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Government guidelines on COVID-19 vaccines

This week the Pharmacy and Poisons Board published guidance on the role of Private Sector in the deployment of COVID-19 Vaccines (March 2021). The guideline describes the Pharmacy and Poisons Board procedure applicable for private sector engagement in supply of the COVID-19 vaccines. The guideline is to be read alongside the guidelines for Emergency and Compassionate Use Authorization of Health Products and Technologies (ECUA). The Emergency Use Authorization of vaccines is prescribed under the Pharmacy and Poisons Act and the Health Laws (Amendment) Act, 2019.

 Emergency Use Authorization

The Emergency Use Authorization is a risk-based procedure for assessing and authorizing unlicensed medicines, vaccines and In Vitro Diagnostics (IVDs) and any critical healthcare product or technology for use primarily during public health emergencies. The purpose of the procedure is to allow rapid authorization decision once an emergency is declared.

 The newly released guideline has been developed to provide guidance to:

  • industry (manufacturers);
  • stakeholders; and
  • local technical representatives

on the documentation requirements and procedure for rollout of COVID-19 vaccines by the private sector.

 Inspiring Hope

The development of COVID -19 vaccines has provided hope that COVID-19 Pandemic might be defeated and may eventually enable us to go back to the normal way of life. Availability of the Vaccine has been a result of a concerted effort by the pharmaceutical sector, global bodies  and regulatory authorities including WHO that has helped in availing the much- needed vaccines to the World. Indeed, Kenya has been part of the global efforts to develop safe and effective COVID-19 vaccines, in particular, enabling the carrying out of clinical trials for one of the successful COVID-19 vaccine, the Astra Zeneca Vaccine.

Prioritizing Vaccine Access

The Government of Kenya has prioritized access to safe and effective COVID-19 vaccines through, membership in the Global Umbrella Facility for pooled procurement of the COVID-19 Vaccine (COVAX), the Africa Centre for Disease Control (CDC) and bilateral engagements with suppliers to bridge any supply gaps and/ or create National Emergency Strategic Reserves.

 COVID-19 vaccination guidelines

In order to ensure a systematic and structured approach to National COVID-19 vaccine deployment, the government developed National COVID-19 vaccination guidelines, 2021. These guidelines stipulate that the Government through the National Vaccine and Immunization program (NVIP) and under the stewardship of the National COVID-19 Deployment and Vaccination Taskforce shall provide vaccination in phased approaches to progressively cover all the target groups, based on vaccine availability.

 The three proposed phases are:

  • Phase I- January- June, 2021,
  • Phase II- July, 2021-June, 2022,
  • Phase III- July, 2022-June, 2023.

Early vaccination (Phase I) is to focus on administration sites that can reach prioritized populations with as much throughput as possible i.e. Levels IV, V and VI hospitals which are estimated at 5% of the total facilities. Phase II Vaccination will be delivered through Level 3 and above health facilities while Phase III Vaccination will be delivered through Level 2 and above health facilities.

Phase I

Phase I runs from 8th March to 30th June, 2021 and prioritizes the vaccination of 1.25 million front line workers (health workers, security personnel, teachers above 50 years of age and clergy. However, due to the current 3rd wave of the COVID-19 Pandemic that the country is experiencing, Kenya has decided to prioritize the vaccination of persons with underlying medical conditions aged 60 years and above during phase I.

Phase II

Phase II shall run from 1st July, 2021 to 30th June, 2022 and targets 9.6 million persons. This will include all persons above 18 years with co-morbidities, all other individuals above 50 years, workers in hospitality, all individuals due for vaccination in Phase I that may have been missed and other priority sectors.

Phase III

Phase III will target 4.9 million persons working in the entertainment sector, retail, banking and those living in congregate settings. In total, the government aims to vaccinate 15.8 million adults over an 18-month period starting March, 2021.

 Geo-politics

Currently, there is a steep demand for COVID-19 vaccines globally. Indeed, it has been reported that the developed countries may horde the vaccines to the detriment of the developing countries, such as, Kenya. The country received early this month (03rd March, 2021) about 1 million doses of the AstraZeneca vaccine (Covishield; manufactured by Serum Institute India) under the Gavi COVAX facility.

 COVID-19 Vaccine Accessibility & Private Sector Engagement

 Kenya launched the COVID-19 vaccination on 05th March, 2021. This was eventually followed by vaccination rollout across the 47 counties through the public sector. Initially the about 1 million Astra Zeneca Vaccine doses were only available through the public health facilities. Introduction of the vaccine in limited public health facilities created challenges of accessibility and possible inequity. This called for rethink of COVID-19 vaccine deployment and availability of the Vaccine at partner private hospitals.

