As Liberians and residents of the country get COVID-19 vaccination shots, 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, and is therefore urging the public to report all adverse reactions to the entity.
In a statement released Tuesday, LMHRA says as part of its mandate, 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.
Therefore, as 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 (side effects) leading to some people in Liberia expressing concerns about getting vaccinated, the LMHRA wishes to report that so far, few minor problems have been reported but there has been no deaths conclusively linked to the vaccines.
The LMHRA also maintains that clear and consistent communication is therefore essential to support people in making the choice to be vaccinated.
“As the vaccination process is ongoing, the LMHRA reports that its team from the Pharmacovigilance & Clinical Trials Department has visited the following facilities: 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,” the statement noted.
Accordingly, the LMHRA team has 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 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 as well as to improve patient care and safety in relation to the use of the vaccines and other medical or health products.
In order to document and trace any side effects, the LMHRA disclosed that 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.
The LMHRA says it would therefore like to note 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 in assessing 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.
These actions, according to LMHRA, might include 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.
Meanwhile, as Coronavirus (COVID-19) once more ravishes the world, the LMHRA management is urging its staff, partners, pharmacies, importers and the entire citizenry of Liberia to follow all health protocols as mandated and lay down by the Ministry of Health (MOH) and the National Public Health Institute of Liberia (NPHIL).
LMHRA is also admonishing residents of Liberia and the general public to properly wear masks at all times while in the public; wash hands as many times as possible; ensure social distancing of a minimum of three feet from each other.
The Authority further encourages all COVID-19 Positive Persons and their Contacts to comply with health authorities and related health rules by keeping their phone lines open, self-quarantine and by submitting to quarantine and observation measures.
“Accordingly, we also encourage all residents of Liberia to turn out at the various Covid-19 vaccine facilities and take their dose as the ‘Vaccine Is Safe’,” LMHRA emphasized.
“LMHRA says, with our collective efforts and collaborations, we can defeat and eradicate this deadly global pandemic in Liberia and the world,” the LMHRA’s statement concluded.