Category: Monkey Pox Vaccine

COPENHAGEN, Denmark, April 2, 2024 Bavarian Nordic A/S (OMX: BAVA) announced today that JYNNEOS, the only FDA-approved mpox vaccine, is now commercially available in the U.S., marking a significant expansion for access to JYNNEOS by establishing additional pathways for vaccine procurement, distribution, and reimbursement by both public and private payers.

Since 2022, in response to the global mpox outbreak, JYNNEOS has been made available through public health channels for individuals at risk of mpox infection. This was made possible through Bavarian Nordics long-standing partnership with the U.S. government to supply the vaccine for the national stockpile and enabled by interim guidance from the Centers for Disease Control and Prevention (CDC), recommending pre- and post-exposure use of the vaccine for individuals at risk during the outbreak. These recommendations were updated in October 2023 by unanimous vote by the CDC's Advisory Committee on Immunization Practices (ACIP), and JYNNEOS is now recommended for routine use in individuals 18 years and older with certain risk factors1.

While mpox no longer constitutes a public health emergency, infections are still occurring throughout the U.S., with around 200 cases every month on average and transmission of the virus having been reported across most of the states in 2024 to-date2. Since the beginning of the outbreak in 2022, more than 32,000 cases have been reported in the U.S., representing a third of all cases reported globally3.

According to estimates from the CDC, two (2) million U.S. individuals are eligible for vaccination against mpox4. Recent data shows 60% of this population remains completely unvaccinated, and 15% have received only one dose of the vaccine5. Real-world data show that protection against mpox disease is superior in vaccinees who received the full schedule of two vaccinations as recommended by the CDC, compared to those who are unvaccinated or have only received one dose of the vaccine6.

Through its existing nationwide vaccine distribution structure, Bavarian Nordic is now making the mpox vaccine commercially available across the nation. As of April 1, health care providers can order JYNNEOS through their preferred wholesaler and distribution partners to make it available for at-risk individuals at local pharmacies and physician offices in addition to public health clinics.

Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, commented: From the beginning of the mpox outbreak, almost two years ago, the prompt availability of an approved vaccine combined with a strong public health response have helped to significantly reduce the impact of this debilitating disease, but unfortunately, mpox has not gone away completely. Building on the trust and reliability as a supplier of vaccines to the U.S. government for more than a decade, we are proud to extend our commitment to improving the nations public health by making our mpox vaccine widely available to at-risk individuals through the regular channels. We look forward to working with healthcare providers across the nation to increase awareness and availability of the mpox vaccine.

Brian Hujdich, Executive Director, National Coalition for LGBTQ Health, commented: The expanded availability of JYNNEOS is a vital step toward ensuring equitable access to healthcare for the LGBTQ+ community and marks a significant stride in preventing the spread of mpox. We must continue to advocate for equitable policies that protect and support the health and well-being of all individuals and encourage those at risk to consult with their healthcare providers regarding vaccination.

About mpox Visit the CDC website for comprehensive information about mpox: https://www.cdc.gov/poxvirus/mpox/about/index.html

About Bavarian Nordic Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in travel vaccines and a preferred partner with governments on vaccines for public preparedness. For more information visit http://www.bavarian-nordic.com.

About JYNNEOS JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) is approved for the prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox and mpox infection. The vaccine was developed in collaboration with the U.S. government originally to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines.

JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in 2019 and in 2021, ACIP voted to recommended JYNNEOS for pre-exposure vaccination of people at occupational risk for orthopoxvirus exposures. In 2022, the CDC issued interim guidance, enabling pre- and post-exposure use of JYNNEOS during the mpox outbreak and an Emergency Use Authorization (EUA) was issued allowing the use of JYNNEOS in people under 18 years. In October 2023, the CDC updated its guidance for use of JYNNEOS, and now recommends routine use of the vaccine for at risk individuals 18 years and older.

Important safety information Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS. Anyone who has experienced a severe allergic reaction following a previous dose of JYNNEOS or following exposure to any component of JYNNEOS may be at increased risk for severe allergic reactions.

Syncope (fainting) has been reported following vaccination with JYNNEOS. Procedures should be in place to avoid injury from fainting.

Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS.

Vaccination with JYNNEOS may not protect all recipients.

In smallpox vaccine-nave healthy adults, the most common (>10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%).

