S. 1932 (117^th): No Vaccine Passports Act

In December 2019, reports began circulating that hospitals in Wuhan, China were seeing cases of a pneumonia-like respiratory illness of unknown origins.

On December 31, 2019, an automated translation of a Chinese media report about a novel respiratory outbreak was posted to ProMED, one of the largest public emerging disease and outbreak reporting systems used to promote communication among infectious disease specialists, including scientists, physicians, veterinarians, epidemiologists, and public health professionals.

The ProMED posting prompted the World Health Organization (WHO) to instruct its China Country Office to request verification of the outbreak from the communist government of the People’s Republic of China.

In response to the WHO-prompted inquiry, the Wuhan Municipal Health Commission issued its first public statement on the outbreak, saying it had identified 27 cases.

On January 3, 2020, in what is clear conduct by the Chinese government to cover up the origins and dangers posed by the outbreak, Dr. Li Wenliang, a physician at Wuhan Central Hospital, was reprimanded by local police in the Public Security Bureau for spreading allegedly false statements about the outbreak online.

On January 3, 2020, the Chinese Center for Disease Control and Prevention (China CDC) Director-General Gao Fu told the United States Centers for Disease Control and Prevention (United States CDC) Director Robert Redfield about a pneumonia outbreak in Wuhan, Hubei Province, China.

On January 6, 2020, the United States Department of Health and Human Services (HHS) Secretary Alex M. Azar II and United States CDC Director Redfield offered to send United States CDC experts to China, and United States CDC issued a Watch Level 1 Alert for Wuhan, meaning that the CDC recognized a heightened risk for travelers, cautioning travelers to use health precautions when traveling to areas in China.

On January 11, 2020, a team led by Professor Yong-zhen Zhang of Fudan University in Shanghai posted the genetic sequence of the novel virus on an open-access platform, sharing it with the world.

On January 14, 2020, the WHO tweeted, Preliminary investigations conducted by the Chinese authorities have found no clear evidence of human-to-human transmission of the novel coronavirus (2019–nCoV) identified in Wuhan, China. The WHO’s assertion has been proven false and completely contrary to medical science given that there have been nearly 163,000,000 cases of infection worldwide, resulting in more than 3,380,000 deaths.

On January 20, 2020, China confirmed person-to-person transmission of the novel coronavirus and infections among medical workers.

On January 21, 2020, the United States CDC announced the first COVID–19 case in the United States.

On January 30, 2020, WHO Director-General Tedros declared the epidemic a Public Health Emergency of International Concern, and President Donald J. Trump announced the formation of the President's Coronavirus Task Force. In a statement from the WHO regarding the second meeting of its International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019–nCoV), the Committee specifically did not recommend any travel or trade restriction based on the current information available.

On January 31 2020, President Trump suspended entry into the United States of most foreigners who were physically present in mainland China during the preceding 14-day period, effective February 2, 2020, and Secretary Azar declared a public health emergency for the United States to aid response to the novel coronavirus.

On February 1, 2020, then-presidential candidate Joe Biden recklessly downplayed the risk of the virus, suggesting in a tweet that President Trump’s efforts to limit the spread of the virus were nothing more than hysteria, xenophobia, and fear-mongering.

Numerous individuals criticized these travel restrictions. When asked if you had to, would you close down the borders? to stop the spread of coronavirus, Senator Bernie Sanders said, no. When asked about these travel restrictions, Representative Nancy Pelosi stated, [a]ctually tens of thousands of people were allowed in from China, it wasn't as it was described as this great moment. WHO Director-General Tedros Adhanom Ghebreyesus was reported to say that widespread travel bans and restrictions were not needed to stop the outbreak and could have the effect of increasing fear and stigma, with little public health benefit. Reportedly, Representative Ami Bera stated that the travel ban probably doesn’t make sense since the outbreak had already spread to several other countries, that such measures were causing an antagonistic relationship with the Chinese, and such mandatory quarantines may be overkill.

Health experts have since noted that the early United States restrictions imposed on travelers from China saved American lives. Former CDC director Dr. Tom Frieden noted that [t]he travel ban with China made a difference … It resulted in a significant delay in the number of people coming in with infection and because of that, that bought time in the U.S. to better prepare.. While testifying before the House of Representatives, Dr. Anthony Fauci was asked if he believed that the travel restrictions saved lives, to which Dr. Fauci answered, yes, I do.

