Exclusive!!! MCAZ Speaks On COVID-19 Vaccines Linked Reactions In Zim

ZIMBABWE commenced its national vaccination initiative in February, 2021, kickstarting a campaign that would later yield positive results in the country’s COVID-19 management matrix. Even though only 14% of the national population has been vaccinated to date, available Ministry of Health and Child Care (MoHCC) data shows that vaccination has been working in minimizing the risk of developing severe infections and deaths.

However, since commencement of the national vaccination program, there has been speculation and skepticism around vaccination, vaccine hesitancy and vaccine phobia as citizens adopted a laid-back approach towards vaccination. The hesitancy has among other things been driven by existing information gaps especially around the side effects and the Adverse Drug Reactions (ADR) and Adverse Events Following Immunization (AEFIs) to look out for after getting jabbed.

In other countries, due advanced surveillance systems and access to health services, it has been easy to detect and follow-up reactions in vaccinated persons. Adverse Drug Reaction refers to any response to a medicine which is noxious and unintended, including lack of efficacy, which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.

Zimbabwe is currently administering four vaccines namely the Sinopharm, Sinovac, Sputnik-V, COVAXIN while the Johnson & Johnson has also been approved for Emergency Use Authorization (EUA) even though it is yet to be rolled out. To breakdown the Adverse Drug Reactions situation in Zimbabwe, our Editor, Michael Gwarisa (MG) spoke at length to the Medicines Control Authority of Zimbabwe (MCAZ) Projetcs and Public Relations Officer, Mr Shingai Gwatidzo (SG) who elaborated and explained in detail where the nation is standing in as far as Adverse Events Following Immunization (AEFIs) and vaccine related reactions and side effects are concerned.

MG: Zimbabwe is administering mainly the Sinopharm and Sinovac manufactured vaccines. Has the Authority reported or received vaccines, both Chinese any reports regarding adverse reactions after people would have been inoculated by the vaccines on the Zimbabwean market and if yes, how many reports has the authority received to date?

SG: Out of a cumulative total of 3.06 million first doses and 2.30 million second doses of COVID- 19 vaccines, the Authority received a total of 96 suspected Adverse Events Following Immunisation (AEFIs) i.e. 70 from Sinopharm, 25 from Sinovac and 1 unspecified.

MG: .Apart from the Sino-vaccines, we also have other vaccines in the mix namely the Sputnik-V and the Covaxin. As comparison, which vaccines had the highest reactions from the four vaccines currently being administered in Zimbabwe?

SG: See response to question 1 above. No reports have been received yet for Sputnik V and Covaxin.

MG: What are some of the prominent reactions the authority has reported or received from the recipients of the vaccines since the country commenced its national vaccination drive in February?

SG: Majority of the AEFIs were consistent with the safety profile of the vaccines as was determined from the clinical studies conducted by the vaccine developers i.e. headache, dizziness, fatigue, general body weakness, itchy skin, itchy rash, chills, sore throat, runny nose, blocked nose, sneezing, nausea, injection site pain, numbness of the injected arm, chest pain etc. A few serious AEFIs were also reported and these included seizures, stroke, angioedema, deep vein thrombosis. Causality assessment is done for all received reports, to determine if the reported reaction could have been caused by the vaccine administered.

MG: How have these reactions been dealt with?

SG: The Ministry of Health and Child Care – Zimbabwe Expanded Programme on immunization- (MoHCC-ZEPI) and the MCAZ are responsible for monitoring the safety of the vaccines as they are being administered. The MCAZ works closely with ZEPI in line with WHO requirements in Medicines Control Authority of Zimbabwe (MCAZ) training HCWs on how to run the vaccination program effectively to minimize the risk to all types of vaccinations including logistics, benefit/risk management communication, AEFI surveillance, AEFI detection, AEFI case management, and not vaccinating high risk group, plus reporting of AEFIs. MCAZ and ZEPI-MOHCC conducted several trainings virtua1 and physical meetings of all HCWs countrywide responsible for vaccination. Since February to September 2021 during COVID-19 vaccination deployment. The Authority has also written and warned the public and HCWs to minimize and monitor COVID-19 vaccines AEFI through bulletins, MCAZ website, Vaccine Safety Net (VSN) and twitter- / facebook. The online medicines and vaccines safety reporting tools by HCWs and consumers hyperlinks can be found on the MCAZ website, www.mcaz.co.zw, under online services e-reporting.

