Hall Render Blog: Vaccine Consternation – Should COVID-19 vaccines be required?
06/11/2021
The following is a blog posted by DFW Hospital Council Associate Member Hall Render. For questions, please contact Chris Wilson at chrisw@dfwhc.org.
After more than a year of global turmoil resulting from the COVID-19 pandemic, a light at the end of the tunnel is beginning to emerge. So far this year, several drug manufacturers, including Pfizer, Moderna and Johnson & Johnson, have manufactured and distributed hundreds of millions of COVID-19 vaccine doses all over the world, especially in the United States.
However, just as the vaccine has become more prevalent, so has a general aversion to the vaccine from some in the public. Questions are being raised at the individual and local level as to whether it is actually safe to get vaccinated, or whether vaccination will be mandated now that the vaccine is becoming more and more widely available.
Many people in the U.S. have stated that they refuse to receive the vaccine, giving various religious, ethical and medical reasons for not doing so. Additionally, many individuals have cited the vaccine’s investigational drug status as a concern regarding whether it is actually safe to get the vaccine.
While the FDA and the Centers for Disease Control and Prevention (“CDC”) have publicly posted substantial information regarding the safety of receiving the vaccine, this widespread public skepticism remains.
The COVID-19 vaccines available in the U.S. currently operate under an Emergency Use Authorization (“EUA”) issued by the Food and Drug Administration (“FDA”). Under an EUA, the FDA can permit the public use of unapproved medical products to diagnose, treat or prevent serious or life-threatening diseases or conditions such as COVID-19 when certain legal and scientific criteria have been met, including that there are no other adequate, approved and available alternatives.
Therefore, the COVID-19 vaccines that are available are still technically investigational and unapproved drugs under FDA regulations. The vaccines, and their safety and efficacy, remain the subject of ongoing clinical research trials through which tens of thousands of individual clinical trial participants have volunteered to receive the vaccines and to be observed in their responses to the vaccines. It is this current investigational status that is a primary factor in many people refusing the current iteration of COVID-19 vaccines.
Many states and large segments of the public have also been outspoken about the position that mandating individuals to receive the vaccine would impinge on individual privacy and freedom.
The federal government has stated definitively that it will not mandate COVID-19 vaccinations that are publicly available under an EUA.1 This seems to be a reasonable stance given the vaccine’s investigational and unapproved status. Whether this stance will be the same once the vaccines are fully approved by the FDA remains to be seen, especially in light of the FDA’s position that, in certain circumstances, businesses may require their workers to receive a COVID-19 vaccination that is still under an EUA.
However, the ability of a business to mandate vaccination would be subject to individual state laws and other applicable laws that would restrict and/or permit such mandates. In light of this emerging issue, certain states have already began to legislate on the issue of COVID-19 vaccination mandates. Texas Governor Greg Abbott in particular has been extremely vocal about the fact that the COVID-19 vaccine will always be optional for Texas citizens. Putting this policy into action, the Texas House of Representatives has decided to be proactive with potential employment discrimination issues associated with the vaccine.
On March 9, 2021, the Texas House introduced House Bill 1687 which would effectively prevent Texas employers from hiring, firing or otherwise treating individuals differently in the employment context as a result of whether they have received a COVID-19 vaccination.2
Essentially, HB 1687 would make it unlawful for Texas employers to discriminate in the hiring of individuals based on their COVID-19 vaccine status. It is highly likely that other state legislatures will follow suit in trying to create laws dealing with the issue of COVID-19 related employment discrimination, especially those in southern “Red” states.
Another popular topic in the U.S. has been the question of whether “vaccine passports” may be required by businesses, governmental agencies, commercial airlines or other types of entities. Essentially, a vaccine passport would be personal documentation evidencing an individual’s COVID-19 vaccination status and would be a person’s “entry ticket” to places that require an individual be vaccinated, including anywhere from tourism hotspots, to businesses that individuals patronize on a daily basis.
Many state governors have been vocal about their stance on vaccine passports, often reducing the issue to a “conservative versus liberal” basis. These concerns often address the fact that vaccine passport requirements may naturally result in class separation and discrimination issues. Because vaccine passports are such a divisive issue, it is unlikely that many states will try to implement vaccine passport mandates.
It is possible that the federal government could try to impose some sort of vaccine passport at some level (mask-less transportation), but this still remains to be seen. Almost certainly, the issue of vaccine passport mandates would be dealt with at the individual business level as business owners determine how best to battle health risks associated with COVID-19 for their employees and patrons.
With all of this in mind, it is safe to say that no one really knows exactly how the federal government, state governments or individual businesses in general will handle potential COVID-19 vaccination mandates or vaccine passports. However, it is almost certain that no matter what changes or restrictions are put in place in the coming months and years, there will be substantial push-back and political discussion on the issue.
1Centers for Disease Control and Prevention, Workplace Vaccination Program (Mar. 25, 2021), https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/essentialworker/workplace-vaccination-program.html#Mandates.
