FDA approval and paid time off would make people more likely to get a shot, poll finds.
By Beth Mole
May 28 2021
<https://arstechnica.com/science/2021/05/cdc-loosened-mask-guidance-to-encourage-vaccination-it-failed-spectacularly/>

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.''

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.

In new results 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.

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
havestarted a rolling data-submission process for a BLA.  [...]

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