Monkeypox Vaccines 2022
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®, IMVAMUNE®), has been licensed by the U.S. FDA since 2019 to prevent monkeypox and smallpox. Jynneos is the only U.S. FDA-approved non-replicating smallpox and monkeypox vaccine for U.S. military and civilian use.
The U.K. began offering IMVANEX® to specific MPVX close contacts in England in May 2022, as did Germany and Spain. And the USA started offering the Jynneos vaccine to healthcare staff in Boston on May 24, 2022, followed by New Your City and Washington DC. In addition, Canada offers MPXV close-contacts with the IMVAMUNE version. On June 28, 2022, the European Medicines Agency (EMA) started a review of data to extend the use of Imvanex to protect people from monkeypox disease.
On June 23, 2022, Brett W. Petersen, MD, MPH Captain, U.S. Public Health Service Deputy Chief, Poxvirus and Rabies Branch Centers for CDC's Advisory Committee on Immunization Practices (ACIP), presented - Medical Countermeasures for Orthopoxviruses. On June 3, 2022, a CDC MMWR reviewed ACIP recommendations for using JYNNEOS for Preexposure Vaccination of Persons at Risk for Occupational Exposure to Orthopoxviruses. The ACIP also recommends that persons who received an ACAM2000 primary vaccination and who are at ongoing risk for occupational exposure to orthopoxviruses may receive a booster dose of JYNNEOS.
Furthermore, 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 ACAM2000 is about 85% effective in preventing monkeypox. However, the immunity duration is unknown, says the CDC.
On June 28, 2022, the U.S. Administration announced the CDC would work with state, territorial, and local health departments requesting the ACAM2000 vaccine to ensure that individuals are fully informed of the benefits and the risks before receiving the vaccine. The WHO published Interim monkeypox vaccine guidance to clarify this use on June 14, 2022.
Note: Moderna Inc. Tweeted on May 23, 2022: we are investigating potential monkeypox vaccines at a preclinical level.
Monkeypox Vaccine Usage
The WHO stated on June 27, 2022, that decisions around immunization with smallpox or monkeypox vaccines (pre-emptive or post-exposure) should be by shared clinical decision-making, based on a joint assessment of risks and benefits, between a healthcare provider and prospective vaccinee, on a case-by-case basis. Post-exposure prophylaxis vaccination is recommended for hMPXV close-contacts and health workers at high risk of West African clade virus exposure to prevent the onset of disease, ideally within four days of exposure, stated the WHO on June 14, 2022. In addition, the UK Health Security Agency's (UKHSA) expanded vaccination strategy (June 21, 2022) recommends offering the Imvanex vaccine, which is shown to be effective against monkeypox, to men considered to be at higher risk of exposure. However, the UKHSA stated, 'There is minimal evidence on whether MVA-BN can prevent or modify disease when given to contacts after possible exposure to the monkeypox virus.'
Monkeypox vaccines have been offered in the USA in Boston, Chicago, Dallas, Denver, Houston, Los Angeles, New York City, San Francisco, and Washington DC. And the leading international cities offering monkeypox vaccines include but are not limited to the following: Berlin, Cyprus, Lisbon, London, Madrid, Montreal, Paris, and Toronto.
As of June 23, 2022, the U.S. FDA and CDC published updated Preparedness and Responses. As of June 28, 2022, the U.S. government had distributed about 300 courses of the TPOXX antiviral smallpox treatment. 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. TPOXX (tecovirimat) has been approved to treat monkeypox patients in the U.K. and Europe.
Chimerix Inc.'s TEMBEXA® is a medical countermeasure approved for smallpox by the U.S. FDA on June 4, 2021. In June 2022, Chimerix agreed with Emergent BioSolutions, Inc. to sell Chimerix's exclusive worldwide rights to brincidofovir, including TEMBEXA.
And Vaccinia Immune Globulin Intravenous (VIGIV) was licensed by the 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).
The overall public health risk for monkeypox virus disease outbreaks at the global level was assessed as 'moderate' by the WHO on June 27, 2022. Furthermore, the WHO Director-General concurred with the advice offered by the IHR Emergency Committee regarding the multi-country monkeypox outbreak on June 25, 2022, and, at present, 'does not determine that the event constitutes a Public Health Emergency of International Concern.'
Breaking outbreak news is posted at Vax-Before-Travel.com/monkeypox-outbreak.
