#Covid-19: NAFDAC Warns About Fake Vaccine, It Should Not Be Ordered

NAFDAC has not received any application from COVID-19 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.
If NAFDAC does not approve, the public should not use.

— NAFDAC NIGERIA (@NafdacAgency) January 15, 2021

UNAPPROVED ORDERING OF COVID-19 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, know they have to submit their application to NAFDAC.

— NAFDAC NIGERIA (@NafdacAgency) January 15, 2021

However, NAFDAC is discussing with manufacturers 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…

— NAFDAC NIGERIA (@NafdacAgency) January 15, 2021

EMERGENCY USE AUTHORISATION AND LICENSING
NAFDAC will use “Reliance” or “Recognition” to expedite EUA for vaccines already approved by more matured regulatory authorities. The full dossier submitted by the manufacturer or Market Authorisation Holder (MAH)…

— NAFDAC NIGERIA (@NafdacAgency) January 15, 2021

POST-MARKETING ACTIVE PHARMACOVIGILANCE OR PHASE 4 CLINICAL TRIAL
Safety of the COVID-19 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.

— NAFDAC NIGERIA (@NafdacAgency) January 15, 2021

…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.

— NAFDAC NIGERIA (@NafdacAgency) January 15, 2021

NAFDAC initiated multi-stakeholder collaboration with NPHCDA, 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).

— NAFDAC NIGERIA (@NafdacAgency) January 15, 2021

The Agency will also use its newly launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with sister agencies. The App is free and healthcare workers can download it for ADR reporting. In-country training on its use has begun for healthcare givers.

— NAFDAC NIGERIA (@NafdacAgency) January 15, 2021