In healthy adults previously vaccinated with a smallpox vaccine, the most common (>10%) solicited injection site reactions were redness (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and itching (32.0%); the most common solicited systemic adverse reactions were fatigue (33.5%), headache (27.6%), and muscle pain (21.5%).

The frequencies of solicited local and systemic adverse reactions among adults with HIV infection and adults with atopic dermatitis were generally similar to those observed in healthy adults.

Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 serious adverse events (SAEs), all non-fatal, which included Crohns disease, sarcoidosis, extraocular muscle paresis and throat tightness.

Cardiac adverse events of special interest (AESIs) considered causally related to study vaccination were reported in 0.08% of subjects who received JYNNEOS and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations. None of the cardiac AESIs considered causally related to study vaccination were considered serious.

To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting http://www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.

Please see full Prescribing Information

Contacts investors Rolf Sass Srensen, Vice President Investor Relations, Tel: +45 61 77 47 43 Graham Morrell, Paddock Circle Advisors (US), graham@paddockcircle.com, Tel: +1 781 686 9600

Contact media Michelle Trasatti, michelle.trasatti@syneoshealth.com, Tel: +1 443-528-7427

Media are also encouraged to visit https://www.bavarian-nordic.com/media/mpox for additional background information and media kit, including photos and b-roll.

References1 Persons at risk include gay, bisexual, and other men who have sex with men, transgender or nonbinary people who in the past 6 months have had one of the following: A new diagnosis of 1 sexually transmitted disease; More than one sex partner; Sex at a commercial sex venue; Sex in association with a large public event in a geographic area where mpox transmission is occurring, sexual partners of persons with the aforementioned risks, and persons who anticipate experiencing any of the aforementioned.

2 CDC, weekly data. Accessed April 1, 2024. https://wonder.cdc.gov/nndss/static/2024/12/2024-12-table968-H.pdf .

3 CDC. Ongoing 2022 Global Outbreak Cases and Data. Accessed April 1, 2024. https://www.cdc.gov/poxvirus/mpox/response/2022/index.html.

4 CDC. JYNNEOS Vaccine Coverage by Jurisdiction as of September 26, 2023. https://www.cdc.gov/poxvirus/mpox/cases-data/mpx-jynneos-vaccine-coverage.html

5 https://www.cdc.gov/poxvirus/mpox/response/2022/vaccines_data.html

6 CDC. 2022/2023 Mpox outbreak: situational awareness and updates (October 25, 2023, ACIP meeting presentation). Accessed April 1, 2024. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-10-25-26/02-MPOX-Minhaj-508.pdf

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Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S. - GlobeNewswire

Following Bavarian Nordics announcement of the US commercial launch of its mpox (monkeypox) vaccine Jynneos (Imvanex/Imvamune), Morris & Dickson has shared that it will be the first US distributor of the vaccine for the rare viral disease.

According to the 3 March press release, the Caddo Parish, Louisiana-based wholesaler is receiving the first shipment of vaccines at an undisclosed date. Morris & Dickson has a storage and transport capability which is a unique attribute of the companys distribution techniques. As per Jynneos label, the vaccine must be kept frozen at -25C to -15C and protected from light.

Jynneos meets a critical public health need and helps ensure equitable access to healthcare, which in turn helps significantly prevent the spread of mpox to at-risk populations, said head of Specialty at Morris & Dickson, Layne Martin in the announcement.

The two-dose, subcutaneously administered vaccine regimen, which first gained US Food and Drug Administration (FDA) approval in September 2019, was recommended for routine usage in adults with specific mpox infection risk factors by the Advisory Committee on Immunization Practices of the US Centers for Disease Control and Prevention (CDC) in October 2023. Previously, the committee recommended the vaccine for this population only at the time of an outbreak.

Jynneos is based on a live non-replicating MVA-BN strain of the modified vaccina virus Ankara which is not able to replicate in human cells and induces a strong cellular and humoral immune response. The vaccine has been a heavy contributor towards Bavarian Nordics revenue surge as the company reported a preliminary revenue of $1bn for 2023.

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Country * UK USA Afghanistan land Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Cte d"Ivoire Croatia Cuba Curaao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Runion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo

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Morris & Dickson will distribute mpox vaccine Jynneos in the US - Pharmaceutical Technology

The following is a summary of Mpox Knowledge and vaccine willingness among a representative analysis of adults in Pennsylvania, published in January 2024, issue of Infectious Diseases by Pinto et al.

