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Monkeypox

Monkeypox vax strategy shift by Biden Administration amid shortages

As the estimated number of monkeypox cases in the United States reaches 8,900, top health officials announced the new move on Tuesday

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Los Angeles Blade file photo

WASHINGTON – The Biden administration, amid criticism it was slow to act on the monkeypox outbreak and still not meeting the demand for vaccines as the number of cases continues to grow, has announced a shift in guidance for implementation of the shot in an effort to enhance availability.

As the estimated number of monkeypox cases in the United States reaches 8,900, top health officials announced the new move on Tuesday as part of a decision by Secretary of Health & Human Services Xavier Becerra to issue a determination under Section 564 of the Federal Food, Drug and Cosmetic Act to justify emergency use authorization of vaccines. The announcement follows up on the Biden administration’s announcement last week declaring the monkeypox outbreak a public health emergency.

Becerra said in a conference call with reporters the 564 determination and change in approach to vaccines would “boost and strengthen” the Biden administration’s response to monkeypox, which has overwhelmingly affected gay and bisexual men, and “safely accelerates and multiplies our supply of effective vaccines by up to fivefold.”

“Today’s action also reaffirms HHS and this administration’s commitment to using all available resources and capabilities to end the monkeypox outbreak and provide the best possible care to those suffering from the virus,” Becerra added.

The new vaccine approach, which may may be considered minor to non-medical observers, would change injections of the JYNNEOS vaccine from the subcutaneous route (delivery of the vaccine under the fat layer underneath the skin) to the intradermal route (delivery of the vaccine into the layer of skin just underneath the top layer). In theory, that would allow for greater accessibility of monkeypox vaccines as it increases the number of doses from each vial of vaccine.

The change was made amid criticism the Biden administration failed to meet the demand for vaccines during the outbreak and geographic inequity as certain metropolitan areas of the country have more access to vaccines than other places.

As The New York Times reported last week, the Biden administration has faced criticism for not moving quickly enough in acquiring and distributing vaccines, including bulk stocks already owned by the U.S. government manufactured in Denmark by Bavaria Nordic now being given to other clients.

“The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak,” the Times reported. “It does not expect the next delivery, of half a million doses, until October. Most of the other 5.5 million doses the United States has ordered are not scheduled to be delivered until next year, according to the federal health agency.”

Biden officials, nonetheless, touted the numbers of vaccines and tests in response to monkeypox as a positive, acknowledging the 1.1 million vaccines being made available as well as delivery of more than 620,000 of those doses, deployment more than 15,000 courses of the monkeypox treatment and increasing the country’s capacity to administer tests on a weekly basis to around 80,000. Meanwhile, officials also promoted the change in approach in vaccines as means to allow greater accessibility to the shots.

Rochelle Walensky, director of the Centers for Disease Control & Prevention, promoted during the conference call the use of intradermal injections and said they’re “often used for TB skin tests and have been used for other types of vaccines.”

Although Walensky conceded some health care providers “may not be as familiar with intradermal administration” as they are with subcutaneous injection, she said CDC would make additional guidance materials available, including a clinician alert message to the Association of State & Territorial Health Officials, outreach to key clinician partners and an education resource video. The change in guidance, Walensky said, is for vaccine implementation in adults and children — where single digit monkeypox cases have been reported — would continue to receive vaccination in the traditional subcutaneous approach.

But health experts aren’t responding with overwhelming praise to the decision to change the guidance on vaccine implementation from subcutaneous injections to intradermal injections, expressing concerns the new approach may be insufficient.

Jennifer Kates, director of global health & HIV policy at the Kaiser Family Foundation, was among those saying the change in guidance on vaccine approach was a mixed bag and told the Blade more data is needed to emulate the effectiveness.

“As we saw with COVID, using these authorities in the context of public health emergencies is an important strategy,” Kates said. “In this case, this step will significantly expand access to vaccines for those most at risk. However, there remain questions about the effectiveness of this approach — real world studies are needed — and challenges to translating vaccines into vaccinations.”

Peter Marks, director of the Center for Biologics Evaluation & Research (CBER) at the Food & Drug Administration, was asked during the conference call with reporters to respond to concerns the change in guidance was insufficient and downplayed the novelty of implementing the vaccines through the intradermal route as “not at all new.”

“In fact, the reason why the Bavaria part of this equation comes from the fact that in Germany, this vaccine was given intradermally originally, in an effort to replicate the original version of the smallpox vaccine,” Marks said. “It’s been given to thousands of people intradermally, so this isn’t the first time it’s been done.”

Walkensky said the intradermal vaccine approach has been implemented amid policies among localities to implement a one-dose approach to the JYNNEOS vaccine through the subcutaneous route. (The D.C. government is one of the jurisdictions that had enacted a one-dose approach amid a vaccine shortage.) There is not data, Walkensky said, to support that approach and “in fact, if anything, there are data saying that that is not protective enough.”

“So by using this alternative strategy of intradermal dosing, not only do we have more doses, but we actually allow people to get two doses in a way that shows immunologic response that’s superimposable from the subcutaneous dosing,” Walkensky said. “So we have more doses, and in fact, we have the ability to doubly vaccinate people so that they get the protection that they need.”