On February 26, 2020, United States CDC confirmed a case of COVID–19 in California in a person who reportedly did not have relevant travel history or exposure to another known patient with COVID–19.

On February 29, 2020, United States CDC reported the first COVID–19 death in United States, though later public reports indicated that the first death from COVID–19 may have been weeks earlier.

In a 60 Minutes interview posted on March 8, 2020, Dr. Anthony Fauci stated that right now in the United States, people should not be walking around with masks … there’s no reason to be walking around with a mask. When you’re in the middle of an outbreak wearing a mask might make people feel a little bit better, and it might even block a droplet, but it’s not providing the perfect protection that people think that it is. And often, there are unintended consequences, people keep fiddling with the masks, and they keep touching their face … But, when you think masks, you should think of healthcare providers needing them and people who are ill. The people who, when you look at the films of foreign countries and you see eight-five percent of the people wearing masks, that’s fine. That’s fine. I’m not against it. If you want to do it, that’s fine … It could lead to a shortage of masks for the people who really need it..

On April 3, 2020, United States CDC updated its guidance on facial coverings, recommending that Americans wear facial coverings in public settings and especially when social distancing measures are difficult to maintain.

On May 15, 2020, the Trump administration announced the establishment of Operation Warp Speed, a public-private partnership to expedite the timeline for development, large scale manufacturing, and delivery of a safe and effective COVID–19 vaccine to the American public. The initial goal of the project was to develop at least 1 vaccine and begin administering it to Americans before the end of 2020. As reported on BioCentury, Dr. Anthony Fauci noted that the fastest a vaccine might be ready for use in an emergency would be 1 year, although the process could take up to 2 years. Before the Senate on March 3, 2020, Dr. Fauci stated that the process would likely take at least 1 to 11/2 years to have a vaccine that could be administered to American persons. Some, such as the analytics firm Clarivate, concluded that it might take at least 5 years for the leading vaccine candidates, like Moderna, to complete the development process through full regulatory approval.

Operation Warp Speed and other government actions sped COVID–19 vaccine development by enabling typical vaccine development steps to be taken simultaneously with manufacturing and distribution planning. As part of these actions, the Federal Government made investments in critical manufacturing capacity, giving pharmaceutical companies confidence that if they invested in developing a vaccine, once the vaccine received authorization from the Food and Drug Administration, these companies would be able to immediately begin distributing the vaccine.

Despite efforts to speed vaccine development to address the COVID–19 pandemic, the emergency use authorization (EUA) process utilized by the Food and Drug Administration (FDA) appears to have met rigorous safety and efficacy standards.

On July 14, 2020, United States CDC issued stronger recommendations to wear masks as a strategy for preventing the spread of COVID–19. United States CDC Director Robert Redfield, in a news release from the agency, identified masks as one of the most powerful weapons we have to slow and stop the spread of the virus.

On December 11, 2020, the FDA issued the first EUA for a vaccine for the prevention of COVID–19 in individuals 16 years of age and older. The EUA allowed the Pfizer-BioNTech COVID–19 Vaccine to be distributed in the United States.

On December 18, 2020, the FDA issued an EUA for the second vaccine for the prevention of COVID–19 in individuals 16 years of age and older. The EUA allowed the Moderna COVID–19 Vaccine to be distributed in the United States for use in individuals 18 years of age and older.

On February 27, 2021, the FDA issued an EUA for the third vaccine for the prevention of COVID–19. The EUA allowed the Janssen COVID–19 Vaccine to be distributed in the United States for use in individuals 18 years of age and older.

Because of the hard work of countless Americans, this public-private partnership, and the funding and support from Congress, multiple safe and effective COVID–19 vaccines have been, and are still being, developed and manufactured, and, as of May 16, 2021, about 273,000,000 vaccine doses had been administered in the United States.

Despite the successful development and rollout of the current COVID–19 vaccines, it is not fully known whether these vaccines will protect people from the emergence and potential future emergence of variants of SARS–CoV–2, the virus that causes COVID–19.

The emergence of future variants of SARS–CoV–2 could require that the United States continue to develop new COVID–19 vaccines and that people receive a COVID–19 booster shot on a regular, potentially annual, basis to maintain immunity.

