Monkeypox Vaccines 2022 — Vax Before Travel

2022-06-19 05:20:19 By : Ms. Tolohas Nicole

Fact checked by Robert Carlson, MD

Fact checked by Holly Lutmer PharmD

Monkeypox virus (MPXV) is a vaccine-preventable viral zoonotic disease that occurs historically in Africa, says the World Health Organization (WHO). A new monkeypox vaccine, Jynneos® (MVA-BN, IMVANEX), has been licensed by the U.S. FDA since 2019 to prevent monkeypox and smallpox.

The U.K. began offering IMVANEX® (MVA-BN) to specific MPVX close contacts in England in May 2022, as did Germany. And the USA began offering the Jynneos vaccine to healthcare staff in Boston, Massachusetts, on May 24, 2022. JYNNEOS® (Canada, IMVAMUNE®) is the only U.S. FDA-approved non-replicating smallpox and monkeypox vaccine for non-military use.

And, because the human monkeypox virus (hMPXV) has a double-stranded DNA genome of ~197 kb and is closely related to the virus that causes smallpox, research indicates the ACAM2000® smallpox vaccine may also protect people from getting monkeypox. According to the U.S. CDC, past data from African research suggests that the initial smallpox vaccine is about 85% effective in preventing monkeypox. However, the immunity duration is unknown, says the CDC. And on May 27, 2022, the WHO confirmed it does not endorse the ACAM2000 vaccine for monkeypox protection. And the WHO published Interim monkeypox vaccine guidance on June 14, 2022.

Neither vaccine is currently available to the U.S. general public. For more information, please visit CDC's Smallpox Vaccination Information for Health Professionals.

Note: Moderna Inc. Tweeted on May 23, 2022: we are investigating potential monkeypox vaccines at a preclinical level.

Post-exposure prophylaxis vaccination is recommended for hMPXV close-contacts, ideally within four days of first exposure, to prevent the onset of disease, stated the WHO on June 14, 2022. Pre-exposure prophylaxis vaccination is recommended for workers at high risk of exposure. All decisions around immunization with monkeypox vaccines should be based on an assessment of risks and benefits on a case-by-case basis, using shared clinical decision-making, says the WHO.

On May 23, 2022, the U.S. FDA published: Smallpox Preparedness and Response Updates. On May 19, 2022, SIGA Technologies, Inc. announced that the U.S. FDA approved the intravenous (IV) formulation of TPOXX® (tecovirimat) to treat smallpox. The IV formulation is an essential option for people unable to swallow the oral version of TPOXX. In addition, on May 12, 2022, the U.S. DoD awarded SIGA an agreement to procure approximately $7.5 million of oral TPOXX, of which approximately $3.6 million is targeted for delivery in 2022. TPOXX (tecovirimat) has been approved to treat monkeypox patients in the U.K. and Europe.

And Vaccinia Immune Globulin Intravenous (VIGIV) was licensed by FDA in 2018 for the treatment of complications due to vaccinia vaccination. In addition, the CDC-held Emergency Access Investigational New Drug Protocol allows deploying VIGIV for NonVariola Orthopoxvirus Infection (e.g., monkeypox).

As of June 17, 2022, the CDC reported that (20) states - Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Maryland, Massachusetts, New York, Nevada, Oregon, Ohio, Oklahoma, Pennsylvania, Rhode Island, Texas, Utah, Virginia, Washington, and Washington DC recently confirmed sixteen additional monkeypox, infected patients, for a total of (113) since early May 2022.

Texas and Maryland reported monkeypox cases in 2021 in people with recent travel history to Nigeria. Previously, forty-seven confirmed, and probable monkeypox cases were reported from six U.S. states, Illinois, Indiana, Kansas, Missouri, Ohio, and Wisconsin, in 2003.

The overall public health risk at the global level is assessed as moderate, considering this is the first time monkeypox cases and clusters are reported concurrently in non-endemic countries in widely disparate geographical areas, says the WHO.

