The Chief Executive Officer (CEO) of the Food and Drugs and Authority (FDA), Delese Mimi Darko has hinted that her outfit like other National Regulatory Authorities globally is using the Emergency Use Authorization (EUA) pathway to ensure timely access to quality and safe medical products including vaccines during pandemics.
According to her, although time is of the essence during pandemics, the EUA pathway subjects all medical product applications to rigorous quality, safety and efficacy assessments prior to approvals.
In a statement signed by the Chief Executive Officer (CEO), it said “To date, the FDA has authorized the importation, distribution, and use of the three Covid-19 vaccines; ie; Sputnik V, Covishield and Johnson & Johnson”
The statement also added that all the vaccines have been authorized for use in several countries around the world.
It further mentioned that the Sputnik V has been authorized in 71, Covishield in 170 and Johnson % Johnson in 74 countries respectively.
“On arrival of consignments, the FDA inspects each batch for compliance with the manufacturer’s instructions on product handling and storage to ensure that the integrity of the cold chain has been maintained during transportation. Furthermore, samples are also taken for analysis, to ensure that critical quality attributes comply with the approved release specifications from the manufacturer. All these processes are completed before vaccines, including vaccines from the COVAX Facility, donation from MTN and the recently imported Sputnik V are formally released to the Ministry of Health” it noted.
The FDA says it takes notice of recent remarks by some commentators which seek to suggest that the vaccines being deployed by the Ghana Health Service are not efficacious.
Below is a copies of the release:
Story by: Joshua Kwabena Smith