The U.S. CDC recommended on August 5, 2022, vaccinating people who have been exposed to monkeypox and people who may be more likely to get monkeypox. The CDC's preferred vaccine to protect against monkeypox is the non-replicating monkeypox vaccine Jynneos® (MVA-BN, IMVANEX®, IMVAMUNE®), which has been licensed by the U.S. FDA since September 24, 2019, to prevent monkeypox and smallpox. Jynneos is the only U.S. FDA-approved monkeypox vaccine for U.S. military and civilian use but is not sold commercially.
On August 10, 2022, the U.S. CDC published 'Interim Guidance' for use of Jynneos and revised vaccination schedules during the 2022 U.S. Monkeypox Outbreak.'
As of August 12, 2022, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) had delivered about 634,213 Jynneos vaccine doses from the Strategic National Stockpile (SNS) to U.S. jurisdictions. On July 21, 2022, the HHS confirmed the federal government would have access to more than 6.9 million Jynneos doses by mid-2023. Initially, the USA began offering Jynneos to healthcare staff in Boston on May 24, 2022, followed by New York City and Washington DC.
Previously, the European Medicines Agency (EMA) approved IMVANEX in 2013 for preventing smallpox in the European Union (EU) and for monkeypox caused by vaccinia on July 27, 2022. The EMA confirmed on July 27, 2022, that a review of clinical data regarding the use of Imvanex to protect people from monkeypox disease is ongoing. The United Kingdom (U.K.) began offering IMVANEX® to specific MPVX close contacts in England in May 2022. The NHS is offering smallpox (MVA) vaccination to people most likely to be exposed to monkeypox. As of July 18, 2022, the U.K.'s Health Services Agency (UKHSA) procured more than 100,000 additional vaccine doses.
And the leading international cities offering the IMVANEX vaccine include but are not limited to Amsterdam, Barcelona, Berlin, Brussels, Copenhagen, Cyprus, Geneva, Frankfurt, Lima, Lisbon, London, Madrid, Montreal, Paris, Rome, Sau Palo, Tel Aviv, Toronto, and Wales.
Smallpox Vaccine Authorizations
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 Maryland-based Emergent BioSolutions developed ACAM2000® smallpox vaccine may also protect people from the hMPXV. According to the U.S. CDC, past data from African research suggests that the ACAM2000 is about 85% effective in preventing a version of the monkeypox virus. However, ACAM2000's immunity duration for the new monkeypox versions is unknown, says the CDC.
On August 2, 2022, the FDA confirmed ACAM2000 could be used against monkeypox under FDA's Expanded Access Investigational New Drug (IND) mechanism, which requires informed consent along with additional IND requirements. On July 28, 2022, the CDC confirmed it would work with state, territorial, and local health departments requesting ACAM2000 to ensure that individuals are fully informed of the benefits and the risks before receiving the vaccine due to significant side effects. Therefore, this vaccine is not recommended for everyone.
Japan's KM Biologics' LC16 "KMB" freeze-dried smallpox vaccine was approved as an additional indication for the prevention of the monkeypox virus by the Japanese Ministry of Health, Labor, and Welfare. On August 2, 2022. Reuters reported demand for this LC16m8 vaccine was increasing on August 3, 2022.
Monkeypox Vaccine Efficacy
As of July 26, 2022, the U.K. Health Security Agency (UKHSA) and the CDC confirmed, 'There is minimal evidence on whether MVA-BN (Jynneos) can modify disease following exposure to this version of the monkeypox virus.' For more information, visit CDC's Smallpox Vaccination Information for Health Professionals. In animal studies performed by Bavarian Nordic in 2019, even at the time of peak immune response, two doses of Jynneos did not prevent monkeypox infection or disease.
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.
Monkeypox Vaccine Candidates
On August 2, 2022, local media reported Serum Institute of India CEO Adar Poonawalla confirmed his firm is conducting research to find a vaccine against monkeypox.
Tonix Pharmaceuticals Holding Corp. TNX-8011 is a preclinical live virus vaccine candidate based on synthesized horsepox to protect people against monkeypox and smallpox. On July 28, 2022, the Company confirmed plans to launch a phase 1 study in Africa in 2023. In addition, the United States Patent and Trademark Office issued a patent on May 31, 2022, entitled "Synthetic Chimeric Poxviruses."
EpiVax, Inc.'s "Epitope-Driven Vaccine" is a smallpox vaccine candidate predicted to be highly effective against monkeypox. The development of VennVax, a DNA-prime, peptide-boost multi-T-cell epitope poxvirus vaccine, was funded by the U.S. National Institutes of Health (SBIR grant #R43AI058376).
Moderna Tweeted on May 23, 2022 - @moderna_tx - we are investigating potential monkeypox vaccines at a preclinical level.
