Extra safety scrutiny is planned as worries about vaccine grow
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 percent of Americans want a COVID-19 vaccine and another 29 percent are unsure.
More striking, while Black Americans have been especially hard-hit by COVID-19, just 22 percent say they plan to get vaccinated compared with 48 percent 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 doctorswho’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.
Among plans from the Centers for Disease Control and Prevention: Texting early vaccine recipients to check how they’re feeling, daily for the first week and then weekly out to six weeks.
Any vaccine before Election Day is extremely unlikely. Over Trump’s objections, the Food and Drug Administration issued clear safety and effectiveness standards that shotsmust 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 topU.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 said.
Even large final tests won’t catch a side effect that happens in, say, 1 in 100,000 people. So there’s an early warning system that monitors every vaccine sold in the U.S. to spot unsuspected side effects.
“It’s a system that has served us very well,” said Dr. Bruce Gellin of the Sabin Vaccine Institute, who once directed the government’s National Vaccine ProgramOffice. “But for this unprecedented vaccination campaign, we need to expand” that monitoring.
Once the FDA clears a vaccine, health workers and other essential workers are expected to get the first doses — and they’ll have to sign an agreement to do so that includes their cell number and email. The CDC will use those registrations to check howthe vaccinated are feeling.
Any health complaint bad enough that they missed work, couldn’t do a normal activity or had to seek medical care gets a follow-up probe, CDC’s Dr. Tom Shimabukuro said.
Separately, the FDA will be checking giant databases of insurance claims and electronic medical records, to see if people who received vaccine also have an uptick in health care.