India’s DCGI Approves COVISHIELD and COVAXIN Vaccines for Restricted Use
Emerging from the latest news, the Drugs Controller General of India (DCGI) greenlit the use of two vaccines, COVISHIELD and COVAXIN, as a response to the COVID-19 pandemic. These vaccines, along with another contender BNT162b2, sought emergency approval from the Central Drug Standard Control Organisation (CDSCO).
Type of Approval
The DCGI has conditionally sanctioned these vaccines for restricted use in emergency situations. This implies that although clinical trials are still underway, the vaccines have been given the go-ahead based on the urgency of the pandemic situation. The companies are expected to continually present data on safety, efficacy and immunogenicity from their ongoing trials. Here, immunogenicity refers to the vaccine’s capacity to trigger an immune response, while efficacy indicates its ability to reduce the number of COVID-19 symptomatic cases.
Reason for Emergency Approval
The driving force behind this rapid approval is the urgent need for a reliable vaccine amidst the global health crisis. Furthermore, mutations of the SARS-CoV-2 virus in various parts of the world, including the UK and India, have added to the urgency.
About COVISHIELD
COVISHIELD is the moniker adopted for an Oxford-AstraZeneca Covid-19 vaccine candidate, formally known as AZD1222 or ChAdOx 1 nCoV19. The University of Oxford and Swedish-British drugmaker AstraZeneca have collaborated on this vaccine, with the Serum Institute of India (SII) as the manufacturing partner for India.
COVISHIELD comprises of a weakened form of a common cold virus found in chimpanzees. This viral vector contains the genetic makeup of the SARS-CoV-2 spike protein that assists the virus in binding with human cells. The immune system is anticipated to recognise this protein as a threat and subsequently build antibodies to combat it. In early trials, COVISHIELD successfully triggered an immune response against the novel coronavirus, thereby securing its position as a leading global contender for the Covid-19 vaccine.
About COVAXIN
COVAXIN is India’s indigenous COVID-19 vaccine, developed by Bharat Biotech, Hyderabad, in collaboration with the Indian Council of Medical Research’s National Institute of Virology, Pune. It is an inactivated vaccine, formulated by killing live microorganisms causing the disease, rendering the pathogen unable to replicate. This process maintains the pathogen intact for the immune system to recognise and develop a response against it.
COVAXIN aims to target more than just the spike protein; it also strives to initiate an immune response against the nucleocapsid protein, which is the shell enclosing the virus’s genetic material. COVAXIN presents an added advantage as it potentially works effectively against newer variants of the virus, including the UK variant. This is due to it containing immunogens from other genes apart from those from the Spike protein. Approval of COVAXIN therefore ensures that India has an extra layer of protection, particularly against potential mutant strains in a dynamic pandemic situation.
