Congressional Science Policy Initiative

Committee hearing resource | House Energy and Commerce

Send in your ideas to help Congress question officials from COVID-19 vaccine-makers AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer.

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, therapeutics, and diagnostics – medical countermeasures (MCMs) – are key to stopping the deadly COVID-19 pandemic.

The House Energy and Commerce Subcommittee on Oversight and Investigations is holding a hearing to question officials from five COVID-19 vaccine companies: AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer.

The Committee wants to hear your thoughts on research and development processes, safety and efficacy standards, manufacturing and distribution strategies, business practices, drug pricing, corporate transparency, vaccines and therapeutics, or coordination between the public and private sectors, 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.

House Energy and Commerce Subcommittee on Oversight and Investigations hearing: Examining the companies making potential COVID-19 vaccines

Tuesday, July 21st at 10am ET

Dr. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca

Dr. Macaya Douoguih, Head of Clinical Development and Medical Affairs, Janssen Vaccines, Johnson & Johnson

Dr. Julie Gerberding, Executive Vice President and Chief Patient Officer, Merck

Dr. Stephen Hoge, President, Moderna

Dr. John Young, Chief Business Officer, Pfizer

Evidence-based sample questions for lawmakers to 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 Friday 7/17/2020.

Realistically communicating vaccine availability to the public

There is great excitement and hope for a COVID-19 vaccine by the end of 2020 or early 2021, and we have seen some encouraging results in small-scale preliminary trials. However, in an interview with the Harvard Business School, Merck CEO Kenneth Frazier said officials are doing a “grave disservice” to the public by talking up the potential for vaccines later this year because there are massive scientific and logistical obstacles to achieving such a feat.

What should be communicated to the American people regarding the likelihood and timing of a safe and effective vaccine that will be broadly available to the public?

Follow-up: If available, how do we ensure the vaccine reaches the communities most affected by COVID-19, i.e. healthcare workers, essential workers, minority 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 your companies 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 are your companies doing to mitigate the risk of SARS-CoV-2 vaccines losing efficacy as a result of new emerging viral strains, which could lead to the coronavirus becoming seasonal? Please describe.

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 will be 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 how your companies are plugged into and coordinating with the US strategy to distribute successful COVID-19 vaccines to Americans quickly and equitably. Please explain the country’s vaccine distribution plan, and your companies’ participation in developing that plan.

Follow-up: How will your companies 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 your research and development teams 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 COVID-19 vaccine candidates.

Last week, “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 National Institutes of Health director Dr. Francis Collins. For his part, Dr. Collins says 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 your companies’ vaccines be used in human challenge trials? Are human challenge trials ethical? Please explain.

Risk of unproven vaccine technology

All of your 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 plainly 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.

Your five companies were selected as Operation Warp Speed finalists. What is your understanding of the basis for a vaccine 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?

Follow-up: Please describe your company’s engagement with Operation Warp Speed. Has there been effective communication? Do you have dedicated points of contact? Are those individuals government employees, contractors, outside advisors, etc.? Please explain.

Protecting health care workers

Tragically, around 600 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.

Partnerships between companies to counter COVID-19

Along with the steroid dexamethasone, remdesivir is one of two drugs that have been shown to help some categories of COVID-19 patients in randomized controlled clinical trials.

Remdesivir is in short supply. For example, as of July 10, Texas had 10,002 hospitalized patients with COVID-19, but the most recent remdesivir shipment headed to Texas only had enough remdesivir for about 3,507 patients. Florida had 6,974 patients, but only enough for 2,733; California had 7,896 patients but only enough for 2,080; Arizona had 3,432 hospitalized patients but enough for 2,080 patients.

Back in May, Gilead – the company that developed remdesivir – licensed the manufacturing of the drug to five generic pharmaceutical companies in India and Pakistan to expand supply for developing countries. Are your companies, or other US-based companies, engaging with Gilead to help ramp up production of remdesivir? Why or why not?

Follow-up: How would you improve the coordination between different companies, and between the public and private sectors, on developing COVID-19 vaccines and therapeutics, and deploying them?

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

Last week, 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 requires hospital workers to enter COVID-19 patient data manually, and the change moves away from a platform that stakeholders are familiar with in the middle of the pandemic.

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? Could this change affect the country’s ability to distribute COVID-19 vaccines equitably?

BARDA suspensions of research into COVID-19 treatments

In June, BARDA “abruptly notified companies and researchers that it was halting funding for treatments for” severe lung impacts of COVID-19.

BARDA also suspended its calls for research proposals into pre- or post-exposure prophylactic treatments for SARS-CoV-2, and ventilators.

Were any of your companies’ COVID-19-related research and development programs, or those of your industry colleagues, setback by this move by BARDA? Please explain.

Follow-up: Do you have any insight into how BARDA’s decisions to suspend this research were made?

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 your companies helping to communicate with the American public about participating in the national effort to counter COVID-19?

Follow-up: How will you 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.

Cost of COVID-19 therapies

Remdesivir is one of only two drugs that have been shown to have any positive impacts whatsoever on COVID-19 patient outcomes.

Gilead Sciences announced that the price for a typical treatment course of remdesivir will be $2,340 for people covered by government health programs and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance plans, income, and other factors.

What is your response to that? Should Americans have to be concerned about the financial aspects of seeking treatment during a pandemic? Do you pledge that your companies will price COVID-19-related and other medicines fairly, to ensure access for all? Please explain.

Airborne spread of COVID-19

A recent assessment signed by 239 scientists stresses the risk of airborne spread of COVID-19.

The researchers emphasize that infected people – many of whom do not show symptoms – produce virus-carrying microdroplets when they breathe out, talk, or cough. These small droplets don’t fall to the ground within six feet, but rather travel longer distances and remain suspended in air. This is particularly problematic for indoor spaces with limited ventilation.

What is your reaction to the risk of airborne transmission of COVID-19? Does this add urgency to your companies’ pursuit of COVID-19 vaccines?

Follow-up: The 239 scientists argued that the guidance from numerous international and national bodies, like the World Health Organization, is insufficient to provide protection from virus-carrying respiratory microdroplets released into the air by infected people.

Was the WHO’s acknowledgement at the end of last week that airborne transmission of COVID-19 may occur powerful enough? How should the risk of airborne spread of COVID-19 impact the guidance from public health organizations like the WHO, or the CDC, for that matter?

Political interference undermining public health

Close to 350 public health organizations, advocacy groups, and local health departments have expressed their concerns that the Administration is “sidelining its own experts [at the Centers for Disease Control and Prevention] and undermining trust in public health officials across the country.” Their letter to Health and Human Services Secretary Alex Azar urged him “to play a more prominent role in shielding the CDC from political interference.”

Please explain how the CDC needs to be more fully leveraged by the Administration to optimally support your work, or the overall US response to COVID-19.

Follow-up: Please describe in what ways public health officials, or perhaps you or your colleagues, may have been undermined by the actions of the Administration.

Unequal impacts of COVID-19

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

Have your companies taken 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

The federal government has poured $10 billion into Operation Warp Speed – Politico piece

COVID-19 vaccines and antibodies advance even faster than expected – Chemical and Engineering News piece

Top US scientists left out of White House selection of COVID-19 vaccine short list – Science piece

Scientists worry ‘Operation Warp Speed’ is missing tried and true vaccines – CNN piece

Trump pushing officials to speed up already-ambitious coronavirus vaccine timeline – Washington Post piece

Operation Warp Speed names 5 COVID-19 vaccine candidates – CIDRAP News piece

Operation Warp Speed selects billionaire scientist’s COVID-19 vaccine for monkey tests – Science piece

How to prepare for a coronavirus pandemic – Foreign Affairs piece

The next plague is coming. Is America ready? – The Atlantic piece

Congressional correspondence

Letter from three leaders on the House Energy and Commerce Committee calls for the Trump Administration to justify US withdrawal from the World Health Organization

Letter from Senator Hirono (D, HI) calling for transparency and accountability during Operation Warp Speed vaccine development

Letter from Senators Warren (D, MA) and Blumenthal (D, CT) and Representative Jayapal (D, WA-7) to Secretary Azar of the Department of Health and Human Services expressing concerns about potential conflict of interest of the chief adviser for Operation Warp Speed

Letter from a bipartisan group of Members of Congress to House Democratic Leadership about the need for needles and syringes for COVID-19 vaccines

Letter from a bipartisan group of Members of Congress to the Centers for Disease Control about the dissemination of novel coronavirus diagnostic tools to state and local jurisdictions

Letter from 31 Democratic Senators to Department of Health and Human Services regarding the US response to the novel coronavirus outbreak

Letter from Senator Markey (D, MA) to the National Institute of Allergy and Infectious Diseases about novel coronavirus vaccine development efforts

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

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