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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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Guatemalan LGBTQ activist granted asylum in US

Estuardo Cifuentes fled country in 2019

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Estuardo Cifuentes outside a port of entry in Brownsville, Texas, on March 3, 2021, shortly after he entered the U.S. (Photo courtesy of Estuardo Cifuentes)

The U.S. has granted asylum to a Guatemalan LGBTQ activist who fled his country in 2019.

Estuardo Cifuentes and his partner ran a digital marketing and advertising business in Guatemala City. 

He previously told the Washington Blade that gang members extorted from them. Cifuentes said they closed their business after they attacked them.

Cifuentes told the Blade that Guatemalan police officers attacked him in front of their home when he tried to kiss his partner. Cifuentes said the officers tried to kidnap him and one of them shot at him. He told the Blade that authorities placed him under surveillance after the incident and private cars drove past his home.

Cifuentes arrived in Matamoros, a Mexican border city that is across the Rio Grande from Brownsville, Texas, in June 2019. He asked for asylum in the U.S. based on the persecution he suffered in Guatemala because of his sexual orientation.

The Trump administration forced Cifuentes to pursue his asylum case from Mexico under its Migrant Protection Protocols program that became known as the “remain in Mexico” policy.

Cifuentes while in Matamoros ran Rainbow Bridge Asylum Seekers, a program for LGBTQ asylum seekers and migrants that the Resource Center Matamoros, a group that provides assistance to asylum seekers and migrants in the Mexican border city, helped create.

The Biden-Harris administration in January 2021 suspended enrollment in MPP. Cifuentes entered the U.S. on March 3, 2021.

“We are profoundly relieved and grateful that my husband and I have been officially recognized as asylees in the United States,” Cifuentes told the Blade on Monday in an email. “This result marks the end of a long and painful fight against the persecution that we faced in Guatemala because of our sexual orientation.”

Vice President Kamala Harris is among those who have said discrimination and violence based on sexual orientation are among the root causes of migration from Guatemala and other countries in Central America.

Cifuentes is now the client services manager for Lawyers for Good Government’s Project CorazĆ³n, a campaign that works “hard to reunite and defend the rights of families impacted by inhumane immigration policies.” He told the Blade he will continue to help LGBTQ asylum seekers and migrants.

“In this new chapter of our lives, we pledge to work hard to support others in similar situations and to contribute to the broader fight for the rights and acceptance of the LGBTQ+ migrant community,” said Cifuentes. “We are hopeful that our story will serve as a call to action to confront and end persecution based on gender identity and sexual orientation.”

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U.S. Supreme Court

US Supreme Court rules Idaho to enforce gender care ban

House Bill 71 signed in 2023

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U.S. Supreme Court (Washington Blade photo by Michael Key)

BY MIA MALDONADO | The U.S. Supreme Court has allowed Idaho to enforce House Bill 71, a law banning Idaho youth from receiving gender-affirming care medications and surgeries.

In an opinion issued Monday, the U.S. Supreme Court granted the state of Idahoā€™s request to stay the preliminary injunction, which blocked the law from taking effect. This means the preliminary injunction now only applies to the plaintiffs involved in Poe v. Labrador ā€” a lawsuit brought on by the families of two transgender teens in Idaho who seek gender-affirming care. 

Mondayā€™s Supreme Court decision enforces the gender-affirming care ban for all other trans youth in Idaho as the lawsuitĀ remains ongoing in the Ninth Circuit Court of Appeals.

Idaho Attorney General RaĆŗl Labrador
Idaho Attorney General RaĆŗl Labrador gives a speech at the Idaho GOP election night watch party at the Grove Hotel in Boise, Idaho, on Nov. 8, 2022. (Otto Kitsinger for Idaho Capital Sun)

The American Civil Liberties Union and the ACLU of Idaho, both of whom represent the plaintiffs, said in a press release Monday that the ruling ā€œdoes not touch upon the constitutionalityā€ of HB 71. The groups called Mondayā€™s ruling an ā€œawful resultā€ for trans Idaho youth and their families.

ā€œTodayā€™s ruling allows the state to shut down the care that thousands of families rely on while sowing further confusion and disruption,ā€ the organizations said in the press release. ā€œNonetheless, todayā€™s result only leaves us all the more determined to defeat this law in the courts entirely, making Idaho a safer state to raise every family.ā€

Idaho Attorney General RaĆŗl Labrador in a press release said the state has a duty to protect and support all children, and that he is proud of the stateā€™s legal stance. 

ā€œThose suffering from gender dysphoria deserve love, support and medical care rooted in biological reality,ā€ Labrador said. ā€œDenying the basic truth that boys and girls are biologically different hurts our kids. No one has the right to harm children, and Iā€™m grateful that we, as the state, have the power ā€” and duty ā€” to protect them.ā€

Recap of Idahoā€™s HB 71, and what led to SCOTUS opinion

Mondayā€™s Supreme Court decision traces back to when HB 71 was signed into law in April 2023.

