The Egyptian Medicines Authority 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 unregistered pharmaceutical and biological preparations, which can be used in public health emergencies such as the spread of epidemics, Including details of the technical requirements for this approval and the requirements that must be met by the producing company.
As for the rules governing the licensing of emergency use, they were issued for the first time globally in March 2020 by the World Health Organization, then followed by them. In June 2020, the American Food and Drug Organization issued the rules for the emergency use license, and the Egyptian Drug Authority worked on issuing the Egyptian rules governing the issuance of the emergency use license for unregistered pharmaceutical preparations in October 2020, and an emergency use license was granted for the first time in Egypt in December 2020 for the Sinopharma vaccine.
Also, the emergency use license has been granted so far to only two vaccines, namely: the Chinese Sinopharm vaccine and the British AstraZeneca vaccine.
How is it done Ensure safety Vaccines and their effectiveness?
The authority indicated that vaccines are evaluated by all the competent departments of the Egyptian Drug Authority in accordance with global standards and rules for preparations of biological products issued by international bodies such as the World Health Organization and the Food and Drug Authority The American and European Health Authority, in addition to the laws, ministerial decisions and local rules for vaccines such as “the rules governing the issuance of the emergency use license for pharmaceutical preparations not registered with the Egyptian Drug Authority.”
What does the emergency use of vaccines mean, Does the concept relate to the danger posed by the vaccine?
It means agreeing to circulate these vaccines for a specified period to ensure their rapid availability in Egypt in cases of crises and emergencies, after evaluating and meeting the requirements for safety, efficacy and quality of the vaccine, and the Drug Authority The Egyptian Authority will not allow the circulation of any biological or pharmaceutical preparation or vaccine or other medical preparations and supplies, except after making sure of the effectiveness and safety of the preparation, through the evaluation of the preparations, their analysis, inspection of the facilities and factories related to the preparations, and the evaluation of All pre-clinical studies, and clinical studies before they are allowed to be circulated, and to monitor the safety and efficacy of these preparations during and after handling, by pharmacovigilance, in order to preserve the citizen’s health.
The authority added that many vaccines were received in Egypt, some of which were developed using a non-living virus (inactivated virus) such as the Sinopharm vaccine, and some of them were developed using a live viral vector with a non-proliferative characteristic such as the Coffishield vaccine, and both stimulate the immune system. To generate a group of antibodies against the Corona virus, the types of which differ according to the nature of the vaccine, and all vaccines that have obtained the approval of the Egyptian Drug Authority are of quality, safety and efficacy.
And 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 many international researches.
The authority stated that some Egyptian research bodies are working to develop vaccines against the emerging corona virus, but none of them has yet entered a stage. Conducting clinical studies.