From the U.S. Government Accountability Office, www.gao.gov

Transcript for: What Manufacturing Challenges Could Delay Vaccine
Distribution? 

Description: In May, the federal government announced plans for
Operation Warp Speed--a partnership between the government and private
pharmaceutical companies to quickly develop and distribute vaccines. And
while vaccines were developed in record time, there are some concerns
about manufacturing challenges and the public perceptions of vaccines.
We talk with GAO experts Karen Howard and Candice Wright to learn more. 

Related GAO Work: GAO-21-319, Operation Warp Speed: Accelerated COVID-19
Vaccine Development Status and Efforts to Address Manufacturing
Challenges

Released: February 2021 

[Intro music:]

[Candice Wright:] Vaccine manufacturing is very complex. So having the
right personnel with the specialized skills is really critical. 

[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. Facing the rapid spread of COVID-19
infections and catastrophic loss of life, the federal government, in
May, announced plans for Operation Warp Speed--a partnership between the
government and private pharmaceutical companies to quickly develop and
distribute vaccines. And while vaccines were developed in record time,
there are some concerns about manufacturing challenges and the public
perceptions of vaccines.   

Today we talk with GAO experts Karen Howard and Candice Wright--
directors in our Science, Technology Assessment, and Analytics
Team--about their new report on Operation Warp Speed. Thank you for
joining me Karen and Candice! 

[Karen Howard:] Thank you Holly. It's a pleasure to be here.

[Candice Wright:] Thank you Holly. Thanks for having me. 

[Holly Hobbs:] So ladies, vaccine companies are challenged with trying
to scale up manufacturing in order to produce hundreds-of-millions of
vaccine doses. Candice, our report looked at these efforts. What were
some of the challenges that vaccine manufacturers faced?

[Candice Wright:] Well, I'll start by saying that Operation Warp Speed
was an unprecedented effort. However, scaling up manufacturing has not
come without its challenges. It's worth noting that before the pandemic
hit, most existing vaccine manufacturing capacity was already in use,
which meant new capacity had to be created or production capacity had to
be shifted from other products. Global demand is really high right now,
and there have been challenges getting goods and equipment. And
actually, we heard from company representatives that some of them have
had to wait 4 to12 weeks for items that typically, before the pandemic,
would have been available within one week. And then, I'll just say, that
you can imagine, you know, vaccine manufacturing is very complex. So
having the right personnel with the specialized skills is really
critical. 

[Holly Hobbs:] You mentioned production capacity and workforce issues.
What is the federal government's role in helping here? 

[Candice Wright:] So we've heard from the agencies and the companies
that there has been good coordination to address the facilities and
workforce issues. For example, the Department of Health and Human
Services helped a vaccine company identify an additional manufacturing
partner in order to increase production of their vaccine. And we also
learned that the U.S. Army Corps of Engineers was overseeing
construction projects and helping to support companies that are
manufacturing products like glass vials and cell cultures. On the
workforce front, DOD has deployed support personnel to assist with
quality control and manufacturing sites until the company can fill their
vacancies.

[Holly Hobbs:] And how about the government's role in helping with the
supplies needed to make vaccines? 

[Candice Wright:] None of the companies that we spoke with have said
that they don't have the supplies they need. Rather, it might just be
taking longer. Some of the types of federal assistance has included
helping to expedite procurement and delivery of essential manufacturing
equipment. Also, developing a list of critical supplies that are common
across the 6 vaccine candidates--like for glass vials and syringes. We've
also learned that DOD and HHS have placed priority ratings on 18
contracts for supplies that are needed for vaccine production. 

[Holly Hobbs:] Karen, our report also looked at vaccine development,
which has been touted as a major success However, there are concerns
that the speed of development has impacted public perception on safety.
What did we find?

[Karen Howard:] That's a great question Holly, and we are aware that
there's a lot of concern that maybe shortcuts were taken--how did we
accomplish this so quickly? Vaccine developers worked very closely with
FDA at every step of the process. So they were constantly in
communication about what steps they could take, how they could combine
steps, perhaps, in a way that would allow them to still get FDA the data
they needed to assess the safety and the effectiveness of the vaccines.
We did find that vaccine developers accelerated some steps or deferred
them until later. For example, in a normal process they might conduct
phase 1 clinical trials in humans, and then they would take a number of
weeks or even months to assess the data from the trial, and then start
phase 2. Well in this case, they would be evaluating data on an ongoing
basis throughout the phase 1 clinical trial so that as soon as it ended
they could very quickly move into phase 2. 

[Holly Hobbs:] So has the effort to get vaccines out the door more
quickly had any impact on public perception? 

[Karen Howard:] I don't think it's the speed at which the process
occurred that concerns people--although I think that gets the blame. I do
think though it's because the process was politicized, it was pulled
into a partisan environment and instead of being an apolitical, global
attempt to solve a really big problem, it became a talking point. And
unfortunately that created a lot of doubt and concern about the vaccine.
FDA did its full normal review. And they determined that they had
sufficient evidence to allow use of the vaccines, of two of the vaccines
now, while clinical trials continue. 

[Holly Hobbs:] So it sounds like Operation Warp Speed celebrates this
major success of producing, in record time, not only one but two viable
coronavirus vaccines. But that the public may have concerns about
vaccine safety, and manufacturing hundreds of millions of doses of these
vaccines has been a challenge. Karen, we have a new tool that we're
publishing on our website (GAO.gov) to help track the progress of
vaccine development and manufacturing. Can you tell us about the
dashboard--for example, what information does our dashboard share that
other dashboards or news outlets don't have? 

[Karen Howard:] I think the main thing that our Operation Warp Speed
dashboard is going to share--or does share--is information on GAO's
analysis and investigation work. We did a lot of our own original
analysis of how far along these vaccines were in their development, and
what processes the vaccine developers went through to produce them. That
information will be on our dashboard and in our published products and
nowhere else. One of our major goals in launching the dashboard is to
provide real time updates. We don't need to wait until we have enough
new information across all of the possible COVID concerns to produce a
major report--instead we can just update that little piece of
information. So that the dashboard itself will stay current in a way
that our published reports may not.     

[Holly Hobbs:] So Candice, last question--what's the bottom line of this
report?

[Candice Wright:] I think, as we talked about before, the COVID-19
vaccine development and manufacturing has been a herculean effort. It
will remain to be seen whether the efforts that have been undertaken
will continue to be promising. And as such we'll continue to monitor the
federal government's efforts and progress towards meeting the vaccine
goals. 

[Holly Hobbs:] That was Karen Howard and Candice Wright talking about
GAO's recent review of Operation Warp Speed. Thank you for your time
ladies! 

[Karen Howard:] Thank you, Holly. 

[Candice Wright:] Thanks, Holly. 

[Holly Hobbs:] And thank you for listening to the Watchdog Report. To
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