The law makes it a felony punishable for up to 10 years for doctors to provide surgeries, puberty-blockers and hormones to trans people under the age of 18. However, gender-affirming surgeries are not and were not performed among Idaho adults or youth before the bill was signed into law, the Idaho Capital Sun previously reported

One month afterĀ it was signed into law, the families of two trans teens sued the state in a lawsuit alleging the bill violates the 14th Amendmentā€™s guarantee of equal protection under the law.

In late December, just days before the law was set to take effect in the new year, U.S. District Judge B. Lynn Winmill blocked the law from taking effect under a preliminary injunction. In his decision, he said he found the families likely to succeed in their challenge.

The state of Idaho responded by appealing the district courtā€™s preliminary injunction decision to the Ninth Circuit, to which the Ninth Circuit denied. The state of Idaho argued the court should at least enforce the ban for everyone except for the plaintiffs. 

After the Ninth Circuitā€™s denial, the Idaho Attorney Generalā€™s Office in February sent an emergency motion to the U.S. Supreme Court, the Idaho Press reported. Mondayā€™s U.S. Supreme Court decision agrees with the stateā€™s request to enforce its ban on trans health care for minors, except for the two plaintiffs.

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Mia Maldonado

Mia Maldonado joined the Idaho Capital Sun after working as a breaking news reporter at the Idaho Statesman covering stories related to crime, education, growth and politics. She previously interned at the Idaho Capital Sun through the Voces Internship of Idaho, an equity-driven program for young Latinos to work in Idaho news. Born and raised in Coeur d’Alene, Mia moved to the Treasure Valley for college where she graduated from the College of Idaho with a bachelor’s degree in Spanish and international political economy.

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The preceding piece was previously published by the Idaho Capital Sun and is republished with permission.

The Idaho Capital Sun is the Gem Stateā€™s newest nonprofit news organization delivering accountability journalism on state politics, health care, tax policy, the environment and more.

Weā€™re part of States Newsroom, the nationā€™s largest state-focused nonprofit news organization.

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Kansas

Kansas governor vetoes ban on health care for transgender youth

Republican lawmakers have vowed to override veto

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Democratic Gov. Laura Kelly vetoed two abortion bills and a measure criminalizing transgender health care for minors. House and Senate Republican leaders responded with promises to seek veto overrides when the full Legislature returned to Topeka on April 26. (Photo by Sherman Smith/Kansas Reflector)

BY TIM CARPENTERĀ | Gov. Laura Kelly flexed a veto pen to reject bills Friday prohibiting gender identity health care for transgender youth, introducing a vague crime of coercing someone to have an abortion and implementing a broader survey of women seeking abortion that was certain to trigger veto override attempts in the Republican-led House and Senate.

The decisions by the Democratic governor to use her authority to reject these health and abortion rights bills didnā€™t come as a surprise given her previous opposition to lawmakers intervening in personal decisions that she believed ought to remain the domain of families and physicians.

Kelly saidĀ Senate Bill 233, which would ban gender-affirming care for trans minors in Kansas, was an unwarranted attack on a small number of Kansans under 18. She said the bill was based on a politically distorted belief the Legislature knew better than parents how to raise their children.

She said it was neither a conservative nor Kansas value to block medical professionals from performing surgery or prescribing puberty blockers for their patients. She said stripping doctors of their licenses for serving health interests of patients was wrong. Under the bill, offending physicians could be face lawsuits and their professional liability insurance couldnā€™t be relied on to defend themselves in court.

ā€œTo be clear, this legislation tramples parental rights,ā€ Kelly said. ā€œThe last place that I would want to be as a politician is between a parent and a child who needed medical care of any kind. And, yet, that is exactly what this legislation does.ā€

Senate President Ty Masterson (R-Andover) and House Speaker Dan Hawkins (R-Wichita) responded to the governor by denouncing the vetoes and pledging to seek overrides when legislators returned to the Capitol on April 26. The trans bill was passed 27-13 in the Senate and 82-39 in the House, suggesting both chambers were in striking distance of a two-thirds majority necessary to thwart the governor.

ā€œThe governor has made it clear yet again that the radical left controls her veto pen,ā€ Masterson said. ā€œThis devotion to extremism will not stand, and we look forward to overriding her vetoes when we return in two weeks.ā€

Cathryn Oakley, senior director of the Human Rights Campaign, said the ban on crucial, medically necessary health care for trans youth was discriminatory, designed to spread dangerous misinformation and timed to rile up anti-LGBTQ activists.

