No serious adverse effect due to the COVAXIN vaccine reveals interim finding from phase 1 clinical trial
Dec 16, 2020
By Priyanka Sharma
New Delhi [India], December 16 : No serious adverse effect related to the vaccine has been reported by COVID-19 vaccine (BBV152) COVAXIN, the interim finding from the phase 1 clinical trial of COVAXIN has stated which has now been published in the pre-print version on Monday.
COVAXIN is an indigenously developed coronavirus vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
A double-blind randomized controlled phase 1 clinical trial was conducted to evaluate the safety and immunogenicity of BBV152 (manufactured by Bharat Biotech) is a whole-virion, inactivated SARS-CoV-2 vaccine, said the document.
"We report the interim findings from this phase 1 clinical trial of BBV152, a whole-virion inactivated SARS-CoV-2 vaccine. The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events. The most common adverse event was pain at the injection site, which resolved spontaneously. The overall incidence rate of local and systemic adverse events in this study was 10 per cent-20 per cent in all vaccine treated arms, which is noticeably lower than the rates for other SARS-CoV-2 vaccine platform candidates and comparable to the rates for other inactivated SARS-CoV-2 vaccine candidates," stated a pre-print document accessed by ANI.
"Reactogenicity was absent in the majority of participants, with mild events. The majority of adverse events were mild and resolved. One serious adverse event was reported, which was found to be unrelated to vaccination.
The document noted that one serious adverse event was reported and the participant was screened on July 25th and vaccinated on July 30th. Five days later, the participant reported fever and headache (initially reported as a solicited adverse event), and on August 8th was found to be positive for SARS-CoV-2 (by a nucleic acid test). The symptoms were initially mild in nature, which the onset of relapsing fever requiring admission to the hospital on August 15th.
After the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved rapidly, without any prescribed medication, it read.
A total of 375 participants were randomized equally and received three vaccine formulations (n=100 each).
"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 document said that BBV152 is stored between 2°C and 8°C, which is compatible with all national immunization program cold chain requirements, and further, efficacy trials are underway.
To ensure generalizability, this study was conducted with participants from diverse geographic locations and socioeconomic conditions, enrolling 375 participants across 11 hospitals, it noted.
"Despite the fact that enrollment occurred during a national lockdown, which led to several operational challenges, the overall participant retention rate was 97%. The sample size was intentionally large to enable the inference of meaningful conclusions regarding immunogenicity and safety," it read adding that BBV152 induced robust binding and neutralizing antibody responses that were similar to those induced by other SARS-CoV-2 inactivated vaccine candidates, it said.
Two doses of the COVAXIN vaccine were administered at a volume of 0.5 mL/dose intramuscularly on days 0 and 14. The follow-up visits were scheduled on days 7, 28, 42, 104, and 194.
The study was performed in a dose-escalation manner wherein after completing vaccination in the first 50 participants and the placebo, the participants were monitored for seven days for safety.
Based on the independent Data Safety Monitoring Board (DSMB) recommendation, the trial was allowed to continue with an enrollment of the remaining participants into all groups, it said.
