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With time, the Monkeypox vaccine provides good protection

In clinical trials, recipients who were HIV negative had an 83 percent immune response 28 days after one dose compared to 98 percent with two doses at 42 days.

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A review of academic literature published in the Journal of Internet Medical Research last year determined, when it comes to information about health topics, social media is not the place to turn. (Unless you follow me, of course!) One study found 87 percent of health-related posts contain misinformation. More than 40 percent of posts about vaccines contain incorrect information.   

These findings are, perhaps, not surprising. But they are important to keep in mind as we doom-scroll for information about monkeypox. 

Iā€™ve already seen a number of posts on Twitter claiming to have monkeypox breakthrough infections after vaccination. One author said they developed a monkeypox rash two weeks after vaccination. While this personā€™s experience was not likely a breakthrough case, the post brings up important questions. How much protection does a person have after being vaccinated and when? And, as some cities move to a one-dose regimen due to vaccine supply, what does research say about the number of doses needed to protect a person?

Monkeypox rashes and lesions can take up to three weeks to develop after exposure to the virus, which means it is possible the Twitter user mentioned above was exposed before vaccination or shortly after. The time following vaccination and when you are exposed to the virus matters in terms of the amount of protection you have. 

Simply put: vaccines do not offer protection immediately after being administered. Remember what we learned when getting our COVID-19 vaccines: no matter which vaccine you received, you were not fully protected until two weeks after the final dose. For the monkeypox vaccine the time to protection is actually longer. Clinical trials indicated it takes up to four weeks for patients to develop strong protection. In fact, two weeks after the first dose, the immune response was just 29 percent! Take extra care during this period to prevent spread.  

Now, what about one dose versus two? With limited monkeypox vaccine supply, cities and states should consider limiting doses to one per person to protect more people.

The U.S. Food and Drug Administration (FDA) approved a vaccine, Jynneos, developed by the U.S. government and Bavarian Nordic in 2019 to protect against both monkeypox and smallpox. The FDA recommended a two dose regimen, four weeks apart. This regimen outperformed an older smallpox vaccine (ACAM2000) for producing an immunological response. The Jynneos vaccine also has fewer side effects and is much safer.

Unfortunately, the Jynneos vaccine is in very short supply. Bavarian Nordic, the only manufacturer of the vaccine worldwide, says it can produce 30 million doses of Jynneos annually, meaning with a full regimen less than 15 million patients worldwide will have full protection. Thatā€™s why cities like Washington, D.C. and New York have chosen to move to a single-dose regimen. The United Kingdom and some countries in Europe have done the same.  

This approach is the right one. 

In clinical trials, recipients who were HIV negative had an 83 percent immune response 28 days after one dose compared to 98 percent with two doses at 42 days. HIV positive recipients had a 67 percent immune response 28 days after one dose. It was 96 percent 42 days after two doses. 

While that data indicates a two-dose regimen is best, with supplies limited, a one-dose regimen for most people is a reasonable approach. That strategy allows double the group of individuals to be immunized ā€” even though there is slightly lower efficacy. A recent article in Science highlighted this important point. Jynneosā€™ CEO, an immunologist, said one dose of the vaccine conferred a ā€œrobust immune response.ā€ 

There is one caveat, however. Based on the clinical trial data, we might need to stick with the original two-dose regimen for people who are immunocompromised or live with HIV (irrespective of immune status).

In the face of what appears to be a public health system in disarray, Americans need to be partners in fighting the virusā€™ spread. Get vaccinated when available. Individuals who are most at risk should sign up now to receive a vaccine. Second, understand it takes time after receiving the vaccine to develop immunity whether you are HIV positive or not. Understand monkeypox symptoms, the timing of symptoms and how to reduce your risk. And, of course, take care when it comes to social media. Spread truth.

Dr. N. Adam Brown is a practicing emergency medicine physician, founder of a healthcare strategy advisory group ABIG Health, and a professor of practice at the University of North Carolinaā€™s Kenan-Flagler Business School. Previously he served as President of Emergency Medicine and Chief Impact Officer for a leading national medical group. Follow him on Twitter @ERDocBrown.

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Monkeypox

US contributes more than $90 million to fight mpox outbreak in Africa

WHO and Africa CDC has declared a public health emergency

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The U.S. has contributed more than $90 million to the fight against the mpox outbreak in Africa. (Photo courtesy of the Centers for Disease Control and Prevention)

The U.S. has contributed more than $90 million to the fight against the mpox outbreak in Africa.

