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. 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