Texarkana Gazette

Virus vaccine worries spur additional scrutiny

- By Lauran Neergaard

Facing public skepticism about rushed COVID-19 vaccines, U.S. health officials are planning extra scrutiny of the first people vaccinated when shots become available — an added safety layer experts call vital.

A new poll suggests those vaccine fears are growing. With this week’s pause of a second major vaccine study because of an unexplaine­d illness — and repeated tweets from President Donald Trump that raise the specter of politics overriding science — a quarter of Americans say they won’t get vaccinated. That’s a slight increase from 1 in 5 in May.

The poll from The Associated Press-NORC Center for Public Affairs Research found only 46% of Americans want a COVID-19 vaccine and another 29% are unsure.

More striking, while Black Americans have been especially hard-hit by COVID-19, just 22% say they plan to get vaccinated compared with 48% of white Americans, the AP-NORC poll found.

“I am very concerned about hesitancy regarding COVID vaccine,” said Dr. William Schaffner, a vaccine specialist at Vanderbilt University who says even the primary care doctors who’ll need to recommend vaccinatio­ns have questions.

“If the politician­s would stand back and let the scientific process work, I think we’d all be better off,” he added.

The stakes are high: Shunning a COVID-19 shot could derail efforts to end the pandemic — while any surprise safety problems after one hits the market could reverberat­e into distrust of other routine vaccines.

On top of rigorous final testing in tens of thousands of people, any COVID-19 vaccines cleared for widespread use will get additional safety evaluation as they’re rolled out.

Any vaccine before Election Day is extremely unlikely. Over Trump’s objections, the Food and Drug Administra­tion issued clear safety and effectiven­ess standards that shots must meet — and Commission­er Stephen Hahn insists career scientists, not politician­s, will decide each possible vaccine’s fate only after all the evidence is debated at a public meeting.

Dr. Anthony Fauci, the top U.S. infectious diseases expert, says that should be reassuring because it means scientists like himself will see all the evidence.

“So the chances of there being secret hanky-panky are almost zero, because everything is going to be transparen­t,” he told The AP.

Here are some things to watch as vaccines get closer to the finish line.

Furthest along in finalstage testing in the U.S. are a vaccine candidate made by Pfizer Inc. and Germany’s BioNTech, and another developed by Moderna Inc. and the National Institutes of Health.

Fauci says “the best bet” is that data about whether one or both work will emerge sometime in November or December.

How soon depends on an independen­t Data Safety and Monitoring Board — the only group that can peek at the data before the study’s finished. At pre-set time points, the board can analyze the number of infections occurring so far among participan­ts and decide if the study should be stopped early because of strong evidence the vaccine works, or if it’s failing, or that it’s too soon to know.

The DSMB also watches for side effects. Many vaccines cause temporary side effects like fever, chills and other flu-like symptoms.And states including New York, Rhode Island and Virginia are forming advisory committees to review the safety of any COVID-19 vaccines that pass FDA.

 ?? Associated Press ?? This May 4 photo provided by the University of Maryland School of Medicine shows the first patient enrolled in Pfizer’s COVID-19 coronaviru­s vaccine clinical trial at the University of Maryland School of Medicine in Baltimore as he receives an injection.
Associated Press This May 4 photo provided by the University of Maryland School of Medicine shows the first patient enrolled in Pfizer’s COVID-19 coronaviru­s vaccine clinical trial at the University of Maryland School of Medicine in Baltimore as he receives an injection.

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