{"id":56907,"date":"2021-03-21T07:25:59","date_gmt":"2021-03-21T11:25:59","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=56907"},"modified":"2021-03-21T07:25:59","modified_gmt":"2021-03-21T11:25:59","slug":"federal-law-experimental-covid-19-vaccines-cannot-be-made-mandatory-under-emergency-use-authorization","status":"publish","type":"post","link":"https:\/\/stateofthenation.co\/?p=56907","title":{"rendered":"FEDERAL LAW<\/b>: Experimental COVID-19 Vaccines Cannot Be Made Mandatory Under \u201cEmergency Use Authorization\u201d"},"content":{"rendered":"

Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA<\/h1>\n

By Aaron Siri
\nSTAT<\/p>\n

E<\/span><\/span>ver since the Food and Drug Administration granted emergency use authorization for two new vaccines, employers, schools, and other organizations\u00a0are grappling<\/a>\u00a0with whether to require Covid-19 vaccination.<\/p>\n

While organizations are certainly free to encourage their employees, students, and other members to be vaccinated, federal law provides that, at least until the vaccine is licensed, individuals must have the option to accept or decline to be vaccinated.<\/p>\n

Knowing what an organization can or cannot do with respect to Covid-19 vaccines can help them keep their employees, students, and members safe and also save the them from costly and time-consuming litigation.<\/p>\n

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Much remains unknown about the safety and efficacy of the vaccine<\/h2>\n

Even though the FDA granted\u00a0emergency use authorizations<\/a>\u00a0for the\u00a0Pfizer\/BioNTech<\/a>\u00a0and\u00a0Moderna<\/a>\u00a0vaccines in December 2020, the clinical trials the FDA will rely upon to ultimately decide whether to license these vaccines are still underway and are designed to last for approximately\u00a0two<\/a>\u00a0years<\/a>\u00a0to collect adequate data to establish if these vaccines are safe and effective enough for the FDA to license.<\/p>\n

The abbreviated timelines for the emergency use applications and authorizations means there is much the\u00a0FDA<\/a>\u00a0does<\/a>\u00a0not<\/a>\u00a0know<\/a> about these products even as it authorizes them for emergency use, including their effectiveness against asymptomatic infection, death, and transmission of SARS-CoV-2, the virus that causes the disease.<\/p>\n

Given the uncertainty about the two vaccines, their EUAs are explicit that each is \u201can investigational vaccine not licensed for any indication\u201d and require that all \u201cpromotional material relating to the Covid-19 Vaccine clearly and conspicuously \u2026 state that\u00a0this product has not been approved or licensed by the FDA<\/strong>, but has been authorized for emergency use by FDA\u201d (emphasis added).<\/p>\n

EUAs are clear: Getting these vaccines is voluntary<\/h2>\n

The\u00a0same section<\/a>\u00a0of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to \u201censure that individuals to whom the product is administered are informed \u2026 of the option to accept or refuse administration of the product.\u201d<\/p>\n

Likewise, the\u00a0FDA\u2019s guidance<\/a>\u00a0on emergency use authorization of medical products requires the FDA to \u201censure that recipients are informed to the extent practicable given the applicable circumstances \u2026 That they have the option to accept or refuse the EUA product \u2026\u201d<\/p>\n

In the same vein, when Dr. Amanda Cohn, the executive secretary of the CDC\u2019s Advisory Committee on Immunization Practices, was asked if Covid-19 vaccination can be required,\u00a0she responded<\/a>\u00a0that under an EUA, \u201cvaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won\u2019t be able to be mandatory.\u201d Cohn later affirmed that this prohibition on requiring the vaccines\u00a0applies to organizations, including hospitals<\/a>.<\/p>\n

The EUAs for both the\u00a0Pfizer\/BioNTech<\/a>\u00a0and\u00a0Moderna<\/a>\u00a0vaccines require facts sheets to be given to vaccination providers and recipients. These fact sheets make clear that getting the vaccine is optional. For example, the one for recipients states that, \u201cIt is your choice to receive or not receive the Covid-19 Vaccine,\u201d and if \u201cyou decide to not receive it, it will not change your standard of medical care.\u201d<\/p>\n

What this means in practice<\/h2>\n

When the FDA grants emergency use authorization for a vaccine, many questions about the product cannot be answered. Given the open questions, when Congress granted the authority to issue EUAs, it chose to require that every individual should be allowed to decide for himself or herself whether or not to receive an EUA product. The FDA and CDC apparently consider this fundamental requirement of choice important enough that even during the height of the Covid-19 pandemic they reinforced that policy decision when issuing their guidance related to the Covid-19 vaccines.<\/p>\n

This means that an organization will likely be at odds with federal law if it requires its employees, students or other members to get a Covid-19 vaccine that is being distributed under emergency use authorization.<\/p>\n

State law often prohibits retaliating against an employee for refusing to participate in a violation of federal law. Organizations that require Covid-19 vaccination in violation of federal law may face lawsuits under these state laws not only to block the policy but also for damages and attorneys\u2019 fees. Such potentially costly lawsuits can be avoided by refraining from adopting policies that require vaccination or penalize members for choosing not to be vaccinated.<\/p>\n

Organizations are free to encourage vaccinations through internal communications, through educational events, and through other measures to urge employees to be vaccinated. They can take these measures so long as: (1) they are not viewed as coercive, (2) the organization makes clear the decision regarding whether to receive the vaccine is voluntary, and (3) the measures comply with the requirements in the EUAs and the related regulations for these products.<\/p>\n

People across the world have had their lives upended during the last year. The urgency to return to normalcy is felt deeply by many. As decision-makers at organizations decide on their Covid-19 vaccination policy, they should be careful to not let this passion lead the organization to run afoul of the law.<\/p>\n

Aaron Siri is the managing partner at\u00a0<\/em>Siri & Glimstad LLP<\/em><\/a>, a complex civil litigation firm with its principal office in New York City. This article is not intended to provide legal advice but to offer broad and general information about the law.<\/em><\/p>\n

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Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-56907","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/56907","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=56907"}],"version-history":[{"count":0,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/56907\/revisions"}],"wp:attachment":[{"href":"https:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=56907"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=56907"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=56907"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}