Biological E. Limited (BE), the Hyderabad-based Indian pharmaceutical and vaccine company, has reported that the World Health Organization (WHO) has granted an Emergency Use Listing (EUL) to its Corbevax vaccine.
It is India’s first indigenously developed COVID-19 vaccine that is based on a protein sub-unit platform.
“The Chief Medicines Officer of India (DCGI) has already approved Corbevax for limited emergency use in adults, adolescents and young people sequentially from December 21 to April 22; as well as India’s first heterologous COVID-19 booster for adults aged 18 and over. on June 22,” the company said in a statement.
BE provided one hundred million doses of CORBEVAX to the Indian government, which were then used in vaccination campaigns across India; basically in 12 to 14-year-olds.
Mahima Datla, Chief Executive Officer of Biological E. Limited, said: “We are pleased with the WHO EUL as it would help us use the platform to further develop COVID-19 vaccines as it begins to have an effect on public health. We are confident that this support from WHO will strengthen our global fight against COVID-19. “
She further added, “We understand that several countries come under a lot of fiscal pressure when it comes to dealing with COVID-19. We aim to reach the people in those countries with CORBEVAX , just as we have done with all our other vaccines. Our commitment is to provide affordable and accessible vaccines that are of high quality and the WHO EUL lays a path for us to make that possible.”
Mahima said: “While several corporations that entered the box of vaccine progression and production during the COVID-19 pandemic exited soon after, either due to lack of budget or lack of success, BE remains committed to offering access to high-quality and affordable vaccines globally by steadily expanding its portfolio of offerings.
BE said it is running a next-generation COVID-19 vaccine against the XBB1. 5 variant of the SARS-CoV-2 virus, which would meet the WHO’s TAG-CO-VAC recommendations.
BE’s vaccine candidate has completed all necessary preclinical studies in animals, suggesting it will provide sufficiently good coverage against the variants circulating recently.
BE recently obtained final approval from the Central Organization for the Standard Control of Medicines (CDSCO) to start clinical trials of the XBB. 1. 5 variant vaccine in India.
Clinical trials at trial sites in India will begin soon.
The Corbevax vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius temperature and presented as 0.5 ml (single dose) vial, 5 ml (10 doses) vial and 10 mL (20 doses) vial pack.