Two doses of monkeypox vaccine urged amid uptick in cases Portland Tribune
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Two doses of monkeypox vaccine urged amid uptick in cases - Portland Tribune
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For Immediate Release: September 24, 2019
The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease.
Following the global Smallpox Eradication Program, the World Health Organization certified the eradication of naturally occurring smallpox disease in 1980. Routine vaccination of the American public was stopped in 1972 after the disease was eradicated in the U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Therefore, although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect. Todays approval reflects the U.S. governments commitment to preparedness through support for the development of safe and effective vaccines, therapeutics, and other medical countermeasures.
Jynneos will be available for those determined to be at high risk of either smallpox or monkeypox infection. This vaccine is also part of the Strategic National Stockpile (SNS), the nations largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency that is severe enough to cause local supplies to be depleted. The availability of this vaccine in the SNS will help ensure that the vaccine is accessible in the U.S. if needed.
Smallpox, which is caused by the variola virus, emerged in human populations thousands of years ago and is a highly contagious and often fatal infectious disease. A person infected with smallpox typically develops a rash characterized by raised pocks on the face and body. The smallpox virus is spread through saliva and droplets from the respiratory tract or by direct or indirect contact with the virus as it is shed from skin lesions. The virus can also be spread through other body fluids and contaminated clothing or bed linen. If a person is infected with smallpox and they are in close contact with others, the virus can spread quickly.
Monkeypox, which does not occur naturally in the U.S., is a rare disease caused by infection with monkeypox virus, which causes symptoms similar to, but milder than, smallpox. Monkeypox begins with fever, headache, muscle aches and exhaustion and can be fatal, even though it is typically milder than smallpox. It is transmitted to people from various wild animals, such as rodents and primates. In 2003, the U.S. experienced an outbreak of monkeypox, which was the first time human monkeypox was reported outside of Africa.
Jynneos does not contain the viruses that cause smallpox or monkeypox. It is made from a vaccinia virus, a virus that is closely related to, but less harmful than, variola or monkeypox viruses and can protect against both of these diseases. Jynneos contains a modified form of the vaccinia virus called Modified Vaccinia Ankara, which does not cause disease in humans and is non-replicating, meaning it cannot reproduce in human cells.
The effectiveness of Jynneos for the prevention of smallpox was determined in a clinical study comparing the immune responses in study participants who received either Jynneos or ACAM2000, an FDA-approved vaccine for the prevention of smallpox. The study included approximately 400 healthy adults, 18 through 42 years of age who had never been vaccinated for smallpox, in which half of the study participants received two doses of Jynneos administered 28 days apart, and half received one dose of ACAM2000. The group vaccinated with Jynneos had an immune response that was not inferior to immune responses to ACAM2000. Vaccine effectiveness for the prevention of smallpox was also inferred from supportive animal studies that showed prior vaccination with Jynneos protected non-human primates who were exposed to viruses related to the smallpox virus.
The effectiveness of Jynneos for the prevention of monkeypox disease is inferred from the antibody responses in the smallpox clinical study participants and from studies in non-human primates that showed protection of animals vaccinated with Jynneos who were exposed to the monkeypox virus.
The safety of Jynneos was assessed in more than 7,800 individuals who received at least one dose of the vaccine. The most commonly reported side effects were pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache and fatigue. No safety concerns that would require a Medication Guide have been identified for Jynneos. Jynneos is administered in two doses given four weeks apart.
The FDA granted the approval of Jynneos to Bavarian Nordic A/S. The FDA granted the application Priority Review and with this approval, the FDA issued a material threat medical countermeasure (MCM) priority review voucher to Bavarian Nordic A/S. The Federal Food, Drug, and Cosmetic Act, as amended by the 21st Century Cures (Cures) Act, authorizes the FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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FDA approves first live, non-replicating vaccine to prevent smallpox ...
Monkeypox is a disease caused by the monkeypox virus. It spreads through close, personal, often skin-to-skin contact.
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Cases as of November 17, 2022
Confirmed cases in BC: 183Health authorities with cases:
Epidemiologicaldata are summarized to provide an understanding of the population(s) affected by monkeypox transmission and potential exposures to support the response.
