Having supplied over 125 crore doses of Covishield in the country, the Serum Institute of India (SII) has sought full market authorisation for its Covid vaccine currently meant for emergency use only.Chief executive Adar Poonawalla today said that the Centre has enough data for full market authorisation.
Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission.
— Adar Poonawalla (@adarpoonawalla) December 31, 2021
If the regular marketing authorisation is granted, Covishield will become the second Covid vaccine in the world to receive such an approval after Pfizer-BioNTech's got a nod in the US.
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.
SII had earlier also sought regular marketing approval in October after it supplied 100 crore doses in India and many other countries.
Emergency use approval to Covishield was granted on January 3, the vaccine playing a crucial role in pandemic control and becoming the mainstay of India's Covid inoculation drive.