Covaxin: India's first indigenous COVID vaccine

Covaxin ( or BBV152 ) is an inactivated virus–based COVID – 19 vaccine that is used to provide protection against infection from the SARS – CoV – 2 viruses in individuals aged 18 years and above. ^[1] ^[4]

2. Who is the manufacturer?

It is an indigenous vaccine developed in India by Bharat Biotech in collaboration with the Indian Council of Medical Research – National Institute of Virology. It is manufactured in Bharat Biotech’s BSL – 3 ( Bio – Safety Level 3 ) high containment facility. ^[2]

3. Current pricing of Covaxin :

In India, this vaccine is priced at Rs. 600 per dose for the state governments and Rs. 1200 per dose for private hospitals. In the export market, the price of this shot has been pegged at $ 15 to $ 20 per dose ( around Rs. 1,125 – 1500 ). The current price of this jab is much higher when compared to the other vaccine ( Covishield ) being used in India. ^[3]

Covaxin: Mechanism of action

This is a highly purified and inactivated vaccine that does not replicate when administered in the body. Therefore, this vaccine is unlikely to cause pathological effects or infect people.
The inactivated virus stimulates the production of activated helper T cells and activated B cells ( immune cells ) that proliferate and produce antibodies.
These antibodies target the spike protein of the live virus when the individual is infected at later stages and provides protection against infection by the live coronaviruses.
Immune – potentiators or vaccine adjuvants are also added to this vaccine to increase and boost its immunogenicity.

Dosage frequency :

Two doses of the vaccine must be administered for optimum efficacy. These are given four to six weeks apart. The shots are administered intramuscularly in the upper arm ( deltoid muscle).

COVAXIN® demonstrated overall clinical efficacy of 78% and efficacy of 100% against severe COVID-19 disease in phase 3 efficacy analysis.#Phase3 #VaccineEfficacy #Covaxin @DrKrishnaElla @SuchitraElla pic.twitter.com/zRnSgLzmMb
— BharatBiotech (@BharatBiotech) April 21, 2021

#Covaxin found to neutralise 617 variant of #COVID19: Dr Fauci https://t.co/3AsDR5nlfJ
— The Tribune (@thetribunechd) April 28, 2021

Is it effective?

This vaccine 78 % interim clinical efficacy in preventing mild, moderate, and severe COVID – 19 infections in those without prior infections after the second dose. It is revealed to be 100 % effective against ‘ severe COVID – 19 disease ‘ in Phase – 3 clinical trials.
It shows over 70 % efficacy against asymptomatic COVID – 19. Covaxin is also effective in reducing hospitalizations and disease transmission.
Preliminary results from studies have shown that this vaccine is also effective in inducing antibodies for neutralizing the UK variant strains and Indian variant strain ( double mutant strain ) of coronavirus. ^[5] ^[6]

Covaxin Indian scenario

This vaccine was granted emergency use approval in India on 3 January 2021 by the Drugs Controller General of India.
Per the government’s CO – WIN portal, over 1,15,40,763 shots of Covaxin have been administered in India ( as of 21 April 2021 ).
The current production capacity of this vaccine is around 10 million vaccine doses as of April 2021. The company has decided to expand the production capacity to manufacture over 70 million vaccine doses per month in July – August 2021.
The All India Institute of Medical Sciences has claimed that this vaccine provides immunity against the disease for 9 to 12 months.

Global acceptance scenario

This vaccine has been approved for emergency use in Iran, Zimbabwe, Mauritius, Nepal, Paraguay, Philippines, Mexico, Myanmar, Guatemala, Nicaragua, Guyana, Venezuela, and Botswana.
The clearance of this vaccine in Brazil has been denied recently due to failure to comply with the “ good manufacturing practices.” [7]
Pennsylvania – based Ocugen has been following an interim analysis of Phase III data related to the efficacy of Covaxin together with Bharat Biotech. Based on this data, the former plans to seek out the FDA to approve this product in the US. The exact timeline of this approval is yet to be disclosed. ^[8]