Family Healthcast: What does the FDA’s emergency approval mean for a vaccine?

Family Healthcast

(WSYR-TV) — Three companies have now entered the third and final phase of testing to see if their vaccines can safely protect people against COVID-19.

But, like everything else right now, politics is playing a role.

Our question is: “What is the FDA’s emergency authority to clear a coronavirus vaccine before it is formally approved?”

It’s a great question and a fierce debate is underway about whether this should happen.

Opponents warn that the FDA could be pressured to cut corners to make a vaccine available before it can be proven safe and effective.

That could undermine the public’s trust in getting a vaccine. But, others say speeding up the process could save thousands of lives.

Here’s a look at what the FDA emergency approval means:

During a public health emergency, the FDA can green light unapproved medical products for life-threatening diseases when there are no approved alternatives.

Since the coronavirus pandemic began, the agency has authorized hundreds of tests, equipment and a few treatments — convalescent plasma being the most recent.

Using that authority, regulators may clear a product once they determine that it “may be effective” and that its “known and potential benefits” outweigh the risks.

That is not nearly as tough as the standards for full approval, which require a product be shown to be safe and effective.

It’s possible that the FDA could use its emergency powers to clear a vaccine for a select population, such as healthcare workers.

The CDC has told state and local health officials to be ready to distribute a vaccine to healthcare workers and other high-risk groups as early as Nov. 1.

Because vaccines, unlike treatments, are given to health people, the nation’s infectious disease doctors say they should be held to a higher standard and go through the full process.

That full approval, though, can take several months.

In a letter dated last week, they demanded that vaccine safety and effectiveness data be “reviewed by internal, as well as independent, experts.”


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