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Bharat Biotech’s Novel Intranasal Vaccine For Covid-19 Found Safe And Effective After Phase 3 Clinical Trial

Author: Medical Team (Alniche Life Sciences)

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Background

With a novel approach to globally immunize the population against deadly corona virus, Bharat Biotech has introduced, intranasal BBV154 vaccine. This is a replication-deficient adenovirus vectored vaccine with pre-fusion stabilized spike protein, durable at 2-8°C temperature range. After getting successful results in phase 1 and phase 2 clinical trial, phase 3 randomized study was accomplished through assessing lot to lot consistency of BBV154 in the age group of 18-65 years of healthy volunteers. This study compared the safety, efficacy and immunogenicity of BBVI54 with Covaxin.

 Introduction

The dense network of blood vessels in the nose, has enlightened the researchers to formulate intranasal route, for administrating BBV154 vaccine. The deadly corona virus attacks through nasal route to damage the respiratory tissues, steering a healthy person to life-threatening situations, worsening the health condition by attacking the respiratory tissues and increasing the body oxygen demand. Administrating the vaccine through intranasal route, might generate local antibodies in the upper respiratory tract and intensify immunity, by neutralising IgG, mucosal IgA, and T cell responses which blocks the infection and transmission of covid 19.

Study design

BBV154 vaccine was developed by fusing the modified chimpanzee attenuated virus with attenuated ChAd viral vector. Resulting ChAd-SARS-CoV-2-S was then administered in mice, Hamster and Rhesus Monkey. Effective immunization was observed in all these animal models.

3160 healthy volunteers were divided as group 1 which involves 3000 subjects and group 2 comprising of 160 subjects.

Firstly, the group 1 was administrated though intranasal route using a dropper with dose of 0.5 ml of replication deficient adenovirus based SARS-COV2 vaccine termed as BBV154 for a randomized phase 3 clinical trial. On the other hand, Group 2 was dispensed by whole virus inactivated SARS-COV-2, Covaxin via intramuscular route, on the day 0 and day 28.

The evaluation of intranasal vaccine as a primary dose schedule and a heterologous booster dose was performed for the volunteers who have previously received two doses of the two commonly administered COVID-19 vaccines in India. Separate and simultaneous clinical trials were conducted.

Way Forward

It was found that BBV154 is safe and efficient to produce antibodies in the upper respiratory tract due to which further transmission of the infection might be prohibited.

The Phase 3 clinical trial was completed successfully and the reports are submitted for regulatory approval. According to the Bharat Biotech, the vaccine would become cost effective approach in low and middle income countries. In response to emerging variants, the intranasal vaccine is efficient for targeted vaccine response with enhanced patient compliance and non-invasive approach for better patient safety.

References:

1. https://www.bharatbiotech.com/intranasal-vaccine.html

2.http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=65443&EncHid=&modid=&compid=%27,%2765443det%27