B.C. is working closely with federal and provincial partners to stop the spread of monkeypox.
While most, but not all, recent global infections are among men who identify as gay, bisexual, or other men who have sex with other men, the virus can affect anyone through close person-to-person contact. Most cases in the current outbreak have occurred from close, intimate contact during sex. The risk to the general population in B.C. is considered low.
We will update this information as we learn more about the current outbreak.
Monkeypox can spread from animals to humans, from person to person and through contact with objects that have been used by someone with monkeypox.
Monkeypox spreads through close, personal, often skin-to-skin contact, including through:
Most cases in the current outbreak have been passed from person to person during close, intimate contact during sex.
Monkeypox can present in different ways. Most people experience symptoms thatlast 2 to 4 weeks and occur in two stages.
In the first stage, symptoms can include:
The second stage usually starts 1 to 5 days after the first stage.
In the second stage, a rash (sores/blisters) develops.
Some people experience symptoms differently. For example:
some may experience first stage symptoms after the appearance of sores
some can have a small number of sores on one or a few body parts, sometimes only in the mouth or genital areas.
Image credit: United Kingdom
Public health is reaching out to known contacts of the cases at risk of developing the infection.
Please note: Public health does not use pre-recorded or automated calls to notify individuals of infections or possibleexposure to monkeypox or other communicable diseases. If you receive one of these scam calls, do not engage and do notprovide personal information over the phone.
If monkeypox is confirmed, public health will contact you to give more instructions. Monkeypox is usually a mild illness and most people recover on their own after a few weeks. However, some people may experience moderate or severe disease, and will need to see their healthcare provider. People experiencing more severe disease may require medications to manage pain or skin infections, or in rare cases, need other supportive treatment in hospital.
Please see your healthcare provider or go to your nearest Urgent Primary Care Centre or Emergency Department if you experience the following after testing positive for monkeypox:
There are no well-established treatments for monkeypox. Antiviral medication may be considered on a case-by-case basis.
A supply of vaccine that protects against monkeypox has been made available to BC by the federal government and vaccination has been offered to at-risk populations since June 2022. The vaccine, called IMVAMUNE, is given in a series of two doses given 28 or more days apart. It can be given following a recognized exposure to infection (ideally within 4 days) to provide protection against monkeypox, or can be given in advance of an exposure. It helps your body build immunity.
People who are eligible can now book first or second dose appointments.
Eligibility for the vaccine in BC has been guided by information about people who have acquired this infection. Should the characteristics of these people change as transmission continues to occur, the eligibility may be adjusted accordingly.
Use of this vaccine to control the outbreak of monkeypox in BC has been successful in bringing cases to a low number. As of October 2022, small numbers of infections continue to occur each week among unvaccinated eligible individuals which is why they continue to be encouraged to get vaccinated.
The vaccine can be used two ways
Two-Spirit and transgender people andcisgender males whoself-identify as belonging to the gay, bisexual and other men who have sex with men community.
The vaccine is not available to individuals of any gender who are not part of the community of gay, bisexual and other men who have sex men, unless they have been identified as a close contact of a confirmed case.
Misidentifying oneself as eligible for monkeypox vaccine directs this critical tool away from people most at risk, and limits its utility in preventing onward transmission, and from protecting the wider population from a bigger outbreak.
Due to limited supply, this vaccine is intended for residents of Canada or those visiting B.C. for prolonged periods of time. People from outside Canada should not travel to B.C.vaccine clinics for immunization; we cannot provide the vaccine to those visiting the province for the purpose of being vaccinated. Please contact your local Public Health unit for information about receiving monkeypox vaccine.
Imvamune is given in a series of two doses. You must wait at least 28 days after your first dose to get your second dose.
Subcutaneous or intradermal injection
To ensure there is enough vaccine to offer second doses to all who are eligible, a second dose will be offered one of two ways: subcutaneous injection or intradermal injection.
To learn more about vaccinations, eligibility criteriaand to book an appointment, refer toyour region:
Appointments are added regularly. If there are no available appointments, please check back.
