Biologics are very specific and highly effective medicinal products derived from living organisms and cannot be produced by chemical means like drugs. Some biologics are extracted from living systems (e.g. blood), others are products of recombinant DNA technology like monoclonal antibodies etc.

Vaccines are biological substances that provides active acquired immunity to a particular infectious disease caused by bacteria and viruses.

Vaccines are administered to a large number of healthy adults and infants; this helps to protect individuals from several life threatening diseases. In Nigeria, vaccination has greatly reduced the burden of infectious diseases and NAFDAC ensures the safety and efficacy of Biologics including vaccines before use.

The public is advised to always consult with healthcare providers to determine the vaccines and biologicals suitable for use and fit for purpose. Vaccines and biologicals should be administered by certified trained personnel.

Patients should report any adverse event following immunization to healthcare provider immediately.

The general public should report all activities that contravene the Agency’s mandate of safe guarding the health of Nigerians to NAFDAC authority.

Healthcare providers should always ensure that only vaccines and other biologics, certified safe and efficacious by NAFDAC are administered to patients. Healthcare providers should forward all reports of adverse events following immunization to the Pharmacovigilance unit of NAFDAC.Healthcare providers should ensure proper cold chain monitoring along its distribution line.

Healthcare providers should interface with designated NAFDAC staff on issues concerning NAFDAC. Please avoid use of external NAFDAC consultants for the purpose of NAFDAC accreditation as their appointments have been revocated.

The role of NAFDAC in safeguarding the health of the nation through immunization activities is to ensure that only safe and efficacious products are administered to the populace. This mandate is implemented through inspection, registration and appropriate laboratory tests alongside document review(certificate of analysis, certificate of release from regulatory authority of country of origin and summary lot protocol) to assure that vaccines and biologics to be used nationwide for immunization are appropriate, safe, of good quality and satisfactory for the intended users.