On Senate Floor, Portman Discusses Participation in Johnson & Johnson COVID-19 Vaccine Trial
Portman Calls for Increased Awareness of Importance of COVID-19 Vaccine in Face of Surging Cases Nationwide
WASHINGTON, DC – Today on the Senate floor, U.S. Senator Rob Portman (R-OH) discussed his participation in the ENSEMBLE phase 3 trial for the COVID-19 vaccine candidate being developed by Johnson & Johnson and managed by CTI Clinical Trial and Consulting Services (CTI) at its research center in Cincinnati, Ohio. At a time when the coronavirus is surging and only about half of Americans have confidence in the upcoming vaccines, Portman felt it was his civic duty to participate in a vaccine trial to raise awareness of the safety and effectiveness while encouraging others to participate as well. He discussed the importance of the vaccines to ensure Americans feel comfortable returning to retail establishments, schools, the workplace and gathering with friends and family. Portman applauded the Trump Administration’s Operation Warp Speed which has led the unprecedented development of the vaccine candidates, and urged his fellow elected officials to stop casting doubt on a potential vaccine for the sake of political victories. Portman also discussed bipartisan legislation he working on to fund a science-driven public advocacy campaign to ensure that when an effective COVID-19 vaccine is available, Americans are ready to get it.
In addition, Portman once again called on Congress to find common ground on another COVID-19 relief bill to provide even more funding towards vaccine development to ensure a COVID-19 vaccine is available as soon as possible.
A transcript of his remarks can be found below and a video can be found here.
“Madam President, I’m here on the floor of the Senate tonight to talk about the encouraging progress we’ve seen in finding a vaccine for the COVID-19 virus that has disrupted all of our lives and caused such great damage over the past year. From the early days of this coronavirus pandemic, a public-private partnership has employed scientists who have worked around the clock to prevent people from getting infected by developing effective vaccines. We saw the results of this effort in the last week with announcements from Pfizer and now Moderna that their interim success rates were above 90 percent during their trials. Other companies have vaccines at various stages of development, and there’s hope that they will have similar results. Getting safe and effective vaccines across the finish line will be a monumental achievement. Not only are we witnessing unprecedented progress in creating an effective, widespread vaccine, we’re doing so at a speed unheard of in modern medical history. This result is going to be our best hope of getting out of this pandemic. With cases rising not only across the country but around the world, we’re running out of other tools needed to stop the pandemic.
“I support the social distancing, the wearing of masks, the PPE, the testing, but I believe widespread inoculation is the most effective way to avoid the negative economic and social impacts the virus and the subsequent mitigation efforts have caused. If these vaccines receive the expected Emergency Use Authorization from the Federal Drug Administration over the coming weeks and months, this will be a testament to the unprecedented support that Congress has provided for vaccine development, the Trump Administration’s innovative approach to cut bureaucratic red tape with Operation Warp Speed and the commitment and ingenuity of our researchers, our scientists, and our manufacturers.
“The bipartisan CARES Act that passed here in March with unanimous support provided $27 billion in funding for countermeasures against COVID, including funding this important vaccine development research. It was money well spent. Thanks to these funds and the innovative approach by the administration, we’ve been able to invest in building the infrastructure to begin manufacturing these vaccines now, so that if a vaccine is approved, we can quickly ramp up distribution. This two-track approach also involves ramping up large-scale clinical trials, which are critical to furthering our scientific understanding of this pandemic and verifying the safety and effectiveness of these vaccines. By using these CARES funds to invest in both research and trials and in manufacturing at the same time, we’re able to ensure that the trials are thorough and methodical, while also ensuring that if and when approved, there is vaccine ready to be distributed.
“At the same time, the Food and Drug Administration, which is the federal agency responsible for approving the use of any new vaccine, has followed the science and moved cautiously. As an example, they’ve actually raised the standards needed for giving an Emergency Use Authorization for a vaccine. Normally a vaccine only needs to be effective about 50 percent of the time to be approved under the EUA -- Emergency Use Authorization. But with coronavirus vaccines, the standard is much higher, by requiring companies to collect more rigorous information to show longer-lasting results from their respective vaccine candidates. This will help ensure greater confidence in the system and I’m grateful that they took these additional, careful steps.
“This progress on the vaccine is critical for our economic recovery as well. When a vaccine and therapeutics are authorized by the FDA and made widely available, and people actually get vaccinated, all of us will feel safer returning to the workplace, retail establishments, restaurants, churches and other places of worship, and schools, as well as feeling more comfortable gathering with friends and family. We’ll finally be able to truly reopen and get millions of Americans back to work. In short, a widely available vaccine is our best bet for getting America back to normal, something we all are desperate for.
“Last month I received a briefing from CTI Clinical Trial and Consulting Services, a research company that’s based in my hometown of Cincinnati, Ohio. I met with them to receive a briefing to find out what’s going on in Ohio and what they’re doing around the country. CTI is a global leader in actually executing these clinical trials that we always talk about for these vaccines and therapeutics, and right now they are helping to conduct clinical trials on potential COVID vaccine being developed by a number of companies, including Jannsen J&J – that’s Jannsen-Johnson & Johnson. I was impressed with the progress they had made in their phase one and phase two trials for this J&J vaccine, as well as the precautions they are taking with regard to the safety and privacy of participants in the trial. In fact, the previous trial of this vaccine found 99 percent of participants developed antibodies to COVID-19. 98 percent still had these antibodies in their system after 29 days. These are encouraging figures that suggest that this J&J vaccine could prove to be another useful tool in our toolkit to fight COVID-19. But there is still a lot of work to be done.
