Cuba advances to phase three trial stage for vaccineMonday, March 29, 2021
The Pan American Health Organization (PAHO) says work to develop a COVID-19 vaccine in Cuba has advanced to the phase three clinical trial stage.
Speaking during a recent COVID-19 digital briefing, PAHO's Assistant Director Dr Jarbas Barbosa said Cuban vaccine manufacturers commenced phase three trial activities two weeks ago.
This included pilot vaccinations involving volunteers, and usually precedes World Health Organization (WHO) prequalification for widescale distribution or emergency use.
Dr Barbosa said the entity is facilitating communication between the manufacturers and the WHO on developments relating to the prequalification arrangements.
He advised that the manufacturers are aware of the criteria they must fulfil to secure WHO prequalification.
“When they finish phase three clinical trial engagements, based on the results they will have about the vaccine's security and efficacy, they can apply to receive prequalification or emergency use listing,” Dr Barbosa further informed.
He said that, thereafter, the vaccine will be considered for procurement by PAHO's Revolving Fund on behalf of the WHO's COVID-19 Vaccine Global Access (COVAX) Facility.
Dr Barbosa said the phase three trial timeline for the vaccine will be guided by the rate of COVID-19 transmission and extent of testing.