Sunday, September 18, 2022









Senator Patty Murray: According to the Centers for Disease Control and Prevention, the U.S. now has over 21,000 confirmed cases of monkeypox -- more than anywhere else in the world, and my home state of Washington has over 500 cases. I've heard from families who are rightly concerned by how bad this has gotten.  And public health officials -- including back in Washington state -- who are frustrated to see our response run into issues we should be prepared for by now. That’s why I continue to push the Biden Administration about my concerns with the monkeypox response, and urge quick action: on testing, treatments, and vaccines, and on clear guidance to the public, health care providers, and state public health officials.  So it's reassuring to see we are making progress. On testing, capacity has increased one thousand percent, and FDA just approved a faster track for additional tests. On vaccines, BARDA is helping to stand up a new vaccine fill and finish site in Michigan, HHS is working to expand the number of distribution sites in states, and the Administration's advice for splitting doses has greatly stretched our vaccine supply.  On outreach, the Administration has started working with states to make vaccines available at events with many people from the LGBTQ+ community in attendance. And perhaps most importantly -- the rate of new cases is going down.  Now that is all encouraging news, but let me be clear -- we must remain vigilant in our response. And these promising improvements don;t excuse the issues I have been hearing about from communities, state health officials, and advocates from the start of this outbreak. Patients have spoken out about how hard it is to get tested -- some even waited days, despite having clear symptoms. Providers have had to jump through hoops to get their patients treatments. And I'm constantly talking to public health officials in my home state of Washington, who have told me how communications with states could have been far clearer -- and faster, and how the challenges in accessing tests and vaccines have delayed our response. I know states have especially struggled with the federal government's decision to forgo the system we typically use to distribute vaccines, the one we are already using for COVID vaccines. When it comes to vaccine distribution, some shipments have been sent to the wrong state, and even spoiled after storage at the wrong temperature. There have been issues with vaccine supply too -- like when thousands of vaccine doses were delayed because FDA had yet to inspect the new plant they were from, or when the Biden Administration missed an opportunity to procure more vaccines at a crucial point in this outbreak. And again, we are seeing inequities worsen this outbreak for some communities. Advocates in the LGBTQ+ community -- who have faced the vast majority of cases -- have also made clear they feel they are being overlooked, or in some instances stigmatized. We need to keep focusing and improving on outreach and on getting information and resources -- like vaccines-- to those who are most in need, and most at risk. And that must include communities of color, who we know don't have equitable access to vaccines. This is especially important as early data suggest Black and Latino communities are disproportionately burdened by this outbreak. We must do better. We need to be applying what we learned from the COVID response, and providing the resources communities have made clear they need.  Of course, there is an enormous difference between this and the COVID pandemic, which is: thanks to decades of investment in smallpox research, we already had tests, treatments, and vaccines ready to go before this crisis even began. That should serve as a reminder to all of us about the immense value of investing in public health preparedness. But it's also why the stumbles in getting these tools deployed were especially frustrating and inexcusable. To learn from this, we need to be clear-eyed about what went wrong. Not just on challenges we faced in the last several months, but that we have faced for decades --challenges that, to be frank, have spanned many Administrations, not just this one. For example, we had over 20 million vials of smallpox vaccine in our national stockpile -- but they weren;t replaced as they expired over the course of a decade. I know I join my Ranking Member and members of this Committee when I say we have to do better -- not just on COVID, not just on monkeypox -- but on public health threats, period. Because we know there will be more. Just last week New York declared an emergency due to polio -- yet another public health risk we need to watch closely. So I want to hear from our witnesses today about not just what they are doing right now to improve our response to the monkeypox outbreak  -- and fast -- but also how we can fix this in the long term and make sure the stumbles of the past couple months never happen again. I want to know what you and the Administration are doing to make sure we have enough tests, treatments, and vaccines for this outbreak-- and get them where they need to go while also maintaining an adequate stock of supplies for any smallpox threats. What are you doing to improve outreach to the LGBTQ+ community, address the disproportionate harm to Black and Latino communities, fight stigma and misinformation, and right the inequities we[ve seen in our response so far? How are we making the most of new research to develop promising vaccines and therapeutics, and then make them more quickly available -- while continuing to uphold the gold standard of safety and effectiveness? And are we getting schools and colleges everything they need to stay open and keep students and the school community safe? I'm glad CDC has provided guidance for K-12 schools -- and fortunately the science tells us elementary and secondary school kids are not at high risk right now, and CDC has also released resources for colleges which is critical with students returning to campus this fall. We need to make sure colleges and universities are equipped to prevent potential outbreaks as students move into dorms and live in close quarters with each other. I realize you've got your work cut out for you on all of this, especially with COVID still raging -- but there's no reason for us to fall behind. So I'm going to keep pushing you here, because families back in Washington state and across the country are counting on you to get it right. That's also why I'm going to keep pushing my colleagues here in Congress about the need for funding to support all this work. I know I'm not the only one here with concerns about the monkeypox response but we can't just say 'this isn't working' without providing the funding to end this outbreak and build the public health system Americans deserve.  So I will continue to work with colleagues on both sides of the aisle, and push to deliver the resources that will help get families the testing, treatments, and vaccines they need.  And I'm interested in hearing from the witnesses on what the needs are when it comes to investing in our monkeypox response. It is also important to me we continue to keep our eyes on the horizon when it comes to future outbreaks and pandemics, and build a stronger public health system for whatever threat comes next.  As the saying goes -- an ounce of prevention is worth a pound of cure. That starts with building a world class public health system, rather than one that lags behind our peers. Our communities deserve to be as safe as anyone in the world, which is why Senator Burr and I are continuing to work to pass our PREVENT Pandemics Act.  Our bipartisan legislation implements the lessons from our COVID response and improves our policies and processes on issues like strengthening supply chains, improving management of our national stockpile, modernizing data systems, and other items which would address many of the challenges we've faced with monkeypox. But a strong public health system also requires strong investments. Because our public health system was underfunded before COVID struck -- and it has been overwhelmed ever since. We have to end the cycle of crisis and complacency by making sustained investments that allow us to build, and maintain, robust public health infrastructure at all levels.  And I'm going to keep pushing for all of these steps, because we should all know by now just how much is at stake. I can tell you, families in Seattle know, parents in Spokane know, nurses in Yakima know, workers in Olympia know, people across Washington state, and across the country, know: COVID was never going to be the last public health crisis we face -- and neither is monkeypox. The question is not whether there will be a new threat -- it is when it will strike and whether we will be ready. The truth is, the monkeypox response so far has not been encouraging -- but there are some clear signs of progress, and there are clear steps we can, and should, take to improve. And I don't just want to hear today about the steps you will be taking -- I want to see action. And you better believe I'll be watching closely.

