Notable Guidance Provisions on Regulatory Preparedness For Licensing/Access To COVID-19 Vaccines in Nigeria
The year 2020 witnessed an outbreak of a deadly respiratory disease caused by a novel coronavirus. The virus was named the “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2) and the disease it caused was named the “Coronavirus Disease 2019” (COVID-19) which claimed several lives when the disease finally got to Nigeria.
On the 11th of March,2020,the World Health Organization (WHO) declared the COVID- 19 outbreak as a pandemic.
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The SARS-CoV-2 pandemic presents an extraordinary challenge to global health. There were at the time of its emergence no licensed vaccines to prevent COVID-19.
Commercial vaccine manufacturers and other entities later developed COVID-19 vaccine candidates using different technologies including RNA, DNA, protein, and viral vectored vaccines.
These Guidance notes forming the focus of this article released by the National Agency For Food and Drug Administration and Control (NAFDAC) aimed at preventing a recurrence of the disease unanswered by a coherent vaccine policy,provided applicants and vaccine manufacturers with:
-Guidance regarding regulatory pathways for approving COVID-19 vaccines;
– The regulatory considerations to take into account when evaluating the quality, safety and efficacy of candidate vaccines;
– Guidance on effective post-marketing surveillance of COVID-19 vaccines.
The Guidelines were developed in the context of the Pandemic COVID-19 Preparedness Framework for regulatory capacity-building and strengthening of pandemic preparedness and response and will be looked at here in detail.
What is the purpose and scope of the NAFDAC Covid-19 Vaccine Guidance notes?
-This regulation provides guidance on the regulatory oversight of COVID-19 vaccines for use in public health emergencies.
-This guidance is aimed to prepare and put in place a regulatory process for COVID-19 vaccines in advance of vaccines that are being developed for that purpose. Such a process would enable NAFDAC to expedite the provision of marketing authorization and lot release of COVID-19 vaccines in response to this pandemic emergency.
– The document specifically provides the general principles for evaluating COVID-19 vaccines and establishing basic emergency procedures for regulating COVID-19 vaccines. A strong emphasis is placed on the decision making processes that have been put in place which minimize duplication and make much-needed vaccines available for use without unnecessary delay during pandemic emergencies.
Other relevant NAFDAC vaccine guidelines should also be consulted as appropriate.
What are the general considerations for regulatory preparedness for COVID-19 vaccines as highlighted in the NAFDAC guidance note?
-The guidance provides for a risk-based approach that:
(a) enables a more flexible response to different scenarios; and
(b) uses a simplified pandemic phase structure (pandemic and post pandemic) phases.
-NAFDAC has reviewed the options available during this public health emergency and has chosen the appropriate procedures to fit the situation.
-The emergency procedures include processes for ensuring information management, effective communication and cooperation between different directorates of the Agency and relevant stakeholders such as public health authorities.
– Plans were developed to address the need for official communication from NAFDAC relevant to specific audiences – such as the public, healthcare workers, national and subnational authorities and international collaborators when needed.
-Existing communication and information-sharing systems will be used.
-The submission of a Risk-management plan which is part of marketing authorization to monitor the safety and efficacy of COVID-19 vaccines used during a pandemic is necessary.
What are the provisions of the guidelines regarding considerations for national regulatory preparedness?
NAFDAC is responsible for developing the following procedures and plans to support future national pandemic COVID-19 preparedness plans and vaccine deployment plans:
i) Suitable regulatory pathways for COVID-19 vaccines during the emergency;
ii) Appropriate vaccine lot release procedures for emergency use;
iii) Post-marketing safety surveillance plans.
