FDA Responds To Questions On Authorization Of COVID-19 Vaccines
The Leadership of the Food and Drugs Authority (FDA) has responded to some frequently asked questions from the general public on the Authorization of COVID-19 vaccines in Ghana.
According to the FDA, it is important that the general public is well informed and educated on the vaccine and availing themselves for the doses when it gets to their turn.
In a publication sighted by ThinkNews Online, it said "Vaccines are an important part of stopping the spread of COVID-19 in Ghana. This is because they offer protection to an individual, by reducing their risk of infection or the severity of their symptoms"
It added that the vaccines also provide protection at a population level, referred to as herd immunity.
ThinkNews Online has also gathered that the vaccination programme is a priority in the fight to prevent the spread of COVID-19.
Responding to how the current COVID-19 vaccines developed so quickly, it stated that Medicines including vaccines are highly regulated – and that is no different from the approved COVID-19 vaccines.
"There are a number of enablers that have made this ground-breaking medical advancement possible and faster compared to other medicines; 1. The different phases of the clinical trial were delivered to overlap instead of run sequentially which sped up the clinical process; 2. Considering the preponderance of the pandemic, the clinical trials had a positive response with thousands of people willing to volunteer; 3. Some of the vaccines used proven and well-studied platforms such as the adenovirus vector platform for the development"
Touching on how COVID-19 vaccines are authorized worldwide, it emerged that there are a number of COVID-19 vaccines approved under Emergency Use Authorization by different National Regulatory Authorities (NRA) worldwide.
Explaining what Emergency Use Authorization (EUA) meant, it hinted that it is when a medical product is authorized for use during a pandemic to ensure timely access to much-needed health products.
"The objective is to make medicines, vaccines, and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy, and quality. This authorization is given for the duration of the pandemic. In the EUA manufactures are requested to submit any additional documentation on the product as and when it becomes available"
It has also been gathered that EUA is given only when the NRA is satisfied that the product has met all efficacy, safety and quality specifications.
Answering how efficacious the COVID-19 vaccines are, the FDA revealed that the vaccines available for COVID-19 have an efficacy of between 60-94%, and are efficacious in preventing symptomatic disease.
"The World Health Organization guidance is that COVID-19 vaccines should demonstrate at least 50% efficacy against severe disease. FDA/HPT/SMC/SMD/VGU/21/VRS.1.1 Page 2 of 2 15th February 2021"
On whether the COVID-19 vaccines have been approved for use in Ghana, the FDA explained that it has adding that it has given Emergency Use Authorization to two COVID-19 vaccines: (i) Sputnik V vaccine from Generium Joint Stock Company, Russia; and (ii) Covishield from the Serum Institute of India.
The FDA, a WHO Maturity Level 3 regulatory agency, has reviewed both of these vaccines and concluded that they are efficacious, safe, and of good quality.
Speaking on whether the vaccines authorized in Ghana be as effective as the ones in other countries, the FDA revealed that the COVID-19 vaccine authorized in Ghana will be as effective as any vaccine authorized by other countries.
"This is because various phases of clinical trials data reviewed by the FDA showed that the vaccines are safe and efficacious"
Touching on how long the vaccine will be effective, it said "We expect these vaccines to work for at least a year – if not longer. This will be updated when information becomes available"
Story by: Joshua Kwabena Smith