Covid-19 vaccine tracking: Covaxin phase 1 trials show promising results
Covaxin phase 1 trials: Results of phase 1 trials of Covaxin vaccine were released in a preprint paper “A Phase 1: Safety and Immunogenicity Trial of an Inactivated SARS-CoV-2 Vaccine -BBV152”. Preprint paper is a scientific manuscript version which is posted on public server before formal peer review.
The vaccine’s results propose the Covid-19 vaccine to be safe and well tolerated in all dose groups. The results also show the triggered immune response by the vaccine.
Covaxin is India’s first indigenous Covid-19 vaccine, which is being developed in collaboration with Hyderabad based Bharat Biotech and ICMR (Indian Council of Medical Research).
The initial findings from phase 1 of the trial, that was placebo-controlled and double blind randomized, was shown to be safe. The immunogenicity of three formulations of Covaxin reported the results which were carried out on 375 volunteers. One adverse reaction during trial was reported but it was later found to be unrelated to Covid-19 vaccine.
The preprint paper was published on MedRxiv, which is a free online portal on health sciences preprints. The paper said, “Reactogenicity was absent in the majority of participants, with mild events. The majority of adverse events were mild and were resolved. One serious adverse event was reported, which was found to be unrelated to vaccination. All three vaccine formulations resulted in robust immune responses comparable to a panel of convalescent serum.”
The analyses was participated by researchers from ICMR, Bharat Biotech, AIIMS New Delhi and Patna, among other institutes. The study noted, “We conducted a double-blind randomized controlled phase 1 clinical trial to evaluate the safety and immunogenicity of BBV152. A total of 375 participants were randomized equally to receive three vaccine formulations. Vaccines were administered on a two-dose intramuscular accelerated schedule on day 0 (baseline) and day 14. The primary outcomes were reactogenicity and safety.”
The report adds that till date 180 vaccine candidates are under development to help fight against the Covid-19 infection. The sequence of virus strain NIV-2020-770 was isolated from a patient and done by ICMR-National Institute of Virology (NIV) and was then provided to Bharat Biotech for vaccine development.
Currently phase 3 clinical trials are being carried out by Bharat Biotech. The firm has applied for EUA (emergency use authorization) to the DCGI (Drugs Controller General of India).