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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 ā€” where single digit monkeypox cases have been reported ā€” 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 ā€” real world studies are needed ā€” 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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The White House

Four states to ignore new Title IX rules protecting transgender students

Biden administrationĀ last Friday released final regulations

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March for Queer and Trans Youth Autonomy in D.C. in 2023. (Washington Blade photo by Michael Key)

BY ERIN REED | Last Friday, the Biden administration released its final Title IX rules, which include protections for LGBTQ students by clarifying that Title IX forbids discrimination based on sexual orientation and gender identity. 

The rule change could have a significant impact as it would supersede bathroom bans and other discriminatory policies that have become increasingly common in Republican states within the U.S. 

As of Thursday morning, however, officials in at least four states ā€” Oklahoma, Louisiana, Florida, and South Carolina ā€” have directed schools to ignore the regulations, potentially setting up a federal showdown that may ultimately end up in a protracted court battle in the lead-up to the 2024 elections.

Louisiana State Superintendent of Education Cade Brumley was the first to respond, decrying the fact that the new Title IX regulations could block teachers and other students from exercising what has been dubbed by some a ā€œright to bullyā€ transgender students by using their old names and pronouns intentionally. 

Asserting that Title IX law does not protect trans and queer students, Brumley states that schools ā€œshould not alter policies or procedures at this time.ā€ Critically, several courts have ruled that trans and queer students are protected by Title IX, including the 4th U.S. Circuit Court of AppealsĀ in a recent case in West Virginia.

In South Carolina, Schools Supt. Ellen Weaver wrote in a letter that providing protections for trans and LGBTQ students under Title IX ā€œwould rescind 50 years of progress and equality of opportunity by putting girls and women at a disadvantage in the educational arena,ā€ apparently leaving trans kids out of her definition of those who deserve progress and equality of opportunity. 

She then directed schools to ignore the new directive while waiting for court challenges. While South Carolina does not have a bathroom ban or statewide “Donā€™t Say Gay or Trans” law, such bills continue to be proposed in the state.

Responding to the South Carolina letter, Chase Glenn of Alliance For Full Acceptance stated, ā€œWhile Supt. Weaver may not personally support the rights of LGBTQ+ students, she has the responsibility as the top school leader in our state to ensure that all students have equal rights and protections, and a safe place to learn and be themselves. The flagrant disregard shown for the Title IX rule tells me that our superintendent unfortunately does not have the best interests of all students in mind.ā€

Florida Education Commissioner Manny Diaz also joined in instructing schools not to implement Title IX regulations. In a letter issued to area schools, Diaz stated that the new Title IX regulations were tantamount to ā€œgaslighting the country into believing that biological sex no longer has any meaning.ā€ 

Governor Ron DeSantis approved of the letter and stated that Florida ā€œwill not comply.ā€ Florida has notably been the site of some of the most viciously anti-queer and anti-trans legislation in recent history, including a “Donā€™t Say Gay or Trans” law that was used to force a trans female teacher to go by ā€œMr.ā€

State Education Supt. Ryan Walters of Oklahoma was the latest to echo similar sentiments. Walters has recently appointed the right-wing media figure Chaya Raichik of Libs of TikTok to an advisory role ā€œto improve school safety,ā€ and notably, Raichik has posed proudly with papers accusing her of instigating bomb threats with her incendiary posts about LGBTQ people in classrooms.

The Title IX policies have been universally applauded by large LGBTQ rights organizations in the U.S. Lambda Legal, a key figure in fighting anti-LGBTQ legislation nationwide, said that the regulations ā€œclearly cover LGBTQ+ students, as well as survivors and pregnant and parenting students across race and gender identity.ā€ The Human Rights Campaign also praised the rule, stating, ā€œrule will be life-changing for so many LGBTQ+ youth and help ensure LGBTQ+ students can receive the same educational experience as their peers: Going to dances, safely using the restroom, and writing stories that tell the truth about their own lives.ā€

The rule is slated to go into effect Aug. 1, pending any legal challenges.

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Erin Reed is a transgender woman (she/her pronouns) and researcher who tracks anti-LGBTQ+ legislation around the world and helps people become better advocates for their queer family, friends, colleagues, and community. Reed also is a social media consultant and public speaker.

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The preceding article was first published at Erin In The Morning and is republished with permission.

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Pennsylvania

Malcolm Kenyatta could become the first LGBTQ statewide elected official in Pa.

