Congressional Science Policy Initiative

Committee hearing resource | Senate Health, Education, Labor, and Pensions

Send in your ideas to help the Senate examine the state of COVID-19 treatments and vaccines and question White House Coronavirus Task Force members.

Engage, and take action! If you have a question or idea you think lawmakers should raise with witnesses during this hearing, or you would like to be a part of FAS’ community of science and health experts, kindly scroll down and submit via the form below. Join our community to contribute your expertise and ideas.

The development, manufacturing, and distribution of safe and effective vaccines, treatments, and diagnostics are key to stopping the deadly COVID-19 pandemic.

On Wednesday, September 9th, the Senate Committee on Health, Education, Labor and Pensions is holding a hearing to question White House Coronavirus Task Force members about the status of COVID-19 treatments and vaccines.

The Committee wants to hear your thoughts on safety and efficacy requirements for COVID-19 treatments and vaccines, the independence of US science agencies, cooperation within the White House Coronavirus Task Force, the companies that are making treatments and vaccines for Americans, how to ensure public confidence in potential treatments and vaccines, or strategies for protecting public health and saving lives, among other issues.

This website gives you an opportunity to tell Congress what issues should be discussed during this critical hearing. You can submit questions that lawmakers should ask witnesses (sample questions below), personal stories about your experiences related to COVID-19 or other infectious diseases, or your general thoughts on how Congress can help Americans through the COVID-19 crisis.

Senate Committee on Health, Education, Labor, and Pensions hearing titled “Vaccines: Saving lives, ensuring confidence, and protecting public health”

Wednesday, September 9, 2020 at 10am ET

Francis Collins, MD, PhD  |  Director, National Institutes of Health

Vice Admiral Jerome M. Adams, MD, MPH  |  Surgeon General of the United States

Evidence-based sample questions lawmakers could ask witnesses. Please share yours for lawmakers.

More sample questions will be added as objective contributions are received from the expert community. Kindly submit your idea via the form below. Last updated Wednesday 9/9/2020.

Potential for FDA Emergency Use Authorization of a COVID-19 vaccine candidate

Heather Pierce, the senior director for science policy and regulatory counsel at the American Association of Medical Colleges, stated: “When the FDA is free from political interference and gets good data, it makes good decisions; but the Emergency Use Authorization mechanism has been shown to be more susceptible to interference, and should not be used for a vaccine.”

Do you agree that the FDA’s Emergency Use Authorization mechanism should not be used for a vaccine? Why or why not?

Justifying an Emergency Use Authorization for a COVID-19 vaccine candidate

Unlike therapeutics, vaccines are given to healthy people who are not acutely ill. It is critical that vaccines do not cause adverse health effects. Premature release of an unproven vaccine would not only have some chance of exposing a wide fraction of the American population to adverse health consequences or ineffective protection from COVID-19, but could also sabotage public confidence in vaccines, as well as FDA’s reputation as a science-based agency.

Given how absolutely critical it will be to maintain public trust in the integrity of FDA’s approval process for COVID-19 vaccines, in your view, is there any possible justification for issuing an Emergency Use Authorization for a vaccine candidate prior to completion of the full FDA review process? Please explain.

Pharma companies’ pledge, scientific integrity, and political interference

Yesterday, nine pharmaceutical companies issued a joint pledge committing to “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.”

What is your reaction to this? Is this customary for vaccine-makers? Why was it necessary?

Follow-up: There are concerns that President Trump may apply political pressure to the vaccine approval process as the country approaches Election Day, and in a recent poll, 35 percent of Americans said they would not take a coronavirus vaccine.

How do you and your agencies plan to navigate this landscape, serving the health interests of Americans? When should the average American expect to access a COVID-19 vaccine?

NIH conditions for funding bat coronavirus research

Dr. Collins, EcoHealth Alliance is a nonprofit research organization that had its $3.7 million NIH grant revoked in April. That grant funded EcoHealth’s bat virus research in China. “Scientific studies suggest that the coronavirus most likely originated in bats, and research on the topic could be crucial to identifying other viruses that might cause future pandemics.”

In July, NIH told EcoHealth that it would reinstate the grant if it met certain conditions. Those conditions included: 1) Obtaining a SARS-CoV-2 sample used by the Wuhan Institute of Virology lab to determine the coronavirus’ genetic sequence, 2) Arranging for an independent team to examine the Wuhan lab and determine whether it had possession of SARS-CoV-2 before December 2019, and 3) figuring out the whereabouts of a scientist at the Wuhan lab whose photo was removed from its website and who is implicated by conspiracy theories as “patient zero” for the coronavirus.

