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U.S. health officials expand approach to monkeypox vaccines as cases crest

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With Southern Decadence coming up, Biden health officials have given an additional 6,000 monkeypox vaccines for New Orleans. (Blade file photo by Michael Key)

At the end of a summer when the number of cases in the monkeypox outbreak rose sharply, the increase in reported infections now appears to be cresting amid increased public messaging and access to vaccines, prompting U.S. health officials to expand their strategy with a new equity-based effort to combat the disease.

Although the reported number of cases, according to most data from the Centers for Disease Control & Prevention, has reached 18,417 in the United States, the number of additional cases decreased from the high at the start of the month, suggesting a downward trajectory in the spread of the disease as vaccines become more readily available.

The number of additional monkeypox cases in beginning to crest, per CDC data.

The numbers are also consistent with a new study finding a significant number of gay and bisexual men, as well as other men who have sex with men, have been limiting contact with casual sex partners, which has been the driving force in the spread of monkeypox. The report from the CDC last week found limiting one-time sexual encounters can significantly reduce the transmission of monkeypox virus, while about half of men who have sex with men are cutting down on sexual activity amid the outbreak, including one-night stands and app hookups.

With the trajectory of monkeypox on the decline, the Biden administration announced a new initiative with the goal of ensuring vaccine distribution is consistent with the value of equity, including on the basis of geographic, racial, and ethnic lines. A total of 10,000 doses of vaccines in the federal government’s supply will be earmarked for localities that have used 50 percent of their allocated supply to support equity interventions, such as outreach to Black and Latino communities, which have been disproportionately affected by the disease or a specific event and celebration for LGBTQ people, health officials announced Tuesday.

Demetre Daskalakis, the Biden administration’s face of LGBTQ outreach for monkeypox and deputy coordinator for the White House monkeypox task force, laid out the details for the new equity-based supplementary initiative in a conference call Tuesday with reporters.

“So what we mean by an equity intervention is what works in your state, county, or city to reach people who we may not be reaching, especially people of color and members of the LGBTQI+ population,” Daskalakis said. “What it means is: It can be working with a specific group or venue that reaches the right people for monkeypox prevention. Once these innovative strategies have been reviewed by CDC, vaccines will be supplied to jumpstart these ideas and accelerate reach deeper into communities.”

The additional equity-based approach to monkeypox vaccine distribution is consistent with the Biden administration’s efforts in recent weeks to distribute additional shots to localities hosting large-scale events for LGTBQ people at the end of the summer, such as Black Pride in Atlanta and Southern Decadence in New Orleans.

Louisiana Gov. John Bel Edwards joined the conference call with reporters on Tuesday and had high praise for the Biden administration for making the additional 6,000 doses of monkeypox vaccine available in time for Southern Decadence, which takes place in the final week of August through Labor Day weekend.

“This is an example — I think a really solid example — of what a federal-state-local partnership and — and then the community providers as well,” Bel Edwards said. “Because the public health folks in New Orleans have been tremendous, but also the community providers.”

Bel Edwards said health officials in the Biden administration have, in addition to providing more vaccines, sent down multidisciplinary teams to New Orleans to help the state organize and prepare as well as set up testing and vaccination sites “that are going to be convenient for the at-risk population.”

A reporter from the New Orleans Advocate on the conference call, however, asked a pointed question on the recent distribution of vaccines to New Orleans in advance of Southern Decadence: The current approach to vaccine administration requires a series of shots, and even with new distribution most people won’t have even had their second shot by that time, so how can Southern Decadence think they will be protected, especially when vaccines take time to become fully effective?

Daskalakis, while promoting the equity-based approach to vaccine distribution, said the Biden administration has been “very clear” that first shot of the monkeypox vaccine “doesn’t mean that you’re protected for the event.”

“We’re going to talk to them about lots of other strategies that they can reduce risk of acquiring monkeypox, but also make it clear that that shot is not for today; it’s for four weeks from now, plus two weeks after that second dose when you get maximum protection,” Daskalakis said.

First death of monkeypox patient reported

Although the number of cases is cresting, concern about monkeypox continues as well as the potential danger of the disease. Case in point: The death of a hospital patient in Texas who had monkeypox, but may have to succumbed to other factors, has drawn attention amid a conventional understanding the skin disease isn’t fatal. The case represents the first time in the United States that a patient with monkeypox died while having the condition.

The patient, as confirmed by the Texas Department of State Health Services on Tuesday, was an adult resident of Harris County who was “severely immunocompromised” and state health officials reviewing the case said it is under investigation to determine what role monkeypox played in the death.

