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Biden administration shifts monkeypox vaccine approach amid shortage

Health experts sees new guidance as mixed bag

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The Biden administration has changed its guidance on monkeypox vaccines to enhance availability amid the shortage.

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, but 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 evaluate 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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US bishops ban gender-affirming care at Catholic hospitals

Directive adopted during meeting in Baltimore.

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A 2024 Baltimore Pride participant carries a poster in support of gender-affirming health care. (Washington Blade photo by Michael Key)

The U.S. Conference of Catholic Bishops this week adopted a directive that bans Catholic hospitals from offering gender-affirming care to their patients.

Since ‘creation is prior to us and must be received as a gift,’ we have a duty ‘to protect our humanity,’ which means first of all, ‘accepting it and respecting it as it was created,’” reads the directive the USCCB adopted during their meeting that is taking place this week in Baltimore.

The Washington Blade obtained a copy of it on Thursday.

“In order to respect the nature of the human person as a unity of body and soul, Catholic health care services must not provide or permit medical interventions, whether surgical, hormonal, or genetic, that aim not to restore but rather to alter the fundamental order of the human body in its form or function,” reads the directive. “This includes, for example, some forms of genetic engineering whose purpose is not medical treatment, as well as interventions that aim to transform sexual characteristics of a human body into those of the opposite sex (or to nullify sexual characteristics of a human body.)”

“In accord with the mission of Catholic health care, which includes serving those who are vulnerable, Catholic health care services and providers ‘must employ all appropriate resources to mitigate the suffering of those who experience gender incongruence or gender dysphoria’ and to provide for the full range of their health care needs, employing only those means that respect the fundamental order of the human body,” it adds.

The Vatican’s Dicastery for the Doctrine of the Faith in 2024 condemned gender-affirming surgeries and “gender theory.” The USCCB directive comes against the backdrop of the Trump-Vance administration’s continued attacks against the trans community.

The U.S. Supreme Court in June upheld a Tennessee law that bans gender-affirming medical interventions for minors.

Media reports earlier this month indicated the Trump-Vance administration will seek to prohibit Medicaid reimbursement for medical care to trans minors, and ban reimbursement through the Children’s Health Insurance Program for patients under 19. NPR also reported the White House is considering blocking all Medicaid and Medicare funding for hospitals that provide gender-affirming care to minors.

“The directives adopted by the USCCB will harm, not benefit transgender persons,” said Francis DeBernardo, executive director of New Ways Ministry, a Maryland-based LGBTQ Catholic organization, in a statement. “In a church called to synodal listening and dialogue, it is embarrassing, even shameful, that the bishops failed to consult transgender people, who have found that gender-affirming medical care has enhanced their lives and their relationship with God.” 

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Federal government reopens

Shutdown lasted 43 days.

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(Washington Blade photo by Michael Key)

President Donald Trump on Wednesday signed a bill that reopens the federal government.

Six Democrats — U.S. Reps. Jared Golden (D-Maine), Marie Gluesenkamp Perez (D-Wash.), Adam Gray (D-Calif.), Don Davis (D-N.C.), Henry Cuellar (D-Texas), and Tom Suozzi (D-N.Y.) — voted for the funding bill that passed in the U.S. House of Representatives. Two Republicans — Thomas Massie (R-Ky.) and Greg Steube (R-Fla.) — opposed it.

The 43-day shutdown is over after eight Democratic senators gave in to Republicans’ push to roll back parts of the Affordable Care Act. According to CNBC, the average ACA recipient could see premiums more than double in 2026, and about one in 10 enrollees could lose a premium tax credit altogether.

These eight senators — U.S. Sens. Catherine Cortez Masto (D-Nev.), Dick Durbin (D-Ill.), John Fetterman (D-Pa.), Maggie Hassan (D-N.H.), Tim Kaine (D-Va.), Angus King (I-Maine), Jacky Rosen (D-Nev.), and Jeanne Shaheen (D-N.H.) — sided with Republicans to pass legislation reopening the government for a set number of days. They emphasized that their primary goal was to reopen the government, with discussions about ACA tax credits to continue afterward.

None of the senators who supported the deal are up for reelection.

King said on Sunday night that the Senate deal represents “a victory” because it gives Democrats “an opportunity” to extend ACA tax credits, now that Senate Republican leaders have agreed to hold a vote on the issue in December. (The House has not made any similar commitment.)

The government’s reopening also brought a win for Democrats’ other priorities: Arizona Congresswoman Adelita Grijalva was sworn in after a record-breaking delay in swearing in, eventually becoming the 218th signer of a discharge petition to release the Epstein files.

This story is being updated as more information becomes available.

