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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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National

Madonna turns Times Square into massive dance floor

Pop icon celebrates Pride month with surprise performance

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Madonna surprised New York fans with an impromptu show in Times Square. (Photo by Alex Antonioni; courtesy Warner Records)


Pop icon Madonna celebrated Pride month with a pop-up performance in New York City’s Times Square on Thursday to the delight of 50,000 fans.

She performed for about 15 minutes high above street level, including several songs from her new album “Confessions II” due on July 3, along with a trio of songs from the first “Confessions on a Dance Floor.”

In addition to the brand new “Love Sensation,” she performed “I Feel So Free” and “Bring Your Love,” plus “Hung Up,” “Get Together” and “I Love New York.” She wished the crowd a happy Pride season; the event was shared with audiences through Grindr’s first-ever livestream. 

Madonna performs in Times Square on Thursday. (Photo by Alex Antonioni; courtesy Warner Records)
(Photo by Ricardo Gomes; courtesy Warner Records)

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Gallup finds LGBTQ support among Americans is dropping

Marriage equality support lowest since 2016

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Progress rainbow flag and trans flag flying. (Washington Blade Photo by Michael Key)

Gallup, one of the leading organizations in public opinion polling, has found that LGBTQ support among Americans is dropping.

The poll, whose data was collected using Gallup’s annual Values and Beliefs survey, was conducted in May and was published on Wednesday. The data was collected through telephone interviews from a sample of more than 1,000 adults living in all 50 states and D.C. using random digit dialing. 

It highlights declining attitudes surrounding LGBTQ issues in multiple areas — from support for same-sex marriage to views on gender identity and the morality of one’s sexuality.

One of the most striking findings was that support for marriage equality fell six points from its 2022-2023 high.

The survey also found that 62 percent of Americans view gay and lesbian relations as morally acceptable, the lowest level since 2016 just after same-sex marriage was legalized nationwide by the U.S. Supreme Court. 

One newer question on the poll found that the perceived morality of changing one’s gender has dropped eight points since 2021, indicating the American public is less supportive of transgender people.

New data from Gallup shows a decline in LGBTQ support. (Graph courtesy of Gallup)

The data attributes much of the decline to shifting Republican views alongside the party itself. Conservative leaders have pushed back against diversity, equity, and inclusion programs that were intended to foster greater acceptance of LGBTQ people and other historically disadvantaged groups.

President Donald Trump has been a guiding force behind waves of anti-LGBTQ sentiment, particularly when it comes to trans rights. The president has enacted multiple executive orders, including Executive Order 14168, “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government,” which mandates that gender be defined by one’s sex assigned at birth. He also signed Executive Order 14183, “Prioritizing Military Excellence and Readiness,” which barred qualified trans applicants from joining the military and led to the removal of trans service members already serving in the armed forces.

Additionally, he signed Executive Order 14201, “Keeping Men Out of Women’s Sports,” which prohibits trans female athletes from participating on women’s and girls’ sports teams.

In February, Gallup found that an estimated 9 percent of Americans identified as part of the LGBTQ community in some form.

The organization also found that 23 percent of adults under age 30 identify as LGBTQ, compared with 10 percent of those ages 30 to 49 and 3 percent or less among those ages 50 and older.

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Ogles faces bipartisan backlash over anti-gay social media post

Tenn. congressman blamed the comment on staffer

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U.S. Rep. Andy Ogles (R-Tenn.) (Photo public domain)

U.S. Rep. Andy Ogles (R-Tenn.), who represents Tennessee’s 5th Congressional District, is facing backlash from LGBTQ advocates and fellow Republicans after a social media post declared that “homosexuality has no place in America.”

“Homosexuality has no place in America. Happy Nuclear Family Month,” the congressman wrote in a post on X that was later deleted.

According to the Williams Institute at UCLA School of Law, an estimated 6.3 percent of U.S. adults identify as LGBTQ.

Following widespread criticism, Ogles removed the post and blamed it on a staff member.

“The post was stupid, hurtful and a complete distraction from my America First focus. The employee has been reprimanded,” Ogles said in a statement.

The Washington Blade reached out to Ogles’s office for comment but did not receive a response by press time.

Among those condemning the message was U.S. Rep. Mike Lawler (R-N.Y.), who called it “absolutely idiotic” in a social media post.

“Homosexuality exists. In America,” Lawler wrote on X. “In fact, Andy, you have family, friends, neighbors, colleagues, and constituents who are gay and lesbian. It doesn’t make them less than or somehow unworthy of being an American.”

U.S. Sen. Ted Cruz (R-Texas) also criticized Ogles’s remarks.

“For all of recorded history, homosexuals have been a part of humanity,” Cruz told TMZ DC. “I think the behavior of consenting adults is their business.”

Chris Sanders, the executive director for the Tennessee Equality Project and Tennessee Equality Project Foundation provided a statement to the Blade about Ogles’s comment.

“The Tennessee Nuclear Family Month resolution has really backfired on conservatives by ensnaring Congressman Ogles in scandal. He used the resolution as a pretext to say that our community doesn’t belong in America, resulting in incredible backlash from across the partisan divide,” Sanders said. “It is a good opportunity for him to pause and reflect on whether it’s time for him to resign. Fighting one’s own constituents is not the purpose of serving in Congress.”

Human Rights Campaign Senior Press Secretary Jarred Keller provided a statement to the Blade regarding Ogles’s comments.

“LGBTQ+ people are woven into the fabric of America, and any politician who questions that is severely out of touch with reality. When so many people are worried about whether they can afford gas to get to work or groceries for their families, the last thing we need is right-wing Republicans targeting marginalized communities with hateful attacks,” Keller said. “Representative Ogles should spend less time attacking LGBTQ+ people and start addressing the issues that actually matter, because last I checked, our community isn’t the reason families are struggling to make ends meet.”

The controversy comes as Tennessee continues to advance legislation affecting LGBTQ residents. The state already has several laws on the books that LGBTQ advocates have criticized, including the Adult Entertainment Act, enacted in 2023, which restricts certain “adult cabaret performances.”

Lawmakers have also introduced additional measures this legislative session, including the “No Pride Flag or Month Act,” which would prohibit state employees, volunteers, and agents from displaying Pride flags or participating in Pride observances while acting in an official capacity.

Another proposal, the “Banning Bostock Act” would seek to limit the application of state anti-discrimination protections based on the U.S. Supreme Court’s decision in Bostock v. Clayton County. Tennessee lawmakers have also passed other measures restricting LGBTQ rights and access to gender-affirming health care.

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