Jenny McQuiston, a CDC official who specializes in research on zoological diseases that spread from animals to people, said in response to a question on the casualty that health officials are also evaluating the death and the role monkeypox played.

“I think it’s important to emphasize that deaths due to monkeypox, while possible, remain very rare,” McQuiston said. “In most cases, people are experiencing infection that resolves over time. And there have been very few deaths even recorded globally. Out of over 40,000 cases around the world, only a handful of fatalities have been reported.”

Despite the cresting in the number of cases, many health experts aren’t sold on the new approach to vaccines announced earlier this month by the Biden administration, which sought to expand existing doses of vaccines fivefold as supply hasn’t met demand. The new vaccine approach calls for injecting 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).

Bob Fenton, a regional administrator for FEMA and the response coordinator for the White House task force, said about 75 percent of jurisdictions have already adopted the new approach to vaccine injection, while an additional 20 percent are working toward a “fully operational intradermal method.”

“We continue to be laser-focused on doing everything within our power to help jurisdictions and clinicians get shots in arms,” Fenton said. “We’re seeing more and more jurisdictions adopt the intradermal administration.”

Data of this new intradermal approach, critics have said, is insufficient to support the idea it will be as effective as subcutaneous injections, although the Biden administration continues to give assurances the new route for injections is tested and safe. According to a report earlier this month in the Washington Post, the manufacturer of the JYNNEOS vaccine in Denmark, Bavaria Nordic, privately threatened to cut off supply of the shots based on a conversation with health officials on objections the vaccine hasn’t been approved for intradermal use.

McQuiston, in response to a question on whether or not U.S. health officials are collecting newly available real-world information on the results of the new vaccine approach, said U.S. health officials continue to receive data on monkeypox and soon onboard information from additional states.

“CDC operates a system called VAERS — or the Vaccine Adverse Event Reporting System — and we’re actively looking at…different types of events that might be reported post-vaccination,” McQuiston said. ” And we are actively gathering information from the different jurisdictions and states and cities about which vaccines they’re administering — whether it’s subcutaneous or intradermal — and we are gathering those data now, as we speak.”

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The White House

‘Trump Rx’ plan includes sharp cuts to HIV drug prices

President made announcement on Friday

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President Donald Trump during his meeting on lowering drug prices through TrumpRx. (Washington Blade photo by Joe Reberkenny)

President Donald Trump met with leaders from some of the world’s largest pharmaceutical companies at the White House on Friday to announce his new “Trump Rx” plan and outline efforts to reduce medication costs for Americans.

During the roughly 47-minute meeting in the Roosevelt Room, Trump detailed his administration’s efforts to cut prescription drug prices and make medications more affordable for U.S. patients.

“Starting next year, American drug prices will come down fast, furious, and will soon be among the lowest in the developed world,” Trump said during the meeting. “For decades, Americans have been forced to pay the highest prices in the world for prescription drugs by far … We will get the lowest price of anyone in the world.”

Trump signed an executive order in May directing his administration “to do everything in its power to slash prescription drug prices for Americans while getting other countries to pay more.”

“This represents the greatest victory for patient affordability in the history of American health care, by far, and every single American will benefit,” he added.

Several pharmaceutical executives stood behind the president during the announcement, including Sanofi CEO Paul Hudson, Novartis CEO Vas Narasimhan, Genentech CEO Ashley Magargee, Boehringer Ingelheim (USA) CEO Jean-Michel Boers, Gilead Sciences CEO Dan O’Day, Bristol Myers Squibb General Counsel Cari Gallman, GSK CEO Emma Walmsley, Merck CEO Robert Davis, and Amgen Executive Vice President Peter Griffith.

Also in attendance were Health and Human Services Secretary Robert F. Kennedy Jr., Commerce Secretary Howard Lutnick, Centers for Medicare and Medicaid Services Administrator Mehmet Oz, and Food and Drug Administration Commissioner Marty Makary.

Under the Trump Rx plan, the administration outlined a series of proposed drug price changes across multiple companies and therapeutic areas. Among them were reductions for Amgen’s cholesterol-lowering drug repatha from $573 to $239; Bristol Myers Squibb’s HIV medication reyataz from $1,449 to $217; Boehringer Ingelheim’s type 2 diabetes medication jentadueto from $525 to $55; Genentech’s flu medication xofluza from $168 to $50; and Gilead Sciences’ hepatitis C medication epclusa from $24,920 to $2,425.

