GS Paper 2:
Topics Covered: Issues related to Health.
Context:
The World Health Organization (WHO) has given pre-qualification, or Emergency Use Listing (EUL) for Bharat Biotech’s Covaxin vaccine.
Please note that:
- The approval has been given by the Technical Advisory Group (TAG), an independent advisory panel of the WHO.
- The approval was expected on October 26, but the WHO had deferred its decision and sought additional clarifications from Bharat Biotech to conduct a final risk-benefit assessment.
- The WHO has already approved six vaccines for emergency use: AstraZeneca’s Covishield, Moderna’s mRNA-1273, Sinopharm’s BBIBP-CorV, Sinovac’s CoronaVac, Pfizer/BioNTech’s Comirnaty, and Johnson & Johnson’s vaccine.
What does this approval mean?
- It has been granted EUL for use in persons 18 years and above, over two doses spaced four weeks apart.
- However, no recommendation has been made for use in children, and available data for use on pregnant women is insufficient to assess safety or efficacy.
- The move is expected to ease international travel for Indians who have opted for the vaccine but experts say that this would be subjected to countries clearing Covaxin through their regulatory processes.
How effective is COVAXIN?
Covaxin was found to have 78% efficacy against Covid-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.
About COVAXIN:
Covaxin is a whole virion-inactivated vaccine against SARS-CoV-2, developed in partnership with the Indian Council of Medical Research and the National Institute of Virology, Pune.
What is emergency use approval?
The EUL is a prerequisite for the COVAX initiative in vaccine supply, and allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
- It is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
To be eligible, the following criteria must be met:
- The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an EUL assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children).
- Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines).
- The product is manufactured in compliance with current Good Manufacturing Practices (GMP) in the case of medicines and vaccines and under a functional Quality Management System (QMS) in the case of IVDs.
- The applicant undertakes to complete the development of the product (validation and verification of the product in the case of IVDs) and apply for WHO prequalification once the product is licensed.
Insta Curious:
What is emergency use authorisation (EUA)? How is it regulated in India? Reference
InstaLinks:
Prelims Link:
- Antigens vs Antibodies.
- How a vaccine works?
- Types of vaccines.
- About DGCI.
- Procedure to be followed for vaccine approval in India.
Sources: the Hindu.