Monkeypox is an uncommon illness resulting from an infection with the mpox virus, which belongs to the same viral family as variola virus, responsible for smallpox.

Researchers conducted a retrospective study to gather current information on the knowledge of mpox, perceived risk, and willingness to vaccinate among a sample of Pennsylvania adults, aiming for representation.

They used a cross-sectional web-based survey (September 2022) to assess the populations knowledge and risk awareness regarding the ongoing mpox outbreak and the willingness to vaccinate if at risk for mpox. Data analyses involved descriptive statistics and logistic regressions.

The results from 1,039 survey respondents indicate no knowledge of mpox symptoms (14.2%) and transmission modalities (12.5%). Those perceiving moderate/high risk were more likely to recognize mpox symptoms (aOR = 2.12). Men who have sex with men were more aware of mpox mimicking sexually transmitted infections (aOR = 3.125), less likely to be uninformed about transmission modes (aOR = 0.17), and more inclined to accept vaccination (aOR = 4.35) compared to women who have sex with men. Self-perceived mpox risk correlated with vaccination willingness (aOR low risk vs. no risk = 3.45 [2.424.92], aOR moderate/high risk vs. no risk = 9.93 [5.8116.99]).

Investigators concluded that while knowledge of mpox was robust, particularly among high-risk groups, understanding of the current outbreak nuances was lacking, emphasizing the importance of targeted education.

Source: journals.lww.com/infectdis/fulltext/2024/01000/mpox_knowledge_and_vaccine_willingness_among_a.15.aspx

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Assessment of Vaccine Willingness and Knowledge about Mpox Among Representative Adults in Pennsylvania - Physician's Weekly

COPENHAGEN, Denmark, April 2, 2024 Bavarian Nordic A/S (OMX: BAVA) announced today that JYNNEOS, the only FDA-approved mpox vaccine, is now commercially available in the U.S., marking a significant expansion for access to JYNNEOS by establishing additional pathways for vaccine procurement, distribution, and reimbursement by both public and private payers.

Since 2022, in response to the global mpox outbreak, JYNNEOS has been made available through public health channels for individuals at risk of mpox infection. This was made possible through Bavarian Nordics long-standing partnership with the U.S. government to supply the vaccine for the national stockpile and enabled by interim guidance from the Centers for Disease Control and Prevention (CDC), recommending pre- and post-exposure use of the vaccine for individuals at risk during the outbreak. These recommendations were updated in October 2023 by unanimous vote by the CDC's Advisory Committee on Immunization Practices (ACIP), and JYNNEOS is now recommended for routine use in individuals 18 years and older with certain risk factors1.

While mpox no longer constitutes a public health emergency, infections are still occurring throughout the U.S., with around 200 cases every month on average and transmission of the virus having been reported across most of the states in 2024 to-date2. Since the beginning of the outbreak in 2022, more than 32,000 cases have been reported in the U.S., representing a third of all cases reported globally3.

According to estimates from the CDC, two (2) million U.S. individuals are eligible for vaccination against mpox4. Recent data shows 60% of this population remains completely unvaccinated, and 15% have received only one dose of the vaccine5. Real-world data show that protection against mpox disease is superior in vaccinees who received the full schedule of two vaccinations as recommended by the CDC, compared to those who are unvaccinated or have only received one dose of the vaccine6.

Through its existing nationwide vaccine distribution structure, Bavarian Nordic is now making the mpox vaccine commercially available across the nation. As of April 1, health care providers can order JYNNEOS through their preferred wholesaler and distribution partners to make it available for at-risk individuals at local pharmacies and physician offices in addition to public health clinics.

Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, commented: From the beginning of the mpox outbreak, almost two years ago, the prompt availability of an approved vaccine combined with a strong public health response have helped to significantly reduce the impact of this debilitating disease, but unfortunately, mpox has not gone away completely. Building on the trust and reliability as a supplier of vaccines to the U.S. government for more than a decade, we are proud to extend our commitment to improving the nations public health by making our mpox vaccine widely available to at-risk individuals through the regular channels. We look forward to working with healthcare providers across the nation to increase awareness and availability of the mpox vaccine.