Monkeypox Technical Briefings
The UKHSA published Technical Briefing #2 on June 24, 2022, an Investigation into the monkeypox outbreak in England (London). Currently, England is judged to be in level 2 - Transmission within a defined sub-population with a high number of close contacts - and is being closely monitored for any evidence of Level 3. The current UK monkeypox strain contains 48 single mutations in its genome relative to the 2018 UK monkeypox strain. Twenty-seven of these mutations are silent because they do not change the viral proteins. Twenty-one of the mutations cause changes in viral proteins.
The journal Nature published the findings from a study on June 24, 2022, concluding that MPXV belongs to clade three and that the outbreak most likely has a single origin. Although 2022 MPXV (lineage B.1) clustered with 2018-2019 cases linked to an endemic country, it segregates in a divergent phylogenetic branch, likely reflecting continuous accelerated evolution. An in-depth mutational analysis suggests the action of host APOBEC3 in viral evolution and signs of potential MPXV human adaptation in ongoing microevolution.
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 an entirely 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. In addition, on June 14, 2022, the CDC Health Alert Network issued CDCHAN-00468: Updated Case-finding Guidance: Monkeypox Outbreak—U.S.
The U.S. Administration announced on June 28, 2022, that the Laboratory Response Network (LRN) had increased its testing capacity to approximately 10,000 tests per week. In addition, the CDC scaled testing capacity to 78 sites in 48 states, primarily at state public health laboratories. This expansion of testing aims to facilitate further reductions in the gap between symptom onset and test results, maximizing access to treatment and vaccines for patients and high-risk contacts early in the course of the monkeypox disease. Previously, the CDC shipped monkeypox tests on June 22, 2022, to Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare.
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 to E.U. countries, and Roche and its subsidiary TIB Molbiol developed LightMix® Modular Virus kits to detect the MPX.
Monkeypox Vaccine News
June 29, 2022 - Quebec health department reported that 7,568 doses of the Imvamune vaccine have been administered since May 27, 2022.
June 28, 2022 - The EMA announced the decision to start its review of Imvanex based on results from laboratory studies (non-clinical data) 'suggesting' that the vaccine triggers the production of antibodies that target the monkeypox virus and may help protect against the disease. The EMA's ETF has recommended that Jynneos can be used to protect against monkeypox disease in the EU.
June 28, 2022 - The European Commission's Health Emergency Preparedness and Response Authority began delivering (Spain) a portion of over 109,090 monkeypox vaccines.
June 27, 2022 - DC Health announced a limited amount of free monkeypox vaccination appointments are available to eligible District adults residents at PreventMonkeypox.dc.gov.
June 25, 2022 - The WHO announced the Director-General concurs with the advice offered by the IHR Emergency Committee regarding the multi-country monkeypox outbreak and, at present, does not determine that the event constitutes a Public Health Emergency of International Concern.
June 24, 2022 - NYC Health confirmed that people who may have been recently exposed to the monkeypox virus could get the two-dose Jynneos vaccine at the Chelsea Sexual Health Clinic at 303 Ninth Avenue, Manhattan. If you are eligible to be vaccinated, you can make an appointment online with MedRite.
June 23, 2022 - Chimerix announced a $9.3 million agreement to procure TEMBEXA® (brincidofovir) with a third party outside of North America, with authorization from the requisite healthcare authority. Execution of this contract will be the responsibility of Chimerix.
June 23, 2022 - SIGA Technologies, Inc. announced approximately $13 million of procurement orders for oral TPOXX (tecovirimat) from two new international jurisdictions and one from an Asia Pacific region.
June 21, 2022 - A strategy published by the UKHSA recommends that some gay and bisexual men at higher risk of exposure to monkeypox should be offered vaccines.
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 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 31, 2022 - Montreal's public health department reported (that 15) people with links to monkeypox patients had been given the Imvamune vaccine, and around ten others were scheduled. In addition, officials have said several Montreal cases were linked to a visitor from Boston.
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 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.
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. Summary of Evidence to Recommendations Frameworks for the use of JYNNEOS®.
March 5, 2018 - The U.S. FDA issued STN: BL 125109 to Cangene Corp, License #1201, for Vaccinia Immune Globulin Intravenous (Human).
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.
Monkeypox Virus Disease
Monkeypox is a viral zoonotic virus that is transmitted from one person to another by physical contact with lesions, body fluids, respiratory droplets, and contaminated materials. Monkeypox disease is caused by the monkeypox virus, a member of the Orthopoxvirus genus in the family Poxviridae. The monkeypox virus has two distinct genetic clades; the Congo Basin and West African clades, says the WHO.