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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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Puerto Rico

The ‘X’ returns to court

1st Circuit hears case over legal recognition of nonbinary Puerto Ricans

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(Photo by Sergei Gnatuk via Bigstock)

Eight months ago, I wrote about this issue at a time when it had not yet reached the judicial level it faces today. Back then, the conversation moved through administrative decisions, public debate, and political resistance. It was unresolved, but it had not yet reached this point.

That has now changed.

Lambda Legal appeared before the 1st U.S. Court of Appeals in Boston, urging the court to uphold a lower court ruling that requires the government of Puerto Rico to issue birth certificates that accurately reflect the identities of nonbinary individuals. The appeal follows a district court decision that found the denial of such recognition to be a violation of the U.S. Constitution.

This marks a turning point. The issue is no longer theoretical. A court has already determined that unequal treatment exists.

The argument presented by the plaintiffs is grounded in Puerto Rico’s own legal framework. Identity birth certificates are not static historical records. They are functional documents used in everyday life. They are required to access employment, education, and essential services. Their purpose is practical, not symbolic.

Within that framework, the exclusion of nonbinary individuals does not stem from a legal limitation. Puerto Rico already allows gender marker corrections on birth certificates for transgender individuals under the precedent established in Arroyo Gonzalez v. Rosselló Nevares. In addition, the current Civil Code recognizes the existence of identity documents that reflect a person’s lived identity beyond the original birth record.

The issue lies in how the law is applied.

Recognition is granted within specific categories, while those who do not identify within that binary structure remain excluded. That exclusion is now at the center of this case.

Lambda Legal’s position is straightforward. Requiring individuals to carry documents that do not reflect who they are forces them into misrepresentation in essential aspects of daily life. This creates practical barriers, exposes them to scrutiny, and places them in a constant state of vulnerability.

The plaintiffs, who were born in Puerto Rico, have made clear that access to accurate identification is not symbolic. It is a basic condition for moving through the world without contradiction imposed by the state.

The fact that this case is now being addressed in the federal court system adds another layer of significance. This is not a pending policy discussion or a legislative proposal. It is a constitutional question. The analysis is not about political preference, but about rights and equal protection under the law.

This case does not exist in isolation.

It unfolds within a broader context in which debates over identity and rights have increasingly been shaped by the growing influence of conservative perspectives in public policy, both in the United States and in Puerto Rico. At the local level, this influence has been reflected in legislative discussions where religious arguments have begun to intersect with decisions that should be grounded in constitutional principles. That intersection creates tension around the separation of church and state and has direct consequences for access to rights.

Recognizing this context is not an attack on faith or religious practice. It is an acknowledgment that when certain perspectives move into the realm of public authority, they can shape outcomes that affect specific communities.

From within Puerto Rico, this is not a distant debate. It is a lived reality. It is present in the difficulty of presenting identification that does not match one’s identity, and in the consequences that follow in workplaces, schools, and government spaces.

The progression of this case introduces the possibility of change within the applicable legal framework. Not because it resolves every tension surrounding the issue, but because it establishes a legal examination of a practice that has long operated under exclusion.

Eight months ago, the conversation centered on ongoing developments. Today, there is already a judicial finding that identifies a violation of rights. What remains is whether that finding will be upheld on appeal.

That process does not guarantee an immediate outcome, but it shifts the ground.

The debate is no longer theoretical.

It is now before the courts.

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National

LGBTQ community explores arming up during heated political times

Interest in gun ownership has increased since Donald Trump returned to office

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Gun rights organizations and advocates say interest in gun ownership seems to have increased in the LGBTQIA+ community since President Donald Trump returned to the White House last year. (Photo by Kaitlin Newman for the Baltimore Banner)

By JOHN-JOHN WILLIAMS IV | As the child of a father who hunted, Vera Snively shied away from firearms, influenced by her mother’s aversion to guns.

Now, the 18-year-old Westminster electrician goes to the shooting range at least once a month. She owns a rifle and a shotgun, and plans to get a handgun when she turns 21.

“I want to be able to defend my community, especially being in political spaces and queer spaces,” said Snively, a trans woman. “It’s just having that extra line of safety, having that extra peace of mind would be important to me.”

