For the record: Safety of covid vaccines: what nafdac wants the public to know
COVID VACCINES IN NIGERIA
The National Agency for Food and Drug Administration and Control (NAFDAC) has not received any application from Covid Vaccine manufacturers yet and therefore no vaccines have been approved by NAFDAC. Covid-19 vaccines are new, and the side effects or adverse events must be well monitored, therefore, if NAFDAC does not approve, the public should not use.
FAKE COVID VACCINES
There are reports of fake vaccines in Nigeria. NAFDAC is pleading with the public to beware. No Covid Vaccines have been approved by NAFDAC. Fake vaccines can cause Covid-like illnesses or other serious diseases that could kill.
UNAPPROVED ORDERING OF COVID VACCINES BY PRIVATE COMPANIES AND BIG CORPORATIONS
Vaccines should not be ordered by any company or corporation. The companies that manufacture the vaccines if they are genuine companies know they have to submit their application to NAFDAC.
GOVERNMENT ESTABLISHMENTS AND AGENCIES
No government establishment or agencies should order Covid vaccines without confirming from NAFDAC if the vaccine has been approved.
However, NAFDAC is discussing with manufactures of candidate COVID-19 vaccines concerning potential Emergency Use Authorization (EUA), registration or licensing of their product as the case may be. The Agency assures applicants that if Phase 3 clinical data are very convincing and robust with regards to safety and efficacy, and the vaccine has been submitted for WHO for Emergency Use Listing, NAFDAC will welcome the application for Emergency Use Authorisation in Nigeria.
EMERGENCY USE AUTHORISATION AND LICENSING
NAFDAC will use “Reliance” or “Recognition” to expedite Emergency Use Authorisation (EUA) for vaccines already approved by more matured regulatory authorities. The full dossier submitted by the manufacturer or Market Authorisation Holder (MAH) will be thoroughly reviewed by the Vaccine Committee that is made up of multiple Directorates in the Agency – Drug Registration and Regulatory Affairs, Drug Evaluation and Research, Pharmacovigilance and Post Marketing Surveillance, Drug, Biologics and Vaccines Laboratory Services.
POST-MARKETING ACTIVE PHARMACOVIGILANCE OR PHASE 4 CLINICAL TRIAL
Safety of The Covid Vaccine Is Premium to NAFDAC This is why active pharmacovigilance is being used. Phase 4 pharmacovigilance is one of the core regulatory activities of the Agency. For COVID-19 vaccines, the Agency has been preparing for the COVID-19 vaccines and vaccination since the early phase of the pandemic – around April 2020. NAFDAC was positioned to a great extent to work online during the lockdown due to digitalization of many of our processes and continuous improvement.
Despite the use of Reliance for the EUA, NAFDAC will note clinical peculiarities in form of Serious or Adverse Events Following Immunisation (AEFIs) in the dossier or application as a guide and caution for what to look out for in each subject after immunization, i.e., during the active pharmacovigilance phase where monitoring of adverse events will be conducted. The Agency has been training her staff for this very important aspect of the immunization.
The Agency established COVID-19 Vaccine Committee that has been busy developing the guidelines and guidance. NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines
Collaboration with Sister Agencies and Partners: NAFDAC initiated multi-stakeholder collaboration with National Primary Health Care Development Agency (NPHCDA), Nigeria Center for Disease Control (NCDC), UNICEF, WHO and Ministry of Health. The focus is to use a holistic approach for the effective immunization or delivery of the vaccines and monitor any Adverse Events Following Immunisation (AEFI). The Agency will also use its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with the sister agencies. The App is free, and millions of healthcare workers can download it free for ADR reporting. In-country training on the use of the App has begun for the healthcare givers.
Tracking and Tracing of the Vaccines: NAFDAC plans to also use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN). The goal is to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion. This effort will create a reliable and predictable supply chain. The multi-stakeholder technical working group has been meeting to address different issues, from access to distribution to traceability (track and trace) of the vaccines, to monitoring of adverse events following immunization.
Working at the Continental Level: NAFDAC is on the Regulators Steering Committee of African Union -3S (Smart, Safety Surveillance) with Ghana, South Africa and Ethiopia. The Steering Committee is collaborating with UK Medicines Healthcare Products Regulatory Agency (MHRA) through funding from Bill and Melinda Gates Foundation. The composition of the Nigeria’s working group (a regulatory officer from NAFDAC and an officer from NPHCDA) was used as a template for the AU-3S which the three other African regulators have adopted. The active pharmacovigilance that will be carried out will be used to harness data in MHRA database for detection of signals, understanding of demographic differences, etc.
The goal is to use Covid-19 Vaccines distribution and immunization as pilot to actively monitor the distribution (with track and trace) delivery and monitoring of AEFIs of the vaccines at the continental level with the ultimate goal to create an African-based vigilance System for safety of medicines. Update:
As an outcome of the Regulators Steering Committee of African Union-3S, a National training of trainers has been scheduled for January 12, 19 and 21, 2021 by MHRA to improve capacity of key staff of NAFDAC and NPHCDA on the data collection overview and information. 120 slots for the participants were allocated to each of the four countries. NPHCDA provided 80 names to ensure that a wide number of their Agency staff and partners understand the data collection overview and information required for the COVID-19 safety surveillance while NAFDAC provided 40 names, including the Ministry of Health.
Prof Mojisola Christianah Adeyeye, PhD, FAS
Director General
15th January 2021
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