Let science, not politics, rule on vaccine approval

There are more unknowns than knowns as the first COVID-19 vaccine trials get underway. Science—not the hype propagated by manufacturers to boost their stock price—will determine the impact of any vaccine that wins Food and Drug Administration approval.

Unless a COVID-19 vaccine is far more effective than previously approved respiratory disease vaccines, it will become just another tool in the public health toolbox for ending the pandemic. How much immunity it provides and how long it lasts may not be known for a year.

That means the most likely scenario for next winter and spring, even with an approved vaccine, is that social distancing and limits on public activities—particularly for at-risk groups like seniors and people with chronic conditions—will remain a part of daily life.

The nation’s experience with the annual influenza vaccine offers a cautionary tale on what to expect. Only 45% of adults got a flu shot during the 2018-19 season.

The shots are modestly effective—about 50%. In a preliminary survey of the effectiveness of the 2019-20 influenza vaccine, the Centers for Disease Control and Prevention tested over 4,000 people who presented at hospitals and physicians offices with flu-like symptoms.

Among the quarter of patients who tested positive for the flu, 37% had been vaccinated. Among those who didn’t test positive, 55% had been vaccinated. It reduced the incidence of the disease. It didn’t eliminate it.

The FDA is using that very low bar for any new COVID-19 vaccine. If it’s just 50% effective, the new vaccine will not provide herd immunity, even if everyone gets their shots. In an interview in late June, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, expressed hopes a COVID-19 vaccine would be 70% to 75% effective.

But even that high number won’t stop the disease’s spread if only about half the population gets vaccinated. A vaccine that effective would still require well over 80% uptake before it could be considered the primary weapon for ending the pandemic.

Here’s the good news. President Donald Trump has endorsed a vaccine and is promoting development through Operation Warp Speed. That’s very different from his months of equivocation on social distancing and wearing masks.

Let’s hope it lasts. His political base is disproportionately represented in the anti-vaxxer crowd. A Gallup poll taken in January (before the pandemic) showed 13% of Republicans believe vaccines are more dangerous than the diseases they fight. That compares to just 7% of Democrats. 

Those numbers are probably lower today given the enormous economic dislocation caused by the pandemic. But sentiment could reverse if Trump loses. Many of his supporters will undoubtedly glom on to anything they can to express opposition to a new administration. A new vaccine will be a likely target for conspiracy theorists.

There’s an even greater threat before the election. The president, who’s badly trailing former Vice President Joe Biden in the polls, will be sorely tempted to order his political appointees at the FDA to override the agency’s system for scientifically determining safety and efficacy. They could authorize emergency use based on preliminary data without even holding an advisory committee meeting.

That’s not what the public wants. Nearly two-thirds of registered voters in a new Morning Consult poll said they want the FDA to fully test a COVID-19 vaccine even if that means delaying its availability. Just 22% said the U.S. should make the vaccine available without completed clinical trials.

If the FDA bows to political pressure, the threat to a successful vaccination campaign won’t come from the right. Millions of Americans will postpone getting the shots until they are assured the vaccine is actually safe and effective.

Source: modernhealthcare.com

Tags: covid-19, pandemic

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