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Health


THE CURSE OF THE INCIDENTAL ILLNESS: SEEN AS SIDE EFFECTS TO COVID VACCINATIONS,
AILMENTS MAY HAVE LITTLE TO DO WITH THEM

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By Helen Branswell Dec. 28, 2020

Reprints
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A health care worker holds a Pfizer/BioNtech Covid-19 vaccine. CHANDAN
KHANNA/AFP via Getty Images
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As Covid-19 vaccines go into broad use, some rare side effects of vaccination
will almost certainly emerge, like the reports of small numbers of people
developing anaphylaxis. But so will medical events whose timing just comes down
to random chance — and the potential ripple effects of those reports already
have experts concerned.

Every single day, people die unexpectedly. They have strokes and heart attacks
and seizures. On an average day, 110 people in this country may develop Bell’s
palsy, a temporary facial paralysis, and another 274 will develop Guillain-Barré
syndrome, a form of paralysis that usually resolves over time. The trigger for
these medical events often isn’t known. But when they happen shortly after
someone gets a vaccine — especially a new one — well, conclusions will be drawn.

“It is logical for people to say: That person had something done to them and
something bad happened in the hours or days after that,” said Art Reingold,
chair of the division of epidemiology and biostatistics at UC Berkeley’s School
of Public Health. “And if it was you or your family member, you would be
inconvincible that that wasn’t true.”

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Except, of course, it often isn’t. Heart attacks occur most commonly in the
morning, yet we don’t blame breakfast for causing them. A heart attack on the
morning after a Covid-19 vaccine, though? That might be another matter.

Related:


A SIDE-BY-SIDE COMPARISON OF THE PFIZER/BIONTECH AND MODERNA VACCINES

But the public doesn’t have a great grasp of the concept that many problems that
occur after vaccination probably aren’t tied to immunization itself. In part,
that’s because that context has been missing from public health messaging about
Covid-19 vaccinations.

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“I think the lay public is fully, fully unprepared for understanding this,” said
Kate O’Brien, director of the WHO’s immunization, vaccines, and biologics
program.

Quickly distinguishing a true side effect signal from an abundance of noise will
be critical to ease the alarm of a public already skittish about vaccines
developed at “warp speed,” experts warned.

The risk of the public misinterpreting such anecdotal reports may be especially
acute early on in the rollout, when elderly adults and people with health
conditions have been prioritized to get the vaccine. Nursing home residents are
in Phase 1a — currently ongoing — and seniors 75 and older are in Phase 1b.
People aged 65 to 74 and those with medical conditions that increase the risk of
severe Covid disease are in Phase 1c. These are people to whom medical events
occur most commonly.

“Things are going to happen to them,” said O’Brien, though she noted that more
medical misfortune would befall people in these groups if they were not
vaccinated.

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Helen Keipp Talbot, who is on the expert panel that devised the vaccine
distribution priority lists for the Centers for Disease Control and Prevention,
actually voted against putting nursing home residents at the front of the line,
in part because vaccinating people who are in frail health first could
inadvertently undermine confidence in the vaccine, given how common heart
attacks, strokes and even deaths are in this population.

“All of the events are going to be temporally associated. But how do you explain
that to the nurse’s aide who’s been taking care of that patient and loves her
like her own grandmother? Who then decides that she’s not going to get
vaccinated and tells everyone else not to get vaccinated?” Talbot told STAT.

“I fear a loss of confidence in the vaccine. That the vaccine will actually
truly be safe, but there will be temporally associated events and people will be
scared to use the vaccine,” said Talbot, an associate professor of infectious
diseases at Vanderbilt University.

In some cases, there’s reason to believe reports of adverse events are likely
due to the vaccine. Anaphylaxis — a potentially life-threatening allergic
reaction — has been linked to multiple types of vaccines in the past.

Related:


WATCH: WHAT TO EXPECT WHEN YOU’RE INJECTED: VACCINE SIDE EFFECTS EXPLAINED

Britain has reported several cases of anaphylaxis among people who have received
the Pfizer vaccine. In the U.S., about 11 cases have been reported since the
vaccine rollout began earlier this month, according to the CDC. Most followed
receipt of the Pfizer vaccine, but a Boston doctor with a shellfish allergy
developed a severe allergic reaction after receiving the Moderna vaccine. If and
when other Covid vaccines are authorized for use, health authorities will be
watching closely to see whether anaphylaxis is linked to all Covid vaccines, or
merely those like the Pfizer and Moderna vaccines which are made using messenger
RNA.

A three-year review of adverse reports logged into a U.S. national vaccine
database found that anaphylaxis after vaccination is rare, occurring at a rate
of about 1.31 per million doses of vaccine administered. Of those cases, 85%
were in people with a history of allergies. None of the 33 cases — out of 25
million vaccinations — died. Some needed epinephrine, the drug in EpiPens, but
others recovered after treatment with antihistamines.

Bell’s palsy, too, has been linked in at least one circumstance to a vaccine, an
intranasally administered flu vaccine that was briefly brought to market in
Switzerland.

Eight people in the Pfizer and Moderna trials, which enrolled nearly 74,000
participants in total, were diagnosed with the condition — seven in the vaccine
arms and one in the placebo arm of the Moderna trial. The jury is still out on
whether Bell’s palsy, which afflicts about 40,000 people a year in the U.S., is
an occasional side effect of taking a Covid-19 vaccine.