“CTI explained to me that they were focused on encouraging more people to join their trials. I asked if it would help if I signed up and they said yes. Along with tens of thousands of other participants, I am now joining this trial for this promising new vaccine. Like other participants in the program, I don’t know if I got the vaccine or if I got a placebo. I enrolled in this vaccine trial for really three reasons. One, because I think it is so important to get this vaccine moving. And these trials are really important to having that be successful. In my view, again, the vaccine is the most effective way for us to defeat this coronavirus.
“Second, I enrolled because I want to encourage others to join these trials around the country. If you are interested, go online. Look at the vaccine trials and join one in your community. And, third, I hope it will convince my fellow Ohioans and others that getting vaccinated makes sense. There is a concerning Gallup poll from last month that found that only half of Americans are comfortable getting the COVID-19 vaccine. That 50 percent of us are not comfortable at this point getting vaccinated. Actually, that’s down from August when two-thirds of Americans said they would be willing to be vaccinated. This concerns me a lot.
“I suspect, in part, this is happening because of the rhetoric we’ve heard from some public officials casting doubt on a vaccine solely because it may be approved by the Trump Administration’s FDA. We need to stop playing politics with people’s health and let the science and the data determine which vaccines get approved. The FDA is being very cautious. And they’re being driven by science. Casting doubt on the efficacy of a vaccine to try to score political points is dangerous and needs to stop.
“Public confidence in vaccines is declining at exactly the time that we need these vaccines the most, and we need to do what we can to reverse that trend. My hope is that by being involved firsthand I can use my platform as a senator to help give people confidence that these new vaccines being developed are safe and effective. The more folks that participate in these trials, the sooner they’ll have the complete data to finalize this phase of the trial and move on to the FDA approval process.
“But just as important as participating in these vaccine trials is what we do here as legislators in Congress to ensure that these vaccines can continue to be developed and deployed safely and rapidly. As I mentioned earlier, the CARES Act provided $27 billion for the development of vaccines and other countermeasures, an unprecedented show of support from Congress in our fight to defeat the underlying health care challenges of this pandemic. Unfortunately, since that bill was passed, the CARES bill, way back in March, eight months ago, we’ve been unable to focus on follow-up with more funding to help this effort. $27 billion is a lot of money, but it only gets us so far in an effort like this.
“What’s also missing from the uses of this $27 billion is the ability to fund a campaign to explain to Americans that there is a safe and effective vaccine out there that they can use. That the science has been followed. As I mentioned there’s a lot of vaccine hesitancy right now. It existed before this pandemic, it’s been unfortunately made worse, again, by some elected officials trying to politicize this science-driven effort.
“That’s why I’m working on bipartisan legislation to support a national awareness campaign that would empower HHS to cut through the politics and promote the scientific advancements we’ve made in order to increase public confidence. We don’t have a vaccine yet and we’re still facing another round of shutdowns with little help to support those who will be impacted by it. That’s the reason why we need to do more in Washington to ensure that the health care response to this pandemic does not falter because this crisis is getting worse, not better. In my home state of Ohio and around the country we’re seeing this and we can make a difference here.
“In Ohio, the number of daily cases has risen every day for the past month. We’re seeing double what we saw just a few weeks ago. In the United States we are now averaging more than 100,000 new cases per day, double the rate from just a month ago. As was predicted, it got colder and people are inside more and the third wave has arrived. Unfortunately we’ve also seen an increase in Ohio in hospitalizations, in ICU patients, and sadly, in fatalities, along with these new cases.
“We need to do more to help the economy, too, and that’s another reason we need a COVID-19 package, a stimulus package because, as this pandemic has worsened, the impressive economic growth we were seeing has slowed down at a time when the economy is still down 10 million jobs since February. What we really don’t want is for those 10 million people in a slowdown of the economy to become long-term unemployed who may never reenter the workforce and, of course, certain sectors like hospitality, restaurants, hotels, travel, entertainment are still struggling badly with no end in sight as some states are beginning to re-implement stricter social distancing measures and even close down these facilities in order to counter the spread of the virus.
“I’m pleased that Leader McConnell has called on Congress to work together to pass another coronavirus response package before the end of the year. We can’t afford to wait any longer. It is my hope that my Democratic colleagues recognize the urgency, as well, and I’ve talked to a number of them who do. We have got to refrain from making this political at this point. We have got to figure out how to work together to find common ground. If we can come together and get a bipartisan coronavirus bill passed before the end of this year that takes a common-sense approach -- targeting the health care challenges of this pandemic, targeting the economic consequences -- we will not only help the men and women working tirelessly in labs around the country to fight this disease, but we will send a clear message to the American people that we are with them in this fight.
“And as we continue this critical national effort, let’s be sure we’re doing our part here in Congress to pass legislation that provides additional funding for treatments and therapies for the coronavirus so that we can be sure we have the resources necessary to treat the virus as people get it.
“Madam President, the time is now for us to put the partisanship aside and figure out how we can work together to give the American people a little hope to address the health care crisis that’s in all of our states and to ensure that the economic consequences are not devastating for the people we represent. I urge my colleagues to come together and do that before we recess for the holidays.”