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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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Florida

Fla. Senate passes ‘Anti-Diversity’ bill that could repeal local LGBTQ protections

Bipartisan coalition urges Florida House to reject ‘extremism’ measure

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The Florida Capitol (Washington Blade photo by Yariel Valdés González)

The Florida Senate on March 4 voted 25-11 to approve an “Anti-Diversity in Local Government” bill that critics have called a sweeping and extreme measure that, among other things, could repeal local LGBTQ rights protections.

According to Equality Florida, a statewide LGBTQ advocacy organization, if approved by the Florida House of Representatives and signed by Republican Gov. Ron DeSantis, 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.”

In a March 4 statement, Equality Florda 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.

The Florida House was scheduled to vote on the bill on Monday, March 9, with opponents hopeful that a broad coalition of both Democratic and Republican lawmakers would secure enough votes to defeat the bill.

“Once again, Gov. DeSantis and Florida lawmakers are advancing one of the most sweeping and extreme bills in the country — this time threatening decades of local progress supporting diverse communities, including the LGBTQ community,” said Equality Florida Senior Political Director Joe Saunders. “This legislation is a sledgehammer aimed at cities and counties that recognize and address the diversity of the people they serve,” he said.

Among the LGBTQ organizations that could be adversely impacted by the bill is the highly acclaimed Stonewall National Museum, Archives and Library located in Fort Lauderdale.

Robert Kesten, the Stonewall organization’s president and CEO, told the Washington Blade the organization receives some funding from Broward County, in which Fort Lauderdale is located, and the city of Fort Lauderdale has provided support by purchasing tables at some of the museum’s fundraising events.

“Based on this legislation, hose things would be gone,” he said. “We also are based in a government building. So, we don’t know what potential side effects that could have.” He noted that the building in question is owned by Broward County and leased by Fort Lauderdale, with the bill’s vaguely worded provision making it unclear whether Stonewall would be forced to leave its building.

“It’s unknown, and we’re really in unchartered waters,” he said.

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13 HIV/AIDS activists arrested on Capitol Hill

Protesters demanded full PEPFAR funding

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(Washington Blade photo by Michael Key)

U.S. Capitol Police on Thursday arrested 13 HIV/AIDS activists in the Cannon House Office Building Rotunda.

The activists — members of Housing Works, Health GAP, and the Treatment Action Group — joined former PEPFAR staffers in demanding full funding of the program that President George W. Bush created in 2003. They chanted “AIDS cuts kill, PEPFAR now!” and unfurled banners from the Rotunda’s second floor that read “Trump and (Office of Management and Budget Director Russell) Vought kill people with AIDS worldwide,” “Over 200,000 deaths since January 2025,” and “Hands off PEPFAR” before their arrest.

(Washington Blade video by Michael K. Lavers)

This protest is the latest against the Trump-Vance administration’s HIV/AIDS policies since it took office.

Secretary of State Marco Rubio on Jan. 28, 2025, issued a waiver that allowed PEPFAR and other “life-saving humanitarian assistance” programs to continue to operate during a freeze on nearly all U.S. foreign aid spending. HIV/AIDS service providers around the world with whom the Washington Blade has spoken say PEPFAR cuts and the loss of funding from the U.S. Agency for International Development, which officially closed on July 1, 2025, has severely impacted their work.

The State Department last September announced PEPFAR will distribute lenacapavir in countries with high prevalence rates. Zambia is among the nations in which the breakthrough HIV prevention drug has arrived.

The New York Times last summer reported Vought “apportioned” only $2.9 billion of $6 billion that Congress set aside for PEPFAR for fiscal year 2025. (PEPFAR in the coming fiscal year will use funds allocated in fiscal year 2024.)

Bipartisan opposition in the U.S. Senate prompted the Trump-Vance administration last July withdraw a proposal to cut $400 million from PEPFAR’s budget. Vought on Aug. 29, 2025, said he would use a “pocket rescission” to cancel $4.9 billion for HIV/AIDS prevention and global health programs and other foreign aid assistance initiatives that Congress had already approved.