Dr. Collins, is it standard practice for NIH to place these types of conditions on grantees? Please explain.

Follow-up: Were these conditions developed by NIH, and if so, what was your involvement? If not, what agency passed these conditions down to NIH? Again, what was your role in this?

Follow-up: Why was the grant revoked in April?

Safety and efficacy of COVID-19 vaccine formulations

Dr. Collins, Vice Admiral Adams, the formulation of potential COVID-19 vaccines is very important for safety and efficacy. One chemical that is routinely incorporated into biopharmaceuticals is polyethylene glycol, or PEG. For example, the Moderna COVID-19 vaccine candidate uses PEG in its formulation.

A number of studies in both animals and humans have indicated that the immune system can make antibodies specifically against PEG, and antibodies against PEG may be relatively widespread in the population. In some cases, PEG appears to reduce the effectiveness of therapies, or even cause adverse effects.

What is your perspective on the inclusion of PEG in the formulation of biopharmaceuticals – is there reason for concern? Is Moderna, or other companies using PEG in their vaccine candidate formulations, screening clinical trial participants to assess whether they have pre-existing antibodies against PEG?

COVID-19 convalescent plasma

Dr. Collins, it was reported that before the FDA’s Emergency Use Authorization of COVID-19 convalescent plasma, you fiercely opposed the authorization, at least without more concrete data.

In your view, was such concrete data produced before the FDA’s August 23 Emergency Use Authorization?

Follow-up: A statement dated September 1 from your agency’s COVID-19 Treatment Guidelines Panel says: “There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19.”

Is that still the case?

Follow-up: How should the American public be thinking about COVID-19 convalescent plasma as a potential treatment?

The need for more COVID-19 testing in the US

Knowing who is infected with the coronavirus is a huge part of getting the outbreak under control in the US, and ramping up testing is the way to learn who’s infected.

So COVID-19 testing isn’t just a tool for diagnosing Americans who feel sick, or evaluating those who are thought to have been exposed to the coronavirus. For example, COVID-19 testing can also be used to survey for the substantial number of infections that do not show symptoms, or to frequently assess people for whom “stay-at-home” is not a viable option.

Dr. Collins, during the July 2nd Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies hearing, you said: “We could get to the point of an extra one million [COVID-19] tests per day just from the Rapid Acceleration of Diagnostics (RADx) program by the first of September, by Labor Day.”

According to the COVID Tracking Project, 662,438 COVID-19 tests were conducted in the US on July 2nd. On September 1st, 698,526 tests were conducted. Just like in July, tens of thousands of new cases are being reported every day.

What is the status of the RADx program and the extra one million [COVID-19] tests per day? What is holding back substantial increases in the amount of testing that can be done in the US? How does this impact the US response to COVID-19?

Changes in federal COVID-19 patient information collection and equitable vaccine distribution

In July, the Department of Health and Human Services assumed control of COVID-19 patient information collection from hospitals from the Centers for Disease Control and Prevention. The company that designed the new HHS information collection system was awarded its $10.2 million contract on a noncompetitive basis.

Like the CDC system, the HHS system required hospital workers to enter COVID-19 patient data manually, and the change moved away from a platform that stakeholders are familiar with in the middle of the pandemic.

Then in August it was reported that the shift to HHS led to delays and data problems, and that hospitals will return to reporting to CDC.

What is your reaction to this? Won’t it be important to have accurate and complete information about where COVID-19 outbreaks are worst to most effectively deploy vaccination? Did this change, and then reversal, affect American lives? Will this incident have lasting impacts on our country’s ability to distribute COVID-19 vaccines equitably?

Airborne spread of COVID-19

An early-July assessment signed by 239 scientists stresses the risk of airborne spread of COVID-19.

The researchers emphasize that infected people – a large portion of whom do not show symptoms – produce virus-carrying aerosols when they breathe out, talk, or cough. These aerosols do not fall to the ground within six feet, but rather travel longer distances and drift in air. This is particularly problematic for indoor spaces with limited ventilation.

Similarly, reports from the National Academies of Sciences, Engineering, and Medicine have raised concerns about the risk of the spread of the coronavirus through the air, as well as recognized that the relative contribution of droplet sizes in COVID-19 transmission is unknown.

It has also become clear that touching a contaminated surface is a relatively minor route of COVID-19 spread. The CDC updated its guidelines to reflect this in May. (But people should still wash their hands, and not touch their faces when out and about.)

