German Cooperation, EU join hands to upgrade FDA towards first ever local vaccine production

The German Development Cooperation and the European Union under the brand Team Europe, have initiated a collaboration to support implementation of Ghana’s first ever major strategic intervention on domestic vaccine production. This forms part of a 10-year Government of Ghana vaccine manufacturing roadmap intended to make Ghana a vaccine manufacturing hub in the sub-region. The partnership will facilitate the upgrade and strengthening of the Ghana Food and Drugs Authority and contribute to the production of various vaccines, including Ghana’s first batch of COVID-19 vaccines.

The ravaging effects of the COVID-19 pandemic have revealed gaps in national health systems and brought many lessons to the fore. About five million lives have already been lost globally to the pandemic (WHO, 2021). Other adverse impacts include job losses, high cost of living, loss of public revenue, and economic decline (World Bank, 2021). As a measure to protect citizens against the pandemic, vaccines have now become a high priority on the agenda of many governments globally.

At the height of the COVID-19 pandemic and the associated high demands for the vaccines globally, which exceed supply, Ghana and many other developing countries could not access adequate vaccine for their populations. Ghana and most African countries could not reach the 40 per cent WHO vaccination target as at the end of 2021. While some other regions and countries have recorded over 50 per cent access to COVID vaccine, only less than 5 per cent of Africa’s population was able to access the vaccines at the end of 2021.
The Chief Executive Officer of the FDA, Mrs. Delese Mimi Darko explains that “this project focuses primarily on the FDA and seeks to strengthen the regulatory systems of the Authority with an objective to maintain requisite WHO and international regulatory standards.”

The Head of Development Cooperation at the German Embassy in Ghana, Mad. Dorothee Dinkelaker notes, “the pandemic has had severe effects on health and economic development in Ghana. Equal access to vaccines is crucial and Germany is committed to support Ghana in her endeavour to establish domestic vaccine production. Supporting the FDA Ghana in fulfilling their role in vaccine production and regulation is an important step in the implementation of the government’s plan.”

The project is co-funded by the EU programme, “Contribution to the Africa Investment Platform (AIP) – leveraging COVID-19 impact mitigation support” and implemented under the German Government funded GIZ-project “Support to Vaccine Manufacturing in Ghana project.”
Within the context of the Global Gateway, is a new European strategy prioritizing among others, the security of supply chains and the development of local manufacturing capacities. The EU will be working with partner countries to diversify their pharmaceutical supply chains and contribute to addressing international supply chain bottlenecks.

Vaccine manufacturing globally is a complex process that requires high precision of standards, rigorous testing and controls. While Ghana’s ambition to establish a vaccine industry is laudable, a lot needs to be done to build the regulatory institutions, systems and processes. “The European Union is equally committed to contributing to an enabling environment for domestic vaccine production in Ghana. Strengthening the Ghana Food and Drugs Authority in their regulatory function for vaccines is therefore well placed,” said EU Ambassador to Ghana, Irchad Razaaly.

The support to Ghana Food and Drugs Authority is in the framework of the Team Europe Initiative (TEI) on manufacturing and access to vaccines, medicines and health technologies (MAV+) in Africa. The initiative will help create an enabling environment for local vaccines manufacturing in Africa and tackle barriers and demand siders, backed by €1 billion from the EU budget and the European development finance institutions such as the European Investment Bank (EIB).

The project is for a period of 27 months, from April 2022 to June 2024, with total funding support of over €2.8 Million Euros; this is co-funded by the European Union and the German Federal Ministry for Economic Cooperation and Development (BMZ). Government of Ghana has already committed an amount of US$ 25 million seed money to the overall vaccine manufacture initiative and this project forms an integral part of the overall roadmap.

The Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH, on behalf of the German Government, has been playing a lead role of facilitating and coordinating the interest and support of various partners on the endeavour towards domestic vaccine production. “We seek to contribute to solutions that support efforts of national governments, development partners and the private sector in the fight against COVID-19; this initiative is a first step to empower African countries and Ghana in particular, to have their own vaccination plants. We remain very committed to support this implementation,” explains Country Director of GIZ Ghana, Mad. Regina Bauerochse Barbosa.

The joint action will involve an upgrade of FDA from WHO Maturity Level 3 to a Maturity level 4 regulatory agency for vaccines, as well as an upgrade of the FDA pharmaceutical microbiology laboratory to a biosafety level 3; capacity building of FDA officers; strengthening of the inspection and licensing function, as well as strengthening of the market authorisation function. The support will ensure that the FDA has the capacity in terms of facilities and personnel to ensure quality, safety, and efficacy of locally manufactured vaccines that meet WHO and international standards.