From COVID-19 Crisis to Opportunity: Ghana’s New Vaccine Institute Nears Completion

 

The closure of borders, social distancing, wearing of nose masks and lockdowns characterised the global response to the Covid-19 pandemic which started in late 2019, spreading to other parts of the world within a matter of weeks.

The pandemic brought devastating impact to human and social life and further exacerbated already fragile healthcare systems, especially in developing nations. Healthcare workers took on new roles and the capacities of hospitals and clinics were stretched to their limits.

“When we first recorded a case, we were scared for our lives,” says Nurse Rhodaline Nimako, a critical care nurse at Ghana’s tertiary health facility; the Korle Bu Teaching Hospital. “We panicked because this was a disease we had not experienced before,” she recalled.”

“It was a difficult time for all of us: health workers, patients and relatives who lost their loved ones,” she added. “We had to live in a new normal of anti-socialisation and hope for the day the pandemic will come to an end.”

Nurse Nimako says she and her colleagues managed to care for patients who were admitted at the isolation/treatment centre going strictly by the World Health Organisation (WHO) and Ghana Health Service (GHS) treatment and safety guidelines.

After several months of disruptions caused by the COVID-19 pandemic, with more than 80,700 Ghanaians getting infected with the virus and over 580 lives lost, the path to recuperation finally began with the announcement of the development of a vaccine.

With the news, that a vaccine had been approved for immunization against COVID-19, the world breathed a sigh of relief. By December 2020 a number of western countries had started vaccinating their citizens.

However, the existence of a vaccine did not initially bring relief to African countries and other countries in the low-to-middle income bracket resulting in an international outcry about the need to make vaccines available for all.

Ghana’s Presidential Advisor on Health, Dr. Anthony Nsiah-Asare says there was a phenomenon of vaccine nationalism, vaccine hoarding and export restrictions combined with the lack of regional vaccine supply across the African continent which left African countries struggling to vaccinate their populations.

On Feb. 24, 2021, Ghana became the first country to receive the initial batch of 600,000 doses of donated COVID-19 vaccine through the COVAX Facility, a worldwide initiative aimed at ensuring equitable access to COVID-19 vaccines.  This shipment arrived two months after wealthier countries had taken the lead in vaccinating their populations.

The donation was targeted at high risk population that included health workers, security personnel, the aged and other front line staff. The vaccination of health workers, other front-line staff and at risk-population gradually paved a way out of the pandemic as more COVID-19 vaccine handouts poured in from developed countries and the 21-million targeted population in Ghana started receiving the much needed vaccine.

“I was very happy about the development of the COVID-19 vaccine because health workers are part of the high risk population and the thought of it reducing the devastating effect of COVID-19 on the vaccinated person gave me some hope,” Nurse Nimako said.

But waiting on support before the country could acquire COVID-19 vaccines did not guarantee a sustainable supply of the much needed vaccine.

For instance, eligible individuals who were vaccinated with the first dose of donated AstraZeneca Vaccine under the COVAX Facility agreement had to wait nearly four months- more than the 12 weeks maximum gap recommended by the World Health Organisation (WHO) – to get the second dose due to the shortage of the vaccine.

These delays pushed Ghana’s government to take a proactive stance.  In response to the threat of a lack of vaccine availability, the government declared its intention of establishing a hub for vaccine manufacturing in the country to help curb the barriers for effective access to the demand for vaccines in Africa.

“Ghana will start producing its own COVID-19 vaccines in January 2024,” declared President Akufo-Addo in his State of the Nation Address in Parliament, in March 2022. “A bill will shortly be brought to you, in this House, for your support and approval for the establishment of the National Vaccine Institute,” he stated

This announcement was followed by the constitution of a 13-member Presidential Vaccine Manufacturing Committee (VMC) whose make up, cutting across all sectors, was charged with developing a road map towards the country becoming a vaccine hub.

By all measurements is a major venture for Ghana and for the African Continent.

Africa, a continent of 54 countries and 1.2 billion people, produces only 1% of the vaccines it administers. The remaining 99% are imported.  An  article in the October 2022 issue of Agenda, the online publication of the World Economic Forum, calls this  feeble production rate of “about 1% of the global supply- a market failure which hsa cost lives and needs urgent attention.”  The article goes on to state  that if Africa’s limited vaccine industry were to be significantly expanded, this kind of market failure could be avoided.

Dr. Anthony Nsiah-Asare notes that the creation of the vaccine manufacturing facility in Ghana is expected to have widespread impact.  Dr. Nsiah-Asare, who also is a member of the VMC,  says not only would the establishment of a vaccine manufacturing plant in Ghana improve global pandemic preparedness, which ultimately benefits everyone, but in periods between pandemics it would also help to create greater vaccine supply resilience for African nations for a wide range of vaccine-preventable diseases.

Ghana is also being innovative in the way it is going about funding this project, he added,  noting that the government  is establishing bilateral and multilateral partnerships in various areas including funding, clinical trials, technology transfer, licensing, and intellectual property.

He opines that Ghana’s approach is not that of a state-owned vaccine manufacturing hub but a private enterprise with a strong backing from the government, based on the reality that it is by no means an easy feat to create a sustainable, multi-billion-dollar industry and to do so practically from scratch.