Brian Hujdich, Executive Director, National Coalition for LGBTQ Health, commented: The expanded availability of JYNNEOS is a vital step toward ensuring equitable access to healthcare for the LGBTQ+ community and marks a significant stride in preventing the spread of mpox. We must continue to advocate for equitable policies that protect and support the health and well-being of all individuals and encourage those at risk to consult with their healthcare providers regarding vaccination.

About mpox Visit the CDC website for comprehensive information about mpox: https://www.cdc.gov/poxvirus/mpox/about/index.html

About Bavarian Nordic Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in travel vaccines and a preferred partner with governments on vaccines for public preparedness. For more information visit http://www.bavarian-nordic.com.

About JYNNEOS JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) is approved for the prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox and mpox infection. The vaccine was developed in collaboration with the U.S. government originally to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines.

JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in 2019 and in 2021, ACIP voted to recommended JYNNEOS for pre-exposure vaccination of people at occupational risk for orthopoxvirus exposures. In 2022, the CDC issued interim guidance, enabling pre- and post-exposure use of JYNNEOS during the mpox outbreak and an Emergency Use Authorization (EUA) was issued allowing the use of JYNNEOS in people under 18 years. In October 2023, the CDC updated its guidance for use of JYNNEOS, and now recommends routine use of the vaccine for at risk individuals 18 years and older.

Important safety information Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS. Anyone who has experienced a severe allergic reaction following a previous dose of JYNNEOS or following exposure to any component of JYNNEOS may be at increased risk for severe allergic reactions.

Syncope (fainting) has been reported following vaccination with JYNNEOS. Procedures should be in place to avoid injury from fainting.

Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS.

Vaccination with JYNNEOS may not protect all recipients.

In smallpox vaccine-nave healthy adults, the most common (>10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%).

In healthy adults previously vaccinated with a smallpox vaccine, the most common (>10%) solicited injection site reactions were redness (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and itching (32.0%); the most common solicited systemic adverse reactions were fatigue (33.5%), headache (27.6%), and muscle pain (21.5%).

The frequencies of solicited local and systemic adverse reactions among adults with HIV infection and adults with atopic dermatitis were generally similar to those observed in healthy adults.

Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 serious adverse events (SAEs), all non-fatal, which included Crohns disease, sarcoidosis, extraocular muscle paresis and throat tightness.

Cardiac adverse events of special interest (AESIs) considered causally related to study vaccination were reported in 0.08% of subjects who received JYNNEOS and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations. None of the cardiac AESIs considered causally related to study vaccination were considered serious.

To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting http://www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.

Please see full Prescribing Information

Contacts investors Rolf Sass Srensen, Vice President Investor Relations, Tel: +45 61 77 47 43 Graham Morrell, Paddock Circle Advisors (US), graham@paddockcircle.com, Tel: +1 781 686 9600

Contact media Michelle Trasatti, michelle.trasatti@syneoshealth.com, Tel: +1 443-528-7427

Media are also encouraged to visit https://www.bavarian-nordic.com/media/mpox for additional background information and media kit, including photos and b-roll.

References1 Persons at risk include gay, bisexual, and other men who have sex with men, transgender or nonbinary people who in the past 6 months have had one of the following: A new diagnosis of 1 sexually transmitted disease; More than one sex partner; Sex at a commercial sex venue; Sex in association with a large public event in a geographic area where mpox transmission is occurring, sexual partners of persons with the aforementioned risks, and persons who anticipate experiencing any of the aforementioned.

2 CDC, weekly data. Accessed April 1, 2024. https://wonder.cdc.gov/nndss/static/2024/12/2024-12-table968-H.pdf .

3 CDC. Ongoing 2022 Global Outbreak Cases and Data. Accessed April 1, 2024. https://www.cdc.gov/poxvirus/mpox/response/2022/index.html.

4 CDC. JYNNEOS Vaccine Coverage by Jurisdiction as of September 26, 2023. https://www.cdc.gov/poxvirus/mpox/cases-data/mpx-jynneos-vaccine-coverage.html

5 https://www.cdc.gov/poxvirus/mpox/response/2022/vaccines_data.html

6 CDC. 2022/2023 Mpox outbreak: situational awareness and updates (October 25, 2023, ACIP meeting presentation). Accessed April 1, 2024. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-10-25-26/02-MPOX-Minhaj-508.pdf

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Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the US - GlobeNewswire

Published 3:48 pm Wednesday, April 3, 2024

RALEIGHThe North Carolina Department of Health and Human Services is reporting a statewide increase in mpox cases. Over the past six months,45caseshave been reported in 12 counties across North Carolina.