Monkeypox Vaccination Considerations
The U.S. FDA issued an Emergency Use Authorization (EUA) on August 9, 2022, allowing healthcare providers to use an alternative dosing regimen of the JYNNEOS Vaccine to expand the total number of doses available for use by up to five-fold. The EUA now allows for 0.1ml of the JYNNEOS vaccine to be administered between layers of the skin (intradermally), as opposed to 0.5ml of the vaccine that is administered under the skin (subcutaneously). On August 9, 2022, the U.S. CDC published 'interim clinical considerations.' The immune response takes 14 days after the second dose of JYNNEOS and 4 weeks after the ACAM2000 dose for maximal development. Therefore, people who get vaccinated should continue to take steps to protect themselves from infection by avoiding close, skin-to-skin contact, including intimate contact, with someone who has monkeypox.
Post-exposure prophylaxis vaccination is recommended to prevent the onset of MPXV, ideally within four days of exposure and before symptoms appear.
Monkeypox Vaccine Coadministration With Other Vaccines
The U.S. CDC says there are no data on administering the Jynneos vaccine at the same time as other vaccines. However, there are additional considerations if administering Jynneos and a COVID-19 vaccine (Interim Clinical Considerations). And people, particularly young adult males, might consider waiting four weeks after Jynneos or ACAM2000 vaccination before receiving a Moderna, Novavax, or Pfizer-BioNTech COVID-19 vaccine, because of the observed risk for myocarditis and/or pericarditis after receipt of ACAM2000 and mRNA vaccines, and the unknown heart health after Jynneos vaccination.
Monkeypox Vaccines For Children
On July 26, 2022, the U.S. CDC confirmed children and adolescents with exposure to people with suspected or confirmed monkeypox infections may be eligible for post-exposure prophylaxis with vaccination, immune globulin, or antiviral medication based on shared decision making, as there is no clinical efficacy data available.
Monkeypox Vaccine Breakthrough Cases
The U.S. CDC stated on August 10, 2022, peak immunity is expected to be reached 14 days after the second dose of Jynneos. The duration of immunity is unknown. And no immune correlate of protection (i.e., minimum threshold level of antibodies needed to prevent symptoms) has been established.'
A non-peer-reviewed study from Paris, France, published on August 4, 2022, concluded 'monkeypox virus breakthrough infections after a single post-exposure vaccination with IMVANEX®. Among the 276 vaccinated individuals, 12 (4%) had a confirmed MPX breakthrough infection with no severe infection. Ten out of 12 patients developed an MPX infection in the five days following vaccination prior to full immunization. And two had a breakthrough infection at 22 and 25 days. Whether the decrease of antibodies from day 14 may explain the late breakthrough infections, especially if the patient had a new exposure to the Monkeypox virus, cannot be confirmed based on our data but could be a hypothesis. the hypothesis of reinfection may strengthen the importance of the second dose of vaccine on Day 28.
Monkeypox Vaccine CPT Codes
The AMA announced Current Procedural Terminology (CPT®) codes had been created for immunizations currently available in the USA. The first code (90622) describes the existing FDA-approved ACAM2000 vaccine manufactured by Sanofi Pastuer Biologics Co. The second code (90611) describes the FDA-approved JYNNEOS vaccine manufactured by Bavarian Nordic.
The WHO Director-General declared on July 23, 2022, that the global monkeypox outbreak represents a public health emergency of international concern. As of August 12, 2022, data sources indicate about 37,500 MPXV patients have been reported. Breaking news is posted at MonkeypoxToday.org.
Monkeypox Vaccine News
August 13, 2022 - CNN reported a letter recently sent to Bavarian Nordic CEO Paul Chaplin, FDA officials responded to concerns Chaplin had raised about the agency's revised vaccination policy. The FDA had determined that the benefits of stretching its limited supply of the two-dose Jynneos vaccine by giving individuals smaller doses outweighed the known possible risks.
August 13, 2022 - This weekly bulletin provides updates on disease threats monitored by ECDC.
August 12, 2022 - DC Health announced expanded eligibility for the monkeypox vaccine, available at this link.
August 10, 2022 - The U.S. CDC published updated interim guidelines.
August 10, 2022 - "The European Medicines Agency will discuss the possibility of a dose-sparing approach (Jynneos)," an EMA spokesperson told Reuters. The WHO is seeking clinical data to support this dosing option.
August 9, 2022 - The Danish Health Authority assessed that the vaccine strategy should be changed so that those who are at greatest risk of infection are now offered a preventive vaccination against monkeypox.
