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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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New York

Two teens shot steps from Stonewall Inn after NYC Pride parade

One of the victims remains in critical condition

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The Stonewall National Memorial in New York on June 19, 2024. (Washington Blade photo by Michael K. Lavers)

On Sunday night, following the annual NYC Pride March, two girls were shot in Sheridan Square, feet away from the historic Stonewall Inn.

According to an NYPD report, the two girls, aged 16 and 17, were shot around 10:15 p.m. as Pride festivities began to wind down. The 16-year-old was struck in the head and, according to police sources, is said to be in critical condition, while the 17-year-old was said to be in stable condition.

The Washington Blade confirmed with the NYPD the details from the police reports and learned no arrests had been made as of noon Monday.

The shooting took place in the Greenwich Village neighborhood of Manhattan, mere feet away from the most famous gay bar in the city — if not the world — the Stonewall Inn. Earlier that day, hundreds of thousands of people marched down Christopher Street to celebrate 55 years of LGBTQ people standing up for their rights.

In June 1969, after police raided the Stonewall Inn, members of the LGBTQ community pushed back, sparking what became known as the Stonewall riots. Over the course of two days, LGBTQ New Yorkers protested the discriminatory policing of queer spaces across the city and mobilized to speak out — and throw bottles if need be — at officers attempting to suppress their existence.

The following year, LGBTQ people returned to the Stonewall Inn and marched through the same streets where queer New Yorkers had been arrested, marking the first “Gay Pride March” in history and declaring that LGBTQ people were not going anywhere.

New York State Assemblywoman Deborah Glick, whose district includes Greenwich Village, took to social media to comment on the shooting.

“After decades of peaceful Pride celebrations — this year gun fire and two people shot near the Stonewall Inn is a reminder that gun violence is everywhere,” the lesbian lawmaker said on X. “Guns are a problem despite the NRA BS.”

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New York

Zohran Mamdani participates in NYC Pride parade

Mayoral candidate has detailed LGBTQ rights platform

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NYC mayoral candidate and New York State Assembly member Zohran Mamdani (Screen capture: NBC News/YouTube)

Zohran Mamdani, the candidate for mayor of New York City who pulled a surprise victory in the primary contest last week, walked in the city’s Pride parade on Sunday.

The Democratic Socialist and New York State Assembly member published photos on social media with New York Attorney General Letitia James, telling followers it was “a joy to march in NYC Pride with the people’s champ” and to “see so many friends on this gorgeous day.”

“Happy Pride NYC,” he wrote, adding a rainbow emoji.

Mamdani’s platform includes a detailed plan for LGBTQ people who “across the United States are facing an increasingly hostile political environment.”

His campaign website explains: “New York City must be a refuge for LGBTQIA+ people, but private institutions in our own city have already started capitulating to Trump’s assault on trans rights.

“Meanwhile, the cost of living crisis confronting working class people across the city hits the LGBTQIA+ community particularly hard, with higher rates of unemployment and homelessness than the rest of the city.”

“The Mamdani administration will protect LGBTQIA+ New Yorkers by expanding and protecting gender-affirming care citywide, making NYC an LGBTQIA+ sanctuary city, and creating the Office of LGBTQIA+ Affairs.”

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U.S. Supreme Court

Supreme Court upholds ACA rule that makes PrEP, other preventative care free

Liberal justices joined three conservatives in majority opinion

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The U.S. Supreme Court as composed June 30, 2022, to present. Front row, left to right: Associate Justice Sonia Sotomayor, Associate Justice Clarence Thomas, Chief Justice John G. Roberts, Jr., Associate Justice Samuel A. Alito, Jr., and Associate Justice Elena Kagan. Back row, left to right: Associate Justice Amy Coney Barrett, Associate Justice Neil M. Gorsuch, Associate Justice Brett M. Kavanaugh, and Associate Justice Ketanji Brown Jackson. (Photo Credit: Fred Schilling, the U.S. Supreme Court)

The U.S. Supreme Court on Friday upheld a portion of the Affordable Care Act requiring private health insurers to cover the cost of preventative care including PrEP, which significantly reduces the risk of transmitting HIV.

Conservative Justice Brett Kavanaugh authored the majority opinion in the case, Kennedy v. Braidwood Management. He was joined by two conservatives, Chief Justice John Roberts and Justice Amy Coney Barrett, along with the three liberal justices, Sonia Sotomayor, Elena Kagan, and Ketanji Brown-Jackson.

The court’s decision rejected the plaintiffs’ challenge to the Affordable Care Act’s reliance on the U.S. Preventative Services Task Force to “unilaterally” determine which types of care and services must be covered by payors without cost-sharing.

An independent all-volunteer panel of nationally recognized experts in prevention and primary care, the 16 task force members are selected by the secretary of the U.S. Department of Health and Human Services to serve four-year terms.

They are responsible for evaluating the efficacy of counseling, screenings for diseases like cancer and diabetes, and preventative medicines — like Truvada for PrEP, drugs to reduce heart disease and strokes, and eye ointment for newborns to prevent infections.

Parties bringing the challenge objected especially to the mandatory coverage of PrEP, with some arguing the drugs would “encourage and facilitate homosexual behavior” against their religious beliefs.

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