Thenational mpox outbreakbegan in late May 2022 and peaked from July to August 2022. A total of 703 cases were reported in North Carolina that year, and only nine cases occurred in 2023.

Thempox virus, formerly known as monkeypox, is primarily spread by prolonged close contact, typically skin-to-skin, that occurs during sexual activity. It is the associated rash, scabs or body fluid which contain the virus. Although anyone can become infected with mpox, cases have predominantly occurred among gay, bisexual or other men who have sex with men.

Fortunately, a safe and effective vaccine is available that reduces the risk of mpox infection, hospitalization and death. Those who are already fully vaccinated with two doses do not need to receive additional mpox vaccine doses.

It is important people know how to protect themselves against mpox infection as we have seen cases increasing across North Carolina over recent months,said Dr. Erica Wilson, medical director for the medical consultation unit in the NCDHHSDivision of Public Health. The JYNNEOS vaccine is an important tool and North Carolina has an ample supply of vaccine.

Vaccines are currently free and available throughout North Carolina, regardless of immigration status. The two-dose JYNNEOS vaccine series is recommended for anyone at risk for mpox and aged 18 years and older, which includes the following:

Thempox vaccine locatorcan be used to find local vaccine providers. Anyone who develops mpox symptoms should seek medical care. Symptoms include a rash on any part of the body, like the genitals, hands, feet, chest, face or mouth. The rash can initially look like pimples or blisters and may be painful or itchy. The rash will go through several stages, including scabs, before healing. Some people experience flu-like symptoms before the rash, while others get a rash first followed by other symptoms. In some cases, a rash is the only symptom experienced.

Other mpox symptoms can include:

People with mpox are usually sick for about two to four weeks and can spread the virus from shortly before symptoms start until their rash is completely healed, meaning until the scabs fall off and new skin appears. Some patients may benefit from antiviral treatment, including those with severe illness or people with HIV that is not well controlled or other immune compromising conditions. Antiviral treatment may also help treat painful or severe mpox disease involving the eyes, mouth, throat, genitals and anus.

NCDHHS is working closely with local health departments and community partners to provide education about mpox, when to get tested and improve vaccine access for people at higher risk. These efforts to enhance communication, education and outreach include social media campaigns, distributing educational materials, theMpox Equity Report, theMpox Communications Toolkitand theTake Pride Nowcampaign.

More information about the virus, how to limit the risk of infection, and how to get vaccinated can be found on theNorth Carolina MpoxandCDC Mpoxwebsites.

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STATE: NCDHHS announces increased cases of Mpox statewide, urges vaccination for protection - The Stanly News ... - Stanly News & Press

Bavarian Nordic has commercially launched its mpox (monkeypox) vaccine Jynneos (Imvanex/Imvamune) in the US, creating more avenues for its procurement, distribution, and reimbursement, and catering to both public and private healthcare providers.

Healthcare providers now have the option to request Jynneos via chosen wholesalers and distribution channels, thereby increasing access for vulnerable individuals at nearby pharmacies, doctors offices, and public health centres.

Mpox is a rare viral disease most commonly found in Central and West Africa. It is similar to smallpox, but less severe and causes fever, rash, and muscle aches and spreads through contact with infected animals or materials.

The US Food and Drug Administration (FDA) originally approved Jynneos in 2019 for the prevention of smallpox and mpox. In May 2022, a case of mpox was confirmed in the UK, originating from a British resident who had travelled to Nigeria. Cases then emerged in countries where the disease is not endemic, and continue to be reported in several endemic countries, according to the WHO. In the 10 major pharmaceutical markets (UK, US, Italy, Spain, France, Germany, Japan, Mexico, Brazil, and Canada), GlobalData epidemiologists estimated there were more than 66,674 incident cases of mpox in 2022.

GlobalData is the parent company of Pharmaceutical Technology.

The same year, following the declaration of public health emergencies from the FDA and WHO, the FDA recommended an emergency use authorisation of the vaccine for the prevention of mpox and smallpox disease in individuals aged 18 years and older who are at high risk of infection.

