The fourth coronavirus vaccine was approved by India’s drug regulator DCGI on Tuesday, allowing Mumbai-based pharmaceutical company Cipla to import the vaccine for limited emergency usage in the country.
“Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna’s Covid-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules , 2019 under Drugs and Cosmetics Act, 1940,” a source said.
“An application received from Moderna through an Indian partner, Cipla, has been granted new drug permission for restricted use, which is commonly known as emergency use authorisation… This new drug permission for restricted emergency use is now in operation,” Vinod K. Paul, member (health) at NITI Aayog and chairman of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), said at a press conference
Moderna is said to be 90 per cent effective against Covid.
The vaccine works by temporarily instructing cells to produce coronavirus spike protein. The protein is located on the COVID-19 virus’s surface.
Cipla announced earlier this month that it intends to fast-track authorisation to import Moderna’s single-dose Covid-19 booster vaccine into India as soon as possible, and that it has asked indemnification and exemptions from price capping, bridging trials, and basic customs duty from the government. Cipla had not yet given the vaccination a name.
Apart from Pfizer, the contemporary vaccine is the second US-based mRNA vaccine to be awarded emergency use authorization.
Quint Fit revealed that mRNA vaccines are based on a revolutionary vaccine technique that uses the pathogen’s genetic code to generate a powerful immune response.
The European Medicines Agency has reviewed the Moderna vaccine, and it passes the World Health Organization’s (WHO) safety and efficacy criteria.
These four vaccines (Covaxin, Covishield, SputnikV and Moderna) are safe for lactating mothers. Vaccine has no association with infertility: Dr. VK Paul, Member-Health, Niti Aayog pic.twitter.com/DLjvW6Oqms— ANI (@ANI) June 29, 2021