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Monkeypox

Supervisor Hahn to host Downey & Long Beach vax pop-ups

“This vaccine is critical to keeping people safe from the MPOX virus and I want to make it as easy as possible for people to get vaccinated”

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Supervisor Hahn's Mpox vaccine pop-up at Hamburger Mary's in Long Beach (Photo Credit: Office of Supervisor Janice Hahn)

DOWNEY, Ca – Los Angeles County Supervisor Janice Hahn will host a series of Mpox vaccine pop-up clinics outside of bars in Downey and Long Beach this coming weekend. These follow a successful Mpox vaccine pop-up that the Supervisor held outside of Hamburger Mary’s in Long Beach earlier this month, where 67 people received a dose.

“This vaccine is critical to keeping people safe from the MPOX virus and I want to make it as easy as possible for people to get vaccinated,” said Supervisor Hahn. “I am partnering with the LA County Department of Public Health, Long Beach Public Health, and the City of Downey to bring these pop-up vaccine clinics to places where people spend their free time and that are considered safe spaces by the LGBTQ+ community.”

Muevelo Fridays is an LGBTQ+ Latino dance party held once a week at The Epic Lounge in Downtown Downey. Falcon and Falcon North are well-established bars serving Long Beach’s LGBTQ+ community. The Falcon is located on East Broadway, home to several other gay bars that attract people from across the region.

“We appreciate that the Supervisor listens to community concerns, especially when it comes to public health, and we’re grateful that she’s using her resources at the county level to bring the mobile testing unit to Downey,” said Downey Councilman Mario Trujillo, who worked with Supervisor Hahn’s office to bring the pop-up to Downey on Friday. “We invite Downey residents and residents from surrounding communities to take advantage of the unit that’s being brought locally for their benefit.”

The vaccine pop-ups are carried out using a cargo van mobile unit. Supervisor Hahn purchased one of these mobile vans to bring COVID-19 vaccines to communities across her district.

On-site vaccination staff are employees of the Los Angeles County and Long Beach public health agencies.             

What:  Supervisor Janice Hahn Mpox vaccine pop-ups

Details:

Friday, September 23, 8pm to 10:30pm
Muevelo Fridays
The Epic Lounge
8239 2nd St., Downey, CA 90241
Saturday, September 24, 8pm to 12am
Falcon
1435 East Broadway, Long Beach, California 90802
Sunday, September 25, 5pm to 9pm
Falcon North
2020 East Artesia Boulevard, Long Beach, California 90805
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Monkeypox

Racial disparities persist in monkeypox outbreak

With the racial disparity ongoing, health observers say additional efforts are needed to reach out to marginalized communities

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Dr. Demetre Daskalakis (Screenshot/YouTube White House)

WASHINGTON – Racial disparities persist in response to the monkeypox outbreak as the numbers of Black and Latino men contracting the disease are now disproportionately high, but that inequity is getting new attention as overall cases drop.

Although overall new cases in the monkeypox outbreak are steadily on the decline after numbers peaked in the summer, a growing share of the continuing numbers belong to men who have sex with men who are racial minorities.

The latest numbers show the racial disparity dramatically. In the week of Sept. 4, Black people consisted of 41 percent of the cases and Latinos consisted of 27 percent, while 26 percent were white and three percent were Asian, according to data from the Centers for Disease Control.

Black people among the new cases of monkeypox were much smaller when numbers were first reported earlier in the summer. For example, the percentage was 18 on June 22 and as low as 8 percent June 8. The percentage of Latinos, as with white people, has been on the decline, although they’re still overrepresented in new cases in the context of their demographics in the U.S. population at large.

The disproportionate impact of new monkeypox cases on racial minorities hasn’t gone unnoticed. As a result, health officials are attempting to shift the focus of the monkeypox outbreak away from gay and bisexual men and other men who have sex with men more broadly and more toward men of color who are sexual minorities.

Sean Cahill, director of health policy research at the Boston-based Fenway Institute, said in an interview with the Washington Blade the racial disparities in the monkeypox outbreak are largely the result of Black and Latino men being “less likely to get vaccinated than their proportion of the population.”

“So they’re more vulnerable to monkeypox, and they’re less likely to get the vaccine,” Cahill said. “So that’s a real problem, and it’s really critical that you know, federal, state and local partners come together and really center equity in the response and try to reduce the burden on Black and Latino gay men, but also increase access to the vaccine to ensure that people can protect themselves.”

The Fenway Institute last week issued a blueprint calling for a more effective federal response to monkeypox, accusing the U.S. government of failing to effectively mobilize existing public health infrastructure to aid communities affected by the virus. The document outlines a range of possible actions, but also concludes marginalized communities are having difficulty accessing vaccines and treatments, which are concentrated at well-resourced institutions less accessible to communities of color.

Cahill, asked to characterize whether the numbers demonstrating racial disparity have changed over time or have remained stagnant, said any trends are difficult to determine because the data on racial demographics has been available only recently and “it’s very imperfect data.”

