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The South African Health Products Regulatory Authority (SAHPRA) said it has finalized the investigation into the 32 people who are believed to have died after receiving the COVID-19 vaccine.
“To date, investigations of 32 death cases have been completed and causality assessment concluded, 28 of which were coincidence with vaccination,” SAHPRA said.
According to the watchdog, this means these deaths were unrelated or related to the vaccination.
“Four cases are unfortunately unclassifiable because there was no information available on the case or the information was completely inadequate. Therefore, the causality assessment could not be conducted or concluded,” explained SAHPRA.
The SAHPRA defines a fortuitous adverse event as an event that occurs after or at the same time as exposure to a drug or vaccine, but which is not caused by that exposure.
In the case of a death that has occurred after a person has received their injection, certain information must be submitted in order to make a full causal assessment.
This includes an autopsy or postmortem examination, a complete clinical history, including comorbidities and allergies, and any medications taken before and at the time of the adverse event.
“It may not be possible to accurately determine causation when the information provided is incomplete,” the statement said, adding that prompt reporting is equally important to ensure a thorough investigation.
Adverse reactions following vaccination
Meanwhile, as of July 31, 2021, SAHPRA said it had received 1,473 post-vaccination adverse event notifications (AEFIs) since the start of the national vaccination rollout program.
According to the drug watchdog, most of them were benign and already listed in internationally approved product information.
“These reports represent a reporting rate of 0.02% of the nearly 7.1 million doses of COVID-19 vaccines administered in South Africa by then. “
The SAHPRA said mild and non-serious AEFI usually resolve itself within days of vaccination and without any sustained negative results.
These can include a mild headache, pain and redness at the injection site, and a mild fever.
Adverse events of special interest
Meanwhile, the World Health Organization (WHO) has designated some unexpected medical issues as Adverse Events of Special Interest (AESI), SAHPRA said.
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The United States Food and Drug Administration (FDA) defines ESIA, serious or not, as an event of scientific and medical concern specific to the sponsor’s product or program, for which continuous monitoring and prompt communication of the investigator to sponsor may be appropriate.
According to SAHPRA, reported serious AEFI, including AEFI, is extremely rare for COVID-19 vaccines.
Serious AEFIs are the side effects that require hospitalization, can be life threatening, cause a birth defect, birth defect, or even death.
“Serious AEFI should be reported immediately by the healthcare professional responsible for the patient’s care,” SAHPRA said.
Additionally, once all information on the case is available, the National Expert Committee on Immunization Safety (NISEC), which is an independent ministerial advisory committee, conducts a causality assessment.
The staff of the SAHPRA and the Expanded Program on Immunization (EPI) of the Department of Health, responsible for the COVID-19 vaccination program, will then provide the secretariat for the weekly meetings of the National Expert Committee on Immunization Safety ( NISEC).
“Once completed, the NISEC assessment is shared with SAHPRA and the department for further measurements, if necessary.”
The public and healthcare professionals are encouraged to report AEFI to the healthcare facility delivering the vaccine on the Med Safety app, which can be downloaded or by calling 0800 029 999.
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