As we continue to deal with the devastating affects of the Coronavirus in our Communities, the Senate Health, Education, Labor, and Pensions Committee held a hearing on Capitol Hill. The hearing discussed the importance of vaccinations and updates on the development of a COVID-19 vaccination. This included questions surrounding the safety and efficacy of the vaccine.
Ridge Policy Group covered the hearing. As a top government affairs firm, we often provide summaries and analyses of Committee hearings and work for our clients. You can find our notes from this hearing below.
Senate HELP Committee Hearing
Vaccines: Saving Lives, Ensuring Confidence, and Protecting Public Health
Wednesday, September 9, 2020
- Francis Collins, MD, PhD, Director, National Institutes of Health
- VADM Jerome M. Adams, MD, MPH, Surgeon General of The United States
Chairman Alexander Opening Statement
I’ve been reading — I was saying to Senator Tim Kaine and Maggie Hassan that I’ve been reading “Guns, Germs, and Steel”, the book that Jared Diamond wrote that won a Pulitzer Prize in 1977. He wrote that there’s nothing new about epidemics that cause mass deaths and social upheaval, and there’s nothing new about where most of the infectious disease come from. Over the last 10,000 years, he says humans have acquired most of our infectious diseases from animals.
During most of history there were basically three ways to deal with these epidemics. One was to isolate the infected. Two, according to Jared Diamond, was that over thousands of years there have been genetic changes in human populations in response to infectious diseases that cause major outbreaks like smallpox. Then there’s a third way that was most common throughout most of history, and that was really to let her rip. Let the virus run — run its course through the population until everyone had either been killed or recovered and developed some immunity.
What’s new about epidemics is modern medicine, including the ability to diagnose the disease and create treatments to make it easier to recover. But the true miracle of modern medicine is vaccines, which can prevent humans from acquiring the disease at all. That’s why today in all 50 states and the District of Columbia, schoolchildren are required to take vaccination for the following diseases: diphtheria, tetanus, the whooping cough, polio, measles, rubella, and chickenpox before entering school.
So the purpose of this hearing is to explore the remarkable progression that science is making toward a COVID-19 vaccine, to remind parents to have their children get their childhood vaccines, and to encourage as many Americans as possible to get the flu vaccine this fall.
First, the progress for the COVID vaccine, Dr. Collins, the Director of the National Institutes of Health, is here today to talk about that. Research and development, Operation Warp Speed, which is working around the clock to develop, manufacture and distribute a safe, effective vaccine to hundreds of millions of Americans. Perhaps most significantly, the Biomedical Advanced Research and Development Authority, we call it BARDA, has taken up the unprecedented step to help speed up manufacturing for hundreds of millions of doses of the vaccine early in the process so they can be ready as soon as the new vaccines are approved by the Food and Drug Administration.
In other words, they’re being manufactured before they’re approved. And if they’re approved, they’ll be ready to distribute. And if they’re not approved, they’ll be thrown in the dumpster.
At the same time the CDC is working on a plan to distribute the vaccine as soon as they are authorized or approved, prioritizing vaccines for health care workers and vulnerable populations. CDC’s plan will be a fair system informed by non-partisan health experts from the National Academies of Science, Engineering, and Medicine and the Advisory Commission (sic) on Immunization Practices.
As inevitably happens, someone suggested, well, you’re speeding up the vaccine because an election is coming and you’ve asked states to get ready to distribute it because an election is coming. Well, I was thinking this morning. What if Dr. Collins showed up — and Dr. Adams saying, well, it will be five years before we’re going to get a vaccine? I think we’d probably throw them out of the room and ask the president to try to find some more effective people.
Vaccines are approved and reviewed by the Food and Drug Administration. FDA can either license the vaccine or authorize it for use during a public health emergency. And the FDA’s stringent approval process is the world’s gold standard. The vaccines that are routinely — that are given to children are specifically recommended by the Advisory Committee on Immunization Practices, an outside group of health experts that looks at all available scientific information about each vaccine.
Are they effective? Smallpox was mankind’s first-ever vaccine and no one on Earth has naturally acquired smallpox since 1977. It has been officially eradicated. Polio was one of the most dreaded — dreaded childhood diseases. Following introduction of vaccines, specifically the vaccine in 1955 and then another in 1963, the number of polio cases fell rapidly to less than 100 in the 1960s, fewer than 10 in the 1970s according to CDC. Thanks to a successful vaccination program, the United States has been polio free since 1979.
Is the doctor’s office safe? The panic has made some parents leery of the doctor’s office. But analysis of patient records according to The Wall Street Journal shows that the immunization rate for recommended routine childhood vaccines has declined about 40 percent from late February through mid-April.So for parents who are worried about taking their children to the doctor, the American Academy of Pediatrics says pediatricians are working to make their offices as safe as possible. They say they’re among the safest places you can be. Don’t be afraid to take your child to see your doctor.
On June 23rd, this committee held a hearing on preparing for the next pandemic. One member of the committee asked, why would we worry about the next pandemic when we haven’t conquered this one yet? Well, in a Wall Street Journal essay on May 23, Jared Diamond provides an answer to that comment. He says that in this age of jet planes, with millions of people carrying infections from one place to another overnight, the next pandemic could be next year and we would be wise to prepare for it.
Fortunately, thanks to an unprecedented effort by the private sector and our government, as well as scientists around the world, there’s likely to be a COVID-19 vaccine ready for the most vulnerable citizens by the end of the year and hundreds of millions of doses available in 2021.
Some of the challenges, apart from finding a vaccine, are: how to distribute it, to whom should it go first, and how to persuade Americans that it’s safe to take.
But while we’re in the midst of dealing with this pandemic, it would be wise to remember in any — any legislation that Congress passes this year to make sure that onshore manufacturing plants are functioning, stockpiles are full, public health is properly funded, and states have the right tools and resources.
Ranking Member Murray Opening Statement
Well, thank you very much, Mr. Chairman. And while you still have a few months left as well a few more hearings, I do want to start off by saluting you for your many years of service to this country, including as senator and chairman of this committee. I know my Democratic colleagues and I will miss you next year.
On the top of today hearing, Mr. Chairman, our country is in the middle of a painful crisis. The COVID-19 pandemic has crowded hospital intensive care units. It’s emptied schools. It’s shuttered businesses. It has deepened damaging health disparities among black, Latino, and tribal communities; people with low incomes, and people with disabilities. It has ravaged prisons, and nursing homes and other congregate care facilities. It has strained our economy, our mental health, and a lot more. It has claimed around 190,000 lives so far, and more each day.