“I don’t know if it’s getting worse or better, the disproportionate racial ethnic impact,” Cahill said. “But it’s definitely there, and it doesn’t seem to be going away.”

The Biden administration, while touting the 20 percent decline in overall cases in the monkeypox outbreak, has also started to recognize the continued disproportionate impact of monkeypox on Black and Latino men who have sex with men.

Rochelle Walensky, director for the Centers for Disease Control & Prevention, said during a conference call with reporters the U.S. government approaches the decline with “cautious optimism.”

“Over the past several weeks, we have also seen the racial and ethnic makeup of this outbreak evolve,” Walensky said. “While monkeypox cases were first seen predominantly in non-Hispanic white men, in the last week, among the cases for which we have race and ethnicity data, non-Hispanic Black men represented 38 percent of cases, Latino or Hispanic men represented 25 percent of cases, and non-Hispanic white men represented 26 percent of cases.”

Among the efforts the Biden administration has undertaken is a pilot program for vaccines reserved for large events and equity. Monkeypox vaccines have been administered to more than 10,000 people, including at Southern Decadence in New Orleans, Atlanta Black Gay Pride, Charlotte Pride, Boise Pride Festival, and Oakland Pride and Pridefest.

Dr. Demetre Daskalakis, the face of LGBTQ outreach for the Biden administration in monkeypox efforts and deputy director the White House monkeypox task force, was among those promoting the pilot program in equity efforts during a conference call with reporters.

“Health departments will use their local experience and connection to the community to identify hyperlocal strategies to improve vaccine access to communities of color, specifically those that are overrepresented in this outbreak,” Daskalakis said.

David Johns, executive director of the National Black Justice Coalition, said in the racial disparities in the monkeypox outbreak are consistent with other trends in public health.

“There have been so many opportunities to learn ways to address health inequities before they grow,” Johns said. “That Black people continue to be disproportionately impacted by this newest health epidemic is additional evidence of how white supremacy works and the importance of democratized responses to crises.”

Biden health officials, asked by the Washington Blade during the virtual meeting why the administration’s stated goal of equity in managing the monkeypox outbreak isn’t producing racial equity among new cases, restated their efforts and talked about the difficulty in achieving that goal.

Walensky, who has also had a lead role in the Biden administration combating the coronavirus pandemic, said racial disparities in the monkeypox outbreak “is not uncommon for many infectious diseases, quite unfortunately,” and defended the U.S. government’s approach to monkeypox.

“And it is exactly for these reasons why we started on these pilot projects before we even saw the shifts in data, as that is often the case in infectious diseases that we have more vulnerable population — racial and ethnic minorities — who are most impacted later on,” Walensky added. “And so, we anticipated this. We have embarked on these activities to address this in exactly this moment.”

Daskalakis, following up in defense of the Biden administration’s efforts on equity, said he’s “spoken to providers on the ground and also promoters at these events who have noted that this effort is really unprecedented in terms of reaching deeply into these communities.”

“I think all of our commitment in the administration is to really focus efforts on equity to resolve the issues that we’re seeing. It is a hard effort and it’s a challenge,” Daskalakis added. “And I think that the way to address equity is intentionally, and this is an example of intentional work to address equity.”

With the racial disparity in the monkeypox outbreak ongoing, health observers say additional efforts are needed to reach out to marginalized communities to ensure they have access to public messaging and vaccinations.

Cahill said although people of color in urban areas go to LGBTQ centers to receive health care, many of them are also getting care through other facilities that aren’t LGBTQ-specific, such as emergency rooms and urgent care clinics .

“I think providing some training and technical assistance to those healthcare organizations in how to provide affirming care to bisexual men could be an important approach and could make it so that people might be more likely to disclose same-sex behavior in those contexts,” Cahill said.

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Monkeypox

LA County Public Health confirms first death due to Monkeypox

The patient was severely immunocompromised & hospitalized. To protect confidentiality & privacy additional information won’t be made public

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Photo Credit: County of Los Angeles

LOS ANGELES – In a press statement issued Monday afternoon, the Los Angeles Department of Public Health, along with the Centers for Disease Control and Prevention (CDC), has confirmed the first death due to monkeypox in a Los Angeles County resident. 

According to the statement the resident was severely immunocompromised and had been hospitalized. To protect confidentiality and privacy, additional information on this case will not be made public the statement added.

LA County Public Health Chief Medical Director Rita Singhal had told reporters last week during a briefing that this second possible death from monkeypox in the U.S. was under investigation.

In the first case, NBC News reported that in late August, the Texas Department of State Health Services reported that a person diagnosed with monkeypox in the Houston area had died. The patient was described in a statement as “severely immunocompromised.”

The role of monkeypox in the patient’s death was under investigation, Texas officials said at the time.

The Centers for Disease Control and Prevention said Friday that a case analysis found that 61% of people in the U.S. who have developed monkeypox also had HIV or another sexually transmitted infection or disease.

Monkeypox cases data in LA County as of September 9, 2022 showed 1,836 cases which included the cities of Long Beach and Pasadena which have separate health departments.

Los Angeles County (excl. Long Beach and Pasadena)1,722, Long Beach 92, and Pasadena 22.

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