Pharmaceutical firm Cipla has received regulatory nod from Drug Controller General of India (DCGI) to import the COVID-19 vaccine developed by US-based biotechnology company Moderna Inc, reports said on June 29.
According to news agency ANI, an official announcement from the government is expected shortly.
Earlier on June 29, Cipla sources confirmed to CNBC TV-18 that an application has been filed with India's apex drug regulatory body, seeking the permission to import the Moderna jabs for restricted emergency use.
"The company is seeking clarity and guidance on factors such as pricing, quantity and indemnity clause," the sources told the news channel.
Moderna, similar to the anti-COVID-19 jab co-developed by US pharmaceutical giant Pfizer, is an mRNA vaccine. It is based on a two-dose regimen, with both the shots to be administered at a gap of 28 days. The vaccine has demonstrated an efficacy of 90 percent.
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.
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The import of Moderna vaccine is expected to boost the government's drive to inoculate all adults by December 31, 2021. The Centre is also in talks with Pfizer over the import of its jabs.
Pfizer CEO Albert Bourla said on June 22 that the company is in the "final stages" of talks with India to export its vaccine. The regulatory approval may be granted soon, he suggested.
Reports had earlier suggested that indemnification was a major point of contention in the talks for import of vaccines between the government and the foreign manufacturers.
Notably, Moderna and Pfizer had earlier declined the request of Indian state governments who had sought to import their jabs. Both the companies underlined that they would deal only with the federal authority - which is the Government of India.