The United States’ Food and Drug Administration’s (FDA) elevation of the Pfizer-BioNTech COVID-19 vaccine from emergency use authorization to full approval appears to be of very little consequence in the eyes of Barbados’ medical practitioners.
President of the Barbados Association of Medical Practitioners (BAMP), Dr Lynda Williams believes the emergency authorisation granted for various vaccine brands currently in circulation on the island, was all that was required.
In a statement on Monday, the FDA described the developments as a “key achievement” for public health, declaring that the public could now be “very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product”.
The process of final approval, much of which was completed for emergency authorisation, requires an analysis of the drug’s benefits that also examines its risks and looks at clinical trials from the drugmaker.
For full approval, the FDA examined data on how people fared six months after being fully vaccinated and inspected manufacturing facilities in the intervening months.
The inability of most vaccine producers to satisfy the requirements for full vaccination, which generally requires years of research, has been cited as one of the main arguments used to fuel vaccine skepticism.
But according to Dr Williams, there is no need for officials here to rely on pronouncements from the FDA regarding the Oxford AstraZeneca and Sinopharm vaccines.
“All of them have different regulatory bodies and the FDA is just one. Even before the FDA had started to use Pfizer under an emergency authorisation, the UK had already approved it,” Dr Williams, an epidemiologist, told Barbados TODAY.
“It is a regulatory body and we use drugs in Barbados that are not FDA [approved], but they are approved. There are many drugs out of Europe that the FDA will not approve, but we must remember there is a bit of politics in this thing,” the doctor contended.
She added that while some anti-vaxxers may be looking for the proverbial hook to hang their hats on, there is established precedent which supports the use of fast-tracked vaccines in emergency situations like pandemics.
“When polio immunization was rolled out, there was no emergency use authorization, there was not even phase one, two or three clinical trials, and they gave it to 1.8 million children and in four years had eradicated polio.
“That was 1960-something. So tell me then, in the middle of a pandemic you can’t do all of the testing that you need for years and years,” Dr Williams added. (KS)