Ghana became the first country in the world to approve a new malaria vaccine - R21.

The vaccine, believed to be a ‘world-changing’ one, has been touted for its effectiveness in combating the disease.

Speaking about why Ghana was chosen to lead the way for this vaccine, the Chief Executive Officer of the Food and Drugs Authority (FDA), De. Delese Darko, said that it is because the country is a Maturity Level 3 National Regulatory Authority for medicines and vaccines regulatory oversight.

Additionally, she added, it is because her outfit, the FDA, has extensive competencies in evaluating the quality of clinical and non-clinical parts of a product, a 3news.com report has said.

“We are also a regional centre of regulatory excellence with clinical trial oversights,” she said.

She also detailed all of the reasons Ghana became the choice by manufacturers of the vaccine, the Oxford University.

“On March 28 this year, the FDA granted approval to R21 malaria vaccine manufactured by the Serum Institute of India which was submitted through the local agent, DEK Pharmaceuticals Ghana.

“The approval was granted following extensive series of reviews and peer reviews of the clinical, non-clinical, and quality parts of the vaccine development procedure.

“The vaccine has been approved for use for the immunization of children between five months to thirty-six months.

“It is a colourless to mild turbid solution for injection, and it is supposed to be stored in a refrigerator and has a shelf life of twenty-four months. Our evaluation indicated that the vaccine has the potential to reduce infant mortality caused by malaria in Africa.”

“Ghana was chosen because the FDA is a level three maturity national regulatory authority for medicines and vaccines and regulatory oversights and has extensive competencies in evaluating the quality of clinical and non-clinical parts of a product. We are also a regional centre of regulatory excellence with clinical trial oversights.”

She made this known while speaking at a press conference in Accra on Thursday, April 13, 2023.

This is the second time in recent years that Ghana’s health acumen has received a major boost after it was selected to be the first for a vaccine.

In 2021, the country became the first in the world to receive the Coronavirus vaccines from the COVID-19 Vaccines Advance Market Commitment (COVAX) facility, at the height of the pandemic.



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