Update: This post has been revised to use the term “Mpox” in place of “monkeypox.” This change is consistent with guidance issued by the World Health Organization and the U.S. Centers for Disease Control and Prevention.
Introduction
Due to a recent change to North Carolina’s minor’s consent law, a minor’s consent is no longer sufficient for a minor to receive a vaccine that has been granted an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) (hereinafter, an “EUA vaccine”). This change has implications for minors, the health care providers who serve them, and the use of vaccines as tools in responses to the COVID-19 pandemic, the Mpox outbreak, and future public health emergencies.
Background
In North Carolina, minors have the legal capacity to consent to receiving certain health services without the concurrent consent of a parent, guardian, or person standing in loco parentis. This authority is derived from G.S. 90-21.5, which is often referred to as “North Carolina’s minor’s consent law.” North Carolina is not unique in allowing minors to access specific health services on their own consent. All 50 states and the District of Columbia permit minors to consent to health services for sexually transmitted infections (STIs) and numerous states allow certain minors to consent to other health services such as immunizations, dental care, contraceptives, prenatal care, substance use treatment, and mental health care.
North Carolina’s minor’s consent law was passed in 1971 and at that time, allowed minors to consent to diagnosis and treatment for venereal and other reportable diseases. In 1977, the statute was amended to allow minors to consent to preventative services, not just diagnosis and treatment, as well as services related to pregnancy, alcohol and other substance use, and emotional disturbance.[1] The law has been revisited several times since then, but the majority of changes have not substantive in nature, until recently. In 2021, Section 9 of Session Law 2021-110 (the “Session Law”) amended G.S. 90-21.5 by carving out EUA vaccines from the minor’s consent framework.
What Does North Carolina’s Minor’s Consent Law Allow?
Generally, under North Carolina law, the consent of a parent, guardian, or person standing in loco parentis is required to provide health services to a minor, which is a person who is less than 18 years of age. There are exceptions to this requirement, one of which is set out in North Carolina’s minor’s consent law. Pursuant to G.S. 90-21.5(a), a minor has the legal capacity to consent to medical health services for the prevention, diagnosis, and treatment of venereal and other reportable diseases, pregnancy, abuse of controlled substances or alcohol, and emotional disturbance. However, a minor’s consent alone is not sufficient to authorize the minor’s receipt of an abortion or sterilization or non-emergency admission of the minor to a 24-hour facility for substance use or behavioral health services. G.S. 90-21.4 establishes protections for information about health services that are provided to minors under G.S. 90-21.5(a). It also establishes civil and criminal immunity for physicians who deliver care to minors in accordance with North Carolina’s minor’s consent law.
G.S. 90-21.5(a) applies only to unemancipated minors (who I will continue to refer to throughout this blog post simply as “minors”). Emancipated minors’ legal capacity to consent to medical health services for themselves and their children is set out in G.S. 90-21.5(b). In North Carolina, a minor who is 16 or 17 years of age may be emancipated by a court or by marriage. Emancipation is uncommon, and a minor who is seeking to access health services on their own consent and who claims to be emancipated should be able to provide proof of emancipation.
Additionally, the law only grants minors the legal capacity to consent to the types of health services described in the statute. A minor must still demonstrate the decisional capacity (sometimes called “competence”) to consent to care. G.S. 90-21.5(a) does not establish a minimum age at which minors are endowed with the legal capacity to consent, which means that minors should be presumed to have the legal capacity necessary to consent to receive the health services described in G.S. 90-21.5(a). In contrast, a minor’s decisional capacity is not presumed and must be assessed on a case-by-case basis.
How Did S.L. 2021-110, Sec. 9 Change North Carolina’s Minor’s Consent Law?
New Carve Out for EUA Vaccines
The Session Law carved out a subset of immunizations from the minor’s consent law by inserting a new Paragraph (a1) into the statute, which reads as follows:
“Notwithstanding any other provision of law to the contrary, a health care provider shall obtain written consent from a parent or legal guardian prior to administering any vaccine that has been granted emergency use authorization and is not yet fully approved by the United States Food and Drug Administration to an individual under 18 years of age.”
Prior to the introduction of this language, under G.S. 90-21.5(a) a minor could consent to receive an immunization for the prevention of a venereal or other reportable disease, regardless of whether the vaccine administered to the minor was under an EUA or approved. Since the Session Law went into effect, a minor’s consent is no longer sufficient for a minor to receive an EUA vaccine. Furthermore, administration of an EUA vaccine to a minor now requires the prior written consent of the minor’s parent or guardian.
Understanding “Authorized” (EUA) v. “Approved”
The new language in North Carolina’s minor’s consent law hinges on the distinction between vaccines that have been granted an EUA but are not “fully approved” by the FDA. But what does this mean? In the United States, the majority of newly developed drugs, tests, medical devices, and other medical products must be reviewed and approved by the FDA before they can be used. The process can look different depending on the product type, but FDA review and approval of a medical product often takes several months, or even years, to complete.
