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Bharat Biotech’s COVID-19 Vaccine Well Tolerated With No Serious Adverse Events: Phase 1 Trial Findings

According to the phase-1 trial findings, after the first dose of Bharat Biotech’s COVID-19 vaccine, the event of adverse reaction were mild or moderate in severity and resolved rapidly, without any prescribed medication

Bharat Biotech's COVID-19 Vaccine Well Tolerated With No Serious Adverse Events: Phase 1 Trial Findings
  • Covaxin can be stored between 2-8 degrees Celsius: Phase 1 trial findings
  • Phase-1 was conducted on 375 participants across 11 hospitals in India
  • 2 doses of Covaxin was administered on participants with 14 days gap

New Delhi: The interim findings of phase 1 clinical trial of COVID-19 vaccine Covaxin, indigenously developed by Bharat Biotech in collaboration with the ICMR (Indian Council of Medical Research), showed that it was well tolerated in all dose groups with no serious or adverse events. The vaccine-induced robust binding and neutralising antibody responses which 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: States Receive Freezers, Ice-Lined Refrigerators For COVID-19 Vaccination: Ministry Of Health

A preprint is a version of a scientific manuscript posted on a public server prior to formal peer review. One serious adverse event was reported, which was found to be unrelated to vaccination, the findings showed. It was a double-blind randomised 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 immunisation programme 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.

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

Also Read: COVID-19 Vaccination Centre Issues Guidelines For Safe Waste Disposal Of Syringes

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.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, according to the findings.

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 neutralising 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.

Also Read: Number Of COVID-19 Vaccines Growing But Volume Of Doses Remains Concern: World Health Organisation Adviser

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (WaterSanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene

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