DNA Explainer: WHO's eligibility criteria, evaluation to approve COVID-19 vaccines for emergency use

Regulatory experts convened by WHO from world over review the data on vaccine's safety, efficacy, quality as part of a risk-versus-benefit analysis.

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DNA Explainer: WHO's eligibility criteria, evaluation to approve COVID-19 vaccines for emergency use
(Image Source: Reuters)

When a company manufactures a vaccine and goes through all the levels of trials by testing its efficacy rate administered on volunteers, it then goes to meet World Health Organisation (WHO) officials to seek emergency use approval from the global body.

The Emergency Use Listing (EUL) by the global health body will provide a platform for the company to supply the doses to several other countries. The listing is basically a license from the WHO to the company to make their vaccine available to people affected by a public health emergency. 

The WHO's Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organisation to procure the vaccine for distribution to countries in need.

Regulatory experts convened by World Health Organisation (WHO) from around the world and WHO's own teams review the data on the vaccine's safety, efficacy, and quality as part of a risk-versus-benefit analysis. The review is done basically to find that the vaccine meets the must-have criteria for safety and efficacy set out by WHO and that the benefits of using the vaccine to offset potential risks.

Eligibility criteria

The vaccine candidate should meet a set of parameters set by the WHO to get the EUL license.

The disease for which the vaccine is intended should have the potential of causing an outbreak, epidemic, or pandemic.

The product, for which the license is being sought, should be manufactured in compliance with current Good Manufacturing Practices (GMP) and under a functional Quality Management System.

The applicants also have to undertake to complete the development of the product and apply for WHO prequalification once the product is licensed.

How the evaluation is done

The pharmaceutical company has to submit data related to the designing of the vaccine and from clinical trials conducted in different countries and on samples of different age groups.

The WHO then evaluates the data in light of international standards checking if the submitted data demonstrate a reasonable likelihood that the vaccine quality, safety, and effectiveness are acceptable.

The health body also measures if the benefits offered by the vaccine outweigh any potential risks.

The data sought by the WHO include details related to manufacturing quality, non-clinical and clinical trials, a plan to monitor quality, safety, and efficacy.

The companies also have to submit an undertaking to the organisation to provide any new data as soon as it is available along with details of labelling.

How the emergency use listing works

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies.

The objective is to make medicines, vaccines, and diagnostics available as rapidly as possible to address the emergency.

These medicines, vaccines, or diagnostics have to adhere to stringent criteria of safety, efficacy, and quality.

The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase 2 and phase 3 clinical trial data.

It will also assess substantial additional data on safety, efficacy, quality, and a risk management plan.

These data are reviewed by independent experts and WHO teams.

Experts from individual national authorities are invited to participate in the EUL review.

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