 Terms & Conditions That Apply

Like any other vaccines, it is important to ensure vaccine efficacy, safety and quality.

COVID-19 vaccines have been developed in a shortened period (though maintaining same standards) resulting in manufacturers fearing litigations by persons or families that may suffer loss or injury. Consequently, manufacturers requested for indemnification from governments. Indeed, indemnification was one of the conditions for vaccines procured through the Gavi COVAX facility to be secured and released to member countries.

Nonetheless, it is noted that the COVAX facility is establishing a No-fault compensation to provide compensation to parties to the COVAX facility participating   countries.   This   shall   support   compensation   as   per   the indemnification agreement. Such a facility is not established in Kenya and thus mechanisms for liability and protection of Vaccines outside the Gavi COVAX facility vaccines (for example Sputnik) need to be established.

Private Sector Involvement

Kenya has a vibrant private sector which contributes 50% of healthcare service delivery. Their role in the deployment of COVID-19 vaccines is therefore very important to ensure increased access and equity. The published guidelines speak to the deployment of the vaccines by the private sector.

 

Importation & Distribution Of The Vaccines

 Any private person or entity that is to be licensed to import and distribute the vaccines must

  • Be duly licensed by the Pharmacy & Poisons Board as a wholesale dealer in medical products and health technology. In order to be eligible for licensure by the Board, the entities must demonstrate adherence to Good Distribution  Practices and Guidelines for Transportation of Pharmaceuticals as issued by the Board. 

In summary, Good Distribution Practices encompasses three main aspects, namely;

  • Premises– Premises should provide protection for the goods from contamination and deterioration, including protection from excessive local heating, humidity/ moisture or undue exposure to direct sunlight.
  • The Personnel– personnel should have the relevant education, training, experience and/ or combination of these elements that will allow them to effectively handle these categories of products.
  • Quality management system– Must assure quality of medicinal products and health technologies.
  • Transportation of pharmaceuticals must ensure that the integrity and quality of pharmaceuticals is safe guarded. The entities must adhere to the laid down importation procedures for Health Products and Health Technologies.
  • The entities shall only distribute the vaccines to legitimate hospitals and clinics as approved  by the Kenya Medical Practitioners and  dentists council (KMPDC).

Some More Conditions

Authorized importers shall in addition to the requisite importation documents, provide a legally binding document stipulating that they would bear the liability in case persons suffer loss or injury from the use of the vaccine.

  • For the avoidance of doubt “an authorized importer” includes the Local Technical Representative and authorized distributor(s) of the product. The authorized distributor(s) shall have the additional requirement to provide a “no-objection letter” from the local representative stipulating the list of specific batches to be imported;
  • Authorized importers are required to have a cover of a prescribed amount from a reputable insurance company to ensure compensation in the event liability attaches as a result of the vaccine;
  • A causality assessment by the Pharmacy and Poisons Board, National Vaccines Immunization Program and the Kenya National Vaccine Safety Advisory committee (KNVSAC) must prove that vaccine might be linked to the injury or loss of life;

 

Vaccine is Voluntary

in view of the voluntary nature of the vaccination, the Pharmacy and Poisons Board recommends:

  • Consent Forms be signed by the recipients of the vaccines prior to administration of vaccines;
  • All the recipients of the vaccines prior to administration of vaccines must be registered through the “Chanjo system”;
  • The imported vaccines should have unique identifiers, such as, QR codes and barcodes to ensure traceability and additionally show real time shelf- life, manufacturers information, lot/batch numbers and expiry date;
  • Traceability and fight against counterfeit vaccines- There is need to ensure product traceability from the manufacturer to the immunization service delivery sites through use of barcodes or QR on each secondary package. Once this is scanned it will inform that the product is not a falsified vaccine and give real-time expiry information;
  • Barcoding or QR coding information must be collected upon arrival of the vaccines at the port of entry;
  • Scan and collect barcodes or QR codes during internal movement in- country and use of software to trace products;
  • Private sector players must ensure adherence to the Board’s approved Safe Management of Pharmaceutical Waste Guidelines   and MOH protocols on healthcare waste management
  • If falsified products are found, the Board shall institute a national re-call procedure and put the affected vaccine under quarantine awaiting further regulatory action.
  • A multi-agency team should be put in place to monitor the movement of the vaccines throughout the supply chain i.e. from manufacturing to the service point.

The Board is monitoring all the adverse effects of the licensed and allowed vaccines on recipients and will advise as need be.

*Content sourced from the PPB Guidance On The Role Of Private Sector In The Deployment Of COVID-19 Vaccines March 2021.

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