Additional reductions included several GSK inhalers — such as the asthma inhaler advair diskus 500/50, from $265 to $89 — Merck’s diabetes medication januvia from $330 to $100, Novartis’ multiple sclerosis medication mayzent from $9,987 to $1,137, and Sanofi’s blood thinner plavix from $756 to $16. Sanofi insulin products would also be capped at $35 per month’s supply.

These prices, however, would only be available to patients who purchase medications directly through TrumpRx. According to the program’s website, TrumpRx “connects patients directly with the best prices, increasing transparency, and cutting out costly third-party markups.”

Kennedy spoke after Trump, thanking the president for efforts to lower pharmaceutical costs in the U.S., where evidence has shown that drug prices — including both brand-name and generic medications — are nearly 2.78 times higher than prices in comparable countries. According to the Pharmaceutical Research and Manufacturers of America, roughly half of every dollar spent on brand-name drugs goes to entities that play no role in their research, development, or manufacturing.

“This is affordability in action,” Kennedy said. “We are reversing that trend and making sure that Americans can afford to get the life-saving solutions.”

Gilead CEO Dan O’Day also spoke about how the restructuring of drug costs under TrumpRx, combined with emerging technologies, could help reduce HIV transmission — a virus that, if untreated, can progress to AIDS. The LGBTQ community remains disproportionately affected by HIV.

“Thank you, Mr. President — you and the administration,” O’Day said. “I think this objective of achieving the commitment to affordability and future innovation is extraordinary … We just recently launched a new medicine that’s only given twice a year to prevent HIV, and we’re working with Secretary Kennedy and his entire team, as well as the State Department, as a part of your strategy to support ending the epidemic during your term.

“I’ve never been more optimistic about the innovation that exists across these companies and the impact this could have on America’s health and economy,” he added.

Trump interjected, asking, “And that’s working well with HIV?”

“Yes,” O’Day replied.

“It’s a big event,” Trump said.

“It literally prevents HIV almost 100 percent given twice a year,” O’Day responded.

A similar anti-HIV medication is currently prescribed more than injectable form mentioned by O’Day. PrEP, is a medication regimen proven to significantly reduce HIV infection rates for people at high risk. Without insurance, brand-name Truvada can cost roughly $2,000 per month, while a generic version costs about $60 per month.

Even when medication prices are reduced, PrEP access carries additional costs, including clinic and laboratory fees, office visits, required HIV and sexually transmitted infection testing, adherence services and counseling, and outreach to potentially eligible patients and providers.

According to a 2022 study, the annual total cost per person for PrEP — including medication and required clinical and laboratory monitoring — is approximately $12,000 to $13,000 per year.

The TrumpRx federal platform website is now live at TrumpRx.gov, but the program is not slated to begin offering reduced drug prices until January.

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The White House

EXCLUSIVE: Democracy Forward files FOIA lawsuit after HHS deadnames Rachel Levine

Trans former assistant health secretary’s name changed on official portrait

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Adm. Rachel Levine (Washington Blade photo by Michael Key)

Democracy Forward, a national legal organization that works to advance democracy and social progress through litigation, policy and public education, and regulatory engagement, filed a lawsuit Friday in federal court seeking to compel the U.S. Department of Health and Human Services to release information related to the alteration of former Assistant Secretary for Health Adm. Rachel Levine’s official portrait caption.

The lawsuit comes in response to the slow pace of HHS’s handling of multiple Freedom of Information Act requests — requests that federal law requires agencies to respond to within 20 working days. While responses can take longer due to backlogs, high request volumes, or the need for extensive searches or consultations, Democracy Forward says HHS has failed to provide any substantive response.

Democracy Forward’s four unanswered FOIA requests, and the subsequent lawsuit against HHS, come days after someone in the Trump-Vance administration changed Levine’s official portrait in the Hubert H. Humphrey Building to display her deadname — the name she used before transitioning and has not used since 2011.

According to Democracy Forward, HHS “refused to release any records related to its morally wrong and offensive effort to alter former Assistant Secretary for Health Admiral Rachel Levine’s official portrait caption.” Levine was the highest-ranking openly transgender government official in U.S. history and served as assistant secretary for health and as an admiral in the U.S. Public Health Service Commissioned Corps from 2021 to 2025.

Democracy Forward President Skye Perryman spoke about the need to hold the Trump-Vance administration accountable for every official action, especially those that harm some of the most targeted Americans, including trans people.

“The question every American should be asking remains: what is the Trump-Vance administration hiding? For an administration that touts its anti-transgender animus and behavior so publicly, its stonewalling and silence when it comes to the people’s right to see public records about who was behind this decision is deafening,” Perryman said.

