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    Provider Briefing
August 11, 2022

The Rhode Island Department of Health (RIDOH) sends provider briefings to all Rhode Island licensees to keep you informed. Please note that information may not directly apply to all providers.

Monkeypox Vaccination Update for Rhode Island Providers

As of August 10, there are 32 confirmed monkeypox cases in Rhode Island.  
 

Food and Drug Administration Authorizes Intradermal Administration for JYNNEOS  

On August 9, the Food and Drug Administration (FDA) announced it was granting Emergency Use Authorization (EUA) for the JYNNEOS vaccine to be administered intradermally. According to a statement from The White House, “Because intradermal administration requires a smaller dose, this change allows the number of available doses to increase by as much as five-fold while continuing to ensure the vaccine meets high standards for safety and quality. The White House National Monkeypox Response team has outlined its plan to implement this approach and ensure providers and public health officials put the alternative dosing regimen into practice.”  

In order to maximize the State’s JYNNEOS vaccine supply, the Rhode Island Department of Health (RIDOH) is now advising its vaccination partners to transition to intradermal administration as soon as it is feasible (i.e., if there are trained staff and available 27 gauge, one quarter to one half inch syringes with integrated needles). The vaccination administration methods are interchangeable. This means that people in Rhode Island who have already received their first dose of JYNNEOS through a subcutaneous administration may receive their second dose intradermally.   

In addition, FDA authorized JYNNEOS for children and adolescents younger than age 18. This age group will receive two doses (0.5 mL per dose), 28 days apart, administered by subcutaneous injection.  
 

US Centers for Disease Control and Prevention COCA Call: Interim clinical Considerations for Monkeypox Vaccination 

During this COCA Call, presenters from FDA and US Centers for Disease Control and Prevention (CDC) will provide updates on FDA’s EUA of the JYNNEOS vaccine and CDC’s Interim Clinical Considerations for using the JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Monkeypox Outbreak. Presenters will also provide training on how to administer the vaccines using the interim clinical considerations. 

When
Thursday, August 11, 2022 
3:00 PM – 4:00 PM Eastern Time (US and Canada) 

Webinar Link
https://www.zoomgov.com/j/1613504249 

Passcode: 181119 

Telephone:  

US: +1 669 254 5252 
or +1 646 828 7666 
or +1 669 216 1590 
or +1 551 285 1373 

Rhode Island Monkeypox Vaccination Campaign 

On Aug. 3 Governor Dan McKee and RIDOH’s Monkeypox Task Force announced an expansion of the state’s monkeypox vaccination efforts by opening vaccine eligibility to additional at-risk populations and scheduling two community clinics on Aug. 5 and 6 that administered 391 doses of JYNNEOS vaccine. These clinics were held for eligible people who registered with RIDOH and had not yet been vaccinated at one of the healthcare facilities vaccinating patients in Rhode Island. 

People vaccinated in Rhode Island are receiving the two-dose JYNNEOS vaccine series. People who were vaccinated at these community clinics received information about where and when to receive their second doses, roughly 28 days later.  

In addition, Open Door Health, The Miriam Hospital Infectious Disease Clinic, and Thundermist Health Center have received limited amounts of monkeypox vaccine and have been vaccinating their eligible patients. More than 300 doses have been administered at these sites to date. These clinics regularly provide care to people who are at elevated risk for monkeypox. Using the clinical judgement of staff and eligibility guidance from RIDOH, these sites have been contacting existing patients about vaccination. 

Vaccine Eligibility 

CDC is using a very specific formula to allocate monkeypox vaccine to states, considering factors such as population size, current monkeypox case counts, and historical data on sexually transmitted infections. Rhode Island’s vaccine eligibility includes: 

  • People who are identified through a case investigation as close contacts of an individual with confirmed monkeypox 
  • Rhode Island residents who are 18 years of age or older, AND 
  • Had multiple sex partners or at least one anonymous sex partner, during the past 30 days AND is: 
    • Any gay, bi, queer, or other man who has sex with men, OR 
    • Any transgender, non-binary, or gender diverse individual who has sex with any men who have sex with men 
RIDOH is working with community organizations to host additional community vaccination events as more vaccine becomes available.  
 

Additional Information for all Providers Administering JYNNEOS Vaccine

 
Providers should review recent monkeypox provider advisories from RIDOH and CDC, as well as CDC’s Monkeypox Information for Healthcare Professionals for additional clinical information, including the July 28 CDC Health Alert Network (HAN) Health Update 471: Update for Clinicians on Testing and Treatment for Monkeypox. Providers are urged to review the information from CDC and take special note of RIDOH’s guidance for Rhode Island clinicians in bold. Providers must immediately report any suspected Rhode Island cases of monkeypox to RIDOH at 401-222-2577 Monday-Friday from 8:30 a.m.-4:30 p.m. or 401-276-8046 after hours to coordinate with RIDOH on testing and treatment.  While the JYNNEOS vaccine is expected to be very effective at preventing monkeypox, we continue to learn about vaccine effectiveness under current circumstances. Providers should continue to counsel patients—including those who are vaccinated—to take steps to protect themselves from monkeypox (see CDC’s prevention guidance).  

Providers administering the JYNNEOS vaccine should review CDC’s new Interim Guidance for use of the JYNNEOS vaccine.  

  • The standard FDA-approved JYNNEOS dosing regimen for adults 18 years of age or older is 2 doses (0.5 mL per dose) administered by subcutaneous injection, separated by 28 days.  
    • Provide the JYNNEOS Vaccine Information Statement (VIS) to all patients prior to vaccination occurring under the FDA-approved dosing regimen.  
  • The FDA has issued an Emergency Use Authorization (EUA) which allows the JYNNEOS vaccine to be given as follows:  
    • Adults 18 years of age or older: 2 doses (0.1 mL per dose) administered by intradermal injection (doses separated by 28 days).  
    • Children and adolescents younger than 18 years: 2 doses (0.5 mL per dose) administered by subcutaneous injection (doses separated by 28 days).  
  • RIDOH recommends providers transition now to intradermal administration under the FDA’s EUA (for adults 18 years of age or older) because this dose-sparing strategy increases vaccine availability by 5-fold.

JYNNEOS is safe with few contraindications and precautions as summarized below: 

  • Contraindication: Persons with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of JYNNEOS vaccine have a vaccine CONTRAINDICATION to receipt of a subsequent dose.  
  • Precaution:  
    • Persons with a previous severe allergic reaction to gentamicin or ciprofloxacin have a vaccine PRECAUTION because the JYNNEOS vaccine contains small amounts of gentamicin and ciprofloxacin.  
    • Persons with a previous severe allergic reaction to chicken or egg protein AND who are currently avoiding exposure to all chicken or egg products have a vaccine PRECAUTION because the vaccine is produced using chicken embryo cells.  
    • Persons with a vaccine PRECAUTION should be counseled about the potential increased risk of allergic reaction, and providers should discuss risks and benefits of vaccination. A 30-minute observation period after vaccination is recommended.  

 

Rhode Island healthcare providers

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