Correction: Jynneos only took 10 minutes to thaw in our experience. Our pharmacist verified with the manufacturer. 10 minutes to thaw is expected. Stability at room temperature is only known for 1 hour (up to 2 excursions lasting 30 min each).

Recommendation is to thaw just prior to administration, move to refrigerator at 2 – 8⁰ as quickly as possible if not administering it immediately after thawing. Stable in refrigerator for a few weeks so best to store frozen. Do not draw up into syringe until ready to administer.

Melanie

From: MCOH-EH <mcoh-eh-bounces@mylist.net> On Behalf Of Swift, Melanie D., M.D., M.P.H. via MCOH-EH
Sent: Wednesday, June 29, 2022 6:06 PM
To: MCOH-EH <mcoh-eh@mylist.net>; msauri@ohcmd.com
Cc: Swift, Melanie D., M.D., M.P.H. <Swift.Melanie@mayo.edu>
Subject: [EXTERNAL] Re: [MCOH-EH] Re: [External] Re: Monkeypox exposure in HCWs

We were able to order Jynneos for specific laboratory staff as one of the commercial labs identified for MPX testing (staff must handle known positive samples for validation purposes). We plan to request it as well for researchers working with replication-competent vaccinia (not MVA) and for the special pathogens team who are also eligible for the Ebola virus.

Here are the applicable occupational groups, from the CDC order form:

Research laboratory personnel who directly handle cultures/animals contaminated or infected with replication-competent vaccinia virus, recombinant vaccinia viruses derived from replication-competent vaccinia strains (i.e., those that are capable of causing clinical infection and producing infectious virus in humans), or other orthopoxviruses that infect humans (e.g., monkeypox, cowpox, and variola)
Clinical laboratory personnel who directly handle samples contaminated or infected with vaccinia, recombinant vaccinia, or other orthopoxviruses
Other healthcare workers (such as physicians and nurses) whose contact with these viruses is limited to contaminated materials (for example, dressings), but who adhere to appropriate infection control measures are probably at lower risk for inadvertent infection than laboratory workers. However, because a theoretical risk of infection exists, vaccination may be considered for this group.

There are some really specific handling, administrative, and documentation requirements.

You submit a roster with specific individuals on it to the CDC. There must be a “PI” who describes the strain they will be working with, what they’re doing and how they’ll handle it. So each research protocol needs its own order form filled out with their PI and study specifics; any clinical care team needs a separate request. There must also be a “receiving MD” who assumes responsibility for storage, administration, and documentation. The receiving MD must submit their license and CV to the CDC. Both physicians sign the order form.
If approved for this specific group, CDC sends you exactly the right number of frozen, single dose vials.
It takes 2 hrs to thaw and once thawed it must be administered within 12 hours.
You can ONLY administer it to people who are listed on the original request. You must return any unused vaccine within 60 days still frozen; you cannot reallocate it to someone who is not on the roster.

The inflexibility in substituting out recipients is more of a problem for clinical teams than research labs. That, plus the limited amount of vaccine on hand, suggests to me the CDC will not initially be distributing this broadly for patient care purposes until supply is readily available. At that time I would think they’ll have to adjust this process. I can’t imagine letting a vaccine waste because of nursing turnover! But if you are the designated place in your region for inpatient care of a suspected monkeypox patient it might be reasonable. Fortunately it doesn’t look like most people need inpatient management.

The need to order for specific people, and administer within 12 hrs of thawing, really requires attention to preordering education and staff screening, and once vaccine is on hand you have to carefully coordinate administration with vaccine storage/thawing.

Jynneos is a thousand times better than dealing with ACAM2000, but let’s hope monkeypox remains relatively mild and difficult to spread person-to-person!

Melanie

Melanie Swift, MD, MPH

(she/her)
Vice Chair, Division of Public Health, Infectious Diseases and Occupational Medicine

Medical Director, Mayo Clinic Physician Health Center

Associate Medical Director, Occupational Health Service

_______________________________
Mayo Clinic
200 First Street SW
Rochester, MN 55905

From: MCOH-EH <mcoh-eh-bounces+swift.melanie=mayo.edu@mylist.net> On Behalf Of Winters, Tom (BIDMC - Occupational Health)
Sent: Tuesday, June 28, 2022 7:18 PM
To: 'MCOH-EH' <mcoh-eh@mylist.net>; msauri@ohcmd.com
Subject: [EXTERNAL] Re: [MCOH-EH] [External] Re: Monkeypox exposure in HCWs

We were able to get 3 vaccine series of Jynneos vaccine from MDPH thru CDC, for our MPXV researchers at the NEIDL at BU.