The U.S. Agency for International Development on Tuesday in a press release announced “up to an additional” $35 million “in emergency health assistance to bolster response efforts for the clade I mpox outbreak in Central and Eastern Africa, pending congressional notification.” The press release notes the Biden-Harris administration previously pledged more than $55 million to fight the outbreak in Congo and other African countries.

“The additional assistance announced today will enable USAID to continue working closely with affected countries, as well as regional and global health partners, to expand support and reduce the impact of this outbreak as it continues to evolve,” it reads. “USAID support includes assistance with surveillance, diagnostics, risk communication and community engagement, infection prevention and control, case management, and vaccination planning and coordination.” 

The World Health Organization and the Africa Centers for Disease Control and Prevention last week declared the outbreak a public health emergency.

The Washington Blade last week reported there are more than 17,000 suspected mpox cases across in Congo, Uganda, Kenya, Rwanda, and other African countries. The outbreak has claimed more than 500 lives, mostly in Congo.Ā 

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Mpox outbreak in Africa declared global health emergency

ONE: 10 million vaccine doses needed on the continent

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The declaration of a public health emergency over an mpox outbreak in Africa has prompted calls for additional vaccine doses for the continent. (Photo courtesy of the Centers for Disease Control and Prevention)

Medical facilities that provide treatment to gay and bisexual men in some East African countries are already collaborating with them to prevent the spread of a new wave of mpox cases after the World Health Organization on Wednesday declared a global health emergency.

The collaboration, both in Uganda and Kenya, comes amid WHO’s latestĀ reportĀ released on Aug. 12, which reveals that nine out of every 10 reported mpox cases are men with sex as the most common cause of infection.Ā 

The global mpox outbreak report ā€” based on data that national authorities collected between January 2022 and June of this year ā€” notes 87,189 of the 90,410 reported cases were men. Ninety-six percent of whom were infected through sex.

Sexual contact as the leading mode of transmission accounted for 19,102 of 22,802 cases, followed by non-sexual person-to-person contact. Genital rash was the most common symptom, followed by fever and systemic rash.

The WHO report states the pattern of mpox virus transmission has persisted over the last six months, with 97 percent of new cases reporting sexual contact through oral, vaginal, or anal sex with infected people.Ā 

ā€œSexual transmission has been recorded in the Democratic Republic of Congo among sex workers and men who have sex with men,ā€ the report reads. ā€œAmong cases exposed through sexual contact in the Democratic Republic of the Congo, some individuals present only with genital lesions, rather than the more typical extensive rash associated with the virus.ā€

The growing mpox cases, which are now more than 2,800 reported cases in at least 13 African countries that include Kenya, Uganda, Rwanda, and prompted the Africa Centers for Disease Control and Prevention this week to declare the disease a public health emergency for resource mobilization on the continent to tackle it.

ā€œAfrica has long been on the frontlines in the fight against infectious diseases, often with limited resources,” said Africa CDC Director General Jean Kaseya. “The battle against Mpox demands a global response. We need your support, expertise, and solidarity. The world cannot afford to turn a blind eye to this crisis.ā€ 

The disease has so far claimed more than 500 lives, mostly in Congo, even as the Africa CDC notes suspected mpox cases across the continent have surged past 17,000, compared to 7,146 cases in 2022 and 14,957 cases last year. Ā Ā 

ā€œThis is just the tip of the iceberg when we consider the many weaknesses in surveillance, laboratory testing, and contact tracing,ā€ Kaseya said.  

WHO, led by Director General Tedros Adhanom Ghebreyesus, also followed the Africa CDCā€™s move by declaring the mpox outbreak a public health emergency of international concern.

The latest WHO report reveals that men, including those who identify as gay and bisexual, constitute most mpox cases in Kenya and Uganda. The two countries have recorded their first cases, and has put queer rights organizations and health care centers that treat the LGBTQ community on high alert.Ā 

The Uganda Minority Shelters Consortium, for example, confirmed to the Washington Blade that the collaboration with health service providers to prevent the spread of mpox among gay and bisexual men is ā€œnascent and uneven.ā€ 

ā€œWhile some community-led health service providers such as Ark Wellness Clinic, Children of the Sun Clinic, Ice Breakers Uganda Clinic, and Happy Family Youth Clinic, have demonstrated commendable efforts, widespread collaboration on mpox prevention remains a significant gap,ā€ UMSC Coordinator John Grace stated. ā€œThis is particularly evident when compared to the response to the previous Red Eyes outbreak within the LGBT community.ā€

Grace noted that as of Wednesday, there were no known queer-friendly health service providers to offer mpox vaccinations to men who have sex with men. He called for health care centers to provide inclusive services and a more coordinated approach.