August 9, 2022 - U.S. HHS Secretary Xavier Becerra took action that will allow the U.S. FDA Commissioner to grant EUA for monkeypox vaccines following the Aug. 4 declaration of a public health emergency. Specifically, the Secretary issued a determination under Section 564 of the Federal Food, Drug, and Cosmetic Act that circumstances justify EUA of vaccines. The FDA then issued a EUA for alternative vaccine dosing.
August 8, 2022 - The U.S. ASPR confirmed the following table details the 617,693 doses of JYNNEOS that have been shipped to jurisdictions.
August 6, 2022 - Local media reported the Phoenix Bar in Faubourg Marigny, New Orleans, says 300 Jynneos vaccines will be given out on a first-come, first-served basis to people who meet the eligibility criteria. The Aug. 9 event is being held in partnership with the Louisiana Office of Public Health.
August 4, 2022 - Local media reported Gwendolyn Herzig, owner, and pharmacist at Park West Pharmacy in Arkansas, said they started giving out the Jynneos vaccine the week of July 25th. Since then, she said they've administered over 80 doses of the two-part Jynneos vaccine.
August 4, 2022 - San Francisco health officials may be considering the use of the ACAM2000 smallpox vaccine to vaccinate people at risk of monkeypox. The California Department of Public Health confirmed to KRON4 that it had ordered 200 doses of ACAM2000. Emergent Solutions, the manufacturer of ACAM2000, told KRON4 that "ACAM2000 is not indicated for the treatment of monkeypox in the US or any other jurisdiction.
August 2, 2022 - The U.S. FDA stated: that we need to rely on the currently approved two-dose Jynneos vaccine regimen at this time to ensure those who receive the vaccine can feel confident in their protection.
July 28, 2022 - Tonix Pharmaceuticals Holding Corp. announced a collaboration with the Kenya Medical Research Institute to plan, seek regulatory approval, and conduct a Phase 1 clinical study in Kenya to develop TNX-8011 as a vaccine to protect people against monkeypox and smallpox. The study is expected to start in the first half of 2023.
July 28, 2022 - New York State confirmed it had secured more than 60,000 doses to date, including those for New York City.
July 27, 2022 - ASPR announced Jynneos allocations (336,710) for the USA.
July 25, 2022 - According to Israel's Health Ministry, the Time of Israel reported four health maintenance organizations and the heads of Israeli hospitals were informed the highest priority monkeypox vaccinations are men born after 1980 who are HIV positive or are taking PreP medication to reduce their chance of contracting HIV.
July 23, 2022 - The Government of Canada has deployed over 70,000 vaccines to provinces and territories.
July 22, 2022 - U.S. Senators Chris Van Hollen and Jeff Merkley sent a letter to the Department of HHS and the CDC urging the agencies to acknowledge inequities in monkeypox vaccine access and immediately increase access to the JYNNEOS vaccine to all communities in the USA.
July 22, 2022 - The EMA announced the CHMP had recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease.
July 21, 2022 - NYC Health announced there would be 17,000 first-dose appointments available to book online or by phone on July 22, 2022, and they will likely fill up quickly. People should get the second dose of the two-dose vaccine at least four weeks after the first dose.
July 19, 2022 - The UKHSA has procured more than 100,000 additional vaccine doses.
July 16, 2022 - Washington, D.C., Mayor Muriel Bowser told CBS "Face the Nation" that the city currently has just 8,000 Jynneos vaccine doses but needs 100,000. And Former U.S. FDA Commissioner Scott Gottlieb commented the window for controlling the spread of monkeypox is "starting to close."
July 15, 2022 - NYC Health reported there are now 461 cases of monkeypox in New York City, which is more than 30% of the recorded cases of monkeypox per the CDC. In addition, approximately 14,500 doses arrived this week from the federal government. The Department will administer these doses at mass vaccination sites and clinics in all five boroughs.
July 7, 2022 - The U.S. HHS announced that it would make an additional 144,000 doses of the JYNNEOS vaccine will begin shipping from the SNS to states and jurisdictions on July 11, 2022.
July 1, 2022 - The U.S. Department of Health and Human Services ordered an additional 2.5 million doses of JYNNEOS, which brings the total vaccines to be delivered in 2022 and 2023 to about 4 million.
July 1, 2022 - Science.org published: Could one dose instead of two suffice?
June 30, 2022 - The Illinois Department of Health will receive 1,291 Jynneos vaccines, and the Chicago Department of Public Health was allocated 3,200 doses, according to the state health department.
June 30, 2022 - The governor of New York announced that 'we will soon have 8,195 doses available. We will continue to work with Dr. Jha and the federal government to ensure future allocations reflect the needs of New Yorkers.'
June 29, 2022 - Quebec health department reported that 7,568 doses of the Imvamune vaccine had 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 E.U.
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 - D.C. 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 23, 2022 - Moderna Inc. Tweeted: we are investigating potential monkeypox vaccines at a preclinical level.
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.