This document provides suggestions for event organizers, business owners, community organizations and leaders to help prevent spread as people gather to celebrate during the Pride festival season. It includes information about:
Learn more: Monkeypox Guidance for Events during Pride Festival Season
Most of the recent monkeypox cases are happening through close contacts between men who identify as having sex with other men.
Stigmatizing people because of a disease is never okay. Anyone can get or pass on monkeypox, regardless of their sexuality.
Be aware of the monkeypox situation in the places you visit and take the same precautions you would use at home. Some people have been exposed or got monkeypox from close contact during sexual activity while travelling.
Domestic travel
International travel
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Monkeypox (MPX) is a rare, but potentially serious viral illness that can be transmitted from person to person through direct contact with body fluid or monkeypox lesions.
The Centers for Disease Control and Prevention (CDC) confirmed the first U.S. monkeypox case on May 18, 2022. In May 2022, Massachusetts confirmed a monkeypox case in a patient with recent travel to Canada; Texas and Maryland each reported a case in 2021 in people with recent travel to Nigeria. Since early May 2022, the United Kingdom has identified nine cases of monkeypox; the first case had recently traveled to Nigeria. None of the other cases have reported recent travel.
On May 26, 2022, DC Health issued a Health Notice for District of Columbia Health Care Providers with clinical recommendations and reporting requirements for any suspected cases.
On June 4, 2022, the DC Public Health Lab confirmed the first positive Orthopoxvirus case in a District resident who reported recent travel to Europe.
On September 22, 2022, DC Health announced the updatedeligibility criteria for monkeypox vaccinations in the District.
Beginning October 15, the monkeypox clinics will merge and collocate with the COVID Centers in Wards 2, 3 and 8.
New DC Health Service Center locations and hours:
The data is updated on Wednesdays. For additional data points on DC cases, click here.
Monkeypox was first discovered in 1958 when two outbreaks of a pox-like disease occurred in colonies of monkeys kept for research. The first human case of monkeypox was recorded in 1970 in the Democratic Republic of Congo during a concentrated effort to eliminate smallpox. Since then, monkeypox has been reported in people in several other central and western African countries.
Monkeypox cases in people have occurred outside of Africa linked to international travel or imported animals, including cases in the US.
In humans, the symptoms of monkeypox can be similar to but milder than the symptoms of smallpox.
Symptoms can begin with:
Within 13 days (sometimes longer) after the appearance of fever, the patient develops a rash, often beginning on the face and then spreading to other parts of the body. The rash can progress from being flat and red, to being a bump, to being fluid-filled, to being pus-filled, and then to being a scab.
Symptoms usually appear between 714 days after exposure but can range between 521 days. The illness typically lasts between 24 weeks.
Monkeypox virus can spread when a person comes into contact with the virus from an infected animal, infected person, or materials contaminated with the virus. Monkeypox virus may spread from animals to people through the bite or scratch of an infected animal, by handling wild game, or through the use of products made from infected animals. The virus may also spread through direct contact with body fluids or sores on an infected person or with materials that have touched body fluids or sores, such as clothing or linens.
Monkeypox spreads between people primarily through direct contact with infectious sores, scabs, or body fluids. It also can be spread by respiratory secretions during prolonged, face-to-face contact. Monkeypox can spread during intimate contact between people, including during sex, as well as activities like kissing, cuddling, or touching parts of the body with monkeypox sores.
There are a number of measures that be taken to prevent infection with monkeypox virus:
There are no treatments specifically for monkeypox virus infections. However, monkeypox and smallpox viruses are genetically similar, which means that antiviral drugs and vaccines developed to protect against smallpox may be used to prevent and treat monkeypox virus infections.
JYNNEOSTM (also known as Imvamune or Imvanex) is an attenuated live virus vaccine which has been approved by the U.S. Food and Drug Administration for the prevention of monkeypox.
If you have symptoms of monkeypox, you should talk to your healthcare provider, even if you dont think you had contact with someone who has monkeypox.
