency use authorisation by the drug regulator. This opens up a clear possibility of this vaccine being imported to India in
the near future,” Paul said.
“Our efforts to invite and to have other internationally developed vaccines, specifically Pfizer and Johnson & Johnson also continue. Those processes are on. We are also looking at increasing the production of availability of vaccines that are being manufactured in our country,” he said.
The Union government had in April fast-tracked approvals for foreign vaccines to have a wider pool of shots as it struggled to control a soaring second wave of infections that crippled its healthcare system.
In separate communications, 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 for use here and sought an approval from the Central Drugs Standard Control Organisation (CDSCO).
On Monday, pharmaceutical company 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 first 100 beneficiaries before rolling out of vaccine for further immunisation programme, according to the approval order,” an official aware of the details said.
On Monday, Cipla filed the application seeking permission for import of Moderna’s vaccine referring to DCGI 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.
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 Food and Drug Administration (FDA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) or the World Health Organization (WHO).
According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive the trial requirement altogether for the well-established vaccines manufactured in other countries.
Meanwhile, Moderna vaccine produced neutralising antibodies against emerging variants, including the Delta variant, in a lab study, the drugmaker said on Tuesday.
The study was conducted on blood serum from eight participants obtained one week after they received the second dose of the vaccine in an early-stage trial. Vaccination produced antibodies against all variants, including additional versions of the Beta variant first identified in South Africa and three lineage variants first identified in India, including the Kappa and the Delta variants.
“These new data are encouraging and reinforce our belief that the Moderna Covid-19 vaccine should remain protective against newly detected variants,” chief executive Stéphane Bancel said.
THE CENTRE HAD IN APRIL FASTTRACKED APPROVALS FOR FOREIGN VACCINES TO HAVE A WIDER POOL OF SHOTS