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Tags: Coronavirus | vaccine | fda | approval

The Real Vaccine Skeptics Work at the FDA

hand turning knob to select phases of vaccine clinical trial

(Dreamstime)

Sally Pipes By Thursday, 12 August 2021 12:25 PM Current | Bio | Archive

Nearly 200 million Americans have received at least one dose of a COVID-19 vaccine since last December.

More than three months ago, Pfizer submitted a formal application for approval of its shot from the Food and Drug Administration. More than two months ago, Moderna did the same for its jab.

Yet there's no telling when that approval will come. The latest rumor from the FDA is next month.

We now have more than eight months of real-world data from hundreds of millions of people worldwide that these vaccines work. But the FDA and its defenders continue to say that we need to wait for the approval process to play out.

So it's worth asking — are the real vaccine skeptics working at the FDA? Their slavish adherence to bureaucratic processes bears at least some responsibility for the resurgence of COVID-19 nationwide — and the deaths it has caused.

Some public officials aren't bothering to wait for the FDA to act. The Biden administration recently mandated that all federal workers and contractors get jabbed or submit to frequent COVID-19 testing. All active-duty members of the military will soon have to get vaccinated, too.

Last week, New York Mayor Bill de Blasio issued a citywide vaccine mandate for a range of indoor activities, including eating in a restaurant and exercising at a gym.

Why has the FDA shown so little urgency in actually approving COVID-19 shots? It was only on July 30 that the agency even suggested it would expedite its review of the Pfizer-BioNTech jab.

Pfizer's vaccine completed a Phase 1 clinical trial last summer. The same is true of Moderna's vaccine. So we've known for a year that both shots are safe. And the evidence that they are powerfully effective gets more convincing by the day as more and more data roll in.

That the FDA continues to withhold full approval in the middle of an unprecedented global health emergency — and despite the minimal risks involved — is incomprehensible. And it's undermining the very important effort to inoculate the nation against COVID-19.

The agency's foot-dragging is directly at odds with the pro-vaccine message coming from the White House. After all, a skeptic might ask, how could it be so important that everyone get vaccinated if even the FDA is hesitant about these injections?

What's more, without full approval, pharmaceutical firms can't advertise their shots directly to consumers. This means that the vaccination campaign is being deprived of the marketing acumen — and healthy advertising budgets — of the pharmaceutical industry.

Yet the FDA's obstructionism rarely earns criticism from the media or those in power. It's far easier — and more convenient — for Democratic partisans to blame right-wing forces or Facebook for promoting vaccine skepticism than to condemn the federal bureaucracy.

To the extent that Democrats and the media establishment do criticize the FDA, it's often to condemn the agency's procedures as lax.

Take the controversy surrounding the dementia drug Aducanumab, which recently received accelerated approval, a pathway for drugs that provide meaningful therapeutic advantages over existing treatments for serious or life-threatening illnesses.

The drug is the first new treatment for Alzheimer's in years. But there are questions surrounding its effectiveness. This has led some to conclude that the FDA moved too quickly in approving the medicine.

That sentiment is backwards. If the last year of COVID-19 has revealed anything, it's that, when a new medicine has been proven safe, the human costs of withholding that treatment can vastly outweigh those of releasing it to the public prematurely.

The FDA has consistently run afoul of this principle since the beginning of the pandemic. Its excessive caution has undeniably cost Americans their lives as a result.

Despite the Biden administration's pleas for people to get vaccinated, vaccine skepticism will remain the official stance of the federal government until the FDA fully approves the COVID-19 shots.

Sally C. Pipes is president, CEO, and the Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is "False Premise, False Promise: The Disastrous Reality of Medicare for All," (Encounter 2020). Follow her on Twitter @sallypipes. Read Sally Pipes' Reports — More Here

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SallyPipes
We now have more than eight months of real-world data from hundreds of millions of people worldwide that the vaccines work. But the FDA and its defenders continue to say that we need to wait for the approval process to play out.
vaccine, fda, approval
690
2021-25-12
Thursday, 12 August 2021 12:25 PM
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