Causality assessment is then conducted to determine whether the vaccines are linked to the AEFIs reported. Part of the assessment looks at the safety profile of the vaccines from the information obtained from the clinical studies to determine whether there is consistency in terms of the safety profile. If any safety issues are noted during causality assessment, the MCAZ takes appropriate action, e.g. issuing alert notices, withdrawing the vaccines from the market, etc. The MCAZ encourages reporting of all suspected AEFIs so that appropriate regulatory decisions can be made. As for AEFI management, this is managed through the MOHCC Expanded Programme on Immunisation (EPI) whereby healthcare practitioners administering vaccines are well trained and equipped to manage any AEFIs that may be experienced.

MG: Which gender and age group are experiencing the most reactions and what would be your advice to any of these groups experiencing reactions?

SG: Distribution by gender for the Sinopharm vaccine: 43 Female, 27 Male Distribution by gender for the Sinovac vaccine: 18 Female, 7 Male Distribution by age group for both vaccines: 29 (31-40), 28 (41-50), 20 (51-60). Note: distribution by age group could simply be relative to the total number of people vaccinated in the irrespective age groups, and not necessarily reflect that a particular age group is more prone to AEFIs. The Authority continues to advise that all suspected AEFIs must be reported regardless of gender or age.

MG: Has the authority received any report of a reaction that resulted in a fatality and what was the health profile of the deceased?

SG: The Authority received 4 suspected AEFIs resulting in death following vaccination. Two (2) were deemed to be coincidental and with insufficient definitive evidence to conclude that the deaths were caused by the vaccines, for example due to underlying medical conditions (hypertension and not on medication). The other two fatality reports were pending post-mortem, and causality assessment will be conducted after the post-mortem reports have been received. It is worth emphasizing that part of the causality assessment process, is to systematically and thoroughly assess whether death would have otherwise occurred in the absence of vaccination i.e. looking at the health status of the patient, any other medication that they are taking and review of the post- mortem reports. This assessment also looks at the findings from the clinical studies that were conducted by the vaccine developers to check whether fatalities linked to the vaccines were reported.

MG: In other parts of the world, those receiving the J&J and other vaccines reported having blood clots especially in women. Has there been any such reports in Zimbabwe?

SG: No reports have been received for the Johnson and Johnson vaccine, as this vaccine is yet to be deployed into the national COVID-19 vaccination programme.

MG: On a scale, what would be your rating in terms of the adverse reactions as a result of the vaccines and is it something that should be of great concern or make people shun vaccination?

SG: Majority of the AEFIs that have been reported are non-serious reports, and are consistent with the safety profile obtained from the clinical studies conducted by the vaccine developers. The CAZ continues to encourage vaccination and advises that it is responsible for monitoring the safety of the vaccines as they are being administered to provide reassurance to the public that the vaccines maintain a positive benefit-risk profile. The Authority encourages reporting of all suspected AEFIs so that appropriate regulatory decisions can be made.

MG: Has the authority also had reactions reports from individuals with pre-existing allergic conditions and which conditions reported the reactions the most?

SG: No reports have been received that fit this description.

MG: What are some of the reactions that those willing to get vaccinated to look forward to and what would be your word of advice to those intending to get jabbed?

SG: The Authority advises the public to look out for minor AEFIS similar to those reported in question 3 above. However, all suspected AEFIs must be reported. As the National Pharmacovigilance Centre, MCAZ is responsible for safety monitoring of medicines, which means that after issuing Emergency Use Authorization (EUA), MCAZ is responsible for processing adverse events following immunization (or side effects) reports that would be submitted.

These reports are then taken through a process known as causality assessment whereby the side effects that are reported are analyzed against the profiles of the suspected vaccines. Decisions are then made depending on the frequency and severity of adverse events, with the overall aim of protecting public health. Adverse Events Following Immunization (AEFI) forms have been adapted for COVID-19 vaccines and distributed through the Ministry of Health and Child Care Expanded Programme on Immunization (EPI).

The Authority has also conducted training for healthcare providers on the completion of AEFI forms, and members of the public are continuously encouraged to report any adverse events they may experience as this would help to continuously monitor the vaccines as they are being administered in Zimbabwe. The online medicines and vaccines safety reporting tools for consumers and health care workers are available from the MCAZ website, under online services, “e-reporting” and can also be accessed by using the hyperlinks https://www.mcaz.co.zw/index.php/online-services/pv-reporting/e-reporting and https://e- pv.mcaz.co.zw /users/login.”

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