-NAFDAC’s preparedness procedures for facilitating the rapid availability of COVID-19 vaccines include:
a).Designated contact point for communications with WHO and other stakeholders on public health/regulatory issues;
b).Allocation of resources to be used when this pandemic alert was declared by WHO;
c). A public risk-communications plan summarizing the basis for decision-making;
d). An existing National Advisory Committee on Vaccines and Biologics (NACVB) for COVID-19 vaccines that:
1.) Include appropriate regulatory and programmatic expertise;
2.) Prepare procedures for evaluation of applications for COVID-19 vaccine;
3) Define the dossier and supporting documents needed for evaluation;
4.)Evaluate and recommend marketing authorization of suitable vaccines to the agency; and
5.) Procedures for interactions (including discussion of options for appropriate sources of vaccine) with the public health agencies that will procure, deploy and administer the vaccines;
6.) A system to accelerate the licensure and lot release of COVID-19 vaccine including recognition of the decisions, or reliance upon the expertise, of supporting NRAs, and the optimizing of available resources in response to the pandemic;
What are the provisions of the guidelines regarding procedures and requirements for lot release of COVID-
19 vaccines by the agency during emergency situations?
The following steps are included in the regulatory preparedness procedures:
– A working procedure for marketing authorization of COVID-19 vaccine.
– Preparation of a template emergency risk–benefit consideration and assessment report;
– A procedure for emergency approval of the NRA recommendation, as appropriate;
– A process to expedite marketing authorization through the WHO collaborative procedure for prequalified vaccines, when appropriate;
– Preparation of an outline post-marketing surveillance plan which includes special provisions for post- marketing surveillance of the COVID-19 vaccine in use.
What are the provisions of the guidelines on reliance on the decisions and expertise of other regulatory authorities?
-Mechanisms have been put in place to consider reliance on the product evaluation decisions made by other NRAs in vaccine-producing countries.
-NAFDAC has established mechanisms and procedures for recognizing the marketing authorization decisions of the NRA of the country producing the vaccine, or of other NRAs with WHO ML 3 and above as appropriate, when considering the licensing of a COVID-19 vaccine. The Agency may rely on the assessment report of such NRAs.
What do the guidelines say on emergency approvals?
-During the pandemic period, the guidelines provide that emergency approval procedures may be used.
-Approval may be based upon limited clinical data or quality data (for example, on stability) and upon expedited evaluation of the available evidence.
-Therefore, the approval may include one or more special conditions for use.
– These can include post-marketing safety reporting requirements, and limitations such as:
a). Use only during the pandemic period.
b).Use only by certain agencies.
c).Use only in certain listed groups at high risk .
What do the guidelines say concerning traceability?
-Mechanisms have been put in place to ensure that effective traceability solutions can be deployed to support the distribution of a COVID-19 vaccine.
-Applicants are therefore expected to deploy Serialisation Technology which are based on proven international global standards. This will enable the achievement of safe and effective distribution and delivery of COVID-19 vaccines.
-The Technology will also ensure that falsified products can be easily detected along the supply chain and also facilitate the conduct of activepost marketing surveillance and pharmacovigilance activities of the COVID-19 vaccines.
What do the guidelines say about quality control preparedness?
-Lot release and quality control of COVID-19 vaccines will be handled by the National Control Laboratory for Vaccines and other Biologicals (NCLVB).
-Vaccines should be produced in compliance with GMP and tested for quality and safety by the vaccine manufacturer.
– Such vaccines should also be subjected to quality control testing (with certificate of analysis issued) and released by the responsible NCL in accordance with the WHO’s Guidelines for independent lot release of vaccines by regulatory authorities (and should be accompanied by a lot release certificate).
– For vaccines supplied through United Nations agencies further release by the NCLVB shall not be performed because such products are prequalified by WHO and released by the responsible NRA/NCL.
– Likewise, WHO prequalified vaccines are normally released by the responsible NRA/NCL and as such will not be subjected to further lot release. The lot release certificate of the responsible NRA/NCL of the producing country shall be duly recognized.
-For non-WHO-prequalified COVID-19 vaccines, the NCLVB of NAFDAC will conduct lot release. The need for further Laboratory testing will be determined on a case by case bases guided by outcomes of risk-based assessment.
-The procedures adopted shall be to ensure the deployment of vaccines without undue delay.