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Jynneos is derived from the parental strain of modified vaccinia virus Ankara, which is a highly attenuated pox virus that has lost the capacity to replicate in human cells. The vaccine is currently the only available approved live, non-replicating mpox vaccine, according to Bavarian Nordic.

The vaccine has been a huge driver of revenue for Bavarian Nordic, with the company reporting Jynneos sales of DKr5bn ($725m) in 2023, and an overall revenue of DKr7.06bn ($1bn) compared to DKr3.15bn ($456m) in 2022. In August 2023, the US Biomedical Advanced Research and Development Authority (BARDA) placed a $120m order for bulk manufacturing of the vaccine.

In the announcement accompanying the launch, Bavarians CEO Paul Chaplin said: Building on the trust and reliability as a supplier of vaccines to the US government for more than a decade, we are proud to extend our commitment to improving the nations public health by making our mpox vaccine widely available to at-risk individuals through the regular channels.

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Bavarian Nordic expands access to mpox vaccine in US - Pharmaceutical Technology

More than 570 cases of mpox have been detected in the U.S. so far in 2024 nearly double the number seen by this time last year.

This infection rate doesn't come close to that seen at the peak of the mpox outbreak in early August 2022, when the U.S. saw an average of about 470 new cases in a week. However, the new data highlight that mpox is still circulating and that there's still a need for people who are at risk of infection to get vaccinated.

The most widely used mpox vaccine in the U.S., called JYNNEOS, is given in two doses spaced a month apart. A person is fully vaccinated two weeks after their second dose, and no booster shots are currently recommended. You can check whether you're eligible for the vaccine and where to get the shots on the Centers for Disease Control and Prevention (CDC) website. Various local health departments, such as those of New York City and San Francisco, also have their own vaccine-site finders.

The vaccine is not widely recommended to everyone. Rather, select groups for example, gay and bisexual men with recent sexually transmitted infection (STI) diagnoses have been identified as at risk of mpox and made eligible for the shots.

Related: Should everyone get a monkeypox vaccine?

"Most of the cases that we're seeing reported are either unvaccinated or under-vaccinated, meaning they either never received a vaccine, or they only got one dose," Dr. Jenni McQuiston, deputy director of the CDC's High-Consequence Pathogens and Pathology division, told ABC News.

Mpox, formerly known as monkeypox, is caused by a relative of the now-eradicated variola virus, which causes smallpox. Mpox viruses come in two broad types: clade I and clade II. Clade I is more likely than clade II to cause severe and fatal disease. Although clade I has not been detected in the U.S. to date, it's possible that travelers could carry the viruses to the country from other places, such as the Democratic Republic of the Congo, the CDC cautioned in December 2023. The JYNNEOS vaccine guards against both clades.

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In general, mpox viruses can cause flu-like symptoms, such as fever, muscle aches, fatigue and swollen lymph nodes. However, during the outbreak's peak in 2022, not all cases involved such symptoms. The disease's characteristic pox rashes typically start out as discolored patches and then progress to raised bumps, blisters, and large, pus-filled pimples that scab over and slough off. Depending on the case, these rashes may first appear around the face and in the oral cavity and then spread to the extremities, or they may initially show up around the genitals and anus.

People with severely weakened immune systems, including those with HIV; children younger than 1 year; people with a history of eczema; and people who are pregnant face a higher risk of severe disease from mpox. The disease most often spreads through close contact with an infected person, especially through contact with their rashes.

Since May 2022, when the mpox outbreak hit the U.S., the country has seen more than 30,000 cases, most of which occurred in 2022. By the start of 2023, infection rates had slowed the U.S. recorded 298 cases between Jan. 1 and March 23, 2023. Compare that to this year, when 576 cases were reported in the same time frame, according to the CDC. (The agency adds that these case counts are provisional and subject to change.)

More than 110 of the cases this year were in New York City, 64 were in California and 50 were in Florida.

Anyone can catch mpox, but from the start of the outbreak, the disease has disproportionately affected gender-diverse and transgender people and also men who have sex with men. People in these groups who have had recent STI diagnoses or who have had more than one recent sex partner are recommended to get vaccinated for mpox.

However, CDC data suggest that mpox vaccination among these and other at-risk groups is not as high as it should be, with large portions of the at-risk population missing one or both vaccine doses.