“The government’s obligation of transparency doesn’t disappear because the information sought relates to a trailblazing former federal official who is transgender. It’s not complicated — the public is entitled to know who is making decisions — especially decisions that seek to alter facts and reality, erase the identity of a person, and affect the nation’s commitment to civil rights and human dignity.”

“HHS’s refusal to respond to these lawful requests raises more serious concerns about transparency and accountability,” Perryman added. “The public has every right to demand answers — to know who is behind this hateful act — and we are going to court to get them.”

The lawsuit also raises questions about whether the alteration violated federal accuracy and privacy requirements governing Levine’s name, and whether the agency improperly classified the change as an “excepted activity” during a lapse in appropriations. By failing to make any determination or produce any records, Democracy Forward argues, HHS has violated its obligations under federal law.

The case, Democracy Forward Foundation v. U.S. Department of Health and Human Services, was filed in the U.S. District Court for the District of Columbia. The legal team includes Anisha Hindocha, Daniel McGrath, and Robin Thurston.

The Washington Blade reached out to HHS, but has not received any comment.

The lawsuit and four FOIA requests are below:

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The White House

Empty seats, canceled shows plague Kennedy Center ahead of Trump renaming

It would take an act of Congress to officially rename the historic music venue, despite the Trump-appointed board’s decision.

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Protesters march in defiance of the changes to the Kennedy Center following Trump's takeover in March. (Washington Blade Photo by Michael Key)

The board of the Kennedy Center in Washington, D.C., voted to rename it the Trump-Kennedy Center, according to the White House Press Office.

White House Press Secretary Karoline Leavitt announced the decision in a post on X Thursday, thanking the president for his work on the cultural center “not only from the standpoint of its reconstruction, but also financially, and its reputation.”

Speaking to reporters later that day at the White House, Trump said he was “surprised” and “honored” by the board’s vote.

“This was brought up by one of the very distinguished board members, and they voted on it, and there’s a lot of board members, and they voted unanimously. So I was very honored,” he said.

Earlier this year, GOP Rep. Mike Simpson of Idaho introduced an amendment that would have renamed the building after first lady Melania Trump, later saying she had not been aware of his efforts prior to the amendment’s public introduction.

Despite the board’s vote (made up of Trump-appointed loyalists), the original laws guiding the creation of the Kennedy Center during the Eisenhower, Kennedy, and Johnson administrations explicitly prohibit renaming the building. Any change to its name would require an act of Congress.

Trump has exerted increasing control over the center in recent months. In February, he abruptly fired members of the Kennedy Center’s board and installed himself as chair, writing in a Truth Social post at the time, “At my direction, we are going to make the Kennedy Center in Washington D.C., GREAT AGAIN.”

In that post, Trump specifically cited his disapproval of the center’s decision to host drag shows.

He later secured more than $250 million from the Republican-controlled Congress for renovations to the building.

Since Trump’s takeover, sales of subscription packages are said to have declined, and several touring productions — including “Hamilton” — have canceled planned runs at the venue. Rows of empty seats have also been visible in the Concert Hall during performances by the National Symphony Orchestra.

“The Kennedy Center Board has no authority to actually rename the Kennedy Center in the absence of legislative action,” House Minority Leader Hakeem Jeffries told reporters.

For decades, the Kennedy Center has hosted performances by LGBTQ artists and companies, including openly queer musicians, choreographers, and playwrights whose work helped push LGBTQ stories into the cultural mainstream. Those artists include the Gay Men’s Chorus of Washington, Harvey Fierstein, and Tennessee Williams.

In more recent years, the center has increasingly served as a space for LGBTQ visibility and acceptance, particularly through Pride-adjacent programming and partnerships.

That legacy was on display at this year’s opening production of Les Misérables, when four drag performers — Tara Hoot, Vagenesis, Mari Con Carne, and King Ricky Rosé — attended in representation of Qommittee, a volunteer network uniting drag artists to support and defend one another amid growing conservative attacks.

“We walked in together so we would have an opportunity to get a response,” said Tara Hoot, who has performed at the Kennedy Center in full drag before. “It was all applause, cheers, and whistles, and remarkably it was half empty. I think that was season ticket holders kind of making their message in a different way.”

The creation of the Kennedy Center is outlined in U.S. Code, which formally designates the institution as the John F. Kennedy Center for the Performing Arts.

As a result, it appears unlikely that Congress will come together to pass legislation allowing the historic venue to be renamed.

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