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U.S. Military/Pentagon

Serving America, facing expulsion: Fight for trans inclusion continues on Veterans Day

Advocates sue to reverse Trump ban while service members cope with new struggles

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Second Lt. Nicolas (Nic) Talbott (Photo courtesy of Talbott)

President Trump signed EO 14183, titled “Prioritizing Military Excellence and Readiness,” on Jan. 27, directing the Department of Defense (DoD) to adopt policies that would prohibit transgender, nonbinary, and gender-nonconforming people from serving in the military.

The Trump-Vance administration’s policy shift redefines the qualifications for military service, asserting that transgender people are inherently incapable of meeting the military’s “high standards of readiness, lethality, cohesion, honesty, humility, uniformity, and integrity,” citing a history or signs of gender dysphoria. According to the DoD, this creates “medical, surgical, and mental health constraints on [an] individual.” Regardless of their physical or intellectual capabilities, transgender applicants are now considered less qualified than their cisgender peers.

On Jan. 28, 2025, GLBTQ Legal Advocates and Defenders (GLAD) Law and the National Center for LGBTQ Rights (NCLR) filed Talbott v. Trump, a federal lawsuit in the U.S. District Court for the District of Columbia challenging the executive order. Originally filed on equal protection grounds on behalf of six active service members and two individuals seeking enlistment, the case has since grown to include 12 additional plaintiffs.

The Washington Blade spoke exclusively with Second Lt. Nicolas (Nic) Talbott, U.S. Army, a plaintiff in the case, and with Jennifer Levi, Senior Director of Transgender and Queer Rights at GLAD Law, who is leading the litigation.

For Talbott, serving in the military has been a lifelong aspiration, one he pursued despite the barriers posed by discriminatory policies.

“Being transgender posed quite the obstacle to me achieving that dream,” Talbott told the Blade. “Not because it [being trans] had any bearing on my ability to become a soldier and meet the requirements of a United States soldier, but simply because of the policy changes that we’ve been facing as transgender service members throughout the course of the past decade… My being transgender had nothing to do with anything that I was doing as a soldier.”

This drive was fueled by early life experiences, including the impact of the Sept. 11 terrorist attacks, which shaped his desire to protect his country.

“Even for an eight-year-old kid, [9/11] has a tremendous amount of impact… I remember thinking, you know, this is a terrible thing. Me, and when I grow up, I want to make sure nothing like this ever happens again,” he said. “I’ve still tried to gear my life in a way that I can be preparing myself to eventually help accomplish that mission of keeping America safe from anything like that ever happening again.”

The attacks inspired countless Americans to enlist; according to the New York City government, 181,510 joined active duty and 72,908 enlisted in the reserves in the year following 9/11. Although Talbott was too young to serve at the time, the events deeply influenced his educational and career path.

“For me, [9/11] just kind of helped shape my future and set me on the path that I’m currently on today,” he added. “It ignited my passion for the field, and it’s something that you know, I’ve carried with me into my adult life, into my professional life, and that I hope to have a career in the future.”

Talbott holds a master’s degree in criminology with a focus on counterterrorism and global security, and while completing his degree, he gained practical experience working with the Transportation Security Administration.

Despite the public scrutiny surrounding the lawsuit and the ongoing uncertainty of his military future, Talbott remains grounded in the values that define military service.

“Being so public about my involvement with this lawsuit grants me the very unique opportunity to continue to exemplify those values,” Talbott said. “I’m in a very privileged spot where I can speak relatively openly about this experience and what I’m doing. It’s very empowering to be able to stand up, not only for myself, but for the other transgender service members out there who have done nothing but serve with honor and dignity and bravery.”

The ban has created significant uncertainty for transgender service members, who now face the possibility of separation solely because of their gender identity.

“With this ban… we are all [trans military members] on track to be separated from the military. So it’s such a great deal of uncertainty… I’m stuck waiting, not knowing what tomorrow might bring. I could receive a phone call any day stating that the separation process has been initiated.”

While the Department of Defense specifies that most service members will receive an honorable discharge, the policy allows for a lower characterization if a review deems it warranted. Compensation and benefits differ depending on whether service members opt for voluntary or involuntary separation. Voluntary separation comes with full separation pay and no obligation to repay bonuses, while involuntary separation carries lower pay, potential repayment of bonuses, and uncertain success in discharge review processes.

Healthcare coverage through TRICARE continues for 180 days post-discharge, but reduced benefits, including VA eligibility, remain a concern. Those with 18–20 years of service may qualify for early retirement, though even this is not guaranteed under the policy.

Talbott emphasized the personal and professional toll of the ban, reflecting on the fairness and capability of transgender service members.

“Quite frankly, the evidence that we have at hand points in the complete opposite direction… there are no documented cases that I’m aware of of a transgender person having a negative impact on unit cohesion simply by being transgender… Being transgender is just another one of those walks of life.”

