A new study on the Covid-19 vaccines has concluded that the doses used for immunization were generally safe, and Kenyans should disregard the misinformation circulating about them. This finding helps dispel the myths and misconceptions that have surrounded the vaccines.
Although the government lifted all mandatory Covid-19 restrictions in March 2022, false claims about the vaccines persist. These include unfounded fears about infertility, population control, dangers for pregnant women, and impotence.
However, according to results from a nine-month study conducted between February and November 2023, only 32 out of a small sample of 100 vaccinated individuals in one site reported experiencing Adverse Events Following Immunization (AEFIs).
Investigators from the Pharmacy and Poisons Board (PPB) described these reactions as mild or moderate and emphasized that there is no cause for concern.
“Overall, the results indicate that the vaccines were well-tolerated, meaning the side effects were temporary and resolved within 48 hours of vaccination,” said Dr. Bramuel Tongola, a regulatory officer at the PPB. He added that the most commonly reported AEFIs included headaches, pain at the injection site, general malaise, fever, dizziness, and cough.
The study was a collaborative effort with the National Vaccines and Immunization Program (NVIP) and the Centre for International Health Education and Biosecurity (CIHEB-Kenya). While presenting the findings, Dr. Tongola also noted that the pattern of AEFIs was consistent with global data from the World Health Organization’s (WHO) VigiBase.
“Age, vaccine type, chronic illness, concurrent medication, and pre-vaccination conditions were potential predictors of AEFIs,” he explained.
The study primarily focused on the Johnson & Johnson and Pfizer vaccines, as these were the ones available during the study period.
“We are pleased to report that no new safety signals were detected when Covid-19 safety data from Kenya, Ghana, Nigeria, South Africa, and Ethiopia were pooled and analyzed by the AU3S Joint Signal Management Group. This further confirms the vaccines’ safety,” he concluded.
Kenya is a member of the African Union Development Agency (AUDA-NEPAD) under the African Union-Smart Safety Surveillance Program, which aims to monitor the safety of medical products, including Covid-19 vaccines. A recent study was conducted to identify the incidence, types, severity, and predictors of Adverse Events Following Immunization (AEFIs) with Covid-19 antigens.
Dr. Bramuel Tongola explained that the study found AEFIs do occur, with approximately 32 out of every 100 people reporting mild adverse events, which vary depending on the specific vaccine they received.
He assured Kenyans that the country has systems in place to ensure that products authorized for use are safe, effective, and of good quality. “The study is a product of these safety systems,” Dr. Tongola emphasized, adding, “Medicines and products in circulation are safe, effective, and of quality.”
Dr. Martha Mandale, the study’s principal investigator, noted that the results confirm the benefits of Covid-19 vaccines far outweigh the risks, making them crucial in the fight against the pandemic.
She highlighted that vaccines have long been a key tool in controlling the spread of diseases during pandemics and epidemics, and Covid-19 vaccines were developed and granted Emergency Use Authorization (EUA) for this purpose.
Dr. Mandale also emphasized that despite the expedited approval process for these vaccines, safety and efficacy remain paramount, which was a key focus of this study. The study was conducted across 17 sites, including public, private, and faith-based facilities serving large populations, representing 15 counties and neighboring regions.
While the study initially aimed to involve 30,000 participants, the researchers were satisfied with the 9,288 who took part, as they provided a representative sample across the country.