India’s first indigenous COVID-19 vaccine, Bharat Bio-Tech’s Covaxin, was granted Emergency Use Listing (EUL) by the World Health Organization on November 3.
Covaxin is a whole virion-inactivated vaccine against SARS-CoV-2, developed in partnership with the National Institute of Virology (NIV), Pune and the Indian Council of Medical Research (ICMR). 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 WHO said.
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.
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.
Emergency use listing
Emergency Use Listing (EUL) is a risk-based procedure in WHO for the assessment and listing of unlicensed vaccines, in vitro diagnostics, therapeutics with the aim of expediting the availability of these products to the people affected during such health emergencies. This will assist in determining the acceptability of using specific products for interested UN procurement agencies and the Member States based on an essential set of available quality, safety, and efficacy and performance data.
This procedure is a test for drug manufacturing companies who wish to submit their products for use during public health emergencies.
Eligibility of candidate products
The EUL deals with three types of products (vaccines, therapeutics and in vitro diagnostics), where each product has specific requirements.
The following criteria must be met for a product to be eligible for evaluation under the EUL procedure.
- The product is intended to treat such disease which is either serious or immediately life-threatening, which can potentially cause an outbreak, epidemic or pandemic, and it is reasonable to consider the product for a EUL assessment, e.g., there are no licensed products for the indication or for a critical sub-population (e.g., children);
- The existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines);
- The medicines and vaccines should be manufactured in compliance with the current Good Manufacturing Practices (GMP), while in the case of IVDs, a functional Quality Management System (QMS) should be followed.
- 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.
Central Drugs Standard Control Organisation (CDSCO)
- CDSCO is the National Regulatory Authority (NRA) of India under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
- The Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules 1945 have incorporated duty for the central & state regulators for the regulation of drugs & cosmetics.
- CDSCO is responsible for giving approval to Drugs, the conduct of Clinical Trials under the Drugs and Cosmetics Act
- CDSCO is jointly responsible, along with state regulators, for the grant of licenses of certain specialized categories of critical Drugs such as I. V. Fluids, Vaccines, blood and blood products, etc.
Emergency Approval in India
- There is no provision in India such as emergency use approval like WHO. However, the 2019 rules provide for the “Accelerated Approval Process” in several situations that would include one like the current pandemic.
- There exists a provision where approval can be granted to a new drug which is still in clinical trials provided that the product is of meaningful therapeutic benefit in such situations.
- Accelerated approval can also be granted if the new drug is intended to be used for the treatment of a critical or life-threatening condition or disease of special relevance to the country and to address the unmet medical needs.
- A new drug or a vaccine can also be considered for approval if remarkable effectiveness is reported, even from phase-II trials.
- In such cases, additional post-licensure studies may be required.