What is your reaction to the risk of airborne transmission of COVID-19? What precautions should be taken?

Risk of COVID-19 to multigenerational households

Vice Admiral Adams, even in areas with low COVID-19 case counts, spread of the coronavirus, particularly by those who do not exhibit symptoms, is a real risk.

What is your advice to households that include older parents or grandparents and children in areas where in-person schooling is an option?

Public COVID-19 vaccine data

To earn the trust of the public and ensure the phase 3 COVID-19 vaccine clinical trial results are available for close scrutiny, the data should be made widely accessible.

How will you ensure that the raw data from human trials of COVID-19 vaccines are made public for scientific scrutiny and debate?

Realistically communicating vaccine availability to the public

Last week, Dr. Anthony Fauci said: “I believe that by the time we get to the end of this calendar year that we will feel comfortable that we do have a safe and effective vaccine.”

Dr. Collins, Vice Admiral Adams, do you concur? When should Americans expect to be able to be inoculated with a safe and effective COVID-19 vaccine?

Follow-up: If available, how do we ensure the vaccine reaches the communities most affected by COVID-19, i.e. healthcare workers, essential workers, underserved communities, and people with pre-existing conditions?

Vaccine distribution to the American people

The Centers for Disease Control and Prevention – CDC – has the lead on planning for COVID-19 immunization infrastructure and vaccine distribution to the American people. The Department of Defense is providing logistical support to CDC. The plan has not yet been completed, but there is an urgent need to know the plan.

Distributing a vaccine to the US population will take intensive cooperation between the public and private sectors, as well as local-state-federal coordination.

Do you believe that the necessary coordination will occur? And please describe any part you or your colleagues have had in the CDC’s planning process.

Follow-up: Please explain any improvements in the planning process that you may believe need to be made.

Follow-up: How will the White House Coronavirus Task Force and the federal government encourage public acceptance of a safe and effective COVID-19 vaccine?

Ensuring vaccine efficacy

SARS-CoV-2, the virus that causes COVID-19, changes over time. While it does not mutate as rapidly as the flu virus or HIV, it does mutate.

What is the outlook for the COVID-19 vaccine candidates that Americans will have access to – could vaccines lose efficacy as a result of new emerging viral strains, or could the coronavirus become seasonal? Please explain.

Ensuring COVID-19 vaccine safety for individuals with compromised immune systems

If a COVID-19 vaccine fully clears safety and efficacy trials by the end of 2020, a vaccine will have been successfully developed in record time.

What is the extent to which the efficacy of these vaccine candidates is being evaluated in individuals with compromised or under-performing immune systems, such as the elderly, or people with cancer, autoimmune disease, recent transplants, AIDS, or undergoing dialysis?

Rapid and equitable distribution of successful COVID-19 vaccines

Please describe the US strategy to distribute successful COVID-19 vaccines to Americans quickly and equitably. Please explain the country’s vaccine distribution plan, and your participation in developing that plan.

Follow-up: How will your agencies encourage public acceptance of a safe and effective COVID-19 vaccine?

Follow-up: What plans are there to scale to billions of doses, or partner globally, to help non-US citizens?

Vaccine safety: Safeguarding against antibody-dependent enhancement of infection

Some vaccines, such as a 2016 vaccine against the dengue virus, intensify the consequences of infection, rather than protect. This is called antibody-dependent enhancement – ADE.

“ADE has been observed in previous attempts to develop coronavirus vaccines. To add to the concern, antibodies typical of ADE are present in the blood of some COVID-19 patients.”

Are vaccine-makers mapping out SARS-CoV-2 viral epitopes that could cause antibody-dependent enhancement of infection, and prioritizing vaccine designs with low-risk epitopes? Please explain.

Possibility and ethics of human challenge trials

A provocative, ethically complicated method called human challenge trials, where healthy volunteers are inoculated with an experimental vaccine and later deliberately exposed to disease, could potentially speed up the testing of coronavirus vaccine candidates.

“Over 100 prominent scientists, including 15 Nobel laureates” called for human challenge trials to be used to test COVID-19 vaccines in an open letter to Dr. Collins. Dr. Collins, you had said that “challenge trials are ‘on the table for discussion – not on the table to start designing a plan.’”

Furthermore, “in April, 35 members of the House of Representatives called on US regulators to consider allowing volunteers to be infected with the coronavirus to speed up vaccine testing.”

Will coronavirus vaccine candidates be used in human challenge trials? Are human challenge trials ethical? Please explain.

