Pharma major Cipla has filed an application with the Drugs Controller General of India seeking permission to import Moderna's COVID-19 vaccine in India.
The firm submitted its application to the drugs regulator on June 28, sources told CNBC TV-18.
People aware of the development also said that DCGI is likely to take up the application soon and may even grant permission to import the COVID-19 vaccine today.
Cipla has said that there is no confirmatory or final agreement on COVID-19 vaccine import yet. "The company is seeking clarity and guidance on factors such as pricing, quantity and indemnity clause," Cipla told CNBC TV-18.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Cipla had earlier sought indemnification, exemptions from price capping, bridging trials and basic customs duty waiver from the Indian government. Similar requests for indemnity and exemption from bridging trials have been made by another US major Pfizer as well.
The two-shot Moderna regime is around 90 percent effective against symptomatic COVID-19 and 95 percent effective against severe disease.
The Moderna Covid-19 vaccine was developed in collaboration with the US National Institutes of Health using messenger ribonucleic acid (mRNA) technology.
Moderna’s vaccine remains stable at -20°C, the temperature of a household freezer, for up to six months. It can remain refrigerated at 4°C for up to 30 days.
This vaccine has been widely used in countries such as Canada, United States and the United Kingdom under emergency use authorisations granted by these countries and the World Health Organisation.Click here for Moneycontrol's full coverage of COVID-19