Unfortunately, instead of leading us in the war against this virus and fighting the pandemic, Trump — President Trump is fighting public health experts. Instead of supporting facts and science, he is supporting conspiracies. He has spread absurd false theories about FDA officials being deep state agents and CDC overstating the death toll.
He has called for less testing, which he blamed for the rising number of COVID-19 cases; wrongly claimed kids aren’t likely to get or transmit the virus; and has repeatedly insisted this will just all go away. The list of inaccuracies and outright lies at a time when truth is a matter and life and death goes on and on. And unfortunately, President Trump is not alone in his deeply flawed response.
I hope instead that Republicans will sit down with Democrats to work on a package that helps our economy and keeps our American families safe, a package that actually increases testing and access to health care; that actually supports our schools, and addresses the childcare crisis and actually protects workers; and most relevant to this hearing today, helps make sure we get safe, effective, trusted vaccines that are widely and equitably distributed and administered.
Vaccines have long been a critical public health tool. And even before this crisis it was important that we encouraged uptake of flu vaccines each year to keep people safe, to make sure vaccines are available and administered to kids across the nation, including through efforts like the Vaccines for Children Program, and build vaccine confidence while combating this information.
But I’m also frustrated that despite my request to the chairman, FDA Commissioner Dr. Hahn and CDC Director Dr. Redfield were not invited to testify today. Those agencies play a very critical role in developing and distributing vaccines, and should be here today.
In the past few weeks, we have not only watched President Trump directly promote conspiracies about FDA and CDC, we’ve also seen reports that he exerted political pressure on FDA to issue an emergency use authorization for convalescent plasma, and on CDC which changed testing guidelines to be more restrictive with no justification and running counter to the consensus of public health experts from across the country.
And these aren’t the first reports of political interference. The Trump administration has previously promoted unproven treatments like hydroxychloroquine and blocked CDC guidance for community reopening.
Recently FDA Commissioner Hahn announced he was prepared to authorize a COVID-19 vaccine before phase 3 trials were complete, but without providing any guidance about when that would be appropriate.
When it comes to a COVID-19 vaccine, we cannot allow President Trump to repeat his alarming pattern of putting politics ahead of science and public health. FDA scientists’ efforts to ensure the safety and efficacy of vaccines must not be undermined by political meddling. CDC’s role in distributing a vaccine and prioritizing who receives the first doses must not be supplanted by politicians or campaign strategists or corporate lobbyists.
We need the FDA to be transparent by issuing an official guidance with standards for granting any vaccine an emergency use authorization, including standards for the independent review of phase 3 data by waiting for the completion of phase 3 clinical trials before moving on any candidates and by committing to make public any data used to green light a vaccine.We need transparency from CDC about how it plans to handle distribution, how its experts will drive the process despite the ill-advised decision to have the Department of Defense rather than CDC lead a lot of this effort, and who will get priority when the first doses are available. We also need transparency on Operation Warp Speed’s contracts and how it is addressing any potential conflict of interest.
In short, we need transparency from top to bottom. And of course, in addition to transparency, we still need a comprehensive national vaccine plan, one of several steps I have called for in the vaccine white paper I put out on the vaccine months ago.
Testing is an ongoing catastrophe, and we cannot risk a repeat performance when it comes to vaccines. The administration must developed an end-to-end national vaccine plan that addresses how we make sure vaccines are safe and effective, how we produce, distribute, and administer hundreds of millions of doses, how we alleviate rather than deepen the health disparities we know exist, and how we overcome barriers to access like cost and proximity to providers and how we promote vaccine confidence in spite misinformation especially when there’s so much misinformation coming from the President of the United States. Developing and distributing safe, effective vaccines is a huge undertaking, and one that cannot be accomplished without a strong, science-driven leadership from the federal government. So I really am glad we have this opportunity it talk about the important challenges that lie ahead, but there are many more questions we need to answer and so many more witnesses we do need to hear from, and I will absolutely keep pushing to make that happen. Thank you, Mr. Chairman.
Dr. Collins Testimony
Well, thank you very much, and perhaps we could get the visuals up on the screen if that’s possible. Chairman Alexander, Ranking Member Murray, and distinguished members of this committee, thank you for inviting me to discuss Operation Warp Speed and the importance of developing safe and effective vaccines. I’m grateful for your longstanding support of NIH and for this opportunity to address how we are working tirelessly with other parts of the government and with industry partners to prevent, diagnose, and treat the novel coronavirus, SARS-CoV-2.
Let me provide a metaphorical illustration about how vaccines work. Your immune system is like an antibody factory. Yes, you have a very sophisticated biotech company inside your body. When you body sees an invader like these three viruses, it designs and antibody, and Y-shaped protein that can counter that specific threat. It may take a week or two for the factory to make that new product, but then keeps the blueprints on file for every antibody it’s every made. The goal of a vaccine, therefore, is to present a completely harmless part of the virus to your body, allowing your factory to work out an effective production strategy. Now, if it’s sometime in the future the actual virus enters your body, your factory can quickly pull up the blueprints and ramp up production, wiping out that virus before it has a chance to multiply and make you sick.
For COVID-19 there are six vaccine candidates engaged in large-scale U.S. trials. Each vaccine has already undergone rigorous testing in animals followed by phase 1 safety testing in a small group of humans. For three of the six vaccines we are already in phase 3 of testing where the goal is to inject 30,000 volunteers located in areas where the virus is actively spreading. Half of the volunteers are injected with a vaccine and half with a placebo, and nobody knows which is which.
Over the next weeks they are followed closely to see if infections occur. A successful vaccine should have many fewer cases of COVID-19 in those who got the actual vaccine versus those who got the placebo. We will also follow all of them for as long as two years to asses safety. We expect the other three candidates to enter phase three in the coming weeks and months.
Now, these six vaccines represent three different scientific approaches. Having this mix in strategies is the best insurance against some unexpected problem. We hope and expect that more than one of these will succeed. They all have one thing in common, the initiation of immune responses against the spike protein of the SARS-CoV-2 virus. And you’ve seen this picture so many times, but that’s the protein you want to raise that antibody against.
We know that people who have survived COVID-19 make neutralizing antibodies for this spike, so we want the vaccine to do the same. Now, the first scientific approach is a very traditional method, recombinant protein technology. Basically you purify the spike protein in the laboratory and you inject that purified protein and the antibody factory goes to work. The laboratory process to produce and purify the protein means that this approach, although it’s tried and true, is on a bit slower trajectory than some of the other candidates, but not much. Novavax plans to initiate their phase 3 trial in mid October. Sanofi and GSK announced their phase 1 clinical trial last week. If results are positive, a phase 3 would start for them by the end of the year.