"We felt like it was really important to get the word out that there is a continued risk from this virus. It's still here," Dr. Brandy Darby, director of the Division of Surveillance and Investigation in the Office of Epidemiology at the Virginia Department of Health, told CNN. The department recently issued a notice about the dozen mpox cases it's seen so far in 2024, in part because it saw 12 in all of 2023.

"We also wanted to give people time to protect themselves ahead of Pride season" in June, Darby said. "We're hoping this might encourage people to go ahead and get vaccinated so they can go out and enjoy their celebrations and not have to worry so much about mpox."

This article is for informational purposes only and is not meant to offer medical advice.

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Mpox cases are far outpacing last year's numbers, CDC reports - Livescience.com

Fewer than 10 new cases were reported nationwide in December 2023, following a peak of 31 in November, according to the UKHSA.

Total English cases rose by 15 in March, the highest this year so far, according to data released on April 4, 2024.

Greater Manchesters health bosses said numbers remained really low in the region, but that vaccination remained important.

Currently, smallpox vaccines, which protect against the mpox virus, are only available to those eligible in Greater Manchester and London.

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Dr Katy Sinka, head of sexually transmitted infections at UKHSA, said: Its important to remember that mpox has not gone away and although these are still low numbers, its vital that all those eligible for the vaccine come forward which is still available in London and Greater Manchester.

While mpox infection is mild for many, it can cause severe symptoms including unusual rashes and blisters, a fever and headache, so its important people remain alert to the risks.

Across the UK, there have been 3,908 confirmed or highly probable mpox cases since May 6, 2022, according to UKHSA.

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Those eligible for the vaccine include gay, bisexual or other men who have sex with men who have multiple sexual partners, participate in group sex or who attend sex on premises venues. Staff who work in these premises are also eligible.

You can find out how to book a vaccine at your nearest clinic through the NHS national service finder.

Analysis carried out by UKHSA indicates that one dose of the vaccine has an 84 per cent effectiveness against symptomatic infection.

The World Health Organization (WHO) renamed the disease from monkeypox to mpox after racist and stigmatising language was reported.

Jane Pilkington, director of population health for NHS Greater Manchester, said: The number of mpox cases in Greater Manchester are extremely low and we have seen little change so far this year.

This is in part due to high numbers of people getting vaccinated during our big mpox vaccination push which took place summer 2022 to summer 2023 and fewer confirmed cases nationally.

However, to maintain these low numbers, people should make sure they know what the signs and symptoms are especially when travelling abroad and remember that its never too late to book a vaccine using the national service finder to find when and where this can be done.

If youre infected with mpox, symptoms usually start five to 21 days later, and often get better by themselves over two to four weeks.

These symptoms can include: unusual rashes or lesions (blisters) on the body including mouth, genitals, and anus; flu-like symptoms including muscle and back aches, shivering (chills) and tiredness; a high temperature; swollen glands in the neck, armpits, or groin and anal or rectal pain.

It is also worth remembering that mpox can be passed on from person to person in a number of ways, including: any close physical contact with mpox blisters or scabs (including during sexual contact, kissing, cuddling, or holding hands); touching clothing, bedding or towels used by someone with mpox; and the coughs or sneezes of a person with mpox when theyre close to you.

If you are worried that you may have mpox, please call ahead before attending a health care centre to help reduce the chance of spreading the virus.

According to the NHS, it can take between five and 21 days for symptoms to appear after you first get infected with mpox.

Symptoms include:

Mpox symptoms (Image: UKHSA)

A rash, which is sometimes confused with chickenpox, usually appears one to five days after the first symptoms, often beginning on the face before spreading to other parts of the body. This can include the mouth, genitals, and anus.

How to protect yourself

If you have a story, I cover the whole borough of Bolton. Please get in touch at jack.fifield@newsquest.co.uk.

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Vaccination warning as monkeypox numbers on the rise - The Bolton News

MPOX cases are continuing to spread because protection from vaccines is fading, a study suggests.

Tens of thousands of Brits were jabbed against the virus previously known as monkeypox after an outbreak in the summer 2022.

But immunity from the vaccine may already be at zero, Swedish researchers suggested.

It means booster doses - and more widespread vaccination - may be needed in order to prevent another surge.

