New Delhi: The Drugs Controller General of India (DCGI) has finally approved, Biological E’s Covid-19 vaccine ‘Corbevax’, for children between 12-18 years of age, as per reports on Monday.
Corbevax is India’s first indigenously developed protein sub-unit COVID-19 vaccine. The vaccine has been developed by Biological E. Limited in collaboration with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.
“CORBEVAX is a “recombinant protein sub-unit” vaccine, developed from a component of the spike protein on the virus’s surface, which helps the body build the immune response against the virus. The vaccine has the Receptor Binding Domain (RBD) protein as an antigen, and also an optimum adjuvant consisting of Dynavax (DVAX) CpG 1018 and alum,” Biological E Limited has said.
Corbevax dosage
The vaccine contains Aluminium Hydroxide gel, CpG 1018 and buffer (tris and NaCl in WFI).
Like those other approved COVID-19 mRNA vaccines, CORBEVAX also requires two doses.
The vaccine will be given as an intramuscular injection, in the deltoid muscle. In case of adults, the vaccine is given in two doses. The second dose is given 4 weeks after the first dose.
How does Corbevax work
CORBEVAX delivers the spike protein to the body directly unlike the three vaccines approved in the U.S.: Pfizer and Moderna’s mRNA vaccines and Johnson & Johnson’s viral vector vaccine, which provide the body instructions on how to produce the spike protein.
History of Corbevax
Drs. Maria Elena Bottazzi and Peter Hotez, the co-directors of the Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine have developed CORBEVAX developed.
Prior to this, in 2003 during the SARS outbreak, they had created a similar type of vaccine by inserting the genetic information for a portion of the SARS virus spike protein into yeast to amplify the amounts of the protein. After isolating the spike protein and adding an adjuvant the vaccine was ready for use.
Since the first SARS epidemic was short-lived, this vaccine had little use. Until the COVID causing virus emerged in 2019 they worked on the same mechanism and created the CORBEVAX vaccine.
The first two phases of the clinical trials of this vaccine involved more than 3,000 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.
“In the pivotal Phase III study conducted with an endpoint of immunogenic superiority, CORBEVAX demonstrated superior immune response in comparison with COVISHIELD vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant,” said an official statement from Biological E.
On the development Biological E managing director Mahima Datla told media: “This significant development helps extend the reach of our vaccine to the age group of 12 to 18 years in our country. We truly believe that with this approval, we are even more closer to finishing our global fight against the Covid-19 pandemic.”
Currently children between 12 to 18 years of age are being vaccinated in the country against the deadly coronavirus.
The COVID wave, which started in 2020 is in its third phase.
