From the U.S. Government Accountability Office, www.gao.gov Transcript for: Operation Warp Speed and the Federal Effort to Accelerate COVID-19 Vaccine and Therapeutic Development Description: Vaccines can take up to 10 years to develop, and sometimes longer. But with the number of COVID-19 cases rapidly increasing and the catastrophic loss of life, the federal government has taken steps to accelerate this effort under Operation Warp Speed. What do these steps look like, and are they having an impact? We talk with two GAO experts--Directors Mary Denigan-Macauley and Alyssa Hundrup-- about a new report on the federal government's support of COVID-19 vaccines and therapeutic development. Related GAO Work: GAO-21-207, COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations Released: November 2020 [Into music] [Mary Denigan-Macauley:] Although FDA has issued some emergency use authorization therapeutics, the decisions behind those were not fully reported. [Holly Hobbs:] Hi, and welcome to GAO's Watchdog Report, your source for news and information from the U.S. Government Accountability Office--I'm Holly Hobbs. Vaccines can take up to 10 years to develop, and sometimes longer. But with the number of COVID cases rapidly increasing and the catastrophic loss of life, the federal government has taken steps to accelerate this effort under Operation Warp Speed. What do these steps look like, and are they having an impact? Today we talk with two GAO experts about a new report on the federal government's support of COVID-19 vaccines and therapeutic development. Joining us are health care policy experts Mary Denigan-Macauley and Alyssa Hundrup, who are both directors in our Health Care Team. Thank you for joining me, Mary and Alyssa! [Mary Denigan-Macauley:] Thank you for having us. [Alyssa Hundrup:] We're glad to be here. [Holly Hobbs:] So, Alyssa, Operation Warp Speed has this goal of producing 300 million doses of the COVID-19 vaccine, and having that initial dose available by January. That deadline is rapidly approaching, right? Is that going to happen? [Alyssa Hundrup:] We're unsure, but that's definitely the question on everyone's mind. So, under Operation Warp Speed, the federal government is providing funding for six different vaccine candidates. Mostly over this past spring and summer, the government identified these six candidates based on an initial look at their safety and effectiveness, and then also their ability to quickly scale-up manufacturing. As of late October, the vaccine developers have reported quite a bit of progress in testing the vaccine through clinical trials with thousands of volunteers. One of the unique things about Operation Warp Speed is that while the vaccine developers are testing their vaccine, they're also simultaneously working on scaling up manufacturing so that millions of doses will be ready just as soon as they're determined to be safe and effective by FDA. So, I don't know that we'll have 300 million doses by January, given that we're already in November, but the vaccine developers working under Operation Warp Speed have made swift progress. [Holly Hobbs:] And what challenges are there for getting the vaccine developed under this accelerated process? [Alyssa Hundrup:] So before the pandemic, most manufacturing capacity was in use for producing other types of vaccines. So they really had to come up with new capacity and create that to accommodate vaccines for COVID-19. In speaking with some industry representatives, we have heard concern of some disruptions in the supply chain. In talking with one company, they told us that they have experienced challenges in obtaining things like different materials and chemicals, and that critical supplies, like glass vials and syringes, have been limited. So now, Operation Warp Speed officials told us that they're working to mitigate these challenges by working directly with developers to identify those critical supply needs and then working with them to acquire and manufacture those specific supplies. [Holly Hobbs:] And so, what is the vaccine development process? And, where are we now? [Alyssa Hundrup:] So before a vaccine, or really any drug for that matter, can be marketed in the United States, it has to be approved by FDA. But before it even gets to FDA for review, the development process involves significant research and testing, which historically has taken many years. In the case of a vaccine for COVID, initial research and testing moved remarkably fast, and several of the vaccine candidates through Operation Warp Speed are in the last stages of that development process with those large-scale clinical trials. And so once a developer has collected sufficient data from these trials, it can then take that information to FDA for review and approval. In fact, one company just recently announced that its early results are showing the vaccine to be very effective in the volunteers, and it has announced that it plans to submit a request to FDA for review around late November. [Holly Hobbs:] And beyond the speed of the vaccine development, are there other differences between the process we're seeing now and a more traditional vaccine development process? [Alyssa Hundrup:] The steps are really the same for the testing. What's different is the rapid production and large-scale manufacturing before a vaccine is