A total 323 suspected COVID-19 Adverse Events Following Immunisation (AEFI), had been reported to the Medicines Control of Zimbabwe (MCAZ) as of July, 8 2022.
By Michael Gwarisa
This is out of a cumulative total of 6.3 million 1st doses and 4.6 million 2nd doses of COVID-19 vaccines that have been administered since the National Vaccination program was launched in February 2021.
This translates to a rate of approximately 0.003% suspected adverse events (approximately 3 reactions for every 10 000 doses administered). 70% of these 323 AEFI reports were received in the 4th quarter of 2021 and only 4% of the 323 AEFI reports have been received in 2022.
The majority (75%) of the 323 adverse events were non-serious and most of these adverse events (87%) have since resolved,” MCAZ Acting Director General, Mr Richard Rukwata told HealthTimes in an interview.
He added that most of the reported AEFIs (commonly known as reactions) were minor/ non serious, with 25% of the suspected reports being classified as serious.
“The most commonly reported non-serious adverse reactions included headache, pruritus, dizziness, injection site pain, vomiting etc. Some of the serious adverse reactions included chest discomfort, shortness of breath, delayed menstruation, palpitations etc. These patients usually recovered after a few days.”
In terms of fatalities, MCAZ said there were some deaths reported to MCAZ where the reporters suspected the vaccines and causality assessment was conducted for all the reports by the MCAZ Pharmacovigilance and Clinical Trials (PVCT) Committee in order to establish a relationship between COVID-19 vaccine/ vaccination and the adverse event.
“Of these reports, two (2) were classified as coincidental due to underlying medical conditions that were deemed to be the cause of deaths. Two (2) were classified as B1 (There was insufficient evidence that the vaccine caused the reactions, but the reactions occurred within a reasonable time frame after vaccination). The causality assessment for eleven (11) reports was unclassifiable since post-mortem reports had not yet been submitted. Reclassification of these reports will be done when the post mortem reports are submitted to the MCAZ.”
By February 2022, MCAZ had recorded 311 AEFI reports which indicated that more women had presented with COVID-19 related AEFI reports according to data from the MCAZ February Bulletin.
From the 311 AEFI reports received, 192 (62%) were from female COVID-19 vaccine recipients, 118 (38%) from male COVID-19 vaccine recipients and in one (1) report the gender was unknown. The majority of reports 239 (77%) were received from the 18-60 years age range.
“To note is that the distribution of AEFIs by age group and gender could simply be relative to the total number of people vaccinated in the respective age groups however gender, did not necessarily reflect that a particular age group is more prone to AEFIs.”
Meanwhile, MCAZ has since dispelled myths and reports that COVID-19 vaccines were causing Erectile Dysfunction in Zimbabwean men.He also said they have not received any reports linked to blood clotting AEFI following COVID-19 vaccination.
“Currently, no erectile dysfunction AEFI reports post COVID-19 vaccination have been received at the MCAZ. Anyone who experiences adverse events/ reactions post vaccination should contact their health care provider to get medical assistance if required. They are also encouraged to report the issue to the MCAZ via the electronic reporting platforms accessible using the MCAZ website https://www.mcaz.co.zw/.
“If someone is concerned that they might be experiencing a suspected side effect after vaccination, it’s important that they immediately contact/ visit their health care provider in order to get medical assistance if required. The health care provider can also report the issue to the MCAZ. If the consumer/patient wishes to directly report any side effect they can use the MCAZ’s online reporting platform accessible from the MCAZ website https://www.mcaz.co.zw/ under the online services,” said Mr Rukwata.
Zimbabwe kicked off its national vaccination program in 2021 with only two main vaccines, the Sinovac and Sinopharm from China currently being administered out of the five COVID-19 vaccines were given Emergency Use Authorisation by MCAZ. These are Sinopharm (China), Sinovac (China), Covaxin (India), Sputnik V (Russia) and Johnson & Johnson (Netherlands).
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