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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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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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Maine

Maine governor signs transgender, abortion sanctuary bill into law

Bomb threats made against lawmakers before measureā€™s passage

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Maine Gov. Janet Mills congratulates members of Maine Women's Basketball. In March the team won the America East championship. (Photo courtesy of Millsā€™s office)

BY ERIN REED | On Tuesday, Maine Gov. Janet Mills signedĀ LD 227, a sanctuary bill that protects transgender and abortion providers and patients from out-of-state prosecution, into law.

With this action, Maine becomes the 16th state to explicitly protect trans and abortion care in state law from prosecution. This followsĀ several bomb threatsĀ targeting state legislators after social media attacks from far-right anti-trans influencers such asĀ Riley GainesĀ andĀ Chaya Raichik of Libs of TikTok.

An earlier version of the bill failed in committee after similar attacks in January. Undeterred, Democrats reconvened and added additional protections to the bill before it was passed into law.

The law is extensive. It asserts that gender-affirming care and reproductive health care are “legal rights” in Maine. It states that criminal and civil actions against providers and patients are not enforceable if the provision or access to that care occurred within Maineā€™s borders, asserting jurisdiction over those matters.

It bars cooperation with out-of-state subpoenas and arrest warrants for gender-affirming care and abortion that happen within the state. It even protects doctors who provide gender-affirming care and abortion from certain adverse actions by medical boards, malpractice insurance, and other regulating entities, shielding those providers from attempts to economically harm them through out-of-state legislation designed to dissuade them from providing care.

You can see the findings section of the bill here:

The bill also explicitly enshrines the World Professional Association of Transgender Healthā€™s Standards of Care, which have been the target of right-wing disinformation campaigns, into state law for the coverage of trans healthcare:

The bill is said to be necessary due to attempts to prosecute doctors and seek information from patients across state lines. In recent months, attorneys general in other states have attempted to obtain health care data on trans patients who traveled to obtain care. According to theĀ U.S. Senate Finance Committee, attorneys general in Tennessee, Indiana, Missouri, and Texas attempted to obtain detailed medical records “to terrorize transgender teens in their states ā€¦ opening the door to criminalizing womenā€™s private reproductive health care choices.”

The most blatant of these attempts was from the attorney general of Texas, who,Ā according to the Senate Finance Committee, “sent demands to at least two non-Texas entities.” One of these entities was Seattle Childrenā€™s Hospital, which received a letter threatening administrators with arrest unless they sent data on Texas patients traveling to Seattle to obtain gender-affirming care.

Seattle Childrenā€™s Hospital settled that case out of court this week, agreeing to withdraw its Texas business registration in return for Texas dropping its investigation. This likely will have no impact on Seattle Childrenā€™s Hospital, which has stated it did not treat any youth via telemedicine or in person in Texas; the hospital will be able to continue treating Texas youth who travel outside of Texas to obtain their care. That settlement was likely compelling due to a nearly identical law in Washington that barred out-of-state investigations on trans care obtained solely in the state of Washington.

The bill has faced a rocky road to passage. A similar bill was debated in January, but after coming under intense attack from anti-trans activists who misleadingly called it a “transgender trafficking bill,” the bill was voluntarily withdrawn by its sponsor.

When LD 227 was introduced, it faced even more attacks from Gaines and Libs of TikTok. These attacks were followed by bomb threats that forced the evacuation of the legislature, promising “death to pedophiles” and stating that a bomb would detonate within a few hours in the capitol building.

Despite these threats, legislators strengthened both the abortion and gender-affirming care provisions and pressed forward, passing the bill into law. Provisions found in the new bill include protecting people who “aid and assist” gender-affirming care and abortion, protections against court orders from other states for care obtained in Maine, and even protections against adverse actions by health insurance and malpractice insurance providers, which have been recent targets of out-of-state legislation aimed at financially discouraging doctors from providing gender-affirming care and abortion care even in states where it is legal.

See a few of the extensive health insurance and malpractice provisions here:

Speaking about the bill, Gia Drew, executive director of Equality Maine,Ā said in a statement, ā€œWe are thrilled to see LD 227, the shield bill, be signed into law by Gov. Mills. Thanks to our pro equality and pro reproductive choice elected officials who refused to back down in the face of disinformation. This bill couldnā€™t come into effect at a better time, as more than 40 percent of states across the country have either banned or attempted to block access to reproductive care, which includes abortions, as well as transgender healthcare for minors. Thanks to our coalition partners who worked tirelessly to phone bank, lobby, and get this bill over the finish line to protect community health.ā€Ā 

Related

Destie Hohman Sprague of the Maine Womenā€™s Lobby celebrated the passage of the bill despite threats of violence, saying in a statement, ā€œA gender-just Maine ensures that all Mainers have access to quality health care that supports their mental and physical wellbeing and bodily autonomy, including comprehensive reproductive and gender-affirming care. We celebrate the passage of LD 227, which helps us meet that goal. Still, the patterns of violence and disinformation ahead of the vote reflected the growing connections between misogyny, extremism, and anti-democratic threats and actions. We must continue to advocate for policies that protect bodily autonomy, and push back against extremist rhetoric that threatens our statesā€™ rights and our citizensā€™ freedoms.ā€

The decision to pass the legislation comes as the Biden administration released updated HIPAA protections that protect “reproductive health care” from out-of-state prosecutions and investigations.

Although the definition of “reproductive health care” is broad in the new HIPAA regulations, it is uncertain whether they will include gender-affirming care. For at least 16 states, though, gender-affirming care is now explicitly protected by state law and shielded from out-of-state legislation, providing trans people and those seeking abortions with protections as the fight increasingly crosses state lines.

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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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