As of June 18, 2022, about (48) countries, including the USA, United Kingdom (Scotland), Venezuela, Uruguay, UAE, Spain, Switzerland, Sweden, Sudan, Slovenia, Romania, Portugal, Poland, Paraguay, Pakistan, Netherlands, Morocco, Mexico, Malta, Latvia, Kosova, Iran, Italy, Israel, Iceland, Hungary, Haiti, French Guyana, Finland, Greece, Germany, Gibraltar, France, Ecuador, Denmark, Czech Republic, Costa Rica, Cayman Islands, Canada, Brazil, Bolivia, Belgium, Bahamas, Austria, Argentina, and Australia, have reported monkeypox cases. Worldwide, the total number of potential MPX cases has reached about 2,662. For a visual global presentation, visit https://monkeypox.healthmap.org/.

The European Centre for Disease Prevention and Control (ECDC) reported on June 15, 2022, 'There have been no (MPX related) deaths.'

The WHO recently stated: 'The situation is evolving rapidly, and WHO expects that there will be more cases identified as surveillance expands in non-endemic countries, as well as in countries known to be endemic who have not recently been reporting cases.' Previously, the Government of the Canary Islands began investigating an event attended by about 80,000 people in the town of Maspalomas, on the island of Gran Canaria, held on May 5, 2022, as one source of the global MPX outbreak.

The CDC updated its Alert - Level 2, Practice Enhanced Precautions, on June 6, 2022, regarding monkeypox outbreaks in multiple countries. In addition, health Canada and the U.K. have issued similar advice for travelers.

As of June 10, 2022, eight African counties recently reported monkeypox cases: Cameroon, Central African Republic (CAR), Democratic Republic of the Congo (DRC), Ghana, Liberia, Nigeria, Republic of Congo, and Sierra Leone. Since the beginning of 2022, the WHO reported 1,536 suspected MPX cases in the WHO African Region, of which 59 cases have been confirmed, and 72 deaths reported. In addition, in May 2022, Nigeria activated an emergency operations center regarding monkeypox activity. As a result, Nigerian officials confirmed 31 MPX cases.

The WHO published on June 14, 2022, Clinical management and infection prevention and control for monkeypox: Interim rapid response guidance. And the U.S. CDC published on June 9, 2022, CDC Monkeypox Response: Transmission. Monkeypox virus is a completely different virus than COVID-19 or measles. It is not known to linger in the air and is not transmitted during short periods of shared airspace. 

A non-peer-reviewed systematic review's results published on June 14, 2022, highlight a concerning lack of evidence-based clinical management guidelines for MPX globally.

On June 14, 2022, the CDC Health Alert Network issued CDCHAN-00468: Updated Case-finding Guidance: Monkeypox Outbreak—U.S. And the UKHSA published on June 10, 2022, Investigation into monkeypox outbreak in England: Technical Briefing #1. Given the reporting delay from symptom onset to case ascertainment, we cannot yet determine if transmissions have stopped increasing. A preliminary estimate of the serial interval is 9.8 days, though with high uncertainty (95% credible interval, 5.9 to 21.4). And there is a small subset of protein mutations involved in virus transmission, virulence, or interaction with antiviral drugs.

Genomic sequencing of viral deoxyribonucleic acid of the monkeypox virus, where available, is being undertaken. In addition, on June 4, 2022, the Nextstrain team updated the genomic epidemiology of the MPX. And data shared during a CDC Media Telebriefing on June 3, 2022, indicates genetic sequencing data indicate at least two distinct monkeypox outbreaks underway outside of Africa.

The WHO says anyone infected with hMPXV should be isolated for 21-days. In addition, any suspected monkeypox case should be separated during the presumed and known infectious periods, that is, during the illness's prodromal and rash stages, which last up to two weeks. As of June 16, 2022, Austria, Belgium, Canada, Germany, UAE, and the U.K. require/advise a 21-day, multi-step quarantine plan for monkeypox patients and close contacts. In addition, the U.K. public health agencies suggest protecting members of your household, hMPXV patients, and close contacts should keep a 1-meter distance away from them.

