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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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District of Columbia

Trial for man charged with assaulting gay men in D.C. park postponed for third time

Indictment says attacker squirted victims with pepper spray

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Meridian Hill Park (Washington Blade photo by Michael Key)

The trial for a 50-year-old man who was arrested July 14, 2022, on charges that he allegedly assaulted five men he believed to be gay at D.C.’s Meridian Hill Park between 2018 and 2021 was postponed for the third time last month and has now been rescheduled for Aug. 19 of this year.   

The arrest of Michael Thomas Pruden came two weeks after a federal grand jury handed down an indictment on June 29, 2022, charging him with five counts of assault on federal park land, one count of impersonating a federal officer and a hate crime designation alleging that he assaulted four of the men because of their perceived sexual orientation. 

Prosecutors with the Office of the U.S. Attorney for D.C. filed a motion in court on Jan. 10 of this year opposing a request by Pruden’s defense attorney to postpone the most recent prior trial date set for Feb. 26. 

“Following indictment in June 2022, the defendant has delayed the trial in this case several times, including by firing two prior attorneys,” the prosecutors’ motion states. “While the government has not previously objected to any continuance, no further delay is warranted,” the motion says. “This is a straightforward case that should proceed to trial as currently scheduled.”

The indictment against Pruden by a U.S. District Court for D.C. grand jury provides some of the details surrounding the case.

“After nightfall, Meridian Hill Park was informally known in the Washington, D.C., community to be a meeting location for men seeking to engage in consensual sexual encounters with other men,” the indictment says. “This practice is colloquially known as ‘cruising,’” the indictment continues. 

“Michael Thomas Pruden frequented Meridian Hill Park after nightfall and on multiple occasions, including those described below, assaulted men in Meridian Hill Park by approaching them with a flashlight, giving them police-style commands and spraying them with a chemical irritant,” the indictment states. 

Virginia court records show that the D.C. indictment against Pruden was handed down 11 months after a U.S. District Court jury in Alexandria, Va., found him not guilty of a charge of assault with a dangerous weapon for allegedly pepper spraying and hitting in the head with a large tree branch a man in Daingerfield Island Park in Alexandria, which is also known as a gay cruising site. 

Federal Public Defender A.J. Kramer, who is representing Pruden in the D.C. case, said in his own motion calling for postponing Pruden’s Feb. 26 trial date that he has at least two other unrelated trials coming up soon and what he called voluminous documents recently provided to him by prosecutors made the latest postponement necessary. 

“Firstly, while Mr. Pruden prefers to go to trial as soon as possible, counsel cannot be ready by February 26, 2024,” his motion states. “Given that the case against Mr. Pruden is actually five cases spanning a three-year period, the discovery is extremely voluminous, in excess of 7,000 pages,” he states in his motion. “Due to this as well as counsel’s other pending matters in the coming weeks, counsel is unable to effectively prepare motions and prep for trial under the current timeline.”

By the 7,000 pages of “discovery” documents, Kramer was referring to the requirement that prosecutors turn over to the defense attorney in advance of a trial details of the evidence prosecutors plan to present at a trial. U.S. District Court Judge Jia M. Cobb approved Pruden’s request for the postponement in a Feb. 5 ruling. 

Court records also show that Pruden was released on personal recognizance following his arrest into the custody of his mother, who lives in Norfolk, Va., where he has been staying since his release. Among other things, conditions for his release prohibit him from having any contact with the individuals he is charged with assaulting and require that he always remain inside his mother’s residence from sunset to sunrise. 

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Texas

Abbott tells UN to ‘pound sand’ amid criticism of anti-LGBTQ policies in Texas

Governor signed seven anti-LGBTQ laws last year

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Texas Republican Texas Gov. Greg Abbott signs the “Save Women’s Sports Act” on Aug. 7, 2023. (Photo courtesy of the Office of the Governor)

Texas Gov. Greg Abbott (R) on Sunday dismissed news coverage of a letter issued last month to the United Nations that expressed alarm over the “deteriorating human rights situation” for LGBTQ people in the Lone Star State.

Signed by Equality Texas, ACLU of Texas, GLAAD, the Human Rights Campaign, and the University of Texas at Austin School of Law Human Rights Clinic, the letter details how Texas legislators introduced 141 bills targeting the LGBTQ community, passing seven into law.

“The UN can go pound sand,” Abbott wrote in a post on X.

In 2023, the governor signed a ban on gender affirming care for transgender youth, a ban on diversity, equity, and inclusion programs at public universities, a ban on transgender athletes competing in college sports, a law allowing schools to use religious chaplains for counseling services, a ban on “sexually oriented performances” on public property accessible to minors (which targets drag shows), a law allowing schools to restrict LGBTQ books, and a ban on nondiscrimination ordinances by local governments.

The groups argued in their letter that these policies constitute a “systemic discriminatory policy” in violation of international human rights laws, such as the International Covenant on Civil and Political Rights, a multilateral treaty whose tenets are enforced by the UN Human Rights Committee.

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National

WATCH: Washington Post grills transphobic Libs of TikTok creator

Chaya Raichik reaffirmed anti-trans views

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Chaya Raichik, founder of Libs of TikTok is interviewed by Washington Post journalist Taylor Lorenz.in California. (Screenshot/YouTube The Washington Post)

Grilled on a range of topics during an interview with Washington Post journalist Taylor Lorenz, Chaya Raichik, spoke about the great replacement theory, the death of Nex Benedict, a 16-year-old nonbinary in high school student in Oklahoma, why she won’t delete her false accusations about the Uvalde shooter and other mass-shooters, her views on gender, feminism and more.

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