Benefits of AstraZeneca vaccine outweigh risks, asserts SFDA

No confirmed cases of platelet deficiency, thrombosis recorded: MoH

April 19, 2021

Saudi Gazette report

RIYADH — Dr. Abdullah Al-Asiri, assistant deputy minister of health for preventive health, reassured the Saudi society that no confirmed cases of platelet deficiency and blood clotting associated presumably with COVID-19 vaccines have so far been registered in the Kingdom.

Dr. Al-Asiri, who is also a consultant in infectious diseases, emphasized that not every stroke after receiving vaccine shots is due to vaccination. “Thanks to God, vaccines are saving lives every day.”

In a statement on his Twitter account, the deputy minister expressed surprise over the rumors regarding some side effects of the vaccine, exclaiming “how a wrong conclusion drawn from a generalization has become the most circulated news!” Pointing to the benefits of vaccination, Dr. Al-Asiri observed: “Members of my family, including parents, siblings, and children, have received the first dose of AstraZeneca and are looking forward to having the second dose soon.”

Meanwhile, the Saudi Food and Drug Authority (SFDA) has assured that the benefits of the Oxford-AstraZeneca coronavirus vaccine outweigh the potential risks according to the approved medical claims. The authority highlighted the major benefits of taking the vaccine, pointing out that the reported side effects were much lower as compared to its great benefits.

The assurances of SFDA came in light of the reported 15 thrombosis and low platelet cases as side effects of the vaccine. According to the number of local reports received by the authority, the rate of incidents of these symptoms in the Kingdom is one infection for every 200,000 people.

It has also been found that there are a number of possibilities for the mechanism of these symptoms occurring with the use of the vaccine, and one of the likely possibilities is that the vaccination will lead to the emergence of an unexpected reaction in the immune system causing tremendous activation in the platelets, which leads to a decrease in their number and the occurrence of clots. Also, there is a possibility of similar side effects with some vaccines used in the expanded vaccination programs.

However, the rate of occurrence of these side effects related to administering of other vaccines, in general, ranged between one case per 1,000,000 to one case per 125,000 people, according to the available evidence.

Okaz/Saudi Gazette has also learned that the SFDA has directed the health authorities, through a circular, to apply precautionary measures, in order to reduce the potential risks due to administering the vaccine in general, with spelling out the following procedures: Inform the vaccine recipient of the need to consult the treating doctor or go to the nearest health center when any of the following symptoms appear and continue for more than three days after receiving the vaccine — dizziness, severe and persistent headache, nausea or vomiting, visual impairment, shortness of breath, severe pain in the chest or abdomen or cold in the extremities, swelling of the legs, small blood spots under the skin in places other than the injection site.

The authority advised to postpone the use of the vaccine for those people who suffer from unstable diseases that required a fundamental change in the treatment plan or required hospitalization during the six weeks prior to the date of administration of the vaccine.

The precautionary measures included consulting the physician and making sure that the potential benefits from receiving the vaccine outweigh the risks for the following groups: people with multiple chronic diseases; people who have risk factors for developing blood clotting disorders such as those who have autoimmune diseases, or women who take birth control pills, or people with a previous history of blood clotting.

The precautionary measures to reduce the risks of the vaccine should also include providing a guide for diagnosing and treating blood clotting disorders after receiving the vaccine, and stressing the need to inform the authority about all cases of side effects associated with COVID-19.

The SFDA follows up the safety file of the vaccines and reviews the reports received by the authority from all its scientific and technical teams and submitting them to the relevant committees such as the causation assessment committee, the advisory committee for blood diseases and infectious diseases, and the advisory committee for pharmacovigilance.

The authority also reviews the data of measuring symptoms and side effects associated with the vaccine available in the World Health Organization database and monitored from various countries of the world, in addition to the evaluation of the available evidence.

April 19, 2021
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