The Liberia Medicines and Health Products Regulatory Authority (LMHRA) has disclosed that the Pharmacovigilance & Clinical Trials Department is monitoring the safety and adverse reactions of the AstraZeneca ChAdOx1 nCoV-19 (AZD1222) or COVID-19 vaccines shot
As thousands of Liberians and residents get vaccinated against COVID-19, The LMHRA is urging the public to report all adverse reactions to the Authority.
The LMHRA maintains that the collection of Adverse Drug Reaction Reports (side effects) remains a cardinal function of the entity in guiding health policy managers to make informed decisions that will ensure the safety of medicines and health products in the country, as stipulated in the LMHRA Act of 2010 as part of its mandate,
The LMHRA reported that so far, few minor problems have been reported but there has been no deaths conclusively linked to the vaccines because the impact of the COVID-19 pandemic has globally resulted in an unprecedented level of public interest in the vaccines; with purported reports of adverse events leading to some Liberia expressing fears about getting vaccinated.
Also, LMHRA maintains that a clear and consistent communication is therefore essential to support the population in making a choice to be vaccinated.
The LMHRA further reported that its team from the Pharmacovigilance & Clinical Trials Department has visited the 14th Military Hospital, SOS Hospital, St. Joseph Catholic Hospital, Duala Market, Waterside Market, ELWA Hospital, SDA Cooper Hospital, JFK Medical Center, Redemption Hospital, Duport Road Health Center and the James N. Davies, Jr. Memorial Hospital in Neezoe, Paynesville, for the purpose of monitoring the adverse reactions or effects as the vaccination process is ongoing.
Accordingly, the LMHRA said a team had also monitored the vaccination process at the Paynesville Red-Light Market, Old Road Joe Bar Market, Johnsonville Market and the Clara Town Market.
LMHRA asserts that the key objectives of the monitoring or outreach were is to follow-up on the assessment of benefit, effectiveness, unpleasant effects and risk of the vaccine candidates (Astrazenica-COVID-19 and nOPV2 Vaccines currently being used in Liberia and to improve patients’ care and safety in relation to the use of the vaccines and other medical or health products.
The Authority said its team provided temporary registration forms to facilities to capture details of patients and ADRs to enhance traceability, after onsite training of vaccinators, encouraged vaccinators to utilize the AEFI (adverse effects following immunization) booklets to record and report ADRs, and the LMHRA teams initiated follow-up calls to some participants at health facilities and homes in order to document and trace any side effects.
The LMHRA notes that it is very important that healthcare professionals not only diligently report any adverse events they see in their patients, and also encouraging people who are being vaccinated to immediately report adverse events to their healthcare professionals or to the LMHRA through its hotlines service.
According to the team, reporting all relevant events will help us to assess the possible role of the vaccine in causing the side effect and assists in identifying safety issues relating to the vaccines or medicines.
Consequently, LMHRA notes that when these side effects are reported, LMHRA, in collaboration with the Ministry of Health, will be able to take decisive action if a safety issue is identified pointing out, “These actions might include according to the authority: issuing safety communications for patients, healthcare professionals and the community; updating the product information or consumer information for the vaccine; preventing the release of a particular batch of vaccine; and, taking other regulatory actions such as restriction of vaccine authorization to a particular subgroup of the community or revocation of authorization for use.”
“Accordingly, we also encouraged all residents of Liberia to turnout at the various Covid-19 vaccine facilities and take their dose as the ‘Vaccine Is Safe and with our collective efforts and collaborations, we can defeat and eradicate this deadly global pandemic in Liberia and the world,” the Authority reiterated.