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The Egyptian Medicines Authority has confirmed to Al-Arabiya.net that the emergency use of pharmaceutical and biological preparations such as Corona vaccines is an exceptional procedure based on a risk study to assess non-pharmaceutical and biological preparations. recorded, which can be used in public health emergencies such as as the spread of epidemics, including details of the technical requirements for this approval and the requirements that must be met by the production company.
As for the rules governing the authorization of emergency use, they were first published worldwide in March 2020 by the World Health Organization, then followed by the American Food and Medicines Organization in June 2020 by issuing emergency use license rules, and the Egyptian Medicines Authority worked. The organization issued an emergency use license for unregistered pharmaceutical preparations in October 2020, and an emergency use license was first granted in Egypt in December 2020 for the Chinese vaccine Sinopharm.
In addition, the emergency use license has so far only been granted to two vaccines: the Chinese vaccine Sinopharm and the British vaccine AstraZeneca.
Egyptian Drug Authority
How to ensure the safety and efficacy of vaccines?
The authority said vaccines are evaluated by all relevant departments of the Egyptian Medicines Authority in accordance with global standards and rules for biologic preparations published by international bodies such as the World Health Organization, the ‘American Food and Drug Authority and European Health. Authority, in addition to ministerial laws, decisions and local rules for vaccines. Such as “The rules governing the issuance of an emergency use license for pharmaceutical preparations not registered with the Egyptian Medicines Authority”.
What does emergency vaccine use mean and does the concept relate to the danger posed by the vaccine?
This means agreeing to circulate these vaccines for a specified period to ensure their rapid availability in Egypt in times of crisis and emergency, after having assessed and met the requirements for the safety, efficacy and quality of the vaccine, and Egyptian Medicines Authority will not allow circulation. of any biological or pharmaceutical preparation or vaccine or other medical preparations and supplies, except after verifying the efficacy and safety of the preparation, evaluating and analyzing the preparations, inspecting the facilities and factories related to the preparations, by evaluating all the preclinical studies and clinical studies before authorizing their circulation, and monitoring the safety and efficacy of these preparations during and after handling, by pharmacovigilance, in order to protect the health of the citizen.
The authority added that many vaccines have been received in Egypt, some of which were developed using a non-living virus (inactivated virus) such as the Sinopharm vaccine, and some were developed using ‘a live viral vector with a non-proliferative property like the Coffeeshield vaccine, and both stimulate the immune system to generate a group of antibodies against the corona virus, and their types differ depending on the nature of the vaccine, and all vaccines that have obtained the approval of the Egyptian Medicines Authority for quality, safety and efficacy.
The effectiveness of these vaccines is still influential with the emergence of new strains of the Corona virus, according to what has been published in numerous international research studies.
The authority said some Egyptian research authorities are working to develop vaccines against the emerging corona virus, but none of them have yet entered the phase of conducting clinical studies.
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