The second scientific approach also uses a well-known vaccine technology harnessing a harmless viral vector called and adenovirus and using it basically as a delivery truck. The adenovirus is modified by inserting a gene to the spike protein. Once the virus enters the individual cells, the spike protein is produced, triggering an immune response. A phase 3 clinical trial of this approach was launched by AstraZeneca on August 31, though it is now as of yesterday on clinical hold, and a similar phase 3 trial will be launched by Jansen later this month.
Finally the newest platform technology is one that was developed at NIH using actually supplemental funds from the Ebola epidemic a few years ago. In this approach, which is now being pursued separately by Pfizer and by Moderna, a small non-infectious snippet of messenger RNA or mRNA from the genome of SARS-CoV-2 is prepared. Injecting this mRNA, which codes for the spike protein into muscle, will spur a person’s own cells to make that protein and then encourage the production of those protective antibodies against SARS-CoV-2.
And before I conclude, I want to address concerns about safety. This is foremost in all our minds. We cannot compromise here. The announcement yesterday about the AstraZeneca vaccine is a concrete example of how even a single case of and unexpected illness is sufficient to require a clinical hold for the trial in multiple countries, and that is what’s happening. There are ways, however, that we have adopted Warp Speed to move quickly while retaining those most rigorous scientific standards, and I think you would want us to do that. People are dying.
Delays that traditionally require many years for a vaccine to be developed had to be addressed. In some instances, we have done that by carrying out steps in parallel that are traditional done in sequence. We’ve eliminated downtime by moving into new phases before data from the previous phase is completely analyzed. We have, as the chairman said, started to manufacture doses of all these vaccines before we know if they work, understanding that we are spending hundreds of millions of dollars for vaccine doses that we may have to throw way if they don’t work. But please hear me now. The rigor of the scientific evaluation on safety and efficacy will not be compromised. As a scientist, I’m excited that the pace of discovery is allowing us to respond to this crisis in record time. As a physician I’m hopeful when I think of the millions of lives that have been saved from other diseases through vaccination and millions more that we can save by developing a safe and effective vaccine for COVID-19. Thank you again for your support. I look forward to your questions.
Dr. Adams Testimony
Well good morning, and thank you, Chairman Alexander, Ranking Member Murray, and committee members for allowing me to address the importance of childhood and adult immunizations, particularly in the context of COVID-19. My central message today is this. Equitable vaccination of America’s children and adults against preventable diseases is safe, smart, good for the economy, and critical in our fight against COVID-19, and the science here is clear. Vaccines save lives, and the U.S. vaccine supply is the safest in history and the safest in the world, and they’re a great value as every dollar invested in the measles vaccine for instance saved society up to $20. This is because the vaccines actually prevent disease, keeping people out of the hospitals and clinic and keeping employees and parents in the workplace.
Yes, despite these benefits less than half of adults get a yearly flu vaccines. Flu vaccines reduce a pregnant woman’s risk of hospitalization by 40 percent and a newborn baby’s risk by 72 percent. However, only half of all pregnant women get recommended flu and whooping cough vaccinations. And pregnant African Americans have even lower vaccination rates, a fact which may contribute to higher infant and maternal mortality. In fact, vaccination among ethnic and minority adults lags far behind already four national averages. 37 percent to of Hispanics, Native Americans, and African Americans get their flu shot versus 48 percent of whites. Among adults, rates of new (inaudible) vaccination exceeds 70 percent in whites but are just over 50 percent in blacks and Hispanics, and these disparities persist for tetanus, zoster, and Tdap as well.
Now, I want to move to childhood vaccinations, and it’s important to note that childhood vaccination rates remain high nationally, but 1 in 10 parents refuses at least one childhood vaccine and almost a third delay a vaccine. We know that unvaccinated children are more likely to be uninsured, to live below the poverty level, and to live in rural areas.
Unfortunately, the fear and access issues induced by COVID-19 have put millions of additional children and adults at risk for vaccine-preventable diseases. So to ensure the benefits of vaccines for all Americans, we must acknowledge and address obstacles to vaccination and in particular those encountered by racial and ethnic minority communities. These obstacles, which I think are also opportunities, include public education and rebuttal of misinformation, addressing practical issues related to access, and increasing provider engagement and trust at the final decision point. Realizing these opportunities will not only save lives, prevent suffering, and make wise use of resources now, but will further serve millions of Americans when we get a safe and effective COVID-19 vaccine.
And with both COVID-19 and the flu circulating this fall, this will be in my opinion the most important flu season of our lifetimes. Less flu and fewer hospitalizations will help conserve precious health care resources. So let me be clear, the best way to prevent the flu is to prevent the flu vaccine, and I hope all of you — all of you here today will get your flu vaccines early and publicly.
That’s why my fall COVID-19 description is twofold. First, we must all practice the three Ws — wash your hands, wear your mask, and watch your distance. And second, we must use every lever to ensure all ages, races, and ethnicity receive recommended vaccinations.
In my written testimony, I outlined efforts underway across HHS to boost vaccination rates and I’ll finish by highlighting just a few. CDC works with providers through the Vaccines for Children, or VCF, and the Section 317 immunization programs to provide over 80 million of doses of vaccines annually, and they’ve increased their flu vaccine purchase twentyfold this year. You can find out where to get vaccinated using CDC’s vaccinefinder.org.
HHS recently launched Catch-Up To Get Ahead, informing parents that’s it’s important and safe for their children to get vaccinated during COVID-19. The Catch-Up To Get Ahead Toolkit is available on vaccines.gov, and again to you senators out there, I’d encourage you to send your staff there because they are great printable documents and digital documents to help people understand that vaccines are safe and effective.
Through a recent amendment through to the PREP Act, HHS authorized licensed pharmacists to administer routine vaccines for children age 3 through 18 during the COVID-19 pandemic. And breaking news that I just got the OK to tell you all about right before I came in, today HHS will be issuing guidance to expand access to safe and effective COVID-19 vaccines when they are made available. State-licensed pharmacists will now be able to administer COVID-19 vaccinations to persons age 3 and older.
