Biological E’s Corbevax bags Emergency Use Listing from WHO
- January 17, 2024
- Posted by: OptimizeIAS Team
- Category: DPN Topics
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Biological E’s Corbevax bags Emergency Use Listing from WHO
Subject: Science and Tech
Section: Health
Context:
- The World Health Organization (WHO) has granted an Emergency Use Listing (EUL) to Biological E Ltd’s (BE) Covid vaccine, Corbevax.
- The Hyderabad-based vaccine-maker’s Corbevax is India’s first indigenously developed COVID-19 vaccine based on a protein sub-unit platform.
Details:
- The Drugs Controller General of India (DCGI) approved Corbevax for restricted use in emergencies among adults, adolescents and young children in a sequential manner from December 2021 to April 2022 as well as India’s first heterologous Covid booster shot for adults aged 18 and above in June 22.
- The Corbevax vaccine is administered through the 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.
- BE has been working on a next-generation Covid vaccine based on the XBB1.5 variant of the SARS-CoV-2 virus, which would conform to WHO TAG-CO-VAC recommendations.
Corbevax development:
- Corbevax, an indigenously produced vaccine, originated from the Baylor College of Medicine’s National School of Tropical Medicine.
- Leveraging a decade of experience in developing recombinant protein vaccines for coronaviruses SARS and MERS, researchers at the School used the genetic sequence of SARS-CoV-2, specifically the spike protein gene, made available in February 2020.
- The gene was cloned and engineered, then inserted into yeast to produce and release copies of the protein, similar to beer production.
- After purification to eliminate yeast remnants, the vaccine was formulated using an adjuvant to enhance the immune response.
- These cost-effective and readily available ingredients contributed to the vaccine’s affordability.
How Corbevax works?
- Corbevax is a recombinant protein sub-unit vaccine designed to target a specific part of the SARS-CoV-2 virus, namely the spike protein on its surface.
- The spike protein is essential for the virus to enter cells and cause infection. By introducing only this protein to the body, the vaccine triggers an immune response without the presence of the entire virus.
- This immune response prepares the body to defend against the virus if it attempts to infect, reducing the likelihood of severe illness.
- While this technology has been used for decades in hepatitis B vaccines, Corbevax represents one of the early Covid-19 vaccines employing this approach, with Novavax also developing a protein-based vaccine awaiting emergency use authorization from regulatory bodies.
How Corbevax is different?
- Corbevax stands out from other approved Covid-19 vaccines by using a different approach. While vaccines like Pfizer and Moderna are mRNA-based,AstraZeneca-Oxford/Covishield, Johnson & Johnson, and Sputnik V are viral vector vaccines, and Covaxin, Sinovac-CoronaVac, and Sinopharm’s vaccines are inactivated vaccines (include killed particles of the whole SARS-CoV-2 virus),Corbevax is a recombinant protein sub-unit vaccine.
- Unlike inactivated vaccines that target the entire virus structure, Corbevax, similar to mRNA and viral vector vaccines, focuses on the spike protein.
- However, Corbevax introduces the spike protein directly rather than instructing cells to produce it.
- Despite being administered in two doses like many other Covid-19 vaccines, Corbevax is expected to be among the cheapest options due to its low-cost production platform.
Emergency Use Listing (EUL) of WHO:
- The WHO Emergency Use Listing Procedure (EUL) is a risk-based assessment process designed to evaluate and list unlicensed vaccines, therapeutics, and in vitro diagnostics, expediting their availability during public health emergencies.
- It aids UN procurement agencies and Member States in determining the suitability of specific products based on essential quality, safety, efficacy, and performance data.
- The procedure covers three product streams (vaccines, therapeutics, and in vitro diagnostics) with specific eligibility criteria.
- These include the severity and immediacy of the targeted disease, the absence of licensed products, compliance with Good Manufacturing Practices (GMP) or Quality Management System (QMS), and the commitment to complete product development and seek WHO prequalification once licensed.
Source: Indian Express