details about covaxin vaccine
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A vaccine that was authorised by the Indian government ahead of phase 3 trials now shows promising results, making Covaxin a potentially valuable addition to the global armoury of vaccines against COVID-19.
A vaccine based on whole inactivated coronavirus has an efficacy rate of 77.8% against symptomatic COVID-19 infections, phase 3 trial data suggest.
Covaxin, also known as BBV152, was authorised for emergency use by India’s Central Drugs and Standards Committee (CDSCO) on 3 January 2021, even though phase 2 clinical trials were unpublished, and larger phase 3 trials still ongoing. Some criticised the decision, but the regulator cited the need for protection against the Alpha variant, which was at that time spreading fast and outcompeting previous variants. The Alpha variant has since been overtaken by the Delta variant.
The main side effects were pain at the injection site, followed by headache, fatigue and fever. No severe or life-threatening adverse events were reported.
The CDSCO and the vaccine’s manufacturer, Bharat Biotech, insisted the vaccine was safe and provided a robust immune response. They also promised that the full phase 3 trial data would be made available by July.
That data has now been published, although it has not yet been peer reviewed.
INACTIVATED VIRUS
Covaxin is an inactivated whole virus vaccine, containing SARS-CoV-2 particles that have been chemically deactivated. That means they can no longer infect cells, but still stimulate a protective immune response. Because the viral particles cannot cause disease, the vaccine is suitable for people with compromised immune systems. Covaxin also contains two adjuvants – chemicals designed to strengthen the immune response to the vaccine – aluminium hydroxide, and a toll-like receptor (TLR) 7/8 agonist. The vaccine comes as a two-dose regimen, recommended to be taken 28 days apart.
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