Biological E. Limited plans to complete production at a rate of 75 million doses of its COVID-19 vaccine Corbevax per month, anticipating over 100 million doses per month from February 2022 which will enable the city-based company to deliver 300 Million doses as promised to the Centre, BE said on Tuesday.
Corbevax, India's first indigenously developed protein sub-unit vaccine against the virus, received the approval from the Drugs Controller General of India (DGCI) today, it said.
According to a press release issued by the vaccine maker soon, the company plans to deliver more than one billion additional doses globally.
''Biological E. Limited plans to complete production at a rate of 75 million doses per month, anticipating over 100 million doses per month from February 2022. These capacities will enable the Hyderabad-based company to deliver 300 Million doses as promised to the Government of India,'' it said.
The vaccine has been developed by Biological E. Limited in collaboration with the Texas Children's Hospital Centre for Vaccine Development (Texas Children's CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.
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.
Mahima Datla, Managing Director, BE limited said, ''Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality.
Corbevax has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well-tolerated, and immunogenic, the company said.
In the pivotal Phase III study conducted with an endpoint of immunogenic superiority, Corbevax demonstrated superior immune response in comparison with the Covishield vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant, the release said.