Moderna’s vaccine gets emergency use nod, India partner Cipla to import jabs
3 min read . Updated: 30 Jun 2021, 12:10 AM IST
PremiumModerna's covid-19 vaccine is the first foreign jab to get approval under the government’s revised norms for accelerated regulatory clearance of covid-19 jabs
Moderna Inc.’s covid-19 vaccine on Tuesday became the first messenger RNA jab and the fourth overall to be authorized for emergency use during the pandemic, with the Drugs Controller General of India granting its local partner Cipla Ltd an import licence.
It is the first foreign vaccine to get approval under the government’s revised norms for accelerated regulatory clearance of covid-19 jabs.
“An application received from Moderna through its Indian partner, Cipla, has been granted new drug permission for restricted use, which is commonly known as emergency-use authorization. This new drug permission for restricted emergency use is now in operation," Vinod K. Paul, member (health) at the NITI Aayog and chairman of the National Expert Group on Vaccine Administration for Covid-19, told reporters on Tuesday.
Mumbai-based drugmaker Cipla’s import licence will allow the company to ship Moderna’s covid-19 vaccines to India. The jabs were donated by the American firm to India.
“Cipla is just facilitating the import of the vaccines for Moderna for their donated quantities. As of now, they do not have a commercial pact," a person in the know said on condition of anonymity.
Moderna, in a statement, said that its covid-19 vaccine received authorization for adults, making India one of more than 50 countries where the jab has been allowed.
“I want to thank the government of India for this authorization, which marks an important step forward in the global fight against the pandemic," said Stéphane Bancel, chief executive officer of Moderna. “We are committed to making our covid-19 vaccine available around the world."
It is not yet clear how many doses Moderna is donating to India and whether these will be distributed through government channels or private ones.
“Cipla is supporting Moderna with the regulatory approval and importation of vaccines to be donated to India. At this stage, there is no definitive agreement on commercial supplies," Cipla said in a statement.
The authorization was given under revised norms that allow the regulator to speed up clearance for a covid-19 vaccine that has already received the nod from either the World Health Organization or any of the four top regulators—US Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare Products Regulatory Agency and Japan’s Pharmaceuticals and Medical Devices Agency.
The latest authorization came even as the government continued to discuss the modalities of providing indemnity to vaccine makers in the country—something that has held up Moderna’s rival Pfizer, which was the first company to apply for emergency authorization back in December.
Pfizer withdrew its application in February after being asked to conduct an Indian bridging study, while the government was reluctant to provide indemnity. However, negotiations over indemnity resumed last month as India faced an acute shortage of vaccines. Paul on Tuesday said discussions on indemnity are ongoing.
Pfizer’s and Moderna’s vaccines are among the most effective, with efficacies of 95% and 94.1%, respectively, and were central to the immunization drive in the US and other developed nations.
Initially, the new regulations said that foreign vaccines getting accelerated authorizations would be required to start a bridging study within 30 days of rollout in India. But this requirement was removed earlier this month, along with the need to conduct quality checks of each batch of jabs at the Central Drugs Laboratory in Kasauli. Instead, the vaccine would be administered to only 100 people initially to collect safety data before being rolled out to the wider public.
The revision means Moderna will not be required to conduct a clinical trial in India, unlike Serum Institute of India and Dr Reddy’s Laboratories, which conducted bridging trials for Covishield and Sputnik V, respectively, to secure authorization. Bharat Biotech’s indigenously developed jab Covaxin is the other vaccine that has received authorization in India.
The move to do away with the need for a bridging study and testing of batches aims to attract more applications and speed up the rollout of jabs.
