Legal Considerations for Scaling Monkeypox Vaccination Efforts

August 30, 2022 | Maggie Davis

As of August 26 there were more than 17,000 cases of Monkeypox Virus (MPV) across 50 states, Puerto Rico, and Washington, D.C. Public health officials from all levels of government are working to respond to the existing outbreak while preparing for the potential of more widespread transmission. MPV is spread through close personal or intimate contact, such as during sex. Gay, bisexual, and other men who have sex with men (MSM) have been disproportionately impacted by MPV, making up the majority of cases so far. Cases have been identified in other populations, and public health experts caution that MPV could become more widespread.

MPV is an orthopoxvirus, closely related to the smallpox virus, first identified in humans in the 1970s. Following a global mass vaccination campaign, the World Health Assembly declared smallpox eradicated in 1980. One reason eradication was possible was that the vaccine used to prevent smallpox provided cross-protective immunity against orthopoxviruses like MPV.

Current Vaccine Options

The two vaccines currently authorized to protect against MPV in the United States (ACAM2000 and JYNNEOS) are both FDA-approved smallpox vaccines. Although the FDA has only licensed ACAM2000 vaccine for smallpox, it is available for use against MPV through an Expanded Access Investigational Drug (EA-IND) application. JYNNEOS is an FDA approved vaccine to immunize adults years 18 and older against smallpox and MPV.

CDC indicates the preferred vaccine to protect against MPV is JYNNEOS for people at high risk for contracting the virus, which includes people who are named as close contacts of someone with MPV and people at increased behavioral risk. As the current outbreak is mostly among gay, bisexual, and other MSM, this population is eligible for vaccination in many jurisdictions without known exposure to the virus. For example, the Maine CDC provides the JYNNEOS MPV vaccine as a pre-exposure prophylaxis (PrEP) to all MSM, including transgender, gender non-conforming, or non-binary people.

With the current spread of the infection, the number of people eligible for vaccination has continued to outpace supply. On August 9, 2022, FDA issued an Emergency Use Authorization (EUA) to allow JYNNEOS to be administered subcutaneously (into the fatty tissue under the skin) to people under 18 years old. Additionally, as part of a dose sparing strategy for JYNNEOS vaccine, the EUA allows for people over the age of 18 to receive the vaccine intradermally (between layers of skin). This new strategy for adult MPV vaccination allows more doses to be extracted from a vial, thereby greatly increasing the number of doses available for vaccination efforts.

Liability Protections for those Giving the MPV Vaccine

The Public Readiness and Emergency Preparedness (PREP) Act empowers HHS to provide liability protections for the use and distribution of covered medical countermeasures. Currently, there are 10 PREP Act declarations in effect, including those for COVID-19, Pandemic Influenza, and Smallpox. In 2008, the HHS Secretary issued the first Smallpox Medical Countermeasures declaration under the PREP Act to encourage the development of smallpox medical countermeasures to include into federal, state, local, and private stockpiles. The Smallpox Medical Countermeasures declaration was amended in 2016 to incorporate authorities granted under the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) and to expand the scope of the declaration to include any future orthopoxvirus exposures. More specifically, expansions would incorporate FDA’s more streamlined authority to issue EUAs of medical products to serve as medical countermeasures to a “serious or life-threatening disease or condition.” As an orthopoxvirus, monkeypox is covered under the 2016 Smallpox Medical Countermeasures declaration.

Under the 2016 declaration (effective until December 31, 2022), FDA authorized medical countermeasures for orthopoxviruses such as monkeypox, which include those under EUA, permitted use as an ED-IND and Expanded Access for Investigational Device Exemption. This also includes the August 9 JYNNEOS EUA to increase available doses and make the vaccine accessible to people under the age of 18.

The existing Smallpox Medical Countermeasures declaration protects any licensed healthcare provider who is authorized to prescribe, administer, or dispense vaccines from liability for providing the ACAM2000 or JYNNEOS vaccines. Unlike the PREP Act Declaration for COVID-19, which provides liability protections for healthcare professionals (e.g., pharmacists, pharm techs, and dentists) who administer the COVID-19 vaccine regardless of their scope of practice under state law, the PREP Act declaration for MPV only covers professionals already authorized to administer vaccines under their state scope of practice laws.

This constraint may slow state and local scaling up of the vaccination workforce for MPV as some healthcare providers that were crucial to the COVID-19 vaccination campaign may not be authorized to administer the MPV vaccine. For example, although pharmacists are authorized to administer at least one vaccine in all 50 states, Puerto Rico, and Washington, D.C., state laws defining a pharmacist scope of practice may limit which vaccines a pharmacist can administer and whether a pharmacist can administer a vaccine to a person under 18.

A recent assessment of pharmacist scope of practice laws found that 37 states authorize pharmacists to administer the MPV vaccine to adults (18+). An additional eight states permit pharmacists to administer the MPV vaccine to adults with a prescription, patient specific collaborative practice agreement, or a standing order. Four states and Washington, D.C. do not authorize pharmacists to administer the MPV vaccine to adults. There are additional restrictions on pharmacists ability to administer vaccines for people under 18 years old, which could limit the professionals able to administer JYNNEOS to people under 18.

Considerations for Vaccinating Teenagers

The August 9 JYNNEOS EUA allows the preferred MPV vaccine to be administered to people under 18 at high risk of exposure to the virus. There are additional considerations for vaccinating teenagers, including the potential need for parental consent prior to administering the vaccine. In certain circumstances, state laws allow minors to consent to medical treatment without the need for obtaining parental consent or notifying parents.

Usually, state laws permitting minor consent are limited to diagnosing and treating a sexually transmitted infection (STI). All 50 states and Washington, D.C. have laws allowing minors to consent to medical treatment for STI diagnosis and treatment. Although MPV is sexually transmissible, meaning it is a general infectious disease that can be spread through sexual contact, it is not a sexually transmitted infection (STI).

Beyond minor consent laws for STIs, a 2019 PEW Report identified at least five states (Alabama, Alaska, Idaho, Oregon, and South Carolina) with laws that allowed minors to consent to healthcare procedures, including vaccination. On July 27, 2022, Washington, D.C. enacted a law specifically allowing minors to consent to vaccinations.