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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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National

DOJ seeks to dismiss some claims in gay FBI employee’s bias lawsuit

David Maltinsky was fired after displaying Pride flag at desk

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A gay FBI trainee was fired after displaying a Pride flag at his desk. (Washington Blade photo by Michael Key)

Attorneys for gay former FBI employee David Maltinsky, who was fired from his job as a non-agent employee at the FBI’s Los Angeles Field Office in October 2025 after more than 16 years of service for displaying an LGBTQ Pride flag at his workstation, filed court papers on July 15 opposing a motion by government attorneys to dismiss some but not all of the provisions in his unlawful discrimination lawsuit seeking to overturn the firing.

Maltinsky’s lawsuit, filed in federal court in D.C. on Nov. 19, 2025, states that FBI Director Kash Patel acted illegally by violating Maltinsky’s First Amendment constitutional rights and the U.S. Civil Rights Act of 1964 by ordering his firing on grounds that he “exercised poor judgement with an inappropriate display of political signage” by displaying the Pride flag.

The firing came at a time when Maltinsky successfully completed 16 weeks of the FBI’s 19-week training program at the FBI training academy in Quantico, Va. to become an FBI Special Agent, according to the lawsuit.

In addition to Patel, who took office as FBI director in February 2025 under the Trump administration, the lawsuit names as defendants the FBI itself, Acting U.S. Attorney General Todd Blanche, and the U.S. Department of Justice, which oversees the FBI.

“Defendants discriminated against Maltinsky for engaging in protected speech, for his sexual orientation, and for opposing discrimination – a clear and brazen violation of federal law and the Constitution,” the lawsuit states in an amended complaint filed May 5, 2026.

The Department of Justice, which is representing the FBI in its response to the lawsuit, did not immediately respond to a request from the Washington Blade for comment on the lawsuit and why it is seeking dismissal of some but not all of the lawsuit’s multiple allegations, including its claim that the firing violated Maltinsky’s First Amendment rights.

In its “Partial” motion filed on June 15, 2026, to dismiss some provisions in the lawsuit, the Justice Department through Assistant Attorney General Brett A. Shumate and Associate Branch Director Christopher Hall, stated that the lawsuit fails to provide sufficient evidence that Maltinsky was fired because he is gay.    

“The Amended Complaint contains no factual allegations that Director Patel or any other decisionmaker expressed hostility toward gay employees, relied on Plaintiff’s sexual orientation in making employment decisions, even knew Plaintiff’s sexual orientation or otherwise indicated that Plaintiff’s status as a gay man played any role in the challenged actions,” the motion states.

Based on that, among other things, the motion says the lawsuit’s claim that the firing violated the U.S. Civil Rights Act of 1964 should be dismissed. A 2020 U.S. Supreme Court decision ruled that the 1964 law bans employment discrimination based on sexual orientation and gender identity along with its other categories including race, religion, and gender.  

In its arguments that the decision to fire Maltinsky was illegal, unconstitutional, and unjust, the lawsuit’s amended complaint points out that FBI officials at the Los Angeles Field Office where Maltinsky worked presented the Pride flag to him and gave him full permission to display it at his workstation.  

“The FBI encouraged and honored Maltinsky’s work by awarding him the 2020 Director’s Award For Excellence-Outstanding Service in Diversity and Inclusion,” the lawsuit says. “In 2022, the Attorney General for the Department of Justice awarded Maltinsky the Attorney General’s Award for Equal Employment Opportunity, DOJ’s highest award for performance in support of the Equal Employment Program,” it says.

“In special recognition of Maltinsky’s efforts to improve the FBI, in June 2021 LAFO [Los Angeles Field Office] leadership entrusted to Maltinsky two Pride flags that had been flown from the flagpole located in front of the LAFO,” the lawsuit complaint continues. “Maltinsky displayed one of those flags at his workstation.”

Although the lawsuit doesn’t say so directly, all of that happened during the administration of President Joe Biden and previous FBI Director Christopher Wray, who held the director’s position from August 2017 to January 2025, when Donald Trump took office as president.

Nathaniel Zelinsky, one of the attorneys representing Maltinsky regarding the lawsuit, told the Blade that because the Justice Department did not contest the lawsuit’s First Amendment provisions, the case will move forward to the discovery stage, in which he and fellow attorneys can seek and obtain government documents, and most likely go to trial. He said that regardless of whether the judge approves the dismissal of the lawsuit provisions the government has asked for, the other provisions and the case as a whole  will continue.

“And those First Amendment claims are extremely serious,” he said. “The government, by its admission, fired David Maltinsky because they did not like the speech he displayed when he put up the Pride flag that was gifted to him by the FBI,” Zelinsky said. “The federal government cannot discriminate against its workers based on their speech.”      