Snively is among what some say is a growing number of LGBTQ gun owners across the United States. Gun rights organizations and advocates say interest in gun ownership appears to have increased in that community since President Donald Trump returned to the White House last year.

The rest of this article can be read on the Baltimore Banner’s website.

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Tennessee

Tenn. lawmakers pass transgender “watch list” bill

State Senate to consider measure on Wednesday

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Tennessee, gay news, Washington Blade
Image of the transgender flag with the Tennessee flag in the shape of the state over it. (Image public domain)

The Tennessee House of Representatives passed a bill last week to create a transgender “watch list” that also pushes detransition medical treatment. The state Senate will consider it on Wednesday.

House Bill 754/State Bill 676 has been deemed “ugly” by LGBTQ advocates and criticized by healthcare information litigators as a major privacy concern.

The bill would require “gender clinics accepting funds from this state to perform gender transition procedures to also perform detransition procedures; requires insurance entities providing coverage of gender transition procedures to also cover detransition procedures; requires certain gender clinics and insurance entities to report information regarding detransition procedures to the department of health.”

It would require that any gender-affirming care-providing clinics share the date, age, and sex of patients; any drugs prescribed (dosage, frequency, duration, and method administered); the state and county; the name, contact information, and medical specialty of the healthcare professional who prescribed the treatment; and any past medical history related to “neurological, behavioral, or mental health conditions.” It would also mandate additional information if surgical intervention is prescribed, including details on which healthcare professional made a referral and when.

HB 0754 would also require the state to produce a “comprehensive annual statistical report,” with all collected data shared with the heads of the legislature and the legislative librarian, and eventually published online for public access.

The bill also reframes detransitioning as a major focus of gender-affirming healthcare — despite studies showing that the number of trans people who detransition is statistically quite low, around 13 percent, and is often the result of external pressures (such as discrimination or family) rather than an issue with their gender identity.

This legislation stands in sharp contrast to federal protections restricting what healthcare information can be shared. In 1996, Congress passed the Health Insurance Portability and Accountability Act, or HIPAA, requiring protections for all “individually identifiable health information,” including medical records, conversations, billing information, and other patient data.

Margaret Riley, professor of law, public health sciences, and public policy at the University of Virginia, has written about similar efforts at the federal level, noting the Trump-Vance administration’s push to subpoena multiple hospitals’ records of gender-affirming care for trans patients despite no claims — or proof — that a crime was committed.

It has “sown fear and concern, both among people whose information is sought and among the doctors and other providers who offer such care. Some health providers have reportedly decided to no longer provide gender-affirming care to minors as a result of the inquiries, even in states where that care is legal.” She wrote in an article on the Conversation, where she goes further, pointing out that the push, mostly from conservative members of the government, are pushing extracting this private information “while giving no inkling of any alleged crimes that may have been committed.”

State Rep. Jeremy Faison (R-Cosby), the bill’s sponsor, said in a press conference two weeks ago that he has met dozens of individuals who sought to transition genders and ultimately detransitioned. In committee, an individual testified in support of the bill, claiming that while insurance paid for gender-affirming care, detransition care was not covered.

“I believe that we as a society are going to look back on this time that really burst out in 2014 and think, ‘Dear God, What were we thinking? This was as dumb as frontal lobotomies,’” Faison said of gender-affirming care. “I think we’re going to look back on society one day and think that.”

Jennifer Levi, GLAD Law’s senior director of Transgender and Queer Rights, shared with PBS last year that legislation like this changes the entire concept of HIPAA rights for trans Americans in ways that are invasive and unnecessary.

“It turns doctor-patient confidentiality into government surveillance,” Levi said, later emphasizing this will cause fewer people to seek out the care that they need. “It’s chilling.”

The Washington Blade reached out to the American Civil Liberties Union of Tennessee, which shared this statement from Executive Director Miriam Nemeth:

“HB 754/SB 676 continues the ugly legacy of Tennessee legislators’ attacks on the lives of transgender Tennesseans. Most Tennesseans, regardless of political views, oppose government databases tracking medical decisions made between patients and their doctors. The same should be true here. The state does not threaten to end the livelihood of doctors and fine them $150,000 for safeguarding the sensitive information of people with diabetes, depression, cancer, or other conditions. Trans people and intersex people deserve the same safety, privacy, and equal treatment under the law as everyone else.”

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