Office of Minority Health is working with Morehouse School of Medicine on a $40 million plan to help engage and inform racial and ethnic minority communities about COVID-19 on vaccinations. And then finally the Public Health Service Commission Corp, which I help lead along with Admiral Giroir, works with underserved populations including Indian Health Services and Bureau of Prisons, leading efforts to increase acceptance of and uptake of the flu vaccine. PHS offices are also working with racial and ethnic communities to engage them in culturally competent ways and to increase access through partnerships with states and federally qualified health centers.
So I want to close with calls to action to, again, you as senators and to your families, to your staff, and to your constituents.
Number one, get your flu shot ideally before the end of October. We want everyone to get their flu shots by Halloween.
Second, catch up on childhood and adult immunizations right now. Clinics and pharmacies around the country are safe, open and ready to vaccinate.
Number three, stop COVID-19 in its tracks by practicing my 3W’s, washing your hands wearing your mask and watching your distance.
Fourth, use your bully pulpits to tweet, text, blog and shout that vaccines are safe, effective, and more important now than ever.
And I just want to throw a quick personal note, we are in the midst of a social justice movement the likes of which we have not seen since the ’60s, in my lifetime. As surgeon general of the United States, I want you to hear me say that achieving health equity is necessary to achieving social justice; and vaccines are the quickest and the easiest way for minorities and at-risk populations to protect their health. So now more than ever we need to help people understand vaccines are safe, vaccines are effective, vaccines are how we achieve — achieve health equity and social justice. Thank you and I look forward to your questions.
Question and Answer
Alexander: Dr. Collins, let’s take the announcement to which you referred about AstraZeneca slowing its trials this morning, or stopping it. What does that do to the effort — to the goal of producing hundreds of millions of vaccines by the end of the year?
- Collins: The reason that we’re investing not in one, but six different vaccines is because of the expectation that they won’t all work, although it be lovely if they did. To have a clinical hold, as is been placed on AstraZeneca as of yesterday because of a single serious (ph) adverse event is not at all unprecedented. And with an abundance of caution at a time like this, you put a clinical hold, you investigate carefully to see if anybody else who received that vaccine or any other vaccines might have had a similar finding of a spinal cord problem. So this ought to be reassuring to everybody listening, when we say we are going to focus first on safety and make no compromises, here is exhibit A about how that is happening in practice. If it turns out that that is a real consequence of this vaccine, it can be shown to be cause-and-effect, then all the doses that are currently being manufactured for that will be thrown away. We do not want to issue something that is not safe.
Alexander: The Centers for Disease Control said that last year the flu vaccine was 39 percent effective, and that last year between 24,000 and 52,000 Americans — 24,000 and 62,000 Americans died of the flu. On the other hand, the polio vaccine seems to be 100 percent effective; if you get the polio vaccine, you don’t get polio, same with some others. Will the COVID-19 vaccine be more like the flu vaccine or more like the polio vaccine in terms of effectiveness?
- Collins: I wish I knew a really crisp answer to that. That’s why we’re doing these large-scale trials to look at safety and efficacy to see what how protective this will be and how long the protection lasts. If I had to guess, I would say this is probably a better virus for a vaccine to really work well than the influenza virus, which is a tough one because it’s changing every year and that’s why we have to be getting a new shot every year. Will be as good as polio or as good as measles, which is 95 percent, 98 percent effective, I would love it if that turned out to be the case, but we will not know until we get through these trials and see what really happens.
Murray: Dr. Collins, as I’ve said, I’ve been very concerned about political interference in decision-making we’ve seen in this administration’s response and the impact it might have on the acceptance of a vaccine. I want to ask you what steps you think federal agencies should be taking right now to build trust with the American people and develop airtight practices to make sure science and public health, not political decision-making for COVID-19 vaccines.
- Collins: Our best antidote is to say exactly what we’re doing. I am reassured, and I hope it will be reassuring to you that there are number of steps in terms of how vaccines are going to be evaluated that are going to get that kind of sense of scientific objectivity. First of all, none of these trials will go even to an FDA review until the DSMB — the Data and Safety Monitoring Board — which is the only group that gets to see what happened as far as protection, as far as safety events, looks at the data. And these are not federal employees; these are very experienced and qualified scientists. Only when they say something’s happening here that looks like it might be actually worth reviewing, does this get brought forward. I hope you also saw the nine CEOs of the companies involved in vaccine development all signed a statement that they won’t put forward something to FDA until they’re convinced that it meets the highest standards of safety and efficacy. And then FDA has its own advisory process and Commissioner Hahn who will speak to you all in two weeks has already said that he will use this vaccine and related Biological Products Advisory Committee, the BPAC, to advise about any idea of using an emergency use authorization for this purpose. So, you can be confident in that as well.
Murray: Dr. Adams let me ask you, because polls show that about 35 percent of Americans wouldn’t to get a COVID-19 vaccine even if were FDA approved and available to them at no cost. What impact would that have on a successful COVID-19 vaccination campaign as well as vaccine confidence for years to come?
- Adams: We have unprecedented levels of vaccine hesitancy in our country and globally. The World Health Organization has called this one of their top 10 public health threats. I think it’s also important to understand that we have once in a century global pandemic superimposed on top of a presidential election and that’s made messaging even more difficult and concerning. As a member of the Coronavirus Task Force, there has been no polarization of the vaccine process what so ever. We have a process in place that I trust as a doctor, as a dad, I’m — I get vaccinated every year, I get my family vaccinated every year and we —
Murray: OK, I appreciate that and I’m running out of time, so I just wanted to say, we need vaccine confidence and that’s really important and political interference can be a huge detriment to that, so can misinformation. Are you making sure the president understands that risk?
- Adams: I am using my bully pulpit as Surgeon General to make sure the entire country understands that vaccines are safe and effective and this COVID vaccine I’m telling people to focus on the process over the politics and the people, because the process is what will assure that these are safe.
Murray: Dr. Collins, you mentioned in your answer to me the Data and Safety Monitoring Board. I’m concerned about the lack of transparency around the roll of these boards in evaluating the safety and efficacy of COVID-19. Who sets the standards for the DSMB to determine the data of whether the data from a Phase III trial show a vaccine is safe and effective enough to end that trial early as some have said?
- Collins: So, when the trial is first proposed the FDA has to review whether in fact the demonstration of safety and efficacy is going to meet a certain standard and that means you have to have a proof and FDA has already said this, that the vaccine is at least 50 percent effective, if it’s less that than it doesn’t meet that standard. The DSMB has those particular parameters in front of them, and they with very careful statistics. NIH is certainly consulted but it is FDA’s authority and responsibility to set those standards.
Murray: OK. I hope that NIH has that critical information, it’s alarming if they don’t.