Risk of unproven vaccine technology

Operation Warp Speed companies are developing viral vector- or gene-based vaccines. These technologies “don’t have the same track record of producing potent and durable immune response that traditional protein-based vaccines do.” There are also concerns about capacity to scale these types of vaccine production to hundreds of millions of doses.

Please explain why the American people should have confidence in the potential of viral vector- and gene-based vaccines. Moreover, do steps need to be taken to ramp up vaccine production capacity?

How vaccine candidates qualify for Operation Warp Speed

Operation Warp Speed decision-making processes may be unclear. According to reporting, “scientists inside HHS say they’re confused by the rapidly changing organizational structure [of Operation Warp Speed] and the role of outside consultants…” from the Boston Consulting Group.

What is your understanding of the basis for a vaccine or therapeutic candidate to qualify for being part of Operation Warp Speed? Do all US organizations have an equal chance of being considered?

Scrutinizing Operation Warp Speed

Operation Warp Speed is the Administration’s effort to rapidly develop and deploy a vaccine. The Department of Health and Human Services website says “HHS Secretary Alex Azar and Defense Secretary Mark Esper oversee Operation Warp Speed, with Dr. Moncef Slaoui designated as chief advisor and General Gustave F. Perna nominated to be chief operating officer.”

Dr. Slaoui is a former executive of the pharmaceutical company GlaxoSmithKline and, because of his role as a government contractor, he does not have to disclose his outside positions, stock holdings, or other potential conflicts of interest.

Is this acceptable to you? Why or why not?

Protecting health care workers

Tragically, more than 1,000 US health care workers have died from COVID-19.

A huge part of protecting health care workers is for our fellow Americans to prevent the spread of COVID-19 by keeping more than 6 feet apart from one another, wearing masks in public, avoiding crowded indoor spaces, and washing our hands, so that fewer people get infected and need to seek treatment for COVID-19.

Should health care workers be first in line to receive COVID-19 vaccines, or other medicines? Why or why not?

Misinformation and COVID-19 vaccines

“The World Health Organization reported in February that it was not only fighting SARS-CoV-2, the virus that causes COVID-19, but also an ‘infodemic,’ which it defined as ‘an overabundance of information – some accurate and some not – that makes it hard for people to find trustworthy sources and reliable guidance when they need it.’”

How do you envision misinformation impacting vaccine development or acceptance? Are you already seeing signs of this?

What steps are you and your teams taking to counter misinformation? What should the federal government be doing? How can Congress help?

Increasing the country’s chances of a successful COVID-19 vaccine

Most vaccine candidates fail, which is why Nobel Prize winner Dr. Michael Kremer and his colleagues have suggested that the country needs 15-20 vaccine candidates to reach a 90% chance of success.

In your opinion, are enough US-based companies developing COVID-19 vaccines? Has the US government done enough to help ensure there will be at least one safe and effective COVID-19 vaccine?

Level of federal investment in COVID-19 vaccine development

The Congressional Budget Office projects that “fallout from the coronavirus pandemic will shrink the size of the US economy by roughly $8 trillion over the next decade.”

Accelerating vaccine development could save tens of billions of dollars.

Given the lives and livelihoods at stake, should more than billions be invested in Operation Warp Speed, or other US COVID-19 vaccine development programs, or the development of therapeutcis? What level of investment do you think is appropriate?

Expediting COVID-19 vaccine phase III trials

Could phase III trials be faster by using population-level statistics, i.e. identifying an effective vaccine through a shift in the dynamics of local spread, as has been proposed in the UK? Please explain.

Potential of biotech advances to fight coronavirus

It is imperative to quickly produce a safe vaccine against coronavirus.

Is it possible that modern proteomics technologies could be used to detect autoantibodies in pre-clinical models or in patients in clinical trials, to safeguard against adverse autoimmune effects, reducing the need to run a long trial while potentially increasing safety? Please explain.

Follow-up: Is it true that the cost of manufacturing nucleic acid vaccines could be reduced hundredfold by using potent vector-encoded adjuvants? Please explain.

Effective emergency funding for public health

Science and fact and reason are the best tools to fight a pandemic. Has the emergency funding provided to the US public health apparatus been sufficient? Please explain why or why not.

Public health messaging to mitigate COVID-19 spread in the US

Early in the pandemic, US public health officials did not recommend that the public wear masks. It turns out that wearing masks can help reduce COVID-19 transmission, and now, Americans should wear masks in public.

If all Americans wore masks in public, kept our distance from one another, avoided crowded, poorly ventilated spaces, and maintained good hygiene (washing our hands and not touching our faces), that would be a major step toward mitigating this deadly disease. This isn’t new; this guidance has been on the CDC’s website.

