No Kenyan appears to have been compensated for any harm arising from Covid-19 vaccines, as the regulator says the jabs were safe and well tolerated.
The Pharmacy and Poisons Board, monitoring the vaccines for safety, said the most reported adverse events following immunisation were headache, injection site pain, general malaise, fever, dizziness, and cough.
“Despite the expedited evaluation and emergency licensure of vaccines, their safety and efficacy should not be compromised, which informed the study's conduct (Vaccine safety monitoring),” said Dr Ahmed Mohamed, director of health products and technologies at PPB.
On Wednesday, PPB presented results covering February 2023 to November 2023 where they observed 9,288 Kenyans from 15 counties to determine the incidence, types, severity, and risk factors for adverse events following immunisation associated with Covid-19 vaccines.
“The PPB has established a strong monitoring and regulatory framework to ensure the safety of HPTs,” Dr Mohamed said.
The PPB did not find unusual or serious adverse effects. No harm has also been reported outside the study period.
“The results indicate that the vaccines were generally safe and well-tolerated. The reported adverse events following immunisation (AEFI) were either mild or moderate and transient, resolving within 48 hours of vaccine administration,” PPB said in a statement.
It said the pattern of adverse events reported in Kenya was consistent with what has been observed globally in the WHO global database, VigiBase, the World Health Organization's global individual case safety report (ICSR) database.
Such effects do not qualify for compensation in the Covax Claims compensation programme established in 2021.
PPB said Kenya is a member of the African Union vaccine safety surveillance programme.
“We are pleased to report that no new signals were detected when the Covid-19 safety data from five countries (Kenya, Ghana, Nigeria, South Africa, and Ethiopia) were pooled and analysed under the AU-3S Joint Signal Management Group, further confirming the safety of the Vaccines,” it said.
The Kenyan report suggests no Kenyan was compensated through the Covax Claims. This is a WHO-approved programme that covers serious bodily injury or illness that requires hospitalisation or prolongs an existing hospitalization, or injuries that result in permanent total or partial impairment, or death, from Covid vaccines.
The programme is ongoing and will end on June 30, 2027.
Deaths attract the highest compensation, at $100 (Sh12,900) per day of hospitalisation up to a maximum of $6,000 (Sh774,060).
Pregnant women who receive the vaccine can also be paid if it harms the unborn child or results in miscarriage.
Payments for the rest are calculated based on the GDP per capita of Kenya times the given harm factor resulting from the vaccine.
One can only apply 30 days after taking the vaccine.
“The reason for this 30-day waiting period is to allow registered healthcare professionals to determine whether the adverse event which you have suffered (or the person you represent, has suffered) is serious,” Covax said.
Minor side effects such as pain, headache or fever are not paid for.
Applications are made through the www.covaxclaims.com website.
Kenyans who take the Russian Sputnik V or any other vaccine not in the Covax programme cannot apply for compensation.
All applications must be supported by evidence from a registered nurse, medical doctor or pharmacist who will provide documentary evidence. The PPB is also consulted.
Covax said all applications will be thoroughly scrutinised and those eligible for compensation will be notified within 30 days.
The patients or their representatives will be notified to choose the method of payment they prefer, and money will be wired within 28 days.
To be paid you will sign an agreement committing not to pursue any other compensation.
“By providing a no-fault lump-sum compensation in full and final settlement of any claims, the Covax programme aims to significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process,” WHO said last month.