- Dr. Collins: Yes we do. I didn’t — I want to make it seem as though that we are not the deciders when it comes to exactly what’s going to be considered acceptable. That’s FDA’s congressional authority.
Enzi: Vice Admiral Dr. Adams, you mentioned childhood vaccination, I know that plays an important roll protecting other age groups and limiting the spread of disease. It helps kids get back to — back to school, which is back to normal, which helps to reassure adults and also allows adults to go back to work. What do we know about the natural immune response that kids have to COVID-19 and when should the company start the process in developing these pediatric products?
- Adams: Important to understand that the initial vaccine trials will be on people age 18 and up and we will make sure — and this is the way we’ve done if for other vaccines that have been developed in the past. We’ll make sure it is safe and effective in adults, and then we will slowly start to move down in age. So the next round I anticipate will be age 12 to 18, and then after that if it continues to be safe and effective we will – we will test in people younger than that, and that’s the way we’ve done it for every vaccine because we can’t just assume that something that’s safe and effective in an adult will be safe and effective in a child.
Sanders: We must make that vaccine free of charge to all people if we want to maximize the number of people who will, in fact, get it and given the fact that we have already paid for it. Will you join us in the effort to make sure that this vaccine will be distributed free of charge to all Americans?
- Adams: Yes, as Surgeon General of the United States, I promise you we will use every federal tool that we have to make sure that cost is not an obstacle for people receiving what will perhaps be the most and highly anticipated vaccine of our lives.
- Collins: And I share that 100 percent.
Sanders: Is that the posture of the administration right now? Is the administration saying that that vaccine will be distributed free of charge to all Americans?
- Adams: I asked that question right before I came in to make sure because I feel strongly about this. The most honest answer I can give you is to the extent that we can ensure that from a federal perspective, yes. As you know there are things we can do in the Executive Branch. There are things you all can do through the Legislative Branch, but every tool that we have we will bring to bear to make sure that cost is not an obstacle.
Sanders; Will you join – and I know this is difficult given the political moment and the nature of that administration – but will you join me and many others in telling the President of the United States to get out of science and let the scientists do their job in moving as rapidly as possible in getting a safe vaccine out to the American people?
- Collins: I know I speak for my colleagues in the government and certainly for the scientific community broadly that that can be the only basis upon which this decision is made, otherwise the public would not be expected to trust us. So that will be the only major. Will it be done by a certain date? I could not possibly tell you right now because I don’t know what’s going to happen in the coming months. I do have cautious optimism that by the end of 2020 at least one of these vaccines will have emerged and turned out to be safe and effective, but even that is a guess and certainly to try to predict whether it happens on a particular week before or after a particular date in early November is well beyond anything that any scientist right now could tell you and be confident that they know what they’re saying. So yes. Science and science alone will be the way in which this decision is made. Otherwise I’ll have no part of it.
- Adams: I want the American people to hear me say this. There will be no shortcuts. This vaccine will be safe, it will be effective, or it won’t get moved along. And when a vaccine is either approved or authorized by the FDA, I and my family will be in line to get it.
Burr: Dr. Collins, you talked about NIH’s efforts to partner with the private sector develop so-called adaptive master protocols for clinical trials. Are we doing something novel here or are we doing exactly the same way we’ve always done?
- Collins: We’re doing something very novel. And I appreciate your raising all of the background here about how we got here, and senator your role in getting BARDA to where it is right now has just been critical for where we are with Operation Warp Speed and having that capability of moving quickly and doing things in a very business-friendly way to try to get the tools that we need in place. But another thing that I had the privilege of helping make happen back in late March and April, was to go to all pharmaceutical companies that we knew had things they could offer here, both in therapeutics and in vaccines and saying, instead of all going off in our own directions, let’s see if we could do something together and put of that came this partnership called ACTIV, which stands for Accelerating COVID 19 Therapeutic Interventions and Vaccines.
Burr: I think the takeaway from toady is we actually see the U.S. government functioning, we see the process of development, of partnership with the private sector in coordination with government actually working. We haven’t changed the rules, we haven’t change the protocols we’ve exercise the latitude that was there in statute for an incident like this.
Burr: Admiral, with the quarantine of, especially our younger population over the past seven months, we’ve got a lot of infants to one-year-olds that have not been exposed to the normal things that they would be exposed to had they not been quarantined.
- Adams: I’m incredibly concerned about the fact that over 4 million, almost 5 million children are behind on their vaccinations because of the COVID-19 pandemic, the regular childhood vaccinations. Im concerned about the levels of herd immunity amongst the populace because adults and children and now haven’t gotten their vaccinations that they normally would have, and that lowers the level of herd immunity.
Casey: So many Americans have questions about how the vaccine will be both manufactured and distributed. It is imperative that any COVID-19 vaccine authorized or approved by the FDA and recommended for widespread dissemination, be both safe and effective, of course, as evidenced by reliable data from randomized controlled clinical trials. It’s also imperative the president, vice president, the White House COVID-19 Task Force must A, tell the truth all the time, not play political games and lead by example. And though I understand, as many of us do, that there will be recommendations from public health experts on who should receive the vaccine first and what we should do and — and all of us should follow those recommendations.
Will you commit to receiving the COVID-19 vaccine in public view once a vaccine becomes available and is authorized or approved by the FDA, yes or no?
- Adams: Absolutely.
- Collins: I’m ready to roll up my sleeve as soon as they say it’s safe and effective.
Casey: We have to understand who received the dose and ensure that each person receives the correct number of doses, especially initially where over vaccination or cross vaccination of different vaccine types could further stress the already short supply. We know the Immunization Information Systems already exist at the state level and they do exactly this type of tracking. I’m concerned, however, that the Administration may be planning to use — may be planning to not use these existing systems. An article in “USA Today” out September 6, cited the CDC document saying, quote, people getting vaccinated will get a COVID-19 vaccination record card that will tell them which vaccine they got, when they got it and when they should get their next shot, unquote.
My first question for you Dr. Adams is, has HHS, Health and Human Services, proved any support to these State Immunization Information Systems? And how are you integrating their capabilities into your planning for vaccine distribution?
Adams: Well very quickly, we are working with states, with advisory committees and with professional organizations to figure out the distribution of what will likely be the most logistically difficult vaccine that we’ve ever deployed. We recognize that there are infrastructures in place at the state level, through the Vaccines for Children’s Program and we’re going to lean on that existing infrastructure.
