Covid-19 vaccine: No serious adverse effect found in indigenous Covaxin trials, says research

The study said the vaccine candidate “induced” neutralising antibody responses, and that vaccine-induced responses were “comparable to those observed in the convalescent serum collected from patients who had recovered from COVID-19.

By: Satata Karmakar | | Published: December 17, 2020 9:27 am

Covid-19 vaccine: Covaxin well tolerated with 'no serious adverse events'

Bharat Biotech’s indigenous Covid-19 vaccine candidate Covaxin, which is currently in late-stage clinical trials, has been found to be well-tolerated, with no vaccine-related serious adverse events, and triggered a robust immune response in its early Phase 1 clinical trial, according to a research paper published by the Hyderabad-based firm, which is yet to be peer-reviewed. Also Read - Alert! Coronavirus spike proteins may evolve to evade immune responses

The vaccine-induced robust binding and neutralizing antibody responses were comparable to those observed in the convalescent serum collected from patients who had recovered from COVID-19, according to the findings which have appeared on medRxiv, a preprint server. Also Read - Covid-19 vaccination: Concerns about adverse effects ‘unfounded, negligible’, says Govt

A preprint is a version of a scientific manuscript posted on a public server prior to formal peer review. Also Read - 'Game changer against Covid-19': Expert panel recommends phase 1 trial of Bharat Biotech's nasal vaccine

SAFETY AND IMMUNOGENICITY OF COVID-19 VACCINE – COVAXIN

One serious adverse event was reported, which was found to be unrelated to vaccination, the findings showed.

It was a double-blind randomized controlled phase 1 clinical trial to evaluate the safety and immunogenicity of Covaxin (BBV152).

The document mentions that BBV152 is stored between 2 degrees Celsius and 8 degrees Celsius, which is compatible with all national immunization program cold chain requirements and further efficacy trials are underway.

According to the “A Phase 1: Safety and Immunogenicity Trial of an Inactivated SARS-CoV-2 Vaccine BBV152”, after the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved rapidly, without any prescribed medication.

ADVERSE EVENTS REPORTED WERE MILD IN NATURE

A similar trend was observed after the second shot was administered. Pain at the injection site was the most common local adverse event.

“One serious adverse event was reported. The participant was vaccinated on July 30. Five days later, the participant reported symptoms of COVID-19 and was found to be positive for SARS-CoV-2,” according to the findings.

“The symptoms were mild in nature, but the patient was admitted to the hospital on August 15. The participant was discharged on August 22 following a negative nucleic acid result. The event was not causally associated with the vaccine,” the findings showed.

To ensure generalisability, the trial was conducted on volunteers from diverse geographic locations and socioeconomic conditions, enrolling 375 participants across 11 hospitals.

“Despite the fact that enrolment occurred during a national lockdown, which led to several operational challenges, the overall participant retention rate was 97 per cent,” the findings showed.

The sample size was intentionally large to enable the inference of meaningful conclusions regarding immunogenicity and safety, the document said.

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 vaccine were administered at a volume of 0.5 mL/dose intramuscularly on days zero and 14. The follow-up visits were scheduled on days 7, 28, 42, 104, and 194.

(With inputs from Agencies)

Published : December 17, 2020 9:27 am

Read Disclaimer