Those eligible for the monkeypox vaccine include individuals who meet one of the following criteria:
The George Washington University School of Medicine & Health Sciences is recruiting volunteers for a monkeypox vaccine clinical trial. Learn more at gwvru.smhs.gwu.edu, or contact (202) 994-1599.
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NEW YORK (AP) U.S. officials are considering broadening recommendations for who gets vaccinated against monkeypox, possibly to include many men with HIV or those recently diagnosed with other sexually transmitted diseases.
Driving the discussion is a study released Thursday showing that a higher-than-expected share of monkeypox infections are in people with other sexually transmitted infections.
Dr. John T. Brooks, chief medical officer for the Centers for Disease Control and Preventions monkeypox outbreak response, said the report represents a call to action.
Brooks told The Associated Press on Thursday that he expected vaccine recommendations to expand and that the White House, together with CDC, are working on a plan for what that will look like.
Currently, the CDC recommends the vaccine to people who are a close contact of someone who has monkeypox; people who know a sexual partner was diagnosed in the past two weeks; and gay or bisexual men who had multiple sexual partners in the last two weeks in an area with known virus spread.
Shots are also recommended for health care workers at high risk of exposure.
The vast majority of monkeypox cases are in men who have sex with men who reported close contact with an infected person during sex. But the new CDC report suggested infections in people with HIV and other STDs may be a bigger issue then previously realized.
The report looked at about 2,000 monkeypox cases from four states and four cities from mid-May to late July.
It found 38% of those with monkeypox infections had been diagnosed with HIV, far higher than their share of the population among men who have sex with men.
The study also found that 41% of monkeypox patients had been diagnosed with an STD in the preceding year. And about 10% of those patients had been diagnosed with three or more different STDs in the prior year.
There were racial differences. More than 60% of Black Americans with monkeypox had HIV, compared with 41% of Hispanic people, 28% of whites and 22% of Asians.
Jason Farley, an infectious disease expert at the Johns Hopkins School of Nursing, said men of color who have sex with men should be at the front of the line for monkeypox vaccine doses. Within those racial and ethnic groups, the next priority should be anyone living with HIV or was recently diagnosed with a STD, he said.
The study has several limitations, including that the data may not be nationally representative, the authors said.
Brooks said the findings could lead to vaccines being recommended for people with recent STD infections, people with HIV, people taking pre-exposure prophylaxis (PrEP) medications to prevent HIV infection and, possibly, prostitutes.
Discussions of expanding eligibility will have to take into account supply of the two-dose vaccine. And any substantial expansion of monkeypox vaccination recommendations may also be subject to review by CDCs outside vaccine advisers, health officials say.
Also on Thursday, the CDC sent a letter to state and local health departments that said federal funds for HIV and STD prevention can also now be used against monkeypox. Cases in the U.S. seem to be declining, officials say.
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The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.
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Africa faces another vaccine apartheid in the fight against monkeypox Mmegi Online
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Africa faces another vaccine apartheid in the fight against monkeypox - Mmegi Online
WASHINGTON, D.C. The Pentagon has announced they will be making the new Monkeypox vaccine mandatory, but just for the Navy.
"After careful research into how Monkeypox is spread, we have determined the Navy to be at dire risk," said Secretary of Defense Lloyd Austin. "The other branches, meh - should be fine."
The Pentagon became aware of the acute danger Monkeypox presented after the entire crew of the U.S.S. Harvey Milk tested positive last week. "That ship is something out of a nightmare, it's like a haunted house right now," said physician Dr. Ryan Walter. "We heard reports of the first case last week, then all of a sudden - boom! The whole ship goes down. Quite the medical mystery."
The new mandate comes on the heels of the Defense Department losing tens of thousands of soldiers who declined the COVID vaccine. "In a time of historic recruitment struggles, we remain committed to losing even more desperately needed servicemen," said Secretary Austin. "Any mandate we can put in place to further weaken military readiness, we are there. Let's be real though, the Navy actually needs this Monkeypox shot."
At publishing time, Navy servicemen had replied to the mandate saying it's "not funny" and that no one will obey any more orders from Secretary Austin "until he takes off that stupid face shield".
Can this liberal California couple handle a Texas cookout?
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