controlled ▪ He was discharged home with pain management medication and an additional week of doxycycline – for “cellulitis” by the patient’s report Thursday, June 9 – Day 8 Thursday, June 10 – Day 9 ▪ The patient’s partner returned to clinic for JYNNEOS post-exposure prophylaxis – 9 days after his last contact with the now confirmed case of monkeypox ▪ The partner’s lesions had almost resolved – there was nothing present to re-swab for Orthopoxvirus ▪ Given the adequacy of the specimen collection, the negative Orthopoxvirus results, and the rapid resolution, the partner was given a diagnosis of folliculitis Lessons Learned ▪ Complete sexual histories need to be taken especially in the presence of symptoms that suggest sexually transmitted infections ▪ Clinical presentation • Rash began in mucosal areas (genital, oral mucosa) • Clinic staff could not see the lesion umbilication in clinic on Day 2, but noticed it on photos the patient subsequently shared • The “prodromal syndrome” – the subjective fever, lethargy, and decreased appetite – began three days after the onset of penile lesions • The patient did not have lymphadenopathy ▪ Considerations for concurrent STIs • The patient was co-infected with urogenital chlamydia ▪ The patient had a sex partner one day before his monkeypox symptoms began who does not appear to have been infected Centers for Disease Control and Prevention Brett W. Petersen, MD, MPH Captain, U.S. Public Health Service Deputy Chief, Poxvirus and Rabies Branch Centers for Disease Control and Prevention Clinician Outreach and Communication Activity (COCA) Call June 29, 2022 Medical Countermeasures for Monkeypox Medical Countermeasures Currently Stockpiled for Orthopoxviruses ▪ Vaccines • JYNNEOS • ACAM2000 ▪ Treatment • Tecovirimat • Vaccinia Immune Globulin Intravenous (VIGIV) • Cidofovir JYNNEOS ▪ JYNNEOS is a live virus vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, nonreplicating orthopoxvirus • Also known as IMVAMUNE, IMVANEX, MVA ▪ Licensed by FDA in September 2019 ▪ Indication • JYNNEOS is indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection • CDC is developing an Expanded Access Investigational New Drug Protocol to allow the use of JYNNEOS for monkeypox in pediatric populations https://www.fda.gov/vaccines-blood-biologics/jynneos ACAM2000 ▪ ACAM2000 is a live, replicating vaccinia virus vaccine ▪ Licensed by FDA in August 2007 ▪ Replaced Dryvax - license withdrawn by manufacturer and remaining vaccine destroyed ▪ Indication • ACAM2000 is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection • CDC-held Expanded Access Investigational New Drug Protocol allows use for Non-Variola Orthopoxvirus Infection (e.g., monkeypox) during an outbreak https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5708a6.htm https://www.fda.gov/media/75792/download ACAM2000 JYNNEOS Vaccine virus Replication-competent vaccinia virus Replication-deficient Modified vaccinia Ankara “Take” “Take” occurs No “take” after vaccination Inadvertent inoculation and autoinoculation Risk exists No risk Serious adverse event Risk exists Fewer expected Cardiac adverse events Myopericarditis in 5.7 per 1,000 primary vaccinees Risk believed to be lower than that for ACAM2000 Effectiveness FDA assessed by comparing immunologic response and “take” rates to Dryvax* FDA assessed by comparing immunologic response to ACAM2000 & animal studies Administration Percutaneously by multiple puncture technique in single dose Subcutaneously in 2 doses, 28 days apart *Both ACAM2000 and Dryvax are derived from the NYC Board of Health strain of vaccinia; ACAM2000 is a “second generation” smallpox vaccine derived from a clone of Dryvax, purified, and produced using modern cell culture technology. ACAM2000 and JYNNEOS Monkeypox Vaccine Pre-Exposure Prophylaxis ▪ On November 3, 2021, the Advisory Committee and Immunization Practices (ACIP) voted to recommend vaccination for select persons at risk for occupational exposure to orthopoxviruses ▪ Policy note published June 3, 2022 • Use of JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) for Preexposure Vaccination of Persons at Risk for Occupational Exposure to Orthopoxviruses: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022 Monkeypox Vaccine Pre-Exposure Prophylaxis ▪ People who should get PrEP include: • Clinical laboratory personnel who perform testing to diagnose orthopoxviruses, including those who use polymerase chain reaction (PCR) assays for diagnosis of orthopoxviruses, including Monkeypox virus • Research laboratory workers who directly handle cultures or animals contaminated or infected with orthopoxviruses that infect humans, including Monkeypox virus, replication-competent Vaccinia virus, or recombinant Vaccinia viruses derived from replication-competent Vaccinia virus strains • Certain