Bharat Biotech’s COVID-19 vaccine COVAXIN is well tolerated with no serious adverse events based on the results of the Phase 1 study

The interim results of the Phase 1 clinical trial with the COVID-19 vaccine Covaxin, locally developed by Bharat Biotech showed in collaboration with the ICMR that it was well tolerated in all dose groups without serious or adverse events. The vaccine induced robust binding and neutralizing antibody responses comparable to those seen in the convalescent serum of patients recovering from COVID-19, according to the findings published on medRxiv, a preprint server.

A preprint is a version of an academic manuscript that was published on a public server prior to formal peer review.

One serious adverse event has been reported that was determined to be unrelated to the vaccination.

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 and 8 degrees Celsius, which is compatible with all cold chain requirements of the national immunization program, and further efficacy studies are being conducted.

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

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A similar trend was observed after the second shot was administered. Injection site pain was the most common local adverse event.

“A serious adverse event was reported. The participant was vaccinated on July 30. Five days later, the participant reported symptoms of COVID-19 and was positive for SARS-CoV-2,” the results say.

“The symptoms were mild in nature, but the patient was hospitalized on August 15th. The participant was discharged on August 22nd after a negative nucleic acid result. The event was not causally linked to the vaccine,” the results showed.

To ensure generalizability, the study was conducted on volunteers from different geographic regions and under socio-economic conditions, involving 375 participants in 11 hospitals.

“Despite the fact that registration occurred during a national lockdown, which created several operational challenges, the overall retention rate of participants was 97 percent,” the results showed.

The sample size was intentionally large in order to be able to draw meaningful conclusions about immunogenicity and safety, the document says.

BBV152 induced robust binding and neutralizing antibody responses similar to those induced by other inactivated SARS-CoV-2 vaccine candidates.

Two doses of the vaccine were administered intramuscularly on days zero and 14 in a volume of 0.5 ml / dose. Follow-up visits were scheduled on days 7, 28, 42, 104, and 194.

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