The Assistant Minister of Health and MOH spokesman, Dr. Muhammad Al-Abdulaali confirmed that the steps taken by the Kingdom to approve the coronavirus vaccine are the same official actions applied by the Saudi Food and Drug Authority (SFDA), which is one of the prestigious bodies at the global level.
He said that there are many positive signs in the reports about the coronavirus vaccines, pointing out that the world treats this issue with great determination and hope without any concessions or compromises. He stressed that the SFDA has strict and accurate procedures to ensure the strength, safety and effectiveness of vaccines before registering and permitting their use. He said the vaccine will help protect life and communities and maintain public health.
He made this statement during the press conference he held today (Sunday) with the participation of Vice President of SFDA for Drug Sector, Dr. Adel Al-Harf.
Dr. Al-Abdulaali revealed that 139 new confirmed cases of Novel Coronavirus (COVID-19) have been reported in the Kingdom; thus bringing the total number to 359,888 confirmed cases, including 3,291 active cases, receiving the necessary medical care. Of these, there are 499 critical cases, while the health condition of the rest is stable. In addition, 202 new recoveries have been recorded, bringing the total recoveries to 350,549 cases, all praise is due to Allah. Also, 12 new deaths have been reported; bringing the total deaths to 6,048, May Allah bestow His mercy upon them. Moreover, 29,142 new Polymerase Chain Reaction (PCR) tests for COVID-19 have been conducted in the Kingdom's laboratories, bringing the total to 10,378,732 tests.
“We understand that community members have some concerns and questions about the effectiveness and safety of vaccines, but at the same time we remind everyone that the official authorities, including their official platforms and accounts, prioritize everyone’s health and will immediately refute any misconceptions or rumors,” he added.
He advised everyone to get the vaccine, including those who have recovered from the infection as there is no evidence that they are protected from a second infection. The vaccine will be received in phases and each phase will have its priority. Also, he advised everyone to avoid rumors and misconceptions, stressing that any new information will be published on the official accounts clearly and transparently.
The health services are still provided through all MOH’s facilities, with 5,595,319 Molecular Diagnostic Tests «Swab Tests» at Make Sure «Taakkad» Centers, 1,675,159 patients were served at Rest Assured «Tetamman» Clinics, in addition to offering medical consultations via 937-Service Center to 22,329,266 beneficiaries, he added.
For his part, Dr. Al-Harf said the process of registering COVID-19 vaccines starts with communication with the manufacturer to overcome all obstacles, to arrange procedures for requesting the vaccine, to develop a mechanism for receiving all related files from the beginning of the clinical studies and to form special work team from all scientific departments.
He said that for registering vaccines we study its quality and safety, inspect the factory, study pharmacovigilance and pharmacological errors before making the final reports. Then the product will be sent to the company for registration as well as any remarks or questions about the product. At last it will be sent to a special committee for approval.
He indicated that the most prominent studies that are evaluated for the vaccine were preclinical studies on animals, followed by clinical trials for humans, and then studies on the quality of the vaccine and the appropriate dose.
The SFDA’s decision to approve the Pfizer/BioNtech vaccine comes after reviewing all scientific data that prove the safety and efficacy of the vaccine. We give our conditional approval to register the vaccine according to the claim that people aged 16 years and over shall be vaccinated against COVID-19 virus. We will follow-up the effect of the vaccine after it uses in order to ensure its safety and to help in early detection of any side effects that may occur to its users, he added.
In cooperation with the concerned agencies, the SFDA has developed guidelines for the health practitioners and another one for vaccine recipients, as well as special forms for reporting any side effects, he said.