3rd Covaxin jab a reality soon? Results for 'booster' dose trials likely in November

The result of clinical trials of Bharat Biotech's Covaxin COVID-19 vaccine's third 'booster' dose is expected by November of this year. The booster dose trial of India's first indigenously manufactured vaccine was first launched in May. The trials were first held at the All India Institute of Medical Sciences (AIIMS) in Delhi and Patna. As many as 12 centres across the country have been conducting trials for Covaxin's booster shot.

In April, the Drug Controller General of India (DCGI) granted Bharat Biotech permission to conduct these clinical trials for the third 'booster' dose. While the results of trials conducted in May are due in August, for the second trial, final results are expected by November 2021. The trials are aimed at assessing the immunogenicity, safety, reactogenicity and tolerability of the Covaxin booster dose.

Earlier this year, while speaking to Republic Media Network's Editor-in-Chief Arnab Goswami, Bharat Biotech Chairperson Dr Krishna Ella had shed light on the possibility of providing citizens with a booster dose of its COVID-19 vaccine, COVAXIN, to further strengthen immunity against SARS-CoV-2. While maintaining that trials for the same were underway, Dr Ella opined there would be a need for a booster dose of the vaccines as it might provide long-term immunity. 

"My gut feeling is that a booster dose will be required. Certainly, if you give a booster dose it might give a long term immunity," Dr Ella had said.

Covaxin Neutralises Both Alpha & Delta Variants Of COVID-19

The COVID-19 pandemic and its continuously evolving variants have wreaked havoc across the globe; and despite this, vaccine hesitancy and politics continues unbridled in many parts of the world. COVAXIN was subjected to such vaccine politics when it was granted emergency use authorisation by India's drug regulator DCGI before its final clinical trial data was released. However, the ICMR-Bharat Biotech vaccine has now come to be accepted as a potent defence against even the newer, more dangerous COVID variants. On Wednesday, the top medical research agency of the US - the NIH - stated that India's first indigenous COVID-19 vaccine effectively neutralizes both the Alpha (B.1.1.7) and Delta (B.1.617) variants. This assumes significance at a juncture when it is yet to be approved by the US Food and Drug Administration and the WHO. A component of the US Department of Health and Human Services, the National Institutes of Health (NIH) has revealed that an adjuvant developed with its funding has contributed to the "success" of Covaxin.

COVAXIN shows overall 78% efficacy

COVAXIN is a Whole Virion Inactivated Coronavirus Vaccine developed by Bharat Biotech in collaboration with ICMR and NIV. It has shown overall 78% efficacy and 100% efficacy against severe COVID-19 disease as per interim results from Phase 3 trials. Bharat Biotech stated that the second interim analysis suggests a reduction in hospitalization cases and decreased transmission in recipients of this vaccine. Moreover, the efficacy against asymptomatic COVID-19 infection was 70%.