SWING AND A MISS —
CDC loosened mask guidance to encourage vaccination—it failed spectacularly
FDA approval and paid time off would make people more likely to get a shot, poll finds.
BETH MOLE - 5/28/2021,
Enlarge / A thrown-away surgical mask lays on the ground.
The Centers for Disease Control and Prevention stunned health officials and experts on May 13 with the abrupt announcement that people fully vaccinated against COVID-19 could forgo masking in most settings—indoor, outdoor, uncrowded, and crowded alike. The guidance was a stark reversal from the health agency’s previous stance, issued just two weeks earlier, that still recommended vaccinated people wear masks among crowds and in many indoor, uncrowded settings.
The CDC said at the time that it was merely following the science for masking. The agency and its director, Rochelle Walensky, highlighted fresh, real-world studies demonstrating COVID-19 vaccines’ high efficacy and ability to lower transmission risks. But the update was also part of an overt effort to encourage vaccination among the vaccine hesitant by emphasizing the perks of being vaccinated—like not needing to wear masks anymore and reclaiming other bits of normal life.
That messaging shift came as states across the country started to see their pace of vaccination slow despite a glut of vaccine doses. Numerous polls have indicated that most of the people eager to get vaccinated already have. Now, with just 62 percent of the US adult population vaccinated, much of the remaining unvaccinated portion is either hesitant or resistant to being vaccinated. It’s that group of people the CDC was trying to reach with the new mask guidance.
“The science is also very clear about unvaccinated people,” Walensky said during the May 13 press briefing, in which she announced the mask guidance update. “[Unvaccinated people] remain at risk of mild or severe illness, of death, or spreading the disease to others. You should still mask, and you should get vaccinated right away… Your health and how soon you return to normal life before the pandemic are in your very capable hands.”Advertisement
Mask blunder
The mask update immediately generated confusion and controversy given the reversal and its abruptness. And according to fresh polling data, the guidance failed spectacularly at convincing unvaccinated people to get vaccinated.
FURTHER READING
CDC defends its abrupt reversal on masks after backlash from expertsIn new results
FDA approval and PTO
A total of 32 percent of unvaccinated people said a full FDA approval (a Biologics License Application [BLA] approval) would make them more likely to get a COVID-19 vaccine. Currently, all three vaccines available in the US have been granted an EUA. The FDA grants EUAs only during public health emergencies, like the COVID-19 pandemic, through a process that is fast-tracked compared with a full BLA approval.
Importantly, both tracks require efficacy and safety data from massive Phase III clinical trials. The main difference between an EUA and full approval is the amount of time that people in the clinical trials are followed after full vaccination. Typically, the FDA likes to have at least six months of follow-up data from a vaccine trail. This allows the trial runners and the FDA to look at how well vaccine protection holds up over that time and if any rare side effects crop up. For an EUA, the follow-up period may only be around two months.
However, the difference is largely moot at this point. With nearly 167 million people in the US alone already given at least one shot, regulators have a wealth of post-market safety data. Also, Pfizer and BioNTech announced in April that they had six-months of trial follow-up data that confirmed the vaccine’s high efficacy and found no safety concerns. Earlier this month, Pfizer and BioNTech, as well as Moderna, announced that they have started a rolling data-submission process for a BLA.
Still, a full approval would seem to go a long way for swaying vaccine holdouts. Forty-four percent of the unvaccinated people in the “wait and see” group said a full FDA approval would make them more likely to get a vaccine, and 29 percent of the “only if required” group said the same.
That’s a far larger effect than those seen with some of the other vaccination boosters mentioned in the poll, such as free Uber rides to vaccine sites or $100 cash for getting a shot. The only thing that came close was paid time off for getting vaccinated and recovering. Twenty-one percent of employed unvaccinated poll respondents said the paid time off would make them more likely to get a vaccine.
from the Kaiser Family Foundation’s ongoing COVID-19 vaccine monitoring poll, 85 percent of unvaccinated people said the CDC’s loosened mask guidance for fully vaccinated people made “no difference” to their vaccination plans. Only 10 percent said the change made them “more likely” to get vaccinated and a final 4 percent or so said the change made them “less likely” to get a shot.