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North Carolina

Authorities investigate officer-involved shooting outside Asheville gay bar

Incident took place near Shakey’s on Wednesday

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(Photo by chalabala/Bigstock)

An officer-involved shooting outside of a gay dive bar, Shakey’s, in downtown Asheville, N.C., left one man dead Wednesday.

The bar released a statement the following morning regarding the incident, stating that bar staff had asked a patron to leave earlier in the night citing concerning behavior. The bar said that later the man was spotted with a gun in the parking lot.

The bar proceeded to call 911, locked the doors to the establishment, and followed dispatcher instructions on how to keep patrons of the bar safe while officers arrived. These protocols included getting patrons away from the windows and staying low to the ground.

According to Shakey’s, shots were fired outside of the business. When the Asheville Police Department officers arrived, they fired back. The individual died from their injuries, according to the police.

“Because of everyone’s quick actions, cooperation, and concern for one another, every customer and every employee inside Shakey’s made it home safely. We are incredibly thankful,” Shakey’s said on their Instagram page. They thanked Asheville police, emergency dispatchers, EMS, and all first responders who were on scene.

On Thursday, a spokesperson for the North Carolina State Bureau of Investigation, Chad Flowers, stated that the suspect involved in the shooting was Arturo Castillo Palomar.

The Washington Blade reached out to the North Carolina State Bureau of Investigation for a comment regarding the possibility of the event being considered a hate crime. They said the issue is currently under investigation and that the findings would be turned over to the district attorney for review.

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Pentagon

Hegseth announces testosterone initiative as trans troop ban continues

SPARTA Pride criticized Pentagon policy

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Defense Secretary Pete Hegseth (Washington Blade photo by Michael Key)

The U.S. military will begin testing and treating service members with hormone therapy despite banning similar medical care for transgender service members.

Defense Secretary Pete Hegseth said Wednesday that troops ages 30 and older will be subject to annual testosterone screenings, while younger service members will have the option to voluntarily opt in. Some troops may then be recommended for hormone therapy, he explained in a video posted to social media.

“Under the supervision of our world-class medical professionals, warfighters age 30 and older are going to be tested annually as part of their periodic health assessment,” Hegseth said in a video posted to X, captioned “The High-T Department of War.”

This push to test testosterone levels, as the hormone is commonly referred to as “T,” runs counter to current medical guidelines. Physicians are generally advised to discuss testosterone therapy only with men who have symptoms consistent with low testosterone and documented low hormone levels on two separate blood tests.

Testosterone is a vital sex hormone that all humans naturally produce. It helps regulate muscle mass, bone density, and sex drive. In men, it is primarily produced in the testicles, while in women it is produced in the ovaries and adrenal glands.

Natural testosterone levels in men decline with age and have long been associated with issues such as erectile dysfunction, low libido, mood changes, and weight gain. However, experts continue to debate whether these conditions should routinely be treated with testosterone therapy.

Hegseth’s announcement aligns with other actions taken by the Trump-Vance administration — including efforts by Health Secretary Robert F. Kennedy Jr. — to make testosterone therapy more accessible for men, particularly those assigned male at birth.

Last month, the Food and Drug Administration proposed easing prescribing restrictions on testosterone gels, pills, patches, and injections following a December advisory panel that recommended reducing regulatory hurdles to expand access to testosterone therapy.

Currently, FDA labeling specifies that these medications are approved only for men with hypogonadism, a medical condition that causes abnormally low testosterone levels.

The announcement came as a shock to many LGBTQ advocates because Hegseth and the Defense Department have cited the use of hormone therapy by trans service members as justification for their dismissal under President Donald Trump’s 2025 executive order, “Prioritizing Military Excellence and Readiness.

The Pentagon continues to pursue implementation of the trans military ban as litigation proceeds. As a result, many trans service members have had their gender-affirming medical care halted, even as similar hormone therapy is now being expanded for cisgender service members. Under the executive order, the military currently disqualifies individuals diagnosed with gender dysphoria and has begun formal administrative separation proceedings for trans personnel.

SPARTA Pride, a nonpartisan nonprofit organization made up of trans service members, veterans, and their allies, issued a statement to the Washington Blade following Hegseth’s announcement.

“If hormone therapy helps warfighters perform at their best, then it cannot simultaneously be used as evidence that transgender service members are unfit to serve,” said Kara Corcoran, executive director of SPARTA Pride. “The same class of evidence-based medical treatment cannot be characterized as readiness-enhancing for one group and readiness-destroying for another.”

The legal fight over trans military service remains ongoing.

On June 1, the U.S. Court of Appeals for the D.C. Circuit ruled that trans service members already serving in the military could continue to do so, while allowing the armed services to continue refusing to enlist new trans recruits.

The Blade reached out to the Pentagon to ask why cisgender service members could receive hormone therapy while trans service members could not, but did not receive a response by the time of publication.

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