Category: Monkey Pox Vaccine

Just when you thought the modern world couldnt become more cartoonish, the Centers for Disease Control and Prevention (CDC) Foundation released the most bizarre advertisement for Mpox vaccinations Tuesday.

For some reason, the CDC Foundation captioned their social media post containing the borderline seizure-inducing ad with the sentence family comes first, even though there is not a single thing about the subject matter that has anything to do with actual families. The entire production is centered on HBOs Dashaun Wesley who the CDC Foundation and apparently other people believe is the King of Vogue (thats Madonna and Ill die on this hill) and the fact he didnt get his second dose of the Mpox vaccine.

Originally called monkeypox, Mpox is a predominantly sexually transmitted disease that has spread mostly through men who have sex with other men. (RELATED: Mans Nose Rots After Monkeypox, Syphilis And HIV Infection)

And it seems that the CDC Foundation ad is specifically targeted to this demographic in a pretty stereotypical way. Personally, the gay men I know wouldnt be seen dead in the pants worn by Wesleys chosen family in the ad, but perhaps thats just a personal bias.

Despite having almost 150,000 followers, the CDC Foundations post received just 31 likes, even though they probably (hopefully) paid Wesley to appear in it to boost engagement. What a weirdo, wrote one user in the comments. Such an odd PSA.

The CDC lists Mpox as a potentially serious disease and is part of the smallpox family. Symptoms range from a rash and flu-like feeling that can last some two to four weeks. The available vaccinations for Mpox have a host of common side effects that all sound pretty similar to the flu.

More here:

CDC Releases World's Weirdest Vaccination Ad - Daily Caller

Mobile Operations Manager Parsia Jahanbani gives the monkeypox vaccine to Henry Tran at Families Together of Orange County in Tustin, CA on Tuesday, August 16, 2022. The Jynneos vaccine consists of two doses administered 28 days apart. (Photo by Paul Bersebach, Orange County Register/SCNG)

As a health communications researcher specializing in vaccine hesitancy, the last few years in my field have been paradoxical. Vaccinations played a large part in ushering us into the post-pandemic world, yet a misinfodemic against vaccines persists. Misinformation about vaccines has eroded confidence in vaccines prevention promise and has inflicted even our progressive state of California. As of August 2023, about 73% of Californians have received the initial series of COVID-19 vaccines, compared to only 38% of children between ages 5 to 11. In recognition of World Immunization Week taking place annually during the last week of April I want to highlight the collective action needed to improve vaccine uptake to protect people of all ages.

Our biggest threat to improving vaccine uptake is the rise in misinformation mostly propagated on social media platforms. Having taken root during the 2016 U.S. presidential election, continuing during the COVID-19 pandemic, and the devastating aftermath of the 2020 U.S. Presidential election misinformation is pervasive.

In my research scrubbing one of the more popular microblogging services, X (formerly Twitter), misinformation around the COVID-19 vaccine clocked in nearly 14.9 million tweets. Our research published in the Journal of Behavioral Medicine delineated the kinds of vaccine misinformation spread on social media. Falsehoods about vaccination ranged across nine categories that undermine vaccine confidence, including falsehoods about vaccine ingredients, safety, side effects, testing of the vaccine, alternatives to vaccinating, effects on the immune system, vaccine efficacy, vaccine information being concealed and doubts about the necessity of the vaccine. When users questions and concerns are not rapidly addressed and information voids ensue, such an environment is conducive to the adoption of pervasive misinformation being turned to and accepted.

Now what were seeing is that the misinfodemic has slowly made its way off our phones and into pediatrician offices nationwide. During the 2022-23 school year, kindergarten vaccination rates did not return to pre-pandemic levels and our nation is now reporting the highest rate of vaccine exemptions, including medical and nonmedical, ever seen. Of the kindergartners with vaccine exemptions, over 93% had a nonmedical exemption. Parents are choosing to exempt their children from life-saving vaccines at the cost of our communitys safety.

Higher rates of unvaccinated people in a community are associated with a greater incidence of vaccine-preventable diseases like measles, which has made a startling return. Take for example the 2014 measles outbreak that began at Disneyland, California, or in 2019, the largest measles outbreak in the U.S. that occurred in a New York City community with a cluster of unvaccinated children. And now, in the first three months of 2024, as reported by the Associated Press, the CDC shows that the number of measles cases is 17 times higher than in the previous three years of the same timeframe.

Why are parents hesitating in getting their children vaccinated or avoiding them altogether? Addressing the scourge of misinformation requires a multi-faceted approach to improve vaccine uptake across the nation.

In a society where facts are distorted and falsehoods proliferate, individuals are robbed of the ability to make sound judgments based on reality. We cannot afford to be passive bystanders in the fight for the truth our communitys health depends on it.

Suellen Hopfer is Associate Professor of Health, Society, and Behavior, with the UC Irvine Program in Public Health. She has affiliated appointments with the UCI School of Medicines Department of Pediatrics and the UCI School of Humanities Department of Asian American Studies.

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The true cost of vaccine misinformation: A vulnerable nation - OCRegister

Special to Iredell Free News

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

The national mpox outbreak began 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.

The mpox 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 NCDHHS Division 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:

Anyone who has or may have multiple or anonymous sex partners; or Anyone whose sex partners are eligible per the criterion above; or People who know or suspect they have been exposed to mpox in the last 14 days; or Anyone else who considers themselves to be at risk for mpox through sex or other intimate contact.

The mpox vaccine locator can 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 fever, chills, swollen lymph nodes, exhaustion, muscle aches and backache, headache and respiratory symptoms (i.e. sore throat, nasal congestion or cough).

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, the Mpox Equity Report, the Mpox Communications Toolkit and the Take Pride Now campaign.

LEARN MORE

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

See original here:

NCDHHS announces increased of number cases of mpox across state, urges vaccination - Iredell Free News

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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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