Paul: Dr. Collins is, considering that the death rate for COVID among children is 0.68 per million, are you in favor of adding a school mandate, you can’t go to school unless you get a COVID vaccine?
- Collins: Well, I think it would be premature for me to make a statement about what would appropriate or not, since we don’t even know to what extent the vaccines that are currently being studied are going to be safe and effective in adults. And as we’ve talked about, we won’t know until later how they work for children.
Baldwin: With one vaccine trial put on hold, what should you and others in — overlooking project Warp Speed be telling these folks who are already about to — or already participating in this phase 3 trial? I imagine some of them are very concerned.
- Collins: Yes, I agree, they probably are. And again, this is fresh information. But again, the company, who has connections now and knows exactly who the individuals are who’ve already been enrolled, are in the best position to basically let them know why there is currently a clinical hold. Again, this is based upon a single severe adverse event which may or may not have anything to do with the vaccine. But it is the best sort of cautious approach to quickly stop and look and see if there’s any other evidence to be concerned about.
Baldwin: Dr. Collins, can you describe how a lack of diversity in clinical trials undermines our effort to develop safe, effective and accessible vaccines? And given the disproportionate impact that COVID-19 has had on communities of color, what should clinical trial sites take into consideration as they work to recruit participants?
- Collins: The NIH has a long history and been doing this kind of community engagement for other things, like HIV for instance, we’re tapping into that. If we don’t succeed in having diversity and the participants in these trials, I think that takes scientifically away from the value of what we’re trying to learn and it certainly makes people wonder are — was this really something that I can say is about me and my community if we weren’t involved in the trial, why should we then think about getting engaged when you say you’ve exceeded. This has to be one of those things that we do all together.
Collins: Dr. Adams, in my state the three groups of people who have been disproportionately affected by COVID-19 have been frontline healthcare workers, black residents of my state and nursing home residents. Who is going to make the decision on the allocation of the vaccine once it becomes available? Who will decide who gets the vaccine first?
- Collins: We’re working with the National Academy of Science, Engineering and Medicine with, again, professional organizations and other advisory groups to come up with an answer to this incredibly difficult question about who gets the vaccine first. I can tell you some principles that we agree on. There are no final recommendations yet, but principles are that healthcare workers and frontline workers should be first in line because we know they’re most likely to be exposed and most likely to spread. Behind them it’s looking at who is most vulnerable and using a scientifically driven and data driven process to determine who is most vulnerable and where that vaccine will have the biggest impact.
Warren: Estimates vary, but some epidemiologists believe that at least 70 percent of the population will need to be immune to COVID-19 ideally for taking the vaccine in order to provide herd immunity necessary to end this pandemic. Is that correct?
- Adams: Yes, ma’am. The estimates that I have seen from experts range from 60 percent to 90 percent, but we certainly need to get over half of the population vaccinated so that we can achieve herd immunity and stop transmission of this virus.
Warren: OK. So, is that your — kind of our minimum target would be about 70 percent give or take. So, the question is, can we do that? Now, the last flu season, for which we have complete data, less than half of U.S. adults, only about 45 percent, got the flu vaccine. Unfortunately, President Trump has undermined trust in vaccines. He has overrule scientists and pressured the FDA into approving products based on weak evidence. He has for a dangerous misinformation about COVID-19 a practice that other Republicans have inherited. And he has appointed a former drug industry executive for financial ties to vaccine makers to run the government’s vaccine effort.
Do the president’s actions encourage public trust in vaccines and increase the number of people likely to get the vaccine or do they discourage Americans from getting vaccinated for COVID-19?
- Collins: I’m not sure I know the answer to that question. I’m more focused on what we can do in the scientific community to try to explain how it is that these decisions get made and certainly working with the Surgeon General trying to be sure that that message is out there.
Warren: You know, just in the past few weeks alone, the president has accused FDA officials of being deep state (inaudible). He’s tweeted conspiracy theories about COVID-19 deaths. And he has implicitly tied vaccine development to his reelections campaign. If Americans who are watching all of this hesitate to take the vaccine because of what he has done, does that help us get to the levels we need to be able to create herd immunity?
- Collins: I just hope Americans will choose to take the information they need from scientists and physicians and not from politicians.
Cassidy: To Dr. Adams, if we’re going to presume vaccines work, we presume that natural infection works. Has there been any thoughts as to how to figure out who has already been exposed, thereby, protected naturally and don’t need the vaccine or at least lower priority as opposed to just vaccinate everybody?
- Adams: We have antigen testing. We have PCR testing. And then we have antibody testing. And antibody testing is how we figure out who has been exposed to the virus and that’s one of the questions that’s come up in conversation about who gets vaccinated first. If you were someone who have been proven to have had the coronavirus in the past by antibody testing or by a diagnosis, then that is someone who we would not put necessarily at the front of the line to get vaccinated until we get to the point where we have enough vaccines for everyone. But also important to remember, this virus has fooled us many times and we still don’t know what we don’t know in terms of how long immunity will last for someone…
Cassidy: If you are going to know what this person has been previously diagnosed, previously infected and/or has been document to have antibody, how are we going to store that information and integrate it with the delivery of immunization to those who are front-line?
- Adams: We work with ASTHO, the Association of State and Territorial Health Officers, and NACCHO, the National Association of City and County Health Officer, these institutions that already had these systems in place and these discussions are occurring right now in anticipation of a vaccine.
Cassidy: It is my understanding that for state immunization registries to be able to address this, they would have to get an appropriation from the federal government. Has any effort have been made already to adapt these registries to take the information as regards COVID vaccination and/or pre-existing COVID immunity?
- Adams: To be brief, I will say that we will have CDC follow up with you, but the answer is yes. The conversation, they’re occurring right now. And the other answer that I have to say as surgeon general is that public health has been long underfunded, including surveillance and registries. And so, we’d be happy to work with you to figure out how to make…
Cassidy: There’s been some question as to whether or not monoclonal antibodies will work to prevent infection. Obviously, there are several ways that you could get monoclonal antibody, but one would be to give to those who are vulnerable. Now, monoclonal antibodies really again a mimicry of the vaccine. Has any thought been there to give monoclonal antibody to say an obese diabetic in order to prevent her from being infected initially?
- Collins: Yes, there has. Monoclonals might be useful therapeutically for people already sick, but they might also be useful as prevention. And you say, yes, this is like a passive vaccine and we do have trials already ongoing for monoclonal antibodies for people in nursing homes and also for people and families where there have been lots of other infections to try to prevent them from getting sick. We don’t know yet exactly how that’s going to work in a preventive mode, but that is something we really want to know. It’s great question.