As vaccinations begin on a larger scale, reports of other potential side effects
will likely pop up. A few cases of something are anecdotes, not data, and
definitely not proof of a causal relationship. While they must and will be
studied, investigations of this sort take time.

The CDC and the Food and Drug Administration have a number of surveillance
systems set up to monitor for potential side effects, as do some other
countries. But it’s going to be important to look for, and be ready to react to,
vaccine safety rumors anywhere they start to swirl, said Steven Black, a
professor emeritus at the University of Cincinnati Children’s Hospital whose
career has focused on vaccine safety.

“The reason I think you need to think globally is that vaccine scares are
global,” said Black, who is also co-director of the Global Vaccine Data Network,
a 17-country collaboration that studies vaccine safety and effectiveness. “We
know very well that misinformation spreads much more quickly than information,
so that a couple deaths in Brazil or a death in Indonesia or whatever, the
public outcry could cause lack of confidence and undermine the whole vaccine
program.’’

Related:


HEALTH TECH’S NEWEST UNICORN IS RUNNING TOWARD MEDICAID PATIENTS LONG
MARGINALIZED IN MEDICINE

Reingold agreed.

“Once there’s a news report people have read, it doesn’t matter what we prove
categorically two years later in a study, that perception will remain, and it’s
hard to combat,” he said.

That’s why it’s so crucial to set expectations before and during a vaccination
campaign. But public literacy about vaccination — the benefits, the risks, and
how to balance the two — is poor, said O’Brien, who points to how often people
insist they contracted flu from a flu shot, even though that is biologically
impossible.

One of the ways vaccine experts try to combat the rise of rumors and unfounded
claims is by knowing background rates of medical events, so that when things
arise, one can get a sense of whether the number of cases is abnormal, or what
might be expected to occur, whether or not a vaccination program was underway.

“If we know that Guillain Barré occurs in 1 in 100,000 people and a million
people have been vaccinated, you would expect 10 cases, maybe,” Black explained.
“But if you have 30, you begin to wonder: Maybe there’s an issue here? So,
knowing background rates as a frame of reference is something that’s being
promoted.”

Differentiating between what’s relevant from what isn’t is going to be tough,
especially with multiple new vaccines (hopefully) starting to be used within a
short period of time. When suspect medical events occur, it will be important to
know which vaccine the individual in question received — though that may be a
bigger challenge than you would expect. Record keeping for immunizations —
especially adult immunizations — isn’t close to where it ought to be, O’Brien
said.

Should it become clear that one, some, or all of the vaccines pose rare risks of
some side effect, how will the public take the news?

Related:


COVID-19 VACCINES ARE SAFE. BUT LET’S BE CLEAR ABOUT WHAT ‘SAFE’ MEANS

“At some point, if events are occurring one in 100 million [vaccinations],
people may be willing to accept that risk if it allows the world to get rid of
Covid and go back to normal life,” Black said. “Because you have to remember,
hundreds of thousands of people are dying of the disease.”

How that risk is communicated, though, will be critical, because many people
can’t easily understand how to assess the significance of a rare risk. “They’re
wary about very rare events and then they text while they’re crossing the street
where they’re much more likely to get killed. Yeah, people do that very poorly,”
Black said.

Giving people a comparison that makes sense to them can help, said Alison
Buttenheim, an associate professor of nursing and health policy at the
University of Pennsylvania, who works on vaccine acceptance.

The idea that 1 in 500,000 people who are inoculated with a Covid vaccine might
have a serious side effect — this is a hypothetical example — might seem too
risky to some people. Explaining to them that they run the same risk of being
hit by lightning in a given year can put a different spin on that piece of
information.

Likewise, pointing out that 1 in 500 New Jersey residents have already died from
Covid-19 can remind people that the risk of not being vaccinated far exceeds the
rare risks the vaccines may possibly pose, Buttenheim said.

At the end of the day, helping the public understand these issues requires
communication — and that isn’t happening on a national level, said Bruce Gellin,
president of global immunization at the Sabin Vaccine Institute, which promotes
access to vaccinations.

The Department of Health and Human Services, not the CDC, has taken the lead on
Covid vaccine communications efforts. But its output to date has been limited.

“It would have been nice if they could come up with a communications strategy at
the same warp speed as they came up with vaccines,” said Gellin, a former
director of HHS’s National Vaccine Program Office.

“My mantra is there’s a vaccine world and there’s a vaccination world, and
they’re not necessarily connected by an arrow. [Operation] Warp Speed was
largely about the vaccine world and about logistics,” Gellin said. “Warp Speed,
unfortunately, was not about a vaccination program. And now what we’re seeing is
that we’re now facing the vaccination program and are under-prepared.”

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ABOUT THE AUTHOR REPRINTS


HELEN BRANSWELL

Senior Writer, Infectious Disease

Helen covers issues broadly related to infectious diseases, including outbreaks,
preparedness, research, and vaccine development.


@HelenBranswell


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 * Neil says:
   December 31, 2020 at 4:14 am
   
   This article already starts with a bias. Tying heart attacks to breakfast is
   very dumb. So it’s possible to get a heart attack from covid or the vaccine
   but not any other side effect. Sadly we don’t need the experiences of the
   elderly to tell us to run from this one. This virus is no different from the
   flu, it’s the response that’s more lethal.

   

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