Indigenous vaccine maker Bharat Biotech announced on February 19 that its COVID-19 vaccine candidate ‘Covaxin’ has got a regulatory nod to conduct clinical trials in the United States.
A statement released by Bharat Biotech read: “Covaxin will be evaluated as a COVID-19 vaccine candidate in the United States. Ocugen announced that the US Food and Drug Administration (FDA) has lifted its clinical hold on the company’s Investigational New Drug Application to evaluate the COVID-19 vaccine candidate, BBV152, known as Covaxin outside the United States.”
Notably, Ocugen Inc is co-developing Bharat Biotech’s Covaxin vaccine candidate for COVID-19 in the US and Canada.
On February 2 last year, Ocugen had announced an exclusive licensing agreement with Bharat Biotech to obtain exclusive rights to develop, manufacture and commercialise the latter's COVID-19 vaccine Covaxin in the US. In October 2021, Ocugen had submitted the Investigational New Drug Application (IND) to the FDA for conducting clinical trials.
Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen had said: “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the US population.”
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Ocugen has also submitted a request to the US Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) of Bharat Biotech’s coronavirus jab for paediatric use. The submission is based on results of a Phase 2/3 paediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India, Ocugen said in a regulatory filing.Follow our coverage of the coronavirus crisis here