Safe Covaxin from Bharat Biotech, based on phase 1 test data
India’s first domestically produced vaccine against Covid-19, Covaxin, triggered a robust immune response and reported no major adverse events show findings from published double-blind, randomized, placebo-controlled phase 1 trial on safety and immunogenicity published by Bharat Biotech in a prepress study Wednesday.
Only one serious adverse event was reported, which was found to be unrelated to vaccination, according to the study.
Covaxin’s Phase 1 results had not yet been released despite the data being first submitted to the Controller General of Drugs of India (DCGI) on October 2 when the company applied for approval to start trials. Phase 3.
“Neutralizing and binding antibody response induced by BBV152… Vaccine-induced neutralizing antibody titers were reported with two divergent strains of SARS-CoV-2. BBV152 is stored between 2 ° C and 8 ° C, which is compatible with all the cold chain requirements of the national immunization program, ”says the document, which has not yet been peer-reviewed.
To be sure, the data provided in the study published Wednesday only pertains to the first of the three-phase clinical trials for the vaccine’s authorization. In Phase 1, the initial testing of the candidate vaccine is carried out in a small number of healthy adults to primarily test its safety. The results of this phase do not influence the market authorization.
Other organizations that have been developing Covid-19 vaccines published data from their Phase 1 trials several months ago. Moderna Inc, for example, released its Phase 1 data in July. The Pfizer / Biontech vaccine, which has already begun to be administered in the United States and Great Britain, published data on the results of Phase 1 of its vaccine in August.
Phase 2 involves a larger number of subjects and focuses on data on the ability of a vaccine to safely produce the desired effect (immunogenicity).
Phase 3 is the fundamental study on which the licensing is based and tests the effectiveness of the immune reaction triggered by the vaccine. The efficacy of the vaccine will be determined only in phase 3 trials. The results of Phase 3 are finally presented as the data on which authorization is obtained. Bharat Biotech has yet to present the results of the phase 3 trials, which began in mid-November. On December 7, the firm had applied to DCGI for an emergency use authorization for Covaxin, after which the Subject Matter Expert Committee (SEC) recommended that it submit safety and efficacy data from Phase 3 trials for your application is considered.
Bharat Biotech has developed the whole virion inactivated SARS-CoV-2 vaccine candidate vaccine (BBV152) in collaboration with ICMR.
In the Phase 1 study, a total of 375 participants were equally randomized to receive three vaccine formulations (n = 100 each); the control arm had 75 participants. Vaccines were administered in an accelerated two-dose schedule intramuscularly on day 0 (baseline) and day 14. The primary outcomes were reactogenicity and safety. The secondary outcomes were immunogenicity. Follow-up visits were scheduled for days 7, 28, 42, 104, and 194.
However, experts say that a lot depends on the results of the phase 3 trial. “At this stage, there are many promising candidate vaccines, but the results of the Phase 3 trial will be significant in terms of which ones will eventually materialize,” he said. the public health expert, Professor K Srinath Reddy, who is also a member of the National Working Group on Covid-19 management.