GreenLight receives Rwanda FDA approval for Covid-19 mRNA vaccine trial

GreenLight Biosciences has received the Rwanda Food and Drugs Authority (Rwanda FDA) approval for a Phase I/II clinical trial of its Covid-19 mRNA vaccine candidate, GLB-COV2-043, as a booster to individuals who have been vaccinated earlier.

The company noted that preparations are currently ongoing for the trial of the vaccine candidate, which is part of its broader Covid-19 strategy.

This includes the development of a universal vaccine for Covid-19 with broader and prolonged protection.

Pending positive immunogenicity and safety data from the trial, GreenLight will look to continue development on potential next-generation vaccine candidates for the disease in Africa.

The Phase I/II clinical trial will evaluate the safety and immunogenicity as measured by humoral and cellular immune-response endpoints.

Eligible adults who have received a two-dose mRNA BNT162b2/Comirnaty vaccine priming course, or a priming and a third injection of the same vaccine and dose will be enrolled in the trial.

Subjects in the trial will be evaluated in four cohorts and receive the GreenLight vaccine candidate in 15μg, 30μg, 60μg, and 90μg doses, respectively.

Each cohort will have ten participants.

GreenLight Biosciences CEO Andrey Zarur said: “This clinical trial marks the necessary first step toward developing an integrated, universal strategy against Covid-19.

“Our previously announced collaboration with the US National Institutes of Health to develop a universal Covid-19 vaccine, and our previously reported scalable mRNA manufacturing process, will enable us to address this disease in a more effective manner.”

The trial will be conducted by Platform Life Sciences, along with GreenLight and clinical investigators, in Rwanda.

In 2021, Greenlight collaborated with the International AIDS Vaccine Initiative (IAVI) for a Covid-19 vaccine trial in Africa.

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