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FDA full approval for Pfizer jab gets frosty reception from anti-vax group

Not satisfied: anti-vaccine demonstrators march on the Cabinet Building earlier this year in protest at the Government’s Covid-19 restrictions (File photograph)

Campaigners opposed to Covid-19 vaccination yesterday questioned claims by US drug regulators that the Pfizer vaccine was safe and deserved full approval.

The Bermuda Freedom Alliance insisted that the drug had still to undergo trials.

Eugene Dean of the BFA said: “If anything, the approval of the Pfizer-BioNTech Covid-19 Injection calls into question the credibility of the individuals making these decisions and the organisations they serve.”

Mr Dean added that “regardless of the severity of the situation or the advancement of the technology involved”, it was “mind boggling” to suggest that “the completion of a 10 to 15 year process” in less than a year was safe.

He was speaking after US Food and Drug Administration gave the Pfizer vaccine the all-clear earlier this week.

The Pfizer shot had earlier been given emergency use status, not complete approval.

But the FDA said the public could be confident the shot met “the high standards for safety, effectiveness and manufacturing quality the FDA requires for an approved product”.

But Mr Dean insisted: “Processes of this nature have always relied on time to provide the necessary data to draw conclusions.

“Unless we have found the means to predict what will happen in a year, two years, five years or even ten years from now without needing to actually live through the experience, I’m not quite sure what difference this approval actually makes.

“While the rigorous testing of facilities, processes, manufacturing quality and the in-depth analysis of data from short term clinical trials is all necessary, we are still in the early phases of the process and only part of the story has been told.”

Mr Dean added: “The other concern is the stark contrast between the reporting of adverse effects in the Pfizer clinical trials and the real time reporting recorded in the various adverse effects reporting databases around the world.

“From the information provided by the FDA, it appears that the deaths and adverse effects being reported globally were completely overlooked during their approval process.

“I’m sure they are fully aware of the data and just as confident that they are capable of producing a well thought out reason for why the data has been overlooked.”

Mr Dean said: “Though this may satisfy those who wish to instil confidence in the FDA’s approval process, it also increases concerns about how this process is being fast tracked during a time when the safety and effectiveness of the injection has come under more scrutiny than ever before.”

The FDA announcement was also criticised by Sophia Cannonier, who has rejected vaccination and who argued that full approval was premature.

Ms Cannonier and her husband, Michael Watson, are facing charges of public safety breaches after the couple refused to quarantine in a government-approved hotel after an overseas trip.

Ms Cannonier asked: “How can the Pfizer vaccine get FDA approval when it hasn’t gone through the trials yet?

“I keep getting telephone calls from people who are having adverse effects and whose relatives are dying.

“So this isn’t reassuring at all. Nobody is reporting the adverse effects of the vaccine and so this approval is not very convincing – it’s scary actually.”

Ms Cannonier said: “There isn’t one person or organisation that’s collecting data on adverse effects.

“We have EMTs coming to us saying that somebody had to be flown off the island.

“We’re hearing cases of cirrhosis and of people getting skin outbreaks.

“A friend of ours died yesterday and she had been in good health. She had the shot six months ago.”

Ms Cannonier claimed: “There are people who are ready and willing to take the vaccine – just not this one. Not until it has been thoroughly tested and proven to be safe.

“We already have vaccine hesitancy here. When people learn about these adverse effects there’s going to be vaccine anger.”

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Published August 25, 2021 at 7:55 am (Updated August 25, 2021 at 7:55 am)

FDA full approval for Pfizer jab gets frosty reception from anti-vax group

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