2Tex. H.B. 1687, 87th Leg., R.S. (2021).
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
The following is a blog posted by DFW Hospital Council Associate Member Hall Render. For questions, please contact Chris Wilson at chrisw@dfwhc.org.
After more than a year of global turmoil resulting from the COVID-19 pandemic, a light at the end of the tunnel is beginning to emerge. So far this year, several drug manufacturers, including Pfizer, Moderna and Johnson & Johnson, have manufactured and distributed hundreds of millions of COVID-19 vaccine doses all over the world, especially in the United States.
However, just as the vaccine has become more prevalent, so has a general aversion to the vaccine from some in the public. Questions are being raised at the individual and local level as to whether it is actually safe to get vaccinated, or whether vaccination will be mandated now that the vaccine is becoming more and more widely available.
Many people in the U.S. have stated that they refuse to receive the vaccine, giving various religious, ethical and medical reasons for not doing so. Additionally, many individuals have cited the vaccine’s investigational drug status as a concern regarding whether it is actually safe to get the vaccine.
While the FDA and the Centers for Disease Control and Prevention (“CDC”) have publicly posted substantial information regarding the safety of receiving the vaccine, this widespread public skepticism remains.
The COVID-19 vaccines available in the U.S. currently operate under an Emergency Use Authorization (“EUA”) issued by the Food and Drug Administration (“FDA”). Under an EUA, the FDA can permit the public use of unapproved medical products to diagnose, treat or prevent serious or life-threatening diseases or conditions such as COVID-19 when certain legal and scientific criteria have been met, including that there are no other adequate, approved and available alternatives.
Therefore, the COVID-19 vaccines that are available are still technically investigational and unapproved drugs under FDA regulations. The vaccines, and their safety and efficacy, remain the subject of ongoing clinical research trials through which tens of thousands of individual clinical trial participants have volunteered to receive the vaccines and to be observed in their responses to the vaccines. It is this current investigational status that is a primary factor in many people refusing the current iteration of COVID-19 vaccines.
Many states and large segments of the public have also been outspoken about the position that mandating individuals to receive the vaccine would impinge on individual privacy and freedom.
The federal government has stated definitively that it will not mandate COVID-19 vaccinations that are publicly available under an EUA.1 This seems to be a reasonable stance given the vaccine’s investigational and unapproved status. Whether this stance will be the same once the vaccines are fully approved by the FDA remains to be seen, especially in light of the FDA’s position that, in certain circumstances, businesses may require their workers to receive a COVID-19 vaccination that is still under an EUA.
However, the ability of a business to mandate vaccination would be subject to individual state laws and other applicable laws that would restrict and/or permit such mandates. In light of this emerging issue, certain states have already began to legislate on the issue of COVID-19 vaccination mandates. Texas Governor Greg Abbott in particular has been extremely vocal about the fact that the COVID-19 vaccine will always be optional for Texas citizens. Putting this policy into action, the Texas House of Representatives has decided to be proactive with potential employment discrimination issues associated with the vaccine.
On March 9, 2021, the Texas House introduced House Bill 1687 which would effectively prevent Texas employers from hiring, firing or otherwise treating individuals differently in the employment context as a result of whether they have received a COVID-19 vaccination.2
Essentially, HB 1687 would make it unlawful for Texas employers to discriminate in the hiring of individuals based on their COVID-19 vaccine status. It is highly likely that other state legislatures will follow suit in trying to create laws dealing with the issue of COVID-19 related employment discrimination, especially those in southern “Red” states.
Another popular topic in the U.S. has been the question of whether “vaccine passports” may be required by businesses, governmental agencies, commercial airlines or other types of entities. Essentially, a vaccine passport would be personal documentation evidencing an individual’s COVID-19 vaccination status and would be a person’s “entry ticket” to places that require an individual be vaccinated, including anywhere from tourism hotspots, to businesses that individuals patronize on a daily basis.
Many state governors have been vocal about their stance on vaccine passports, often reducing the issue to a “conservative versus liberal” basis. These concerns often address the fact that vaccine passport requirements may naturally result in class separation and discrimination issues. Because vaccine passports are such a divisive issue, it is unlikely that many states will try to implement vaccine passport mandates.
It is possible that the federal government could try to impose some sort of vaccine passport at some level (mask-less transportation), but this still remains to be seen. Almost certainly, the issue of vaccine passport mandates would be dealt with at the individual business level as business owners determine how best to battle health risks associated with COVID-19 for their employees and patrons.
With all of this in mind, it is safe to say that no one really knows exactly how the federal government, state governments or individual businesses in general will handle potential COVID-19 vaccination mandates or vaccine passports. However, it is almost certain that no matter what changes or restrictions are put in place in the coming months and years, there will be substantial push-back and political discussion on the issue.
1Centers for Disease Control and Prevention, Workplace Vaccination Program (Mar. 25, 2021), https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/essentialworker/workplace-vaccination-program.html#Mandates.
2Tex. H.B. 1687, 87th Leg., R.S. (2021).
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.