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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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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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Glisten’s 30th annual Day of Silence to take place April 10

Campaign began as student-led protests against anti-LGBTQ bullying, discrimination

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(Photo courtesy of Glisten)

Glisten’s 30th annual Day of Silence will take place on April 10.

The annual Day of Silence began as a student-led protest in response to bullying and discrimination that LGBTQ students face. It is now a national campaign for the LGBTQ community and their allies to come together for LGBTQ youth. 

It takes place annually and has multiple ways for supporters to get involved in the movement. 

Glisten, originally GLSEN, champions LGBTQ issues in schools, grades K-12. Glisten’s mission is to create more inclusive and accepting environments for LGBTQ students through curriculum, supportive measures, education campaigns, and engagement, such as the Day of Silence. 

There are three main ways for the community to get involved in the Day of Silence. 

Glisten has a Day of Silence frame, a series of pictures used as profile photos across social media that feature individuals holding signs. The signs allow for personalization, by providing a space to put the individual’s name, followed by filling in the prompt “ … and I am ENDING the silence by…” 

Participants are encouraged to post the photo on social media and use it as a profile picture. The templates can be found on Google Drive through this link. 

Using #DayOfSilence and #NSCS, as well as tagging Glisten’s official Page @glistencommunity, is another way to participate in the Day of Silence. 

Glisten also encourages participants to tag creators, friends, family and use a call to action in their caption, to call attention to the facts and stories behind the Day of Silence. 

“Today’s administration in the U.S. wants us to stay silent, submit to their biased and hurtful conformity, and stop fighting for our right to be authentically ourselves,” said Glisten CEO Melanie Willingham-Jaggers. “We urge supporters to use their social platforms and check in with local chapters to be boots on the ground to help LGBTQ+ students feel seen, heard, supported, and less alone. By participating in the ‘Day of Silence,’ you are showing solidarity with young people as they navigate identity, safety, and belonging. Our voices matter.”

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South Carolina

Man faces first S.C. ‘hate intimidation’ charge 

Timothy Truett allegedly shot at gay club in Myrtle Beach on April 1

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The South Carolina flag waving over the state. (Washington Blade Photo by Michael K. Lavers)

A South Carolina man remains in custody on a more than $300,000 bond after he allegedly opened fire at a Myrtle Beach nightclub on April 1, according to WMBF.

Reports say 37-year-old Timothy James Truett Jr., of Clover, S.C., was detained by the Myrtle Beach Police Department after the April 1 incident outside Pulse Ultra Club. He was later arrested and charged with possession of a weapon during a violent crime, discharging a firearm into a dwelling, discharging a firearm within city limits, malicious injury to real property valued over $5,000, and assault or intimidation due to political opinions or the exercise of civil rights.

At 10:57 a.m. on April 1, officers responded to a call about a possible shooting at Pulse Ultra Club, located in the 2700 block of South Kings Highway.

In an affidavit released later, the club’s owner, Ken Phillips, said he was doing paperwork that morning when he heard “five or six” gunshots. He went outside and found a window and the windshield of his SUV shattered by bullets. An SUV with blue plastic covering one window was left at the scene.

Police later reviewed footage that showed a silver vehicle stopping in the middle of the road. The video appeared to capture muzzle flashes coming from the passenger-side window.

According to the affidavit, an officer later pulled over a vehicle driven by Truett and found spent shell casings in the back seat, along with a gun.

Documents do not detail why Truett was ultimately charged under the state law covering assault or intimidation tied to political opinions or the exercise of civil rights.

As of April 1, records show Truett is being held in Horry County on a combined bond of more than $312,000.

WMBF spoke with Phillips after the incident and asked whether there was any prior conflict that might have led to the shooting.

“I don’t know if it’s personal, I don’t know if it’s related to being gay, I don’t know if it’s related to the bar issues,” Phillips told WMBF. “Anybody with a mindset of pulling out a weapon in broad daylight is not right.”

“My primary concern has and always will be the safety of my community and my customers,” he added. “It’s given me great concern … as to how far people will go.”

WMBF also spoke with Adam Hayes, vice chair of Myrtle Beach’s Human Rights Coalition, who was involved in pushing for the ordinance. He said that while the incident itself is troubling, it shows the policy is being put to use.

The ordinance is intended to deter “crimes that are motivated by bias or hate towards any person or persons, in whole or in part, because of the actual or perceived” identity, in the absence of a statewide hate crime law.

“It’s nice to see that something we put into policy is not just a piece of paper, that it’s actually being used,” said Hayes.

He said the shooting underscores the need for a statewide hate crime law in South Carolina and added that the incident has left the local LGBTQ community shaken.

South Carolina and Wyoming are the only two states in the U.S. without a comprehensive statewide hate crime law.

Truett remains in jail as of publication.

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