“When we’re losing thousands of those qualified, experienced individuals… those are seats that are not just going to be able to be filled by anybody … military training that’s not going to be able to be replaced for years and years to come.”

Talbott also highlighted the unique discipline, dedication, and value of diversity that transgender service members bring—especially in identifying problems and finding solutions, regardless of what others think or say. That, he explained, was part of his journey of self-discovery and a key reason he wants to continue serving despite harsh words of disapproval from the men leading the executive branch.

“Being transgender is not some sad thing that people go through… This is something that has taken years and years and years of dedication and discipline and research and ups and downs to get to the point where I am today… my ability to transition was essential to getting me to that point where I am today.”

He sees that as an asset rather than a liability. By having a more diverse, well-rounded group of people, the military can view challenges from perspectives that would otherwise be overlooked. That ability to look at things in a fresh way, he explained, can transform a good service member into a great one.

“I think the more diverse our military is, the stronger our military is… We need people from all different experiences and all different perspectives, because somebody is going to see that challenge or that problem in a way that I would never even think of… and that is what we need more of in the U.S. military.”

Beyond operational effectiveness, Talbott emphasized the social impact of visibility and leadership within the ranks. Fellow soldiers often approached him for guidance, seeing him as a trusted resource because of his transgender status.

“I can think of several instances in which I have been approached by fellow soldiers… I feel like you are a person I can come to if I have a problem with X, Y or Z… some people take my transgender status and designate me as a safe person, so to speak.”

With the arrival of Veterans Day, the Blade asked what he wishes the public knew about the sacrifices of transgender service members. His answer was modest.

“Every person who puts on the uniform is expected to make a tremendous amount of sacrifice,” Talbott said. “Who I am under this uniform should have no bearing on that… We shouldn’t be picking and choosing which veterans are worthy of our thanks on that day.”

Jennifer Levi, GLAD Law’s Senior Director of Transgender and Queer Rights, also spoke with the Blade and outlined the legal and human consequences of the ban. This is not Levi’s first time challenging the executive branch on transgender rights; she led the legal fight against the first Trump administration’s military ban in both Doe v. Trump and Stockman v. Trump.

Levi characterized the policy as overtly cruel and legally indefensible.

“This policy and its rollout is even more cruel than the first in a number of ways,” Levi explained. “For one, the policy itself says that transgender people are dishonest, untrustworthy and undisciplined, which is deeply offensive and degrading and demeaning.”

She highlighted procedural abuses and punitive measures embedded in the policy compared to the 2017 ban.

“In the first round the military allowed transgender people to continue to serve… In this round the military policy purge seeks to purge every transgender person from military service, and it also proposes to do it in a very cruel and brutal way, which is to put people through a process… traditionally reserved for kicking people out of the military who engaged in misconduct.”

Levi cited multiple examples of discrimination, including the revocation of authorized retirements and administrative barriers to hearings.

She also explained that the administration’s cost argument is flawed, as removing and replacing transgender service members is more expensive than retaining them.

“There’s no legitimate justification relating to cost… it is far more expensive to both purge the military of people who are serving and also to replace people… than to provide the minuscule amount of costs for medications other service members routinely get.”

On legal grounds, Levi noted the ban violates the Equal Protection Clause.

“The Equal Protection Clause prevents laws that are intended to harm a group of people… The doctrine is rooted in animus, which means a bare desire to harm a group is not even a legitimate governmental justification.”

When asked what she wishes people knew about Talbott and other targeted transgender military members, Levi emphasized their extraordinary service.

“The plaintiffs that I represent are extraordinary… They have 260 years of committed service to this country… I have confidence that ultimately, this baseless ban should not be able to legally survive.”

Other organizations have weighed in on Talbott v. Trump and similar lawsuits targeting transgender service members.

Human Rights Campaign Foundation President Kelley Robinson criticized the ban’s impact on military readiness and highlighted the counterintuitive nature of removing some of the country’s most qualified service members.

“Transgender servicemembers serve their country valiantly, with the same commitment, the same adherence to military standards and the same love of country as any of their counterparts,” Robinson said. “This ban by the Trump administration, which has already stripped transgender servicemembers of their jobs, is cruel, unpatriotic, and compromises the unity and quality of our armed forces.”

Lambda Legal Senior Counsel Sasha Buchert echoed the legal and moral imperative to reverse the policy.

“Every day this discriminatory ban remains in effect, qualified patriots face the threat of being kicked out of the military,” she said. “The evidence is overwhelming that this policy is driven by animus rather than military necessity… We are confident the court will see through this discriminatory ban and restore the injunction that should never have been lifted.”

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