Connect with us

National

Biden administration shifts monkeypox vaccine approach amid shortage

Health experts sees new guidance as mixed bag

Published

on

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.”

Advertisement
FUND LGBTQ JOURNALISM
SIGN UP FOR E-BLAST

Federal Government

Gay Venezuelan man ‘forcibly disappeared’ to El Salvador files claim against White House

Andry Hernández Romero had asked for asylum in US

Published

on

Andry Hernández Romero (Photo courtesy of the Immigrant Defenders Law Center)

A gay Venezuelan asylum seeker who the U.S. “forcibly disappeared” to El Salvador has filed a claim against the federal government.

Immigrant Defenders Law Center, who represents Andry Hernández Romero, on Friday announced their client and five other Venezuelans who the Trump-Vance administration “forcibly removed” to El Salvador under the Alien Enemies Act of 1798, filed “administrative claims” under the Federal Tort Claims Act.

The White House on Feb. 20, 2025, designated Tren de Aragua, a Venezuelan gang, as an “international terrorist organization.”

President Donald Trump less than a month later invoked the Alien Enemies Act of 1798, which the Associated Press notes allows the U.S. to deport “noncitizens without any legal recourse.” The White House then “forcibly removed” Hernández, who had been pursuing his asylum case in the U.S., and more than 250 other Venezuelans to El Salvador.

Immigrant Defenders Law Center disputed claims that Hernández is a Tren de Aragua member.

Hernández was held at El Salvador’s Terrorism Confinement Center, a maximum-security prison known by the Spanish acronym CECOT, until his release on July 18, 2025. Hernández, who is back in Venezuela, claims he suffered physical and sexual abuse while at CECOT.

“As a Venezuelan citizen with no criminal record anywhere in the world, I would like to tell not only the government of the United States but governments everywhere that no human being is illegal,” said Hernández in the Immigrant Defenders Law Center press release. “The practice of judging whole communities for the wrongdoing of a single individual must end. Governments should use their power to help every person in the nation become more aware and informed, to strengthen our cultures and build a stronger generation with principles and values — one that multiplies the positive instead of destroying unfulfilled dreams and opportunities.” 

Immigrant Defenders Law Center filed claims on behalf of Hernández and the five other Venezuelans less than three months after American forces seized then-Venezuelan President Nicolás Maduro and his wife, Cilia Flores, at their home in Caracas, the Venezuelan capital.

Maduro and Flores have pleaded not guilty to federal drug charges. Delcy Rodríguez, who was Maduro’s vice president, is Venezuela’s acting president.

‘Due process and accountability cannot be optional’

Immigrant Defenders Law Center on Friday also made the following demands: 

  • The Trump administration must officially release the names of all people the United States sent to CECOT to ensure that everyone has been or will be released. 
  • The federal government must clear the names of the 252 men wrongfully labeled as criminal gang members of Tren de Aragua.  
  • DHS (Department of Homeland Security) must end the practice of outsourcing torture through third‑country removals, restore humanitarian parole, and rebuild a functioning, humane asylum system.  
  • DHS must reinstate Temporary Protected Status for all individuals who cannot safely return to their home countries, halt mass deportations and unlawful raids and arrests, and guarantee due process for everyone navigating the immigration system.  
  • Congress must pass the Neighbors Not Enemies Act, which would repeal the Alien Enemies Act.   

“In all my years as an immigration attorney, I have never seen a client simply vanish in the middle of their case with no explanation,” said Immigration Defenders Legal Fund Legal Services Director Melissa Shepard. “In court, the government couldn’t even explain where he was — he had been disappeared.” 

“When the government detains and transfers people in secrecy, without transparency or access to the courts, it tears at the basic protections a democracy is supposed to guarantee,” added Shepard. “What this experience makes painfully clear is that due process and accountability cannot be optional. They are the only safeguards standing between people and the kind of lawlessness our clients suffered. We must end third country transfers, restore the asylum system, and humanitarian parole, and reinstate temporary protective status so this nightmare never happens again.” 

Continue Reading

The White House

Trump proclamation targets trans rights as State Dept. shifts visa policy

Recent policy actions from the White House limit transgender rights in sports, immigration visas, and overarching federal policy.

Published

on

President Donald Trump stands in the Roosevelt Room in December 2025. (Washington Blade Photo by Joe Reberkenny)

In a proclamation issued by the Trump White House Thursday night, the president said he would, among other things, “restore public safety” and continue “upholding the rule of law,” while promoting policies that restrict the rights of transgender people.