It gets worse. The poll broke unvaccinated people into three groups: people who said they would “definitely not” get vaccinated, people who would get vaccinated “only if required,” or people who would “wait and see.” Those most resistant to getting vaccinated were the least likely to be swayed by the CDC’s latest guidance. Among the “definitely not” group, 98 percent said the change made no difference to them and the remaining 2 percent said they were less likely to get vaccinated—zero percent said they were more likely to get a vaccine. For the “only if required” group, 89 percent said the CDC change made no difference.
Overall in the poll—which collects data on a nationally representative sampling of adults—62 percent said they had already gotten their vaccine (which tracks with CDC vaccination data), 12 percent said they would wait and see about vaccination, 7 percent said they would only get vaccinated if they were required, and 13 percent said they would “definitely not” get vaccinated. That “definitely not” portion has largely remained the same throughout the polling, which stretches back to December.
While the CDC’s loosened masking guidance was clearly not persuasive to the unvaccinated, the poll explored other tactics that could boost vaccination. The two ideas that seemed to have the most sway were: 1) if the Food and Drug Administration grants a vaccine full approval, rather than the current Emergency Use Authorizations (EUA); and 2) if employers provided paid time off to get vaccinated and recover from any side effects, like feeling under the weather the day after a dose.
It gets worse. The poll broke unvaccinated people into three groups: people who said they would “definitely not” get vaccinated, people who would get vaccinated “only if required,” or people who would “wait and see.” Those most resistant to getting vaccinated were the least likely to be swayed by the CDC’s latest guidance. Among the “definitely not” group, 98 percent said the change made no difference to them and the remaining 2 percent said they were less likely to get vaccinated—zero percent said they were more likely to get a vaccine. For the “only if required” group, 89 percent said the CDC change made no difference.
Overall in the poll—which collects data on a nationally representative sampling of adults—62 percent said they had already gotten their vaccine (which tracks with CDC vaccination data), 12 percent said they would wait and see about vaccination, 7 percent said they would only get vaccinated if they were required, and 13 percent said they would “definitely not” get vaccinated. That “definitely not” portion has largely remained the same throughout the polling, which stretches back to December.
While the CDC’s loosened masking guidance was clearly not persuasive to the unvaccinated, the poll explored other tactics that could boost vaccination. The two ideas that seemed to have the most sway were: 1) if the Food and Drug Administration grants a vaccine full approval, rather than the current Emergency Use Authorizations (EUA); and 2) if employers provided paid time off to get vaccinated and recover from any side effects, like feeling under the weather the day after a dose.
FDA approval and PTO
A total of 32 percent of unvaccinated people said a full FDA approval (a Biologics License Application [BLA] approval) would make them more likely to get a COVID-19 vaccine. Currently, all three vaccines available in the US have been granted an EUA. The FDA grants EUAs only during public health emergencies, like the COVID-19 pandemic, through a process that is fast-tracked compared with a full BLA approval.
Importantly, both tracks require efficacy and safety data from massive Phase III clinical trials. The main difference between an EUA and full approval is the amount of time that people in the clinical trials are followed after full vaccination. Typically, the FDA likes to have at least six months of follow-up data from a vaccine trail. This allows the trial runners and the FDA to look at how well vaccine protection holds up over that time and if any rare side effects crop up. For an EUA, the follow-up period may only be around two months.
However, the difference is largely moot at this point. With nearly 167 million people in the US alone already given at least one shot, regulators have a wealth of post-market safety data. Also, Pfizer and BioNTech announced in April that they had six-months of trial follow-up data that confirmed the vaccine’s high efficacy and found no safety concerns. Earlier this month, Pfizer and BioNTech, as well as Moderna, announced that they have started a rolling data-submission process for a BLA.
Still, a full approval would seem to go a long way for swaying vaccine holdouts. Forty-four percent of the unvaccinated people in the “wait and see” group said a full FDA approval would make them more likely to get a vaccine, and 29 percent of the “only if required” group said the same.
That’s a far larger effect than those seen with some of the other vaccination boosters mentioned in the poll, such as free Uber rides to vaccine sites or $100 cash for getting a shot. The only thing that came close was paid time off for getting vaccinated and recovering. Twenty-one percent of employed unvaccinated poll respondents said the paid time off would make them more likely to get a vaccine.
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