According to the FDA fact sheets on COVID–19 vaccines, there are certain populations for whom existing COVID–19 vaccines are not indicated or authorized or for whom there is insufficient data to inform vaccine-related risks including—

Because of potential risks that the vaccine poses to certain people, it is important that every patient is able to consult his or her doctor to determine whether one of the COVID–19 vaccines is appropriate for that patient.

Consistent with fundamental human rights, and medical and legal ethics and proper standards of medical care, every American has the right to informed consent with respect to medical treatment, meaning that he or she has a right to be fully informed about the nature of his or her health care and to participate in and voluntarily make decisions related to his or her care. In addition, every patient has a right to medical privacy to expect that the decisions and nature of care will be kept confidential by his or her health care provider and anyone who has access to the individual’s medical records, including vaccination records.

At various times in history, governments and medical professionals have violated these and other inherent rights including by coercing patients, failing to properly inform patients of, or even intentionally begin deceptive with patients about, their rights and the risks inherent with various medical procedures, experiments, and studies—including the Tuskegee syphilis experiments, forced sterilization, lobotomy procedures, electro-shock therapy, certain psychological studies, collection and utilization of individuals’ cells and parts of their body, or from fetal tissue of a patient’s offspring, without knowledge or consent, and eugenics laws.

The absence of informed consent not only constitutes a violation of medical ethics and standards of care, in some cases, treatment may also constitute a crime, such as battery.

Criminal battery stemming from violations of medical ethics and informed consent standards have led to a significant degree of distrust of the government, public health officials, and medical professionals by certain groups and communities including among the most vulnerable populations such as ethnic minorities, immigrants, economically disadvantaged, unmarried mothers, those with disabilities, and those with mental illnesses.

On January 12, 2021, United States CDC issued an order requiring proof of a negative COVID–19 test for all air passengers arriving from a foreign country to the United States, and on February 14, 2021, the United States CDC announced it would not recommend required testing for domestic air travel.

On March 19, 2021, the WHO released draft recommendations for a Smart Vaccine Certificate—what amounts to a form of a vaccine passport that would, per WHO’s Smart Vaccination Certificate Working Group, support COVID–19 vaccine delivery and monitoring and to serve current and future requirements, toward the dual purposes of (1) supporting continuity of care; and (2) cross-border uses.

The International Air Transport Association has developed the Travel Pass Initiative to gather information on entry and exit testing requirements, allow passengers to create a digital passport that verifies testing and vaccination status, and establish the capability of sharing health data with government authorities.

The European Commission has proposed a Digital Green Certificate on March 17, 2021, to prove a passenger’s vaccination status, test results, and COVID–19 antibodies that may be adopted by a country for public health restrictions.

The State of New York is testing a vaccine certification to be used for admission into public events.

More than 225 companies and organizations are involved in what is known as the Vaccination Credential Initiative, a program intended to establish standards for developers to build digital vaccine passports.

On April 2, 2021, the United States CDC announced vaccinated people could travel safely. On April 5, 2021, the United States CDC recommended, but did not require, passengers to be vaccinated, though cruise ships are still not permitted to resume normal operations.

The White House, while saying the COVID–19 Task Force will not create a vaccine passport, has engaged in a multi-agency coordination effort led by the Office of the National Coordinator for Health Information Technology to develop criteria and principles for a vaccine passport created by the private sector.

The private sector, which includes many large technology companies that previously have shown disregard for privacy and a willingness to engage in censorship of Americans while bowing to the will of the Chinese Communist party, are pursuing digital vaccine passports that can be adopted by governments and other public establishments to authenticate personal health information.

During a March 2, 2021, virtual meeting lead by the Federal Health IT Coordinating Council on behalf of the Biden Administration, a slide presentation included the following: Proof of individual COVID-related health status is likely to be an important component of pandemic response, proof of immunization will likely become a major, if not the primary, form of health status validation, and a unified Federal approach [is] required to ensure Federal activities are working toward the same common goals for vaccine [passports]. Additionally, the presentation suggested the Biden Administration expects that Federal entities would likely require vaccine verification for a variety of purposes and that the Federal government will inevitably be involved with vaccine credential solutions … ..

The Federal Health IT Coordinating Council also listed a number of international organizations and private companies that are working on the development of vaccine passports.