Kaine: Is there any benefit to the United States for — to not participating in the COVAX project of the World Health Organization, GAVI and CEPI?
- Collins: I will say that the United States is engaged on the global stage and trying to see what can be done about COVID-19 and that’s for me, personally, a very important priority. We have invested and continue to in GAVI, which is a critical part of how vaccines can get manufactured and distributed. All of our global health experts are deeply engaged in communicating and working with their colleagues in other countries. And I do think you’ve heard from the administration a clear sense that if we are able by the end of the next six or nine months to have hundreds of millions of doses of vaccine, we would want to be sure that those become available to those countries that need the most and may not have their own resources.
Kaine: In other vaccines that require two doses, a significant percentage of people, somewhere between 40 and 65 percent in some studies, who get the first dose will not get the second dose, and then a significant percentage of the people who get the second dose don’t get it in time. They will get it months or many months later after they are able to get it. What’s the effect on a two-dose vaccine if you just get the first dose and don’t get the second dose?
- Collins: I think with all of the two-dose trials it looks as if the first dose does give some response but not the level that you would really like to see and then you give that second dose and you’re up in the range of antibodies that people have developed — who got actually natural infection from COVID-19. Hence, if you want to be as effective as possible, you go to that second dose.
Murkowski: I have been working with several of my colleagues on this committee, Senator Brown, Senator Hassan here, SAVE Act. This is the Safe Authorizations for Vaccines during Emergencies, basically, making sure that we are — we are ensuring a level of public independent expert review of the vaccine candidates. I know you may not wish to comment on specific legislation. What can you give me?
- Collins: I think we have a tough situation for the whole nation, but I’m sympathetic with your particular circumstances with the history in Alaska of hesitancy being even greater. This is going to be a need for all hands-on deck leaders in the Congress, people in the local communities, have to get altogether to figure out how to convey this message.
- Adams: Well, we know that when it comes to vaccines and most health advice, the people will trust their local provider more than they will trust anyone else out there. So, what we’re trying to do with arm local providers with the facts, CDC’s campaign really has scripts and sheets to help people talk about some of the frequently asked questions. We’re engaging with social media influencers. We need to get Lady Gaga, for instance, who someone I never thought about I’d invoke in congressional testimony, but I gave her a shout out because she had mask that she wore at the video music awards last week and people will listen to Lady Gaga before the listen to the Surgeon General. So, we need to very much engage. And Dr. Collins and I have been adamant that we want people to understand there are protections built in, the process is strong. If we follow the process and people will understand the process, they will have confidence. But everyone out there who says, I won’t take this vaccine if or I don’t trust this vaccine unless it is still in further hesitancy and hurting us.
Hassan: Dr. Adams, last week, you told ABC News that you have confidence in the COVID-19 vaccine review process because data safety monitoring boards would not allow a product to move forward unless there is, quote, “good evidence that these vaccines are efficacious,” close quote. What protocols are in place to ensure that these boards do not stop clinical trials until they also collect sufficient safety data, including for high risk populations, and what specific steps have been taken to ensure that these decisions will not be subject to political influence from the White House?
- Adams: I will be very quick in my answer because this is more in Dr. Collins’ lane. But as an example, the FDA generally advises a minimum population size for pre-licensure safety database for preventive vaccines to exceed 3,000 patients. These trials have 30,000 patients in them.
Hassan: If we expect the American public, Dr. Adams, to have confidence in these products, we need to ensure that they have full confidence in the review process. In addition to the general meeting they are holding in October, do you believe FDA’s vaccines and related biological products advisory committee should hold public meetings, review clinical trial data and release their findings to the public before FDA approves or authorizes any vaccine product as they normally would?
- Adams: I think we need to follow the process because the process works. I think we need to be careful about inserting new barriers in the process because it is just as unethical to prolong the process.
Hassan: Do you believe that the CDC’s advisory committee on immunization practices should meet publicly review data and issue public recommendations for each COVID-19 vaccine that enters the market so health care providers across the country are confident giving these vaccines to their patients?
- Adams: Again, I believe we need to follow the process and engage health care provider so that everyone has confidence, yes.
Romney: I wonder if it does not make sense for our government to put out a very comprehensive effort to dispel this growing sense of vaccines being bad. And I don’t know how you do that, but it would come to mind that you’re doing that with regards to tobacco and massive advertising on TV. You can have debates. You could call in these people who write these books and have discussions with them, which are which are publicized. You can have much more aggressive campaign on the — on the social media. I guess the question I am asking is, should we be doing more than we’re doing and what could we be doing to resolve the debate, the uncertainty that so many Americans have about the wisdom of receiving vaccine.
- Collins: I’ll start, but the Surgeon General have a lot to say about this. This has been, of course, an issue for our country, not just in this season of COVID-19 but before that, and particularly one has seen the consequences of that with measles, for instance, which in the year 2000 we declared that the U.S. had succeeded in effectively getting rid of measles. And now, last year, we had more than a thousand cases and people have forgotten the kids die of that that disease and continue to die in other parts of the world. I must say frustrating and sometimes even causes you a little bit of anger and frustration that this kind of misinformation is so readily spread about people who have another agenda. And we have a hard, hard road to go to try to counter that when so many people don’t see in their own experience the reason why this is such a lifesaving activity.
- Adams: Department of Health and Human Services is using a three-tiered approach to improve vaccine confidence through research and evaluation, collaboration and partnerships, communication strategy, the knowledge dissemination. I put out an op-ed earlier this year with the secretary and with the CDC Director Redfield. We’re working with platforms like Twitter and Pinterest and Facebook to make sure appropriate and accurate information is displayed prominently when people do a search. CDC developed Vaccinate with Confidence, a strategic framework to strengthen vaccine confidence. We’re working with a minority medical schools like Morehouse and beyond.
Romney: Clearly, very little data, but are we evaluating the promise of vaccine efforts in other countries and do they have much prospects for being a value to us?
- Collins: We certainly are to the extent that the information is being made available. And obviously, what you like to see is a publication that’s been peer-reviewed and some of that is starting to come now from the vaccines are being developed in China and Russia. I must say the way in which the Russians roll this out, declaring victory before they had gone much beyond the Phase 1 trial, did not win them a lot of confidence in the scientific community. And so, we really have to be insistent that if somebody is going to say this vaccine is safe and effective that they have lived up to that very high standard and I think our country establishes those standards and others generally follow them as well.
