COVAXIN - India's First indigenous COVID-19 Vaccine
COVAXIN, India's indigenous
COVID-19 vaccine by Bharat Biotech is developed in collaboration with the
Indian Council of Medical Research (ICMR) - National Institute of Virology
(NIV). The indigenous, inactivated vaccine is developed and manufactured in
Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.
The Drugs Controller General of
India (DCGI) approved Covaxin, which was developed locally by Hyderabad-based
Bharat Biotech International Ltd. in collaboration with the Indian Council of
Medical Research, and is still in phase III trials.
The placebo-controlled,
double-blinded clinical trial to evaluate the safety and immunogenicity of the
vaccine enrolled approximately 375 participants.
Of these, 300 subjects received the vaccine doses while 75 subjects received the placebo. Participants received two intramuscular doses of vaccine on day 0 (baseline) and day 14.
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Interim data showed that on day
28, all participants who received the vaccine had significantly elevated Spike
binding IgG antibodies and neutralising antibody titers.
The vaccine-induced antibody responses and could potentially neutralise both homologous (vaccine virus strain) and heterologous (divergent) SARS-CoV-2 strains.
Bharat Biotech’s Covid-19 vaccine
shows no serious adverse effects in trial
Indian firm Bharat Biotech has reported interim results from the Phase I clinical trial that showed its Covid-19 vaccine, COVAXIN (BBV152), induced a robust immune response with no serious adverse effects.
The vaccine, stored between 2°C
and 8°C, is ideal for all national immunisation programme cold chain needs,
Bharat Biotech noted.
“Permission for restricted use in
clinical trial mode has been allowed which means consent of participants has to
be taken and there has to be a regular follow up of participants”.
https://www.bharatbiotech.com/covaxin.html
https://www.pharmaceutical-technology.com/news/bharat-biotech-covaxin-trial/
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