Roche and its subsidiary TIB Molbiol developed LightMix® Modular Virus kits to detect the MPX. The LightMix® Modular Orthopox /Monkeypox Virus Kits are assays that detect Orthopoxviruses, including the monkeypox virus, using quantitative PCR (qPCR). To do this, the first sample uses an established N.A. extraction method. The assay is then performed on either a LightCycler® 480 II Instrument or cobas z 480 Analyzer. On May 25, 2022, the Monkeypox virus Nucleic Acid Diagnostic Kit developed by Sansure Biotech obtained the C.E. certification, which means it can be distributed in E.U. countries.

June 18, 2022 - Toronto Public Health is offering the Imvamune® vaccine at least 24 vaccination opportunities to protect residents and help curb the monkeypox virus outbreak. The full list of clinics for eligible residents is available on the City of Toronto Monkeypox webpage.

June 17, 2022 - The U.K. Health Security Agency detected 46 additional monkeypox cases in England, increasing the total number of confirmed patients in the U.K. to 574. There are currently 16 confirmed cases in Scotland, 2 in Northern Ireland, and 6 in Wales.

June 17, 2022 - The Public Health Agency of Canada confirmed 168 monkeypox cases in Canada. The MPX breakdown by province is Quebec (141), Ontario (21), British Columbia (4), and Alberta (2).

June 16, 2022 - The Oregon Health Authority reported the state’s first probable case of the human monkeypox virus (hMPXV).

June 14, 2022 - Bavarian Nordic A/S announced the European Health Emergency Preparedness and Response Authority had ordered 110,000 MVA-BN vaccine doses.

June 11, 2022 - Toronto Public Health is holding vaccination clinics to immunize high-risk individuals against the monkeypox virus.

June 10, 2022 - The U.S. Department of Health and Human Services ordered an additional 500,000 doses of liquid-frozen JYNNEOS®.

June 8, 2022 - The Lancet published a Correspondence: Tracking the 2022 monkeypox outbreak with epidemiological data in real-time.

June 8, 2022, The U.S. CDC published a guide for people concerned about or infected with the MPX.

June 7, 2022 - The Texas Department of State Health Services is investigating a single case of MPX infection in a Dallas County resident with recent international travel. 

June 7, 2022 - SkyNews reported new legislation in the UK means all doctors in England must notify Health Protection Team if they suspect a patient has monkeypox. Notifiable Disease weekly reports are published for 2022.

June 5, 2022 - The WHO issued a 'Multi-country monkeypox outbreak - situation update as of June 4, 2022. As it is standard practice for large gatherings, and even more so during the COVID-19 pandemic, authorities and event organizers are invited to apply the WHO-recommended risk-based approach to decision-making for mass gatherings.

June 3, 2022 - The U.S. CDC published a Morbidity and Mortality Weekly Report that urges health departments, clinicians, and the public to remain focused on monkeypox cases.

June 2, 2022 - EuroSurveliance published a Rapid Communication: This study serves as a first step in understanding human MPX spread in a naive population in a non-endemic country and provides information to tailor preventive measures. 

May 31, 2022 - Montreal's public health department reported (that 15) people with links to monkeypox patients had been given the Imvamune vaccine, and around 10 others were scheduled. Officials have said several Montreal cases were linked to a visitor from Boston.

May 30, 2022 - The WHO hosted: the EPI-WIN webinar: Monkeypox outbreak: what we need to know.

May 29, 2022 - Germany's Health Minister Karl Lauterbach confirmed they would receive 240,000 vaccine doses against monkeypox.

May 27, 2022 - The U.S. CDC issued an Alert - Level 2, Practice Enhanced Precautions, regarding monkeypox outbreaks. 

May 24, 2022 - The U.S. CDC conducted a COCA call and presentation: What Clinicians Need to Know About Monkeypox in the United States and Other Countries.

May 22, 2022 - Belgium has become the first country to announce compulsory monkeypox quarantine. Anyone testing positive must isolate for three weeks.

May 20, 2022 - The U.S. CDC issued CDCHAN-00466, confirming the initial monkeypox case in Massachusetts.

May 19, 2022 - Bavarian Nordic A/S announced it secured a contract with an undisclosed buyer to supply its EU-approved IMVANEX® (Jynneos) smallpox/monkeypox vaccine. 

May 18, 2022 - The WHO confirmed monkeypox vaccinations (MVA-BN, Jynneos) are offered to higher-risk contacts in England.

