Covaxin
Covaxin (development name, BBV152) is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology.[1]
This article is about Bharat Biotech's COVID-19 vaccine. For Novavax's vaccine, see Covovax. For the global vaccine alliance, see COVAX.On 3 November 2021, the World Health Organization (WHO) validated the vaccine for emergency use, as the first Indian-developed covid vaccine to be approved.[2][3] By 31 January 2022, Covaxin had been granted emergency use approval in 13 countries.[4]
Medical uses
Effectiveness
A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[5] Effectiveness is generally expected to slowly decrease over time.[6]
Manufacturing
As an inactivated vaccine, Covaxin uses a more traditional technology that is similar to the inactivated polio vaccine. Initially, a sample of SARS-CoV-2 was isolated by India's National Institute of Virology and used to grow large quantities of the virus using vero cells. From then on, the viruses are soaked in beta-propiolactone (BPL), which deactivates them by binding to their genes, while leaving other viral particles intact. The resulting inactivated viruses are then mixed with the aluminium-based adjuvant Alhydroxiquim-II.[1][9][10]
The vaccine is produced with Bharat Biotech's in-house vero cell manufacturing platform[11] that has the capacity to deliver about 300 million doses.[12] The company is in the process of setting up a second plant at its Genome Valley facility in Hyderabad to make Covaxin. The firm, in collaboration with the Government of Odisha, is establishing another facility at Odisha Biotech Park in Bhubaneswar to commence Covaxin production by June 2022.[13][14]
In December 2020, Ocugen entered into a partnership with Bharat Biotech to co-develop and exclusively commercialise Covaxin in the US market;[15][16] in June 2021, the partnership was extended to cover Canada.[17] In January 2021, Precisa Medicamentos entered into an agreement with Bharat Biotech to supply Covaxin to Brazil.[18] The contract was terminated in July 2021 after the Brazilian government suspended procurement to investigate allegations of irregularities in pricing.[19]
In May 2021, Haffkine Bio-Pharmaceutical Corporation Limited of Haffkine Institute entered into a memorandum of understanding (MoU) with Bharat Biotech and announced that the production of Covaxin by them will commence after obtaining support from the Maharashtra state government and approval from the Indian government[20] whereas Indian Immunologicals Limited (IIL) has signed a commercial agreement with Bharat Biotech for producing the drug substance, a critical component of the vaccine[21] Bharat Immunologicals and Biologicals Corporation (BIBCOL) will also manufacture the vaccine.[22]
On 1 April 2022, Bharat Biotech announced that it was cutting production due to reduction in demand. On 2 April the WHO said that a March 2022 inspection of facilities used to manufacture Covaxin had uncovered good manufacturing practice deficiencies.[23]