Although Grace pointed out the fear of discrimination ā€” and particularly Uganda’s Anti-Homosexuality Act ā€” remains a big barrier to mpox prevention through testing, vaccination, and treatment among queer people, he confirmed no mpox cases have been reported among the LGBTQ community.

Uganda so far has reported two mpox cases ā€” refugees who had travelled from Congo.

ā€œWe are for the most part encouraging safer sex practices even after potential future vaccinations are conducted as it can also be spread through bodily fluids like saliva and sweat,ā€ Grace said. 

Grace also noted that raising awareness about mpox among the queer community and seeking treatment when infected remains a challenge due to the historical and ongoing homophobic stigma and that more comprehensive and reliable advocacy is needed. He said Grindr and other digital platforms have been crucial in raising awareness.

The declarations of mpox as a global health emergency have already attracted demand for global leaders to support African countries to swiftly obtain the necessary vaccines and diagnostics.

ā€œHistory shows we must act quickly and decisively when a public health emergency strikes. The current Mpox outbreak in Africa is one such emergency,ā€ said ONE Global Health Senior Policy Director Jenny Ottenhoff.

ONE is a global, nonpartisan organization that advocates for the investments needed to create economic opportunities and healthier lives in Africa.

Ottenhoff warned failure to support the African countries with medical supplies needed to tackle mpox would leave the continent defenseless against the virus.  

To ensure that African countries are adequately supported, ONE wants governments and pharmaceutical companies to urgently increase the provision of mpox vaccines so that the most affected African countries have affordable access to them. It also notes 10 million vaccine doses are currently needed to control the mpox outbreak in Africa, yet the continent has only 200,000 doses.

The Blade has reached out to Ishtar MSM, a community-based healthcare center in Nairobi, Kenya, that offers to service to gay and bisexual men, about their response to the mpox outbreak. 

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White House urged to expand PrEP coverage for injectable form

HIV/AIDS service organizations made call on Wednesday

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Apretude is a long-lasting PrEP injection that has proven to be significantly more effective at reducing the risk of sexually-acquired HIV. (Photo courtesy of ViiV Healthcare)

A coalition of 63 organizations dedicated to ending HIV called on the Biden-Harris administration on Wednesday to require insurers to cover long-acting pre-exposure prophylaxis (PrEP) without cost-sharing.

In a letter to Chiquita Brooks-LaSure, administrator of the Centers for Medicare and Medicaid Services, the groups emphasized the need for broad and equitable access to PrEP free of insurance barriers.

Long-acting PrEP is an injectable form of PrEP that’s effective over a long period of time. The FDA approved Apretude (cabotegravir extended-release injectable suspension) as the first and only long-acting injectable PrEP in late 2021. It’s intended for adults and adolescents weighing at least 77 lbs. who are at risk for HIV through sex.

The U.S. Preventive Services Task Force updated its recommendation for PrEP on Aug. 22, 2023, to include new medications such as the first long-acting PrEP drug. The coalition wants CMS to issue guidance requiring insurers to cover all forms of PrEP, including current and future FDA-approved drugs.

“Long-acting PrEP can be the answer to low PrEP uptake, particularly in communities not using PrEP today,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “The Biden administration has an opportunity to ensure that people with private insurance can access PrEP now and into the future, free of any cost-sharing, with properly worded guidance to insurers.”

Currently, only 36 percent of those who could benefit from PrEP are using it. Significant disparities exist among racial and ethnic groups. Black people constitute 39 percent of new HIV diagnoses but only 14 percent of PrEP users, while Latinos represent 31 percent of new diagnoses but only 18 percent of PrEP users. In contrast, white people represent 24 percent of HIV diagnoses but 64 percent of PrEP users.

The groups also want CMS to prohibit insurers from employing prior authorization for PrEP, citing it as a significant barrier to access. Several states, including New York and California, already prohibit prior authorization for PrEP.

Modeling conducted for HIV+Hep, based on clinical trials of a once every 2-month injection, suggests that 87 percent more HIV cases would be averted compared to daily oral PrEP, with $4.25 billion in averted healthcare costs over 10 years.

Despite guidance issued to insurers in July 2021, PrEP users continue to report being charged cost-sharing for both the drug and ancillary services. A recent review of claims data found that 36 percent of PrEP users were charged for their drugs, and even 31 percent of those using generic PrEP faced cost-sharing.

The coalition’s letter follows a more detailed communication sent by HIV+Hepatitis Policy Institute to the Biden administration on July 2.

Signatories to the community letter include Advocates for Youth, AIDS United, Equality California, Fenway Health, Human Rights Campaign, and the National Coalition of STD Directors, among others.

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