May 18, 2022 - The Massachusetts Department of Public Health confirmed a man was hospitalized with the monkeypox after traveling to Canada.

May 18, 2022 - The media reported Portugal's Health Ministry confirmed five monkeypox cases and it is studying more than 20 suspicious cases in the Lisbon region.

May 18, 2022 - Health authorities in Spain issued a media alert regarding a possible outbreak of monkeypox after (23) men showed symptoms. A spokesperson for Madrid's regional health department said that the National Microbiology Centre is working to determine a final diagnosis.

May 7, 2022 - The U.K. Health Security Agency confirmed individuals had been diagnosed with monkeypox in England.

November 3, 2021 - The CDC's Advisory Committee and Immunization Practices voted to recommend vaccination for select persons at risk for occupational exposure to orthopoxviruses.

March 5, 2018 - The U.S. FDA issued STN: BL 125109 to Cangene Corp, License #1201, for Vaccinia Immune Globulin Intravenous (Human).

June 2, 2022 - The WHO Africa workgroup reveals mutations that appear across the new sequences. The genomes from the current monkeypox outbreak share 40-some mutations that distinguish them from 2018. 

May 30, 2022 - China-based Zelixir Biotech announced it has predicted more than 600 structures and added functional annotations of proteins from monkeypox virus proteomes, which are expected to help develop structure-based drug design and monkeypox vaccines.

May 27, 2022 - The U.S. CDC published: Use of JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) for Preexposure Vaccination of Persons at Risk for Occupational Exposure to Orthopoxviruses.

May 24, 2022 - The Lancet published: Clinical features and management of human monkeypox: a retrospective observational study in the U.K. Interpretation - Prolonged upper respiratory tract viral DNA shedding after skin lesion resolution challenged current infection prevention and control guidance.

May 23, 2022 - Study: Multi-country outbreak of Monkeypox virus: genetic divergence and first signs of microevolution. The researchers released nine additional genome sequences of the Monkeypox virus, causing a multi-country outbreak. These sequences were obtained from clinical specimens collected from nine patients on May 15 and 17, 2022. The multi-country outbreak most likely has a single origin, with all sequenced viruses released so far* tightly clustering together.

May 23, 2022 - A new study was published by Virological, concluding the multi-country outbreak most likely has a single origin. 

November 3, 2021 - U.S. CDC's ACIP recommendation: Summary of Evidence to Recommendations Frameworks for Use of JYNNEOS®.

July 14, 2020 - ScienceDirect published a Conference Report: Human monkeypox – After 40 years, an unintended consequence of smallpox eradication.

December 12, 2017 - Improving the Care and Treatment of Monkeypox Patients in Low-Resource Settings: Applying Evidence from Contemporary Biomedical and Smallpox Biodefense Research; these data—and data from biomedical research involving burns, superficial wounds, herpes, eczema vaccinatum, and so forth—suggest that MPX patients could benefit from clinical support to mitigate the consequences of compromised skin and mucosa. This should include preventing and treating secondary bacterial infections (and other complications), ensuring adequate hydration and nutrition, and protecting vulnerable anatomical locations such as the eyes and genitals. 

August 5, 2015 - Study: Evasion of the Innate Immune Type I Interferon System by Monkeypox Virus.

Monkeypox is a viral zoonotic virus that is transmitted from one person to another by contact with lesions, body fluids, respiratory droplets, and contaminated materials. Monkeypox could therefore emerge as the most important orthopoxvirus infection in humans. Monkeypox is caused by the monkeypox virus, a member of the Orthopoxvirus genus in the family Poxviridae. The monkeypox virus has identified two distinct genetic clades of the Congo Basin and the West African clades. Human infections with the West African clade appear to cause less severe disease compared to the Congo Basin clade, with a case fatality rate of 3.6% compared to 10.6% for the Congo Basin clade. 

Monkeypox endemic countries are Benin, Cameroon, the Central African Republic, the Democratic Republic of the Congo, Gabon, Ghana (animals only), Ivory Coast, Liberia, Nigeria, the Republic of the Congo, Sierra Leone, and South Sudan. The historical burden of monkeypox is not known since its origin is undefined, says the WHO. 

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