When a public health emergency strikes and there is a need for novel medical countermeasures, such as new vaccines or treatments, the FDA’s typical review and approval process may not be conducive to a timely and effective emergency response. In these situations, companies may submit an application asking the FDA to grant an EUA for a medical product that they have developed. EUAs can be granted only when the following criteria set out in 21 U.S.C. 360bbb-3 are met:
- The Secretary of the United States Department of Health and Human Services (HHS) has declared an emergency under Section 564 of the Federal Food, Drug, and Cosmetic Act that involves a serious or life-threatening situation;
- There is reasonable belief, based on the scientific evidence available, that the product for which an EUA is sought is effective at diagnosing, treating, or preventing the disease or condition involved in the declared emergency;
- The known benefits outweigh the known risks associated with the product given the material threat posed by the disease or condition involved in the declared emergency;
- There is no adequate, approved, and available alternative product; and
- Any other criteria that the HHS Secretary may prescribe have also been met.
If granted, an EUA can either allow the use of an unapproved product or a new use of an already approved product that was not contemplated when the product was previously given FDA approval. Once granted, EUAs are only effective for the duration of the underlying declared public health emergency.
Products that have successfully undergone the FDA’s typical process are described as “approved,” while products that have been granted an EUA are described as “authorized.” During the public health emergency caused by the COVID-19 pandemic, the FDA granted EUAs for COVID-19 vaccines as well as other medical products used to combat the disease, such as face masks, diagnostic tests, and monoclonal antibody treatments. Some of those products, including several vaccines, eventually obtained FDA approval. To many people, the difference between the terms “approved” and “authorized” is not immediately apparent, which may be why the phrase “fully approved” (which is not an official term used by the FDA) has taken hold during the COVID-19 pandemic.
Impacts of the Change in the Law: COVID-19, Mpox, and Beyond
The New Language is Limited to Vaccines
While the FDA can grant an EUA for a diversity of medical products, the new language in North Carolina’s minor’s consent law only applies to vaccines. This means that minors with decisional capacity can continue to access, on their own consent, the services described in G.S. 90-21.5(a) that may involve a product that has been granted an EUA as long as that product is not a vaccine.
Requirement for Written Consent of the Minor’s Parent or Guardian
If a minor’s consent alone is no longer sufficient to receive an EUA vaccine, does that mean that minors in North Carolina cannot access EUA vaccines at all? The answer is no. Per G.S. 90-21.5(a1), an EUA vaccine can be administered to a minor if the written consent of the minor’s parent or guardian is obtained beforehand.
Health care providers serving minors should take note of the difference between this requirement and G.S. 130A-153(d), which states that a parent, guardian, or person standing in loco parentis to a minor may consent to administration of a vaccine to the minor. Persons standing in loco parentis are not named in G.S. 90-21.5(a1), which is the more specific of the two statutes, and are therefore likely not authorized to give consent for the administration of an EUA vaccine to a minor.
Immediate Impacts During the COVID-19 Pandemic
The changes to North Carolina’s minor’s consent law for EUA vaccines went into effect on August 20, 2021. At that time, the only COVID-19 vaccines available to minors were still under EUAs. Prior to the Session Law, a minor with decisional capacity could consent to prevention (EUA vaccine), diagnosis (testing), and treatment for COVID-19, which is a reportable disease in North Carolina. When North Carolina’s minor’s consent law changed on August 20, 2021, minors with decisional capacity could still consent to diagnosis and treatment for COVID-19, but not to prevention of the disease by receipt of a COVID-19 vaccine.
This situation changed for older minors on August 23, 2021, when the FDA approved the Pfizer-BioNTech COVID-19 vaccine for use in individuals ages 16 and older. Since then, the FDA has issued additional approvals for the use of the Pfizer-BioNTech vaccine in select younger age groups. At the time of this publication, the Moderna Spikevax vaccine is still only approved for use in people 18 years and older but is available under an EUA to younger individuals. Health care providers serving minors will need to stay tuned in to the evolving landscape of COVID-19 vaccines as the FDA grants approvals and EUAs for the use of vaccines in different age groups and for different purposes, such as primary series versus booster doses.
Implications for the Mpox Outbreak
In August 2022, HHS Secretary Xavier Becerra declared the Mpox outbreak in the United States to be a public health emergency. The FDA quickly issued an EUA for the JYNNEOS vaccine, allowing it to be used as part of the Mpox outbreak response. In contrast to COVID-19 vaccines, the JYNNEOS vaccine was developed well before the current Mpox public health emergency. The JYNNEOS vaccine was originally approved by the FDA in 2019 for use as a vaccine against smallpox and Mpox for people age 18 and older. The recently issued EUA for JYNNEOS allows the vaccine to be administered subcutaneously to people under age 18 who are at high risk for Mpox infection. In light of the changes to North Carolina’s minor’s consent law, minors who are eligible to receive the JYNNEOS vaccine to prevent Mpox will need the written consent of a parent or guardian in order to be immunized.
Future Public Health Emergencies
For minors and the health care providers who serve them, North Carolina’s minor’s consent law can sometimes be tricky to navigate. The recent addition of statutory language at G.S. 90-21.5(a1) has added a new analytic step for those trying to interpret and implement the law by carving out EUA vaccines from the existing minor’s consent framework and requiring the written consent of a minor’s parent or guardian. This change in the law has had immediate implications for minors and their access to certain types of preventative care amidst the COVID-19 pandemic and Mpox outbreak. However, the COVID-19 pandemic and Mpox outbreak will almost certainly not be the last public health emergencies of our lifetimes. Health care providers and others involved in emergency preparedness and response should be aware of the recent change to North Carolina’s minor’s consent law and its implications during future public health emergencies when EUA vaccines may once again be a key tool used in the emergency response.
