As India approves Corbevax, here’s what you need to know about the new COVID-19 vaccine

HYDERABAD: City-based Biologicals E. Ltd. (BE), one of the world’s largest vaccine manufacturers, is excited to welcome DGCI’s approval for its CORBEVAX, India’s first indigenously developed protein sub-fighting agent against COVID-19. Unit vaccine has been approved.

CORBEVAX is a “recombinant protein sub-unit” vaccine developed from the receptor binding domain (RBD) of the spike protein on the surface of the virus, combined with Dynavax’s CpG 1018 adjuvant with alum, which allows the body to contract the virus. Helps in creating an immune response against

The vaccine has been developed by Biologicals E. Ltd. in collaboration with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) Houston, Texas, USA.

According to BE, the vaccine will be effective in both scale and affordability, providing sustainable access to low- and middle-income countries.

Clinical Basis and Vaccine Characteristics:

Corbewax Completed two Phase III clinical trials involving over 3000 subjects between the ages of 18 and 80 years at 33 study sites across India. The vaccine was found to be safe, well tolerated and immunogenic.

• In the pivotal Phase III study with immunogenic superiority endpoint, CORBEVAX demonstrated a better immune response than the COVISHIELD vaccine when antibodies against the parental–Wuhan strain and the globally dominant delta (nAb) Geometric Mean Neutralizing titers (GMT) were assessed. Type. CORBEVAXTM vaccination also produced significant Th1 skewing cellular immune responses.

• Based on correlations of protection assessments conducted during the CORBEVAX nAb GMT Moderna and Astra-Zeneca Vaccine Phase III studies against the parent-Wuhan strain indicating a vaccine effectiveness of >90% for the prevention of symptomatic infections.

• CORBEVAX nAb GMT against the delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies.

• While no subjects taking CORBEVAX or COVISHIELD had serious adverse events, CORBEVAX had 50 percent fewer adverse events than COVISHIELD.

In the continuous monitoring of Phase II studies, CORBEVAX showed high persistence of the immune response, as in the second dose at six months of NAB GMT <30% गिरावट से संकेत मिलता है, जबकि अधिकांश टीकों के साथ> 80% decline has been observed.

Vaccine Rollout Timeline:

Biologicals E. Ltd. plans to complete production at the rate of 75 million doses per month, with an expectation of 100+ million doses per month from February 2022. These capabilities enable the Hyderabad-based company to deliver 300 million doses as promised to the Indian government. ,

Soon, the company plans to deliver more than a billion additional doses globally.

Peter Hotez, Professor and Dean of the National School of Medicine, said: “Our scientists at Texas Children’s Hospital and Baylor College of Medicine are thrilled to help develop this vaccine, possibly the first one designed specifically for global health. Kovid is the vaccine.” Co-director of Tropical Medicine and Texas Children’s Hospital Center for Vaccine Development at Baylor.

Mahima Datla, Managing Director, Biologicals E. Ltd. said, “Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. As our background, we have created an affordable and effective COVID-19 treatment plan. Resolve to develop -19 vaccine. It has become a reality now.”

Mahima further added, “Corbevax’s journey has been eventful and no words will go short to appreciate and acknowledge the contribution of all our colleagues and their continued support in this endeavour. We especially thank our Prime Minister Mr. Would like to give. Narendra Modi ji to make vaccination a national mission. His vision and the advance commitments we got towards CORBEVAX were instrumental in expanding and building our capacity to such a great extent.

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