Vaccines & BiologicsVaccines, Blood and Biologics
Vaccines, like other biologics in general, are derived from living cells or animal tissues. Due to the biological nature and intrinsic variable nature of the products, the starting materials used in their production and biological test method (bioassay) used in their analysis, require special quality control and regulatory approaches.
Vaccines are unique in the fact that they are usually administered to very large number of healthy people in Nigeria, mostly infant in the National Programmes for Immunization, thus safety and quality are paramount.
NAFDAC in its effort to achieve its mandate as the National Regulatory Authority (NRA) for vaccines performs the six critical WHO REQUIREMENTS for regulation.
The six critical functions are as follows: –
1) Licensing (Registration) of vaccines and other biologics – Refer to Regulatory and Registration Directorate.
2) Inspection – Refer to Drug Evaluation and Research Directorate
3) Laboratory assess (Laboratory Services)
4) Lot Release (Laboratory Services)
5) Post Marketing Surveillance -Pharmaco Vigilance & Post-Marketing Survey Directorate.
6) Clinical trial authorization –Refer to Regulatory and Registration Directorate.
Licensing/registration may be defined as a process that declares that the products is in conformity with the essential requirements and other provisions in relation to wholesomeness acceptable quality, safety and efficacy.For guidelines and regulations, refer to Regulatory and Registration Directorate.
OVERVIEW OF BIOLOGICS LABORATORY / HISTORY
The National Control Laboratory for Vaccines and other Biologics (NCLVB) is a unit under the LABORATORY SERVICES DIRECTORATE of the National Agency for Food and Drug Administration and Control (NAFDAC). It was formerly under the Central Drug / Vaccine Quality Control Laboratory and was then known as The National Vaccine Quality Control Laboratory.
The National Vaccine Quality Control Laboratory was commissioned on the 15th of February, 1999 by the then Honourable Minister of Health Professor Debo Adeyemi.
The commissioning of the laboratory came at a time when there was a concerted effort worldwide to control and eradicate vaccine preventable diseases such as Poliomyelitis, Measles, Mumps, Rubella, Diphtheria, Tetanus, Pertussis, Haemophilus influenza type b (Hib), Meningitis, Hepatitis A and B, Varicella etc.
The Laboratory was saddled with the responsibility of ensuring the safety, potency, efficacy and Lot release of vaccines in conjunction with being a resource for the performance of the six critical functions of a National Control Authority (NCA) recommended by the World Health Organization (WHO).
The National Vaccine Quality Control Laboratory officially became autonomous from the Central Drug / Vaccine Quality Control Laboratory on 24th August, 2009. It has since then changed to National Control Laboratory for biologics (NCLB) and presently National Control Laboratory for vaccines and other biologics (NCLVB)
To effectively perform its functions, NCLVB consists of the following units:
1. Chemistry Lab
2. Microbiology Lab
3. Serology Lab
4. In-Vivo Lab
5. Tissue Culture Lab
6. Quality Assurance Unit
7. Sample Receipt Unit
8. Administration Unit
9. Specification and Archiving Unit
10. Animal Facility
The laboratory has qualified experienced personnel in Vaccine Quality Control testing, trained abroad and locally.
SERVICES / FUNCTIONS / ACTIVITIES
- Laboratory makes pronouncement on the quality, safety, efficacy and fitness for use of vaccines, biologicals and medical diagnostic devices after analysis / evaluation. Some test parameters carried out in the various Laboratory units include physico-chemical test (APl, Ph, Adjuvants, Stabilants, Protein, Residue, impurities etc.). Sterility test, ldentity test, General safety test, Bacteria endotoxin test, ln-vivo/in-vitro potency test, VVM and Thermos stability test.
- Participate in the cGMP Inspection of manufacturing Facilities.
- Participate in vaccine clinical trial by testing for potency and safety of the product to be used for clinical trial e.g. IPV clinical trial.
- The Laboratory performs confirmatory test on vaccines where there is suspicion of cold chain breakage etc.
- Review dossiers, protocols and other quality documents.
- The laboratory ensures maintenance of the Cold Chain, which is monitored via the Vaccine Vial Monitor (VVM) placed on the product. Also, the lab equally carries out some test methodologies to determine the stability of vaccines in the temperatures outside the ones recommended by the manufacturer. In line with the afore mentioned, thermos-stability testing and VVM authenticity test are carried out by the laboratory.
- Lot release of vaccines and other biologics (which includes sampling of vaccines and biologics in conjunction with PID and DER as the need arises);Lot release is key to the control of vaccines and other similar biologics which are inherently variable due to the biological nature of raw material and production process. Therefore, post licensing monitoring for vaccines and other biologics by lot release is considered unique. Lot release is a post-licensure activity conducted by the agency on batches (lots) of vaccines and biologics before they are authorized for sale or use. While lot release has traditionally been considered to be an essential regulatory function for vaccines, independent lot release involves the confirmation that each lot meets the specifications in the approved marketing authorization for the product which includes, as a minimum a review of Summary Lot Protocols of the manufacturer, sampling and laboratory testing.
- The laboratory also carries out risk-based lot release using trend data, minimal test and protocol review.
INFORMATION TO THE PUBLIC
The general 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.
INFORMATION TO HEALTHCARE PROVIDERS
Healthcare providers should at all times 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.
ROLE OF NAFDAC ON IMMUNIZATION
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.