Bharat Biotech's COVID-19 vaccine likely to begin human trials by July

New Delhi: Bharat Biotech, the country’s pandemic vaccine leader, is working on an intranasal vaccine against coronavirus disease (Covid-19) called “CoroFlu”.

Bharat Biotech is collaborating with virologists at the University of Wisconsin–Madison and the vaccine company, FluGen, for the project.

CoroFlu is in the animal testing phase in the US, and is expected to move to human trials in the next three months.

“Bharat Biotech will manufacture the vaccine, conduct clinical trials, and prepare to produce almost 300 million doses of vaccine for global distribution. Under the collaboration agreement, FluGen will transfer its existing manufacturing processes to Bharat Biotech to enable the company to scale up production and produce the vaccine for clinical trials,” said Raches Ella, head, business development, Bharat Biotech.

Bharat Biotech has commercialised 16 vaccines, including the one developed against the H1N1 flu that caused the 2009 pandemic.

CoroFlu will build on the backbone of FluGen’s flu vaccine candidate known as M2SR, a novel live influenza vaccine that protects mice and ferrets against highly pathogenic avian influenza.

Based on an invention by the University of Wisconsin­–Madison virologists and FluGen co-founders Yoshihiro Kawaoka and Gabriele Neumann, M2SR is a self-limiting version of the influenza virus that induces an immune response against the flu.

Kawaoka’s lab will insert gene sequences from SARS-CoV-2, which causes Covid-19, into M2SR so that the new vaccine will also induce immunity against the coronavirus.

Refinement of the CoroFlu vaccine concept and testing in laboratory animal models at the University of Wisconsin–Madison is expected to take up to months.

“Bharat Biotech in Hyderabad will then begin production scale-up for safety and efficacy testing in humans. CoroFlu could be in human clinical trials by October,” said the company in a statement.

“Four Phase-I and Phase-II clinical trials involving hundreds of subjects have shown the M2SR flu vaccine to be safe and well-tolerated. This safety profile, M2SR’s ability to induce a strong immune the response, and the ability of influenza viruses to carry sequences of other viruses make M2SR an attractive option for rapidly developing CoroFlu as a safe and effective SARS-CoV-2 vaccine,” it added.