The complexity and cost involved in vaccine development and production can run into billions of dollars considering the large, fixed overhead costs, the need for highly trained skilled labour, intense quality assurance and control, and the challenges of reliably producing vaccine of sufficient and consistent quality.

It’s estimated that Ghana needs about $200 million to fully develop and manufacture Covid-19 vaccine and other vaccines for various infectious diseases locally, said Professor William Kwabena Ampofo, VMC Secretary.

This amount would be used for the establishment of a National Vaccine Institute, Vaccine Secretariat, procurement of vaccine plants, technology transfer, installation of equipment, licensing of intellectual property rights, research, and clinical trials, among others, he said.

In anticipation of the vaccine manufacturing facility construction, plans are already underway to strengthen and, where necessary, create the infrastructure system to support this new facility, he continued.

For example, he noted, the country is strengthening its regulatory agency, the Food and Drugs Authority (FDA) to be ready to meet World Health Organization (WHO) regulation standards when the vaccine production facility is finally set-up and running.

“In order for the vaccines that would be produced to be internationally certified and accepted, the FDA is being strengthened to attain a Level 4 WHO  Lab status to be able to effectively regulate vaccine and pharmaceuticals, noted  Delese Darko, FDA, Chief Executive Officer. “The FDA will be responsible for the review of licensing applications, the lot release, and the monitoring of the performance of the vaccines when manufactured,” she said.

FDA chief  Darko adds that the Authority has launched a project for its institutional and technical strengthening which is being supported by European Union (EU) and German International Corporation (GIZ).

The project she continued, will, among other things, help upgrade the FDA from the current WHO maturity level 3 (ML3) to a level 4 regulatory agency for vaccines, establish a pharmaceutical microbiology lab to provide a bio-safety level 3 lab for testing of vaccines, strengthening the Authority’s inspection and licensing functions including licensing authorisation by training more FDA officers and reviewers.

“This would augment our efforts and set the tone for the effective regulation for the manufacturing of vaccines in Ghana by 2024,” she said.

Despite the complexities involved, Ghana has been attracting support for her efforts to develop and complete this project.

The European Union (EU) and the German Development Cooperation (GIZ) under the brand, ‘Team Europe’, a joint COVID-19 response, has become a close ally to Ghana’s vaccine manufacturing endeavour and together have pledged support to this venture.

Since the announcement of the plans for the vaccine manufacturing facility the two organizations have initiated a collaboration to support the implementation of Ghana’s first strategic effort to begin   domestic vaccine production.

German Ambassador to Ghana,  Daniel Krull, commends the government for opting for the private sector approach. “We believe that this is the way forward and this would lead to swift results and is more sustainable,” he said. .

Ambassador Krull said the partnership is part of the 700m Euros Ghana-Germany development aid to facilitate the upgrade and strengthening of Ghana’s FDA  and contribute to the production of various vaccines, including Ghana’s first batch of COVID-19 vaccines.

“Actors in the sector need competent regulatory bodies that are internationally recognised. So, the certification element is key to the future endeavour of the private sector,” he said, adding that “.Germany has committee 5 million Euros for the development of the vaccine production in Ghana for the next three years.”

Once established, Ghana’s new facility will be outstanding in a larger African context. Currently, there are fewer than ten African vaccine manufacturing facilities and these are based in five countries: Egypt, Morocco, Senegal, South Africa and Tunisia. There is limited upstream production with most local companies only engaging in packaging and labelling, and occasionally fills and finish steps.

Ghana, Rwanda and Senegal have partnered with the German biotechnology company, BioNTech SE, to fill, finish, and package BioNTech mRNA vaccines. BioNTech’s approach to this project is to establish scalable vaccine production by delivering turnkey mRNA manufacturing facilities based on a container solution.

The creation of Ghana’s vaccine manufacturing facility is viewed as the first step in the chain of domestic vaccines production which is expected to improve vaccine supply in Africa.

The COVID-19pandemic has had severe effects on health and economic development in Ghana, said Dorothee Dinkelaker, head of the Development Cooperation at the German Embassy in Ghana. “Equal access to vaccines is crucial and Germany is committed to support Ghana in her endeavour to establish domestic vaccine production,” she said. ”

Ghana health officials note that this project remains on track for completion by the target date.

“The National Vaccine Institute is about 95% complete and will be operational by first quarter of 2023 to facilitate and coordinate all activities of vaccine production and manufacturing in Ghana,” said  Dr. Nsiah-Asare. The necessary legislation is also forthcoming, he added, noting that an  act of Parliament to support and put the National Vaccine Institute in place would also be passed soon.

“We will have a National Vaccine Institute Secretariat and we will start putting in the necessary personnel. We have started training and we are working together with the private sector for a robust Institute,” he said.

Ghana’s venture into domestic production of vaccines is also triggering other, very positive responses, he continued.

For example, he noted, Gavi, the Vaccine Alliance leading the effort to  ensure equal access to COVID19 vaccines and helping African countries get them, is now looking to reshape its markets to assure that 30% of its vaccines will be produced in Africa.

By Jamila Akweley Okertchiri