The White House in January announced an expansion of the global gag rule to ban U.S. foreign aid for groups that promote “gender ideology.” President Ronald Reagan in 1985 implemented the original regulation, also known as the “Mexico City” policy, which bans U.S. foreign aid for groups that support abortion and/or offer abortion-related services. The Council for Global Equality and other groups say the expanded rule will adversely impact HIV prevention efforts around the world.

A press release that Housing Works and Health GAP issued on Thursday notes more than $977 million “in appropriated PEPFAR funding for HIV prevention and treatment was unspent by the end of fiscal year (FY) 2025 — triple amount unspent at the end of FY 2024.”

“Activists predict this backlog will worsen rapidly in FY 2026 unless Congress immediately reasserts its Constitutionally-mandated oversight authority,” notes the press release.

The press release also indicates funding for the Centers for Disease Control and Prevention’s PEPFAR programs “will run out” by April 1 because “only 45 percent of their FY26 funding has been transferred from the State Department.

“Unless funding is transferred immediately, CDC’s global HIV programs across sub-Saharan Africa, Asia and the Caribbean will grind to a halt,” notes the press release.

The activists demanded Trump, Vought, Rubio, and Congress do the following:

  • Activists are calling for full obligation of appropriated PEPFAR funds and rejection of growing political interference in global and domestic HIV programs 
  • Immediately release already-appropriated, unobligated PEPFAR funds 
  • Break the blackout on PEPFAR data, so Congress and people with HIV know how funding is being spent and can program based on data  
  • Activists are calling for full obligation of appropriated PEPFAR funds and rejection of growing political interference in global and domestic HIV programs.

“PEPFAR has saved more than 26 million lives and changed the trajectory of an epidemic,” said Housing Works CEO Charles King. “However, the Trump administration’s decision, over the objection of Republicans in Congress, to freeze PEPFAR funding has caused decades of progress to come undone and has been a death sentence for people with HIV relying on life-saving treatment. The U.S. must immediately restore PEPFAR funding and regain our standing in the global fight against HIV.”

King is among the activists who were arrested.

(Washington Blade video by Michael K. Lavers)

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Texas

Talarico beats Crockett in Texas primary

Pro-LGBTQ seminarian hopes to turn seat blue

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Texas state Rep. James Talarico (Screen capture via James Talarico/YouTube)

Texas state Rep. James Talarico won a hard-fought primary Tuesday to become the state’s Democratic nominee for U.S. Senate, defeating U.S. Rep. Jasmine Crockett in one of the year’s most closely watched and competitive Democratic contests.

Talarico, a Presbyterian seminarian and three-term lawmaker from Round Rock, was declared the winner by the Associated Press early Wednesday morning after a closely tracked vote count that drew national attention.

“Tonight, the people of our state gave this country a little bit of hope,” Talarico told the AP. “And a little bit of hope is a dangerous thing.”

With 52.8% of the vote to Crockett’s 45.9%, Talarico secured the nomination outright, avoiding a runoff and capping months of sharp contrasts between the two candidates over strategy, messaging, and how best to compete statewide in Texas. Democrats hope the competitive primary — and the relatively narrow margin — signals growing momentum in a state that has not elected a Democrat to the U.S. Senate since 1988.

Talarico has long expressed support for the LGBTQ community, a position he highlights prominently on his campaign website. Under the “Issues” section, he directly addresses assumptions that might arise from his faith and background as a seminarian in a deeply conservative state.

“My faith in Jesus leads me to reject Christian Nationalism and commit myself to the project of democracy,” his website reads. “Because that’s the promise of America: a democracy where every person and every family — regardless of religion, race, gender, sexual orientation, or any other difference between us — can truly be free and live up to their full potential.”

Crockett struck a conciliatory tone following her defeat, emphasizing party unity ahead of November.

“This morning I called James and congratulated him on becoming the Senate nominee,” Crockett told Politico. “Texas is primed to turn blue and we must remain united because this is bigger than any one person. This is about the future of all 30 million Texans and getting America back on track.”

Talarico also drew national attention earlier in the race when “Late Show” host Stephen Colbert said he was initially unable to air an interview with the state legislator due to potential FCC concerns involving CBS. The episode sparked a broader political debate.

Brendan Carr, chair of the Federal Communications Commission, appointed by President Donald Trump, told reporters the controversy was a “hoax