State lawmaker a prominent Biden-Harris 2024 reelection campaign surrogate

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President Joe Biden, Malcolm Kenyatta, and Vice President Kamala Harris (Official White House Photo by Adam Schultz)

Following his win in the Democratic primary contest on Wednesday, Pennsylvania state Rep. Malcolm Kenyatta, who is running for auditor general, is positioned to potentially become the first openly LGBTQ elected official serving the commonwealth.

In a statement celebrating his victory, LGBTQ+ Victory Fund President Annise Parker said, ā€œPennsylvanians trust Malcolm Kenyatta to be their watchdog as auditor general because thatā€™s exactly what heā€™s been as a legislator.”

“LGBTQ+ Victory Fund is all in for Malcolm, because we know he has the experience to win this race and carry on his fight for students, seniors and workers as Pennsylvaniaā€™s auditor general,” she said.

Parker added, “LGBTQ+ Americans are severely underrepresented in public office and the numbers are even worse for Black LGBTQ+ representation. I look forward to doing everything I can to mobilize LGBTQ+ Pennsylvanians and our allies to get out and vote for Malcolm this November so we can make history.ā€ 

In April 2023, Kenyatta was appointed by the White House to serve as director of the Presidential Advisory Commission on Advancing Educational Equity, Excellence and Economic Opportunity for Black Americans.

He has been an active surrogate in the Biden-Harris 2024 reelection campaign.

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The White House

White House debuts action plan targeting pollutants in drinking water

Same-sex couples face higher risk from environmental hazards

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President Joe Biden speaks with reporters following an Earth Day event on April 22, 2024 (Screen capture: Forbes/YouTube)

Headlining an Earth Day event in Northern Virginia’s Prince William Forest on Monday, President Joe Biden announced the disbursement of $7 billion in new grants for solar projects and warned of his Republican opponent’s plans to roll back the progress his administration has made toward addressing the harms of climate change.

The administration has led more than 500 programs geared toward communities most impacted by health and safety hazards like pollution and extreme weather events.

In a statement to the Washington Blade on Wednesday, Brenda Mallory, chair of the White House Council on Environmental Quality, said, ā€œPresident Biden is leading the most ambitious climate, conservation, and environmental justice agenda in history ā€” and that means working toward a future where all people can breathe clean air, drink clean water, and live in a healthy community.”

ā€œThis Earth Week, the Biden-Harris Administration announced $7 billion in solar energy projects for over 900,000 households in disadvantaged communities while creating hundreds of thousands of clean energy jobs, which are being made more accessible by the American Climate Corps,” she said. “President Biden is delivering on his promise to help protect all communities from the impacts of climate change ā€” including the LGBTQI+ community ā€” and that we leave no community behind as we build an equitable and inclusiveĀ clean energy economy for all.ā€

Recent milestones in the administration’s climate policies include the U.S. Environmental Protection Agency’s issuance on April 10 of legally enforceable standard for detecting and treating drinking water contaminated with polyfluoroalkyl substances.

“This rule sets health safeguards and will require public water systems to monitor and reduce the levels of PFAS in our nationā€™s drinking water, and notify the public of any exceedances of those levels,” according to a White House fact sheet. “The rule sets drinking water limits for five individual PFAS, including the most frequently found PFOA and PFOS.”

The move is expected to protect 100 million Americans from exposure to the “forever chemicals,” which have been linked to severe health problems including cancers, liver and heart damage, and developmental impacts in children.

An interactive dashboard from the United States Geological Survey shows the concentrations of polyfluoroalkyl substances in tapwater are highest in urban areas with dense populations, including cities like New York and Los Angeles.

During Biden’s tenure, the federal government has launched more than 500 programs that are geared toward investing in the communities most impacted by climate change, whether the harms may arise from chemical pollutants, extreme weather events, or other causes.

New research by the Williams Institute at the UCLA School of Law found that because LGBTQ Americans are likelier to live in coastal areas and densely populated cities, households with same-sex couples are likelier to experience the adverse effects of climate change.

The report notes that previous research, including a study that used “national Census data on same-sex households by census tract combined with data on hazardous air pollutants (HAPs) from the National Air Toxics Assessment” to model “the relationship between same-sex households and risk of cancer and respiratory illness” found “that higher prevalence of same-sex households is associated with higher risks for these diseases.”

“Climate change action plans at federal, state, and local levels, including disaster preparedness, response, and recovery plans, must be inclusive and address the specific needs and vulnerabilities facing LGBT people,” the Williams Institute wrote.

With respect to polyfluoroalkyl substances, the EPA’s adoption of new standards follows other federal actions undertaken during the Biden-Harris administration to protect firefighters and healthcare workers, test for and clean up pollution, and phase out or reduce use of the chemicals in fire suppressants, food packaging, and federal procurement.

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