The vaccination programme in the UK ended in July 2023.

Cases of mpox are currently double the number seen this time last year in the US, according to the Centers for Disease Control and Protection (CDC).

Dr Klara Sonden, of the Public Health Agency of Sweden, said: Our results indicate a rapid decline in neutralising antibodies after two doses.

These results, together with the continued spread of mpox in Europe, has prompted the consideration of a booster dose.

Long-term protective immunity might need a booster dose for its maintenance.

Mpox causes a blistering rash, a high temperature, headache, muscle aches, backache, swollen glands, shivering, exhaustion and joint pain.

The global mpox outbreak exploded two years ago, with more than 30,000 cases in the US and 3,500 in the UK getting infected.

The virus was particularly prevalent in gay and bisexual men and it killed three people in the UK and 32 in the US.

The disease was declared no longer a public health emergency in the US last year, with cases dipping thanks to a mass vaccination scheme.

However, latest CDC data show some 570 cases have been detected in the US so far this year twice the number at the same point in 2023.

Health officials last week issued a warning that cases are increasing in Virginia, with four patients hospitalised since the start of the year.

Dr Brandy Darby, of the Virginia Department of Health, told CNN: We felt like it was really important to get the word out that there is a continued risk from this virus. It's still here.

We also wanted to give people time to protect themselves ahead of Pride season.

"We're hoping this might encourage people to go ahead and get vaccinated so they can go out and enjoy their celebrations and not have to worry so much about mpox."

Mpox is a virus that is more common in west or central Africa and is spread by physical contact with mpox blisters or scabs, including during sexual contact.

Touching clothing, bedding or towels used by someone with mpox and the coughs or sneezes of a person with mpox when they're close to you can also spread it.

The latest study, which will be presented at this years European Congress of Clinical Microbiology and Infectious Diseases in Barcelona, looked at how strong immunity is now.

Researchers looked at data from 100 men who visited a sexual health clinic in Stockholm in 2022.

They tested their blood before their first dose of a MVA vaccine, before their second dose, 28 days after their second dose, and three months after their second dose.

The MVA vaccine is a version of the smallpox vaccine. It was offered to those most at risk people in the UK in the summer of 2022, including gay, bisexual and other men who have sex with men.

The study found disease-fighting antibodies fell within a year of vaccination, and to zero within the first few months if the patients hadn't had a smallpox vaccine previously.

Some 67 of the 100 tested were certain they had never had a smallpox vaccine before - the jab was de-escalated globally in the 1970s after the disease was eliminated.

The study said among those without prior smallpox vaccination, fewer than half of the group showed any detectable antibodies at all 28 days after the second vaccination.

Dr Sonden said: Our findings corroborate other studies showing that mpox vaccination results in neutralising antibodies only in a proportion of vaccinees.

A significant decline occurs already during the first month post-vaccination.

Immunity after previous MPXV infection mounts a higher and more robust neutralising response. In conclusion, the findings merits the study of booster doses.

The researchers were backed by another team in Austria, who have reported a breakthrough case in a man who has had two doses of the vaccine.

A 35-year-old was fully vaccinated in November 2022, but fell unwell with mpox in January 2024 - even more severe than those unvaccinated, the Public Health Authority in Vienna stated.

A second breakthrough case reported in March 2024 is under investigation.

The MVA vaccine was originally given as one dose to those most at-risk in the UK due to a shortage.

But now, the second dose is offered around three months after the first.

The NHS mpox outbreak vaccination programme ended in July 2023. But it is still available in London and Greater Manchester to eligible people.

The first symptoms of monkeypox include:

Source:The NHS

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Vaccine protection against mpox fading, warns study as cases start creeping up before summer celebra... - The Sun

Published by Mirror

By Estel Farell-Roig Mpox, previously known as monkeypox, is on the rise in the US, according to Centers for Disease Control and Prevention data. The country as seen the number of infections double compared to this time last year. While the 2022 outbreak which saw cases across the country reach 32,000 is largely over, experts say some high-risk groups should continue taking extra precautions. According to a CDC expert, most reported cases are people who are either unvaccinated or under-vaccinated which means they only had one dose. The Jynneos vaccine is two doses and is advised for tho

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Mpox Cases Soar In US As High-risk Groups Urged To Get Vaccinated By Experts - Towleroad