ā€œEvery credible medical organization ā€” representing over 1.3 million doctors in the United States ā€” calls for age-appropriate, gender-affirming care for transgender and nonbinary people,ā€ Oakley said. ā€œThis is why majorities of Americans oppose criminalizing or banning gender-affirming care.ā€

Abortion coercion

Kelly also vetoed House Bill 2436 that would create the felony crime of engaging in physical, financial or documentary coercion to compel a girl or woman to end a pregnancy despite an expressed desire to carry the fetus to term. It was approved 27-11 in the Senate and 82-37 in the House, again potentially on the cusp of achieving a veto override.

The legislation would establish sentences of one year in jail and $5,000 fine for those guilty of abortion coercion. The fine could be elevated to $10,000 if the adult applying the pressure was the fetusesā€™ father and the pregnant female was under 18. If the coercion was accompanied by crimes of stalking, domestic battery, kidnapping or about 20 other offenses the prison sentence could be elevated to 25 years behind bars.

Kelly said no one should be forced to undergo a medical procedure against their will. She said threatening violence against another individual was already a crime in Kansas.

ā€œAdditionally, I am concerned with the vague language in this bill and its potential to intrude upon private, often difficult, conversations between a person and their family, friends and health care providers,ā€ the governor said. ā€œThis overly broad language risks criminalizing Kansans who are being confided in by their loved ones or simply sharing their expertise as a health care provider.ā€

Hawkins, the House Republican leader, said coercion was wrong regardless of the circumstances and Kellyā€™s veto of the bill was a step too far to the left.

ā€œItā€™s a sad day for Kansas when the governorā€™s uncompromising support for abortion wonā€™t even allow her to advocate for trafficking and abuse victims who are coerced into the procedure,ā€ Hawkins said.

Emily Wales, president and CEO of Planned Parenthood Great Plains Votes, said HB 2436 sought to equate abortion with crime, perpetuate false narratives and erode a fundamental constitutional right to bodily autonomy. The bill did nothing to protect Kansas from reproductive coercion, including forced pregnancy or tampering with birth control.

ā€œPlanned Parenthood Great Plains Votes trusts patients and stands firmly against any legislation that seeks to undermine reproductive rights or limit access to essential health care services,ā€ Wales said.

Danielle Underwood, spokeswoman for Kansas for Life, said ā€œCoercion Kellyā€ demonstrated with this veto a lack of compassion for women pushed into an abortion.

The abortion survey

The House and Senate approved a bill requiring more than a dozen questions be added to surveys of women attempting to terminate a pregnancy in Kansas. Colorful debate in the House included consideration of public health benefits of requiring interviews of men about reasons they sought a vasectomy birth control procedure or why individuals turned to health professionals for treatment of erectile dysfunction.

House Bill 2749 adopted 81-39 in the House and 27-13 in the Senate would require the Kansas Department of Health and Environment to produce twice-a-year reports on responses to the expanded abortion survey. The state of Kansas cannot require women to answer questions on the survey.

Kelly said in her veto message the bill was ā€œinvasive and unnecessaryā€ and legislators should have taken into account rejection in August 2022 of a proposed amendment to the Kansas Constitution that would have set the stage for legislation further limiting or ending access to abortion.

ā€œThere is no valid medical reason to force a woman to disclose to the Legislature if they have been a victim of abuse, rape or incest prior to obtaining an abortion,ā€ Kelly said. ā€œThere is also no valid reason to force a woman to disclose to the Legislature why she is seeking an abortion. I refuse to sign legislation that goes against the will of the majority of Kansans who spoke loudly on Aug. 2, 2022. Kansans donā€™t want politicians involved in their private medical decisions.ā€

Wales, of Planned Parenthood Great Plains Votes, said the bill would have compelled health care providers to ā€œinterrogate patients seeking abortion careā€ and to engage in violations of patient privacy while inflicting undue emotional distress.

Hawkins, the Republican House speaker, said the record numbers of Kansas abortions ā€” the increase has been driven by bans or restrictions imposed in other states ā€” was sufficient to warrant scrutiny of KDHE reporting on abortion. He also said the governor had no business suppressing reporting on abortion and criticized her for tapping into ā€œirrational fears of offending the for-profit pro-abortion lobby.ā€

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Tim Carpenter

Tim Carpenter has reported on Kansas for 35 years. He covered the Capitol for 16 years at the Topeka Capital-Journal and previously worked for the Lawrence Journal-World and United Press International.

The preceding story was previously published by the Kansas Reflector and is republished with permission.

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The Kansas Reflector is a nonprofit news operation providing in-depth reporting, diverse opinions and daily coverage of state government and politics. This public service is free to readers and other news outlets. We are part of States Newsroom: the nationā€™s largest state-focused nonprofit news organization, with reporting from every capital.

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