Using ACAM2000 for these researchers is the last resort.

Tom Winters, MD

Med Director

Research Occupational Health Program

Occupational Health Officer

National Emerging Infectious Disease Lab

From: MCOH-EH <mcoh-eh-bounces@mylist.net> on behalf of Michael A. Sauri, MD, MPH&TM, FACP, FACPM <msauri@ohcmd.com>
Sent: Tuesday, June 28, 2022 4:10 PM
To: 'MCOH-EH' <mcoh-eh@mylist.net>
Subject: [External] Re: [MCOH-EH] Monkeypox exposure in HCWs

Dr. Scott,

I serve as an Occupational Medicine consultant for several research facilities who are currently working with orthopox viruses (including Monkeypox). For such non-highly attenuated vaccinia strains, we have been giving workers ACAMBIS 2000 vaccination (via CDC). My Staff and I are up-to-date with our Vaccinia vaccination and have administered over 3000 smallpox vaccinations over three decades at Occupational Health Consultants (OHC). Compared to a every 10-year boosting cycle for researchers working with non-highly attenuated vaccinia strains , a booster is recommended by CDC every 3 years for anyone working with the more virulent orthopox viruses (e.g. Monkeypox virus) .

I spoke with our CDC Vaccinia Vaccine contact earlier this month and CDC plans to use Jynneos (replication-deficient modified vaccinia Ankara) vaccine for “ring vaccination” strategy for high-risk close contacts of monkeypox cases in the USA. Jynneos is currently being used for “ring vaccination” in the UK. At that time, CDC had only 1000 doses of Jynneos available.

In addition to the ACAM2000 and Jynneos vaccines, TPOXX (Tecovirimat) and Tembexa (brincidofovir, a lipid conjugate of cidofovir), alone or in combination have been shown to be effective antiviral therapies for cases of severe monkeypox in immunocompromised victims. The US government has stockpiled 1.7 million courses of Tecovirmat in the Strategic National Stockpile. Imvanex in Europe and Imvamune in Canada (makers of Jynneos) are starting to gear up vaccine production in response to the monkeypox outbreak.

Depending on the number of Monkeypox cases in the USA, there may not be enough Jynneos to give to researchers working with Monkey Pox virus until the end of the year. Consequently, we are continuing to offer ACAM2000 to anyone who is planning to work with the Monkeypox virus. Prior to releasing any Jynneos vaccine, CDC is requesting that organizations provide them with a list of their healthcare workers who will be assigned to treatment teams for a Monkey Pox victims, as well as, their researchers who plan to work with Monkeypox virus.

I hope this is helpful.

Michael

Michael A. Sauri, MD, MPH&TM, FACP,

FACPM, FACOEM, FRSTM&H, CTropMed

Medical Director

Occupational Health Consultants

2301 Research Blvd, Suite 125

Rockville, MD 20850

Tel 301-738-6420

Fax 301-990-3534

msauri@ohcmd.com

From: MCOH-EH <mcoh-eh-bounces+msauri=ohcmd.com@mylist.net> On Behalf Of William.Scott
Sent: Tuesday, June 28, 2022 12:45 PM
To: 'MCOH-EH' <mcoh-eh@mylist.net>
Subject: [MCOH-EH] Monkeypox exposure in HCWs

Looking for input of protocols for dealing with health care works exposer to Monkeypox.

Our institution are interested in preparing for possible evaluation and care of patients with rule out Monkeypox.

Additionally I am interested in knowing if anyone in our group has look at this from an employee exposure process.

Cheers.

Bill

William Scott, MD, MPH, FACOEM

Clinical Associate Professor, Carle Illinois College of Medicine,

Clinical Assistant Professor, University of Illinois College of Medicine at Urbana-Champaign

Head, Occupational & Envionmental Medicine & Employee Health

Carle Foundation Hospital, Carle Physician Group.

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