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NAFDAC Unveils Safety Measures For COVID-19 Vaccines In Nigeria




The National Agency for Food and Drug Administration and Control (NAFDAC) has commenced a campaign to sensitise Nigerians on its plans about the COVID-19 vaccine.

This is to ensure the safety of the vaccines and guide against abuse by manipulative elements.

Already, NAFDAC has informed Nigerians that it has not received any application from COVID-19 vaccine manufacturers, stressing that if NAFDAC does not approve, the public should not use any vaccine.

NAFDAC has also made it clear that vaccines should not be ordered by any company or corporation in Nigeria. However, NAFDAC has listed several measures put in place to ensure the vaccines are well handled, distributed, and administered. They include:

1. Emergency use of authorisation and licensing NAFDAC will use “Reliance” or “Recognition” to expedite Emergency Use Authorisation for vaccines already approved by more matured regulatory authorities. Furthermore, the full dossier submitted by the manufacturer or Market Authorisation Holder will be thoroughly reviewed by the vaccine committee that is made up of multiple directorates in the agency.

2. Post-marketing active pharmacovigilance or phase 4 clinical trial The safety of the COVID-19 vaccine is premium to NAFDAC. This is why active pharmacovigilance is being used. NAFDAC will note clinical peculiarities in form of Serious or Adverse Events Following Immunisation in the dossier or application as a guide and caution for what to look out for in each subject after immunization.

3. Collaboration with sister agencies and partners NAFDAC initiated a multi-stakeholder collaboration with the National Primary Health Care Development Agency, Nigeria Center for Disease Control, UNICEF, World Health Organisation, 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 (AEFIs).

4. Tracking and tracing of the vaccines NAFDAC plans to also use the traceability with GS1 technology to monitor the vaccine distribution using the 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.

5. 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 the UK Medicines Healthcare Products Regulatory Agency through funding from Bill and Melinda Gates Foundation.

The goal is to use COVID-19 vaccines distribution and immunization as a 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 the safety of medicines.

The Federal Government had earlier said that Nigeria will receive its first batch of the COVID-19 vaccines in March 2021.

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