How are should the US Government be communicating with the American public about participating in the national effort to counter COVID-19?

Follow-up: How will you and your agencies help encourage public acceptance of a safe and effective COVID-19 vaccine?

Federal funding of emerging infectious disease research

In order to overcome COVID-19, US research and development is key to produce treatments and vaccines and save lives.

Have the additional investments Congress has made in basic and applied research toward COVID-19 been sufficient? What about translational research? In your view, is the funding being distributed and used effectively? Please explain.

Unequal impacts of COVID-19

There are differential impacts of COVID-19 on different racial, ethnic, and socioeconomic groups.

Is the White House Coronavirus Task Force taking steps to address these disparities? What are you doing to ensure that COVID-19 vaccines will be distributed equitably?

Nonpartisan analysis and research

Quick reads

The Reward and Risk of Expediting COVID-19 Testing and Vaccine Development – Government Accountability Office WatchBlog

Herd immunity for COVID-19 – GAO Science and Tech Spotlight

COVID-19 vaccine development – GAO Science and Tech Spotlight

Review of the federal response to COVID-19 – GAO WatchBlogHighlights

How prepared are we for a pandemic? – GAO WatchBlog

Novel Coronavirus 2019: Global Implications and Responses – Congressional Research Service In Focus

Coronaviruses – GAO Science and Tech Spotlight

US faces long-standing challenges related to defending against biological threats – GAO Highlights

Capabilities and challenges of technologies to enable rapid diagnoses of infectious diseases – GAO Highlights

Presidential authority to mobilize US industry to mitigate coronavirus – CRS Insight

COVID-19: Current Travel Restrictions and Quarantine Measures – CRS Legal Sidebar

Primer on the World Health Organization – CRS In Focus

Deep dives

Development and Regulation of Medical Countermeasures for COVID-19 – CRS Report

COVID-19: Opportunities to Improve Federal Response and Recovery Efforts – GAO Report

Overview of US Domestic Response to the COVID-19 Novel Coronavirus – CRS Report

Additional Efforts Would Enhance Likelihood of Effective Implementation of US National Biodefense Strategy – GAO Report

US faces long-standing challenges related to defending against biological threats – GAO Report

Capabilities and challenges of technologies to enable rapid diagnoses of infectious diseases – GAO Report

Exploring Lessons Learned from a Century of Outbreaks: Readiness for 2030 – National Academies of Sciences, Engineering, and Medicine Report

Global Health Risk Framework: Resilient and Sustainable Health Systems to Respond to Global Infectious Disease Outbreaks – NASEM Report

Supplemental resources

Press clips

There’s a legitimate way to end coronavirus vaccine trials early, Fauci says – CNN piece

US FDA to bring outside experts to review COVID-19 vaccines – Reuters piece

Inside Trump’s pressure campaign on federal scientists over a COVID-19 treatment – Washington Post piece

Moderna failed to disclose federal support in vaccine patents, researchers say – Washington Post piece

Coronavirus missteps from CDC and FDA worry health experts – NBC News piece

It has come to this: Ignore the CDC – New York Times opinion piece

One-third of Americans would refuse coronavirus vaccine, survey finds – South China Morning Post piece

US won’t join global coronavirus vaccine effort after WHO fallout – Yahoo News piece

Congressional correspondence

Senate Health, Education, Labor, and Pensions Committee Democrats call on Chair Alexander (R, TN) and Ranking Member Murray (D, WA) to hold a hearing on the independence of US health and science agencies.

House Energy and Commerce Committee Chair Frank Pallone, Jr. (D, NJ-06), Subcommittee on Health Chair Anna G. Eshoo (D, CA-18), and Subcommittee on Oversight and Investigations Chair Diana DeGette (D, CO-1) call on the Food and Drug Administration to authorize or approve a COVID-19 vaccine based on science and the protection of public health, not political expediency.

Bipartisan bills

Ensuring Access to COVID-19 Preventive Care Act of 2020, H.R.6231

Cure the Coronavirus Act, H.R.6019

Coronavirus Relief Fund Flexibility Act, S.3638

Coronavirus Community Relief Act, H.R.6467

Coronavirus Worker Relief Act, H.R.6207

2020 Coronavirus Preparedness and Response Supplemental Appropriations Act, H.R.6074

Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S.1379

Health Care Workforce Protection Act of 2019, H.R.4982

National Strategy for Pandemic Influenza Update Act, H.R.5730

Science. Policy. Service. Progress.

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