FDA reviewing two more vaccines


The Food and Drugs Authority (FDA) has confirmed it is currently reviewing two more vaccines submitted by global pharmaceutical companies for emergency authorisation and use in Ghana to combat the COVID-19 pandemic.

Delese Mimi Darko, Chief Executive Officer of the regulator, told journalists at a virtual press soiree that the authority will soon come out with its decision on the yet-to-be-named two vaccines and assured that it will be in the best interest of the country.

“Apart from these two, we have received two other vaccine applications and we are reviewing them. We as the FDA cannot force people and vaccine-makers to come to us, we can only encourage them,” she said.

Already, the FDA has given emergency approval and authorisation for the use of two COVID-19 vaccines procured by government in its fight against the pandemic. Covidshied and Sputnik V from Russia, according to the FDA are “efficacious, safe and of good quality” for use.

Ms. Darko added that FDA is also talking to Pfizer and Moderna on receiving their data and samples for review, while Johnson and Johnson (J&J) is working through the African Vaccine Regulatory Forum (AVAREF) – a platform that brings together National Regulatory Authorities (NRAs) and national Ethics Committees (ECs) on the African continent with the objective of strengthening clinical trial regulation in Africa to secure continent-wide regulation.

As chair of the AVAREF committee, Ms. Darko noted that should J&J get clearance via AVAREF, then the entire continent can procure that vaccine for use. Even as the FDA is working on authorisation, she added, the decision as to which vaccine to procure for the citizenry is at the behest of the Ghana Health Service.

Local content

Despite the multiplicity of FDA-approved immune booster products, Ms. Darko noted that there is no local manufacturer of vaccines and no local COVID-19 drug-maker in Ghana.

Vaccines in Ghana

On Wednesday, February 24, Ghana became the first country outside India to receive COVID-19 vaccine doses shipped via the COVAX Facility – a historic step toward the goal of ensuring equitable distribution of COVID-19 vaccines globally in what was the largest vaccine procurement and supply operation in history. The delivery is part of a first wave of arrivals that will continue in the coming days and weeks.

COVAX is co-led by Gavi, the Vaccine Alliance, the World Health Organisation (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI), working in partnership with UNICEF as well as the World Bank, civil society organisations, manufacturers and others.

FDA’s capabilities

Ms. Darko stated that as a Maturity Level 3 World Health Organisation (WHO) ranked food and drugs regulator, the FDA is more than capable when it comes to approvals and authorisations. She noted that even before the WHO backed the Oxford/Astrazeneca vaccine, the FDA had through its stringent process approved – and was therefore not surprised with the WHO’s decision.

The WHO ranked the Food and Drugs Authority (FDA) as a Maturity Level 3 regulator last year for its medicines regulatory system that ensures the safety, quality and efficacy of all medical products imported, manufactured or distributed in the country.

The Maturity Level 3 is second highest in the four-tiered WHO classification of national medicines regulatory systems. This makes Ghana the second country after Tanzania in the African Region and among fifty-one globally to attain this status

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