There has been vile propaganda on social media and even in some of the traditional media against the COVID-19 vaccine, but the Food and Drugs Authority (FDA), a World Health Organisation (WHO) Level.
Three regulator, has urged Ghanaians to trust in its regulatory role to ensure that rigorous steps were taken with the health and well-being of the Ghanaian in mind.
Consequently, it has called on Ghanaians to make themselves available for the vaccine.
In a document on frequently asked questions (FAQs) on the authorisation of COVID-19 Vaccines, the FDA explained that vaccines were an important part of stopping the spread of the COVID-19 in the country.
“This is because they offer protection to an individual, by reducing their risk of infection or the severity of their symptoms. Vaccines also provide protection at a population level, referred to as herd immunity, so the vaccination programme is a priority in the fight to prevent the spread of COVID-19,” it added.
Explaining how the current vaccines were developed quickly, the document explained that the medicines, including vaccines, were highly regulated, which was no different from the approved COVID-19 vaccines.
It said there were a number of enablers that made it possible for the vaccine to be developed and cited ground-breaking medical advancement compared to other medicines.
“The different phases of the clinical trial were delivered to overlap instead of run sequentially, which sped up the clinical process. Considering the preponderance of the pandemic, the clinical trials had a positive response, with thousands of people willing to volunteer. Additionally, some of the vaccines used proven and well-studied platforms such as the adenovirus vector platform for the development,” it further added.
Emergency Use Authorisation
The document explained that there were a number COVID-19 vaccines approved under the Emergency Use Authorisation (EUA), by different National Regulatory Authorities (NRA) worldwide.
Explaining the EUA, it said: “This is when a medical product is authorised for use during a pandemic to ensure timely access to much needed health products”.
The EUA, it further explained, had the objective 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 authorisation is given for the duration of the pandemic. In the EUA manufacturers are requested to submit any additional documentation on the product as and when it becomes available,” it added.
The document added that the EUA was given only when the NRA was satisfied that the product met all efficacy, safety and quality specifications.