even approved by FDA that is the biggest difference from a more traditional process. Under that traditional process, the manufacturing really wouldn't get underway until a vaccine was approved for use by FDA. But now, under Operation Warp Speed, that's already happening so that a vaccine can be distributed and administered just as soon as FDA determines it is safe and appropriate to do so. [Music] [Holly Hobbs:] So, it sounds like the federal government has a plan and process in place to rapidly develop vaccines and therapeutics to treat COVID-19. But that--despite these efforts--there are still challenges in completing this work. Mary, the report talks about the use of Emergency Use Authorization for vaccine and therapeutic development. What does this authorization allow the government to do that it couldn't do before? [Mary Denigan-Macauley:] What it does is it gives the government the ability to allow a treatment or vaccine that hasn't yet been approved to be temporarily used. So, if you're really sick with COVID-19, it's possible that you could receive an experimental treatment when there is otherwise no other alternative. You may have heard of some of the treatments in the news, for example, like remdesivir. It was developed as an experimental drug for the Ebola virus, and it is showing some promise with COVID. For vaccines, as Alyssa mentioned, it can expedite the process for getting vaccines more quickly than through the full FDA approval process, which can end up taking years. [Holly Hobbs:] And, are there any drawbacks for using the Emergency Use Authorization? [Mary Denigan-Macauley:] There always will be tradeoffs when you're moving quicker. While the Emergency Use Authorizations can provide us flexibility and help make treatments available more quickly during the emergency, unfortunately we don't always know if they'll work. And in the case of COVID, we've already had some that have been revoked. And it's one reason that it's really important for FDA to be transparent about the evidence that it has when it makes a decision whether or not to authorize an experimental treatment or a vaccine so that anyone using that particular therapeutic can make an informed decision. And so for example, in the case of hydroxychloroquine and chloroquine, those were two drugs that were approved originally by FDA to go ahead and be treated for malaria. And when it was authorized as an emergency use temporary treatment for COVID, before it was actually revoked, it ended up causing a drug shortage, and so that's another tradeoff that you can see, is that you end up with a drug shortage. Another drawback that you can see, too, is there's concern about vaccine hesitancy. If the public could be hesitant to get a vaccine if it becomes available through an emergency use process, and if it becomes available through that emergency use process, there may be less certainty on the public side about its effectiveness rather than if it's a licensed vaccine. [Holly Hobbs:] And Mary, did our report make any recommendations related to vaccines and therapeutics? [Mary Denigan-Macauley:] In our report, we found that, although FDA has issued some emergency use authorization therapeutics, the decisions behind those were not fully reported or uniformly reported to the public. And so we had concerns that this lack of transparency could negatively impact the public's trust in FDA, which is particularly important right now given the gravity of the pandemic. So, we made a recommendation to that effect that FDA needs to identify ways to more uniformly disclose the information behind its scientific review and decision-making for authorizing any therapeutic or vaccine when it comes to emergency use authorizations. [Holly Hobbs:] And last question, ladies. What's the bottom line of this report? [Alyssa Hundrup:] Operation Warp Speed, this partnership, has really enabled the government, alongside private industry, to move at an unusually fast pace to address the complex challenge of developing a vaccine for COVID. So, our work will continue as we monitor the federal government's efforts on this very critical undertaking. [Holly Hobbs:] And Mary? [Mary Denigan-Macauley:] Yeah. If we look at emergency use authorizations, they came about after 9/11 and the anthrax attacks. And the purpose was to provide the federal government the flexibility to move quickly to be able to have treatments and therapies in the case of a chemical, biological, nuclear attack, whether it be a natural disaster - for example, a natural disease like we have now - or an intentional one. And while being able to move quickly and having that flexibility is incredibly important, we don't want to lose sight of the need to be transparent, to build the public's confidence in any decisions that the federal government makes, now and going forward. [Holly Hobbs:] That was GAO's Mary Denigan-Macauley and Alyssa Hundrup talking about their new report about federal efforts to develop COVID vaccines and therapeutics. Thank you for your time, ladies! [Mary Denigan-Macauley:] Thank you! [Alyssa Hundrup:] Yeah, thank you for having us! [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 leave a rating and review to let others know about the work we're doing. For more from the congressional watchdog, the U.S. Government Accountability Office, visit us at GAO.gov.