“We are keeping men out of women’s sports, enforcing Title IX as it was originally written, and ensuring colleges preserve — and, where possible, expand — scholarships and roster opportunities for female athletes,” the proclamation reads. “At the same time, we are restoring public safety and upholding the rule of law in every city so women, children, and families can feel safe and secure.”

The statement comes amid a broader series of actions by the Trump administration targeting transgender people across multiple federal policy areas, including education, health care, and immigration. A nearly complete list of policies the current administration has put forward can be found on KFF.org.

One day before the proclamation was issued, the U.S. State Department announced changes to visa regulations that could impact transgender and gender-nonconforming people seeking entry into the United States.

The policy, published March 11 and scheduled to take effect April 10, introduces changes to the Diversity Immigrant Visa Program, commonly known as the “DV Program.” The rule is framed by the department as an effort to strengthen oversight and prevent fraud within the visa lottery system, which allocates a limited number of immigrant visas annually to applicants from countries with historically low rates of immigration to the United States.

However, the updated language also standardizes the use of the term “sex” in federal regulations in place of “gender,” a change that LGBTQ advocates say could create additional barriers for transgender and gender-diverse applicants.

The policy states: “The Department of State (‘Department’) is amending regulations governing the Diversity Immigrant Visa Program (‘DV Program’) to improve the integrity of, and combat fraud in, the program. These amendments require a petitioner to the DV Program to provide valid, unexpired passport information and to upload a scan of the biographic and signature page in the electronic entry form or otherwise indicate that he or she is exempt from this requirement. Additionally, the Department is standardizing and amending its regulations to add the word ‘shall’ to simplify guidance for consular officers; ensure the use of the term ‘sex’ in lieu of ‘gender’; and replace the term ‘age’ in the DV Program regulations with the phrase ‘date of birth’ to accurately reflect the information collected and maintained by the Department during the immigrant visa process.”

Advocates say the shift toward using “sex” rather than “gender” in federal immigration rules reflects a broader push by the administration to roll back recognition of transgender identities in federal policy.

According to the National Center for Transgender Equality, an estimated 15,000 to 50,000 undocumented transgender immigrants currently live in the United States, with many entering the country to seek refuge from persecution and hostile governments in their home countries.

Continue Reading

Florida

Fla. House passes ‘Anti-Diversity’ bill

Measure could open door to overturning local LGBTQ rights protections

Published

on

(Photo by Catella via Bigstock)

The Florida House of Representatives on March 10 voted 77-37 to approve an “Anti-Diversity in Local Government” bill that opponents have called an extreme and sweeping measure that, among other things, could overturn local LGBTQ rights protections.

The House vote came six days after the Florida Senate voted 25-11 to pass the same bill, opening the way to send it to Republican Gov. Ron DeSantis, who supports the bill and has said he would sign it into law.

Equality Florida, a statewide LGBTQ advocacy organization that opposed the legislation, issued a statement saying the bill “would ban, repeal, and defund any local government programming, policy, or activity that provides ‘preferential treatment or special benefits’ or is designed or implemented with respect to race, color, sex, ethnicity, sexual orientation, or gender identity.”

The statement added that the bill would also threaten city and county officials with removal from office “for activities vaguely labeled as DEI,” with only limited exceptions.

“Written in broad and ambiguous language, the bill is the most extreme of its kind in the country, creating confusion and fear for local governments that recognize LGBTQ residents and other communities that contribute to strength and vibrancy of Florida cities,” the group said in a separate statement released on March 10.

The Miami Herald reports that state Sen. Clay Yarborough (R-Jacksonville), the lead sponsor of the bill in the Senate, said he added language to the bill that would allow the city of Orlando to continue to support the Pulse nightclub memorial, a site honoring 49 mostly LGBTQ people killed in the 2016 mass shooting at the LGBTQ nightclub.

But the Equality Florida statement expresses concern that the bill can be used to target LGBTQ programs and protections.

“Debate over the bill made expressly clear that LGBTQ people were a central target of the legislation,” the group’s statement says. “The public record, the bill sponsors’ own statements, and hours of legislative debate revealed the animus driving the effort to pressure local governments into pulling back from recognizing or resourcing programs targeting LGBTQ residents and other historically marginalized communities,” the statement says.

But the statement also notes that following outspoken requests by local officials, sponsors of the bill agreed to several amendments “ensuring local governments can continue to permit Pride festivals, even while navigating new restrictions on supporting or promoting them.”     

The statement adds, “Florida’s LGBTQ community knows all too well how to fight back against unjust laws. Just as we did, following the passage of Florida’s notorious ‘Don’t Say Gay or Trans’ law, we will fight every step of the way to limit the impact of this legislation, including in the courts.”

Continue Reading

Popular