She was speaking Wednesday at the US Senate Committee on Health, Education, Labor and Pensions.  Appearing before the committee were Dr Rochelle Walensky (Director of the CDC), Dawn O'Connell (Assistant Secretary for Preparedness and Response), Dr. Robert Califf (FDA Commissioner) and Dr Anthony Fauci (NIH Director).  Murray is the Committee Chair, Senator Richard Burr is the Ranking Member.

Committee Chair Patty Murray: [. . .] I say, frankly, too many missteps were made early on in the response and a couple hundred cases turned into 21,000.  It is unacceptable to communities who already experience barriers to accessing healthcare like the LGBTQ+ and the Black and the Latino communities that are hardest hit by this outbreak.  Access to testing was an early challenge in the monkeypox response with many people reporting significant delays in both accessing the test and learning their results.  To continue to have these challenges around testing is just simply unacceptable.  So, Dr Walensky, let me start with you.  How is the CDC working to make sure that tests are more accessible and results are available earlier?

Dr Rochelle Walensky: Thank you, Senator, for that question.  One of the big challenges that we had in terms of access to testing was both patients understanding that they were presenting with a new infection and providers understanding that this was a new infection that they had to test for. Indeed, another important clinical consideration was that people were coming in requesting a test when they had no symptoms and they had no rash.  As Dr Califf noted, the test for this infection is a swab of the rash so if there is no other FDA approved test, we need to have a rash in order to conduct those tests.  So much of what we've done -- and I should mention that we've always had more capacity than we've had tests coming in -- to date, we've used about 14 to 20% of our capacity.  But to address these access issues, we had to work with clinicians, we had to work with patients, we had to do an extraordinary amount of outreach so that providers would understand how to test, patients would understand when to come in for a test and our public health partners would know not to gatekeep those tests.  And so that was a work that we did early on.

Yes, Walensky, and that is your job.  That is your defined job.  That's what the CDC does.  Stop making excuses and pretending you were suddenly tasked with new responsibilities.

Chair Patty Murray: Dr Califf, Secretary [Xavier] Becerra recently declared that FDA can use the emergency use authorization pathway for monkeypox tests.  How will that improve the availability of new tests and what steps are you taking to improve on the progress that you've made?

Dr Robert Califf:  First of all, let me concur with Dr Walensky, there's never been a shortage of tests but there's been a shortage of access to tests because of inefficiencies in the system so the EUA authority has enabled us -- we've given one EUA already but we also have five commercial labs which are offering the tests at this point and we issued a guidance just the other day which, uhm, makes it clear that individual institutions that are developing laboratory developed tests should proceed ahead and we've given people clear guidance templates for developing their tests and figuring out if they work.  So I'd say, on all fronts, the gates are open under a watchful eye because we also must keep in mind that one of the lessons from COVID was that when the gates were open a lot of the tests turned out to be not so good, got a lot of them out there and we had to reign them back in.

Chair Patty Murray:  I -- Well, look.  I'm encouraged by the declining cases.  But it really is imperative that we remain vigilant.  And despite efforts by HHS to increase access to vaccines, some people in my home state of Washington still go to great lengths to get one -- including crossing the border into Canada to get one.  Now people, understandably, want to be vaccinated before they get exposed but that means we need more vaccines.  Ms. O'Connell, some serious stumbles were made this year when it came to our vaccine supply.  What have you done to make sure that never happens again? And what are you doing to increase the supply and distribution of vaccines right now.

Dawn O'Connell: Chairman Murray, thank you so much for that question.  What's most important to us is that those who need access to this vaccine get it.  So if you continue to hear from constituents that are unable to access the vaccine or having to cross the border, please let us know.  We are in the business right now of knocking down those hurdles and making sure the vaccine can be accessed.  We did take a very small stockpile that was intended for small pox that was eventually intended to be lyophilized -- freeze dried -- for small pox and converted it to this active monkeypox response.  And that required a couple of challenging problems to solve.  We moved the fist 372,000 vials, as I mentioned in my opening statement, immediately.  We needed FDA to approve -- and they were terrific partners moving quickly -- to approve that second manufacturing line that began, uh, drew the 800,000 vials we were waiting for.  That's what it manufactured on. We needed that approval to happen before we could deploy those. FDA worked quickly and we got those out in July.  We have also ordered an additional 5.5 million vials of the bulk drug substance that was intended to be lyophilized for small pox -- we have ordered that to be filled and finished and shipped to the United States.  And the 2.5 million of those will be manufactured in the United States. 

 The hearing can best be summed up with one statement from Ranking Member Richard Burr, "You failed on vaccines."


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