Egypt closer to exporting COVID vaccines after reaching 2nd highest WHO classification

Ahram Online , Tuesday 2 Aug 2022

Egypt is one step closer to exporting homemade COVID-19 vaccines after the World Health Organisation (WHO) rated the Egyptian Drug Authority (EDA) maturity level three (ML-3), its second highest rating, according to the WHO’s Regional Office for the Eastern Mediterranean (EMRO).

A file photo of the Egyptian Drug Authority's officials during a press conference (photo courtesy of the EDA)


This makes the EDA the first national vaccine regulatory authority to reach ML-3 status in the Eastern Mediterranean region and the ninth globally, the WHO EMRO said in a statement on Monday.

The statement added that Egyptian vaccine manufacturers are now eligible to apply for WHO pre-qualification and emergency use listing, which will eventually allow Egypt to export COVID-19 vaccines to other countries. 

Pre-qualification is program to ensure that medicine meets acceptable standards of quality, safety and efficacy, while the emergency use listing helps assess the suitability of novel health products during public health emergencies.

The WHO's statement said that its classification is carried out based on its global benchmarking tool to ensure vaccine quality, safety and effectiveness.

Explaining the classification levels, WHO said that maturity level one means some elements of the regulatory system exist, while level two indicates an evolving national regulatory system that partially performs essential regulatory functions.

Level three confirms that a stable, well functioning and integrated regulatory system is in place, while the highest level, level four, is achieved by a regulatory system operating at an advanced level of performance and continuous improvement.

An official benchmarking mission revealed that the EDA had attained ML-3, the WHO pointed out.

The process was conducted by 15 international assessors in March, using an evaluation tool cross cutting nine functions with a set of indicators and sub-indicators, it added.

Recently, Egypt and five African countries have emerged as the first African recipients of mRNA technology under the global mRNA technology transfer hub initiative.

An mRNA vaccine is a type of vaccine that uses a copy of a molecule called messenger RNA to produce an immune response.

This platform is used to manufacture vaccines against COVID-19 and can be applied to produce other types of vaccines; it is also used in several applications of immunotherapy for infectious diseases and cancers. 

Egypt is among the region’s main producers of medical and pharmaceutical products, including vaccines.

In June 2021, the WHO announced that it had selected a South African consortium to run the technology transfer project, with the training of the recipient countries scheduled to begin in March 2022.

Clinical trials for the awaited vaccines are expected to start in the fourth quarter of 2022, while a first approval could potentially be in 2024, according to the WHO.

In previous remarks, Hossam Abdel-Ghaffar, the spokesman for the Ministry of Health and Population, said such a “huge" step will help Egypt become a regional hub for manufacturing coronavirus vaccines.

Egypt was selected due to its "solid" legislative structure represented in the drug authority law and the clinical research law, which enables manufacturing bodies to function amid clear governing rules, he added.

Egypt, through state-run Egyptian Holding Company for Biological Products and Vaccines VACSERA, is already producing the China-made Sinovac vaccine as part of an agreement with the Chinese side, and also started clinical trials for two domestic vaccines, COVI-VAX and Egy-Vax.

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