From the U.S. Government Accountability Office, www.gao.gov

Transcript for: Vaccine Safety 

Description: The U.S. has put a lot of its hope for combating the
effects of the coronavirus pandemic behind two vaccines developed in
record time—one year instead of the more typical 5-10 years. But how
safe are these vaccines and how is safety determined? We talk with GAO
expert Karen Howard to find out more. 

Related GAO Work: GAO-21-342SP, Science & Tech Spotlight: Vaccine Safety

Released: February 2021 

[Intro music:]

[Karen Howard:] FDA did do a full review of the data from the Pfizer and
Moderna vaccines and determined that the benefits outweighed any
potential risks such as side effects.

[Holly Hobbs:] Hi and welcome to GAO's Watchdog Report, your source for
news and information from the U.S. Government Accountability
Office—celebrating 100 years of fact-based, nonpartisan government
oversight. I’m Holly Hobbs. The U.S. has put a lot of its hope for
combating the effects of the coronavirus pandemic behind two vaccines
developed in record time-one year instead of the more typical 5-10
years. But how safe are these vaccines and how is safety determined?
Today we talk with Karen Howard—a director in our Science, Technology
Assessment, and Analytics team—about our new Science & Technology
Spotlight on Vaccine Safety. Thank you for joining us Karen! 

[Karen Howard:] Happy to be here, Holly!

[Holly Hobbs:] So Karen, let’s start with how does the FDA determine
whether vaccines are safe? What do they weigh when determining safety?

[Karen Howard:] So FDA took the same process that they take with all
vaccinations where they’re comparing the benefits that individuals get
from the vaccine to the side effects that they might experience. So all
of us might be familiar with getting, for example, an annual flu
vaccine. Your arm gets sore. There’s some pain and some tenderness that
goes away fairly quickly. That’s a legitimate side effect, but it’s not
considered to be a problem when compared with the benefits we get from
being vaccinated from the flu. As another example, there’s a childhood
disease called Rotavirus that we vaccinate against in children. It is a
very severe disease that causes severe dehydration and even death in
some cases. But that vaccine for Rotavirus does have a potentially
significant side effect. In about 1 in a 100,000 children, it can cause
intestinal blockage. However, FDA has determined that the benefits of
the vaccine, which prevents about 40,000 to 50,000 childhood
hospitalizations per year in the United States, outweigh the occasional
rare occurrences of that side effect, and that doctors are able to
manage that side effect. So that’s the kind of determination that FDA
makes with all of its vaccines. 

[Holly Hobbs:] So are the vaccines safe? 

[Karen Howard:] We took a very close look at the vaccine candidates
under Operation Warp Speed-including the ones from Pfizer and Moderna
that are currently being used. We found that the vaccine companies
followed all of the normal steps. There have been some allergic
reactions, but those are at a rate of about 5 reactions per 1 million
people vaccinated. This reaction is easily managed by watching patients
for 15 to 30 min after vaccination. And there have been no severe or
long-term effects from those reactions. FDA did do a full review of the
data from the Pfizer and Moderna vaccines and determined that the
benefits outweighed any potential risks such as side effects. So the
benefits of course would be a high-level of protection against getting
COVID-19. The data showed good efficacy for those vaccines.  

[Holly Hobbs:] So, if FDA is saying that the vaccines are safe, do we
know why some people are hesitant to get vaccinated?

[Karen Howard:] For some people, they might have concerns that corners
were cut or that steps were skipped to get these to market so quickly.
We know from our work that that’s not the case—that all of the
appropriate steps were taken. They were just creatively compressed and
combined so that they could meet those timeframes. For other people,
they may have misunderstandings about the risks of vaccines in general,
or these COVID vaccines in particular. We also know that the public is
generally less willing to accept side effects for vaccines compared to
the side effects they might be willing to accept for treatments for
diseases. And for some groups, especially communities of color there is
a historic distrust of the medical system due to some unethical human
experimentation that has occurred in the past, and that can cause
hesitation both to participating in clinical trials as well as hesitancy
to get the vaccine itself once it’s available. 

[Holly Hobbs:] So what happens if people don’t take the vaccine? 

[Karen Howard:] The biggest impact of course would be that we won’t
achieve widespread immunity as a country. That means the disease will
continue to spread, people will continue to get sick and even die, and
the unvaccinated portion of the population will be especially hard hit.
It also means that we won’t be able to reopen schools the way we would
like to. To allow businesses to get back up and running. It could
prevent some people from being able to safely visit their family
members. Basically, just prevents us from getting back to normal life as
a country. 

[Holly Hobbs]: And how might new variants of the coronavirus impact the
effectiveness of the available vaccines?

[Karen Howard:] We do have some early data that indicates that some
vaccines appear to be more effective than others against the new
variants. But it does look like that even when the vaccines aren’t as
effective as we might like at preventing the disease from these new
variants, they still do a good job of protecting against more severe
forms of the disease that might put a person in the hospital or even
lead to death. So getting a vaccine is still the best choice even if
it’s not as effective against the new variants as we would like. The
vaccine companies are also working hard right now on booster shots that
they hope will improve immunity against the new variants and against any
other variants that might appear in the future. 

[Music]

[Holly Hobbs:]: So it sounds like the 2 available COVID vaccines are
safe and critical for fighting the health and economic impacts of the
pandemic. But that misunderstandings about their safety could cause some
individuals to delay or refuse vaccination, which may increase
preventable deaths and lead to longer-lasting economic impacts. Karen,
what are the kinds of questions that policymakers should be asking to
help promote vaccine use? 

[Karen Howard:] I think we need to be exploring how we can do a better
job of addressing the concerns that people have. How we can be more
transparent with the data that we have. How we can let people know the
rigor of the clinical trials that went into those approvals. How we can
publicize the benefits of reaching widespread immunity as a country and
worldwide through vaccination. Basically, just more transparency and
better education. 

[Holly Hobbs:] When it’s your turn, when a vaccine becomes available to
you, will you get vaccinated? 

[Karen Howard:] Absolutely. I’m eagerly looking forward to my
opportunity.

[Holly Hobbs:] Last question, Karen, what’s the bottom line of this
report? 

[Karen Howard:] Vaccines continue to be our best way to provide
widespread immunity to a very dangerous, and even deadly diseases,
protecting our families and friends and getting back to our normal
lives.

[Holly Hobbs:] That was Karen Howard talking about GAO’s recent
Spotlight on Vaccine Safety. Thank you for your time Karen! 

[Karen Howard:] Thank you, it’s my pleasure.

[Holly Hobbs:] And thank you for listening to the Watchdog Report. To
hear more podcasts, subscribe to us on Apple Podcasts. And make sure you
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For more from the congressional watchdog, the U.S. Government
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