Smith: I introduced my COVID-19 Treatment Act, which would ensure that (inaudible) health insurance through Medicaid or CHIP or people who don’t have health insurance at all will be able to get free COVID-19 vaccine. Can you just confirm that the federal government will buy this vaccine and also the supplies that are needed to administer the vaccine and make that available to providers at no cost?
- Collins: Yes, I can confirm that. As part of our Operation Warp Speed as these various vaccines are chosen to be put forward and their deals are negotiated that allows the government to buy and own tens or in some cases hundreds of millions of doses that then can be provided for free to providers. And along with that, of course, all of the other materials you need, like syringes and vials and PPE, is part of the package. I think the administration has made it clear that no one should be denied this vaccine. It needs to be completely free.
- Adams: And we’re talking about COVID, but I think it’s important that we just operate under the underlying belief that all vaccines should be provided at minimal cost to people because they save lives and they’re cost effective, they’re cost savings.
Jones: So, Dr. Collins, Dr. Adams, each take one or two of these theories, tell us what you’ve heard or what’s the most outrageous thing and debunk it for us as quickly as you can so that the American people right here on the record know that they should not follow these absolutely crazy theories that are out there about vaccines.
- Adams: Vaccines do not cause autism and people need to understand that. We’ve looked at the trials. We’ve looked at studies. Vaccines do not cause autism.
- Collins: And I am agreeing with that one, but I have to tell you the craziest one I have heard, which is this is all designed by Bill Gates, and when you get the vaccine, it has a chip in it that’s going to get stuck into your system and it’s going to watch everything you’re doing, and people believed that stuff.
Jones: So, none of the vaccines are designed to kind of be Big Brother over people and to follow them. They’re designed — I take it — to save lives, correct?
Jones: Can we in Congress help get that voice out there?
Adams: We need to acknowledge past wrongs that have occurred. And you all might be surprised to hear me giving a shout out to Bill Clinton, but Bill Clinton apologized for the Tuskegee experiment several years ago. We need to acknowledge Tuskegee. We need to acknowledge Henrietta lacks. We need to acknowledge these wrongs occurred, then we need to address the situation that caused them to happen.
And again, we talked about the process, Phase 1, Phase 2, Phase 3 trials, data safety monitoring boards and committees and whole agency at HHS that have been stood up to make sure these type of things never ever happen again. And then we need to engage, and that’s what you’re talking about, sir. We need to get out there where the people are and use trusted advocates.
Rosen: I introduced a bipartisan Ensuring Understanding of COVID-19 to Protect Public Health Act to make sure that this critical research happens and that it includes at the very diverse set of patients. This bill was included in the House-passed HEROES Act and I ask support from my colleagues and especially on this committee to make sure it’s included in the next public package passed by the Senate that’s going to help us.
Dr. Collins, what recommendations do you have for making sure that rural areas are not left out of the critical vaccine distribution?
- Collins: Distribution issues are critically important and are under intense planning process right now, recognizing that warp speed has not just the role of trying to encourage the clinical trials but also the manufacturing and then the distribution, everything like the cold chain and how do you actually get these doses to the places where they need to be, recognizing that were going to need to do this a priority way so that the most vulnerable people get the doses first.That means thinking about rural communities and all the ways that could happen, but it’s going to be working with the states and CDC has already deeply engaged in that. I think they got a little misunderstood when they said to the states, you know, we need to be ready by November 1st just in case. I think they were trying to say let’s be prepared here and not wait to the last minute, and that is very much the conversation that’s going on.
- Adams: We have infrastructure in place to get vaccines out to those territories. But you are right, we have to acknowledge that we still have done a poor job of making sure we have equitable distribution of vaccines before there’s the COVID vaccine in those communities and we need to double up on those efforts. We’re working with state and local health departments to make sure that occurs and I stand ready to work with you to make sure people know vaccines are safe and effective and that we’re addressing that practical issue, availability, convenience, cost, service quality and satisfaction, making sure that not just it’s there but the people can get it easily and are happy with the way they received it.
Alexander: Congress, after the last several pandemics, took a number of steps, giving that the Food and Drug Administration more authority, giving the National Institutes of Health additional funding and some more flexibility, creating — moving the stockpile management, creating manufacturing plants that would be ready in case we needed them up. How valid is that point that in fact as we think about preparing for the next pandemic?
Collins: I think that’s very true. I think it is traditional right now the bemoan that we weren’t ready for COVID-19 that we somehow let things lapse, we weren’t perfectly ready, that’s for sure, and there were some things that probably could have been in better position to be ready for this. But there were things that Congress had done over the past couple of decades, the creation of BARDA, other things that you’ve mentioned, that made it possible to move more swiftly now.
Now, we need to learn from this one. And of course, this is the worst pandemic we’ve had in more than a century. So, maybe will learn even better this time to be prepared so that as we get through this, and we are going to get through this, and COVID-19 will slip into the rearview mirror that we don’t imagine that we’re done with pandemics because COVID-23 or whatever the next thing might be is out there lurking, and we should learn from these lessons and not do anything other than prepare.
Alexander: The way I’m hearing you talk is that developing herd immunity is a good thing, right? I mean you want to get to a point where a large number — and I believe used the number 60 to 90 percent of the population — is — has some form of immunity from a disease. So, herd immunity, by itself, nothing wrong with herd immunity, right?
Collins: No. It’s how you get there.
Alexander: You’ve headed up the so-called shark tank, the red X operation, which we funded. I want to make sure that I know one, what is the output right now? How many — how many fast tests have the shark tank produced that people can take to determine whether they have COVID-19? And do you have the funding you need to get done what we asked you to do?
- Collins: Well, Senator, I really appreciate your leadership in making it possible. Just beginning on April 25th for us to ramp up something that’s never been done before and invite a lot of small businesses and academics who had really creative ideas about how to do testing for SARS-CoV-2 to come forward and jump into the shark tank and show what they could do and get a lot of advice and sometimes some difficult criticism and see whether they were ready for the big time. Could they actually expand their capacity? Could develop a sufficient validation and get exported and deployed? Just as of last week, we’re now up to 16 of these technologies that have made it through this process, very interesting technologies, 16 different ones. And collectively now, those add up to roughly 2 million tests a day that would not of been there before all of this came along. Some of them are land-based tests. Some of them are based on genome sequencing. Some of them are point-of-care. But collectively, they are moving along. And together with what Admiral Giroir has been doing, which is also dramatic in terms of its expansion with things like the Abbott Binax test. I think we are on that pathway towards getting to enough tests that almost anybody would say.