The development, implementation, and utilization of vaccine passports, whether by Federal or State government, or the private sector, has the potential for significant misuse and abuse, leading to the denial of constitutionally protected freedoms such as freedom of association and freedom of movement, and could allow the government or corporate interests to begin to track people’s health status on a large-scale basis.

There currently exists no clear regulatory framework to fully protect the privacy of United States citizens and United States nationals with respect to their vaccination records and negative COVID–19 test results.

The widespread utilization of vaccine passports will certainly lead to discrimination by businesses that provide public accommodations as they could begin to require a customer to demonstrate his or her health status, through the presentment of a vaccine passport or other papers or by requiring that the customer disclose his or her protected health information, before the business agrees to serve or otherwise do business with such individual, meaning the denial of service in such cases could be based on an individual’s disability, health status, or familial status, such as a restaurant denying service to a man who has not been vaccinated based on the advice of his doctor due to a previous anaphylaxis (allergic) reaction to an ingredient found in the COVID–19 vaccines.

The widespread acceptance of vaccine passports could also lead to employment discrimination, where employers take adverse employment actions against employees who are not vaccinated because of an underlying health condition and without regard to the Americans with Disabilities Act of 1990 (42 U.S.C. 12101 et seq.) (ADA), which requires an interactive process whereby the employer follows the law to assess if the employee can and should be reasonably accommodated under the ADA. For example, without proper disability protections, an employer could terminate a female employee who has not been vaccinated based on the advice of her doctor simply because she is pregnant.

In February 2021, a business in New York told its employees that the business was instituting a vaccine mandate and, when a woman who worked there decided against getting a COVID–19 vaccine because she was trying to get pregnant, she was told her employment was being terminated.

In March 2021, a woman in Cumberland County, Pennsylvania was suspended from her job after her employer issued a vaccine mandate for its employees. The woman, who said she is not anti-vaccination, wanted sufficient time to consult with her doctor to see if the vaccine was appropriate for her.

For women who are pregnant or breastfeeding, the CDC has indicated that the potential risks of COVID–19 vaccines to the pregnant person and the fetus are unknown because these vaccines have not been studied in pregnant people. Accordingly, it is highly likely that the implementation and use of vaccine passports, refusal to provide services to unvaccinated persons, and decision by employers to impose a vaccine mandate and to take adverse employment actions against unvaccinated employees, are likely to be unfair and discriminatory, disparately impacting women because of their sex.

Given that several COVID–19 vaccines are not recommended for children under the age of 12, the implementation and widespread utilization of vaccine passports could lead to the refusal to provide services to unvaccinated persons, such as the denial of services to families with small children, meaning certain vaccine-related policies could lead to age or familial-status-related discrimination.

The denial of public services and public accommodations, as well as adverse employment actions, based on COVID–19 vaccination status, lack of or refusal to present a vaccine passport, refusal to get vaccinated, or requiring an individual to explain the underlying reason why they are not vaccinated, could constitute unlawful discrimination, including as to sex, age, familial status, disability, or based on genetic or other health condition.

Any United States person that requests the vaccine records of a United States individual, including data such as a copy or other digital record of a vaccine passport or similar proof of vaccination, should be regarded as having collected protected health information and should be regarded as a covered entity as defined under the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191).

The policy of the United States is to recognize, defend, and protect the inherent rights of the individual, including the right to privacy, the right of liberty, the right to be secure in one’s person, the right of the individual to be informed about any medical procedures, treatment, or vaccination, and the right of the individual to provide or withhold consent to such procedures, treatment, or vaccination.

Congress recognizes that special vigilance is required, especially in times of crisis or emergency to ensure that government agencies do not try to take advantage of, manipulate, or enflame public fear, stoke hatred of minority groups, or increase intolerance toward the diversity that builds our Nation.

Congress finds that there is a clear need for the Federal Government to take specific action to restore public trust by protecting the privacy and voluntary informed consent rights of patients specifically regarding vaccinations and an individual’s vaccination records.

Furthermore, the protection of such individual rights to make one’s own medical decisions in consultation with his or her health care provider without fear of coercion, forced vaccination, loss of civil liberties, or risk of adverse employment action is especially needed at a time when it is critical for our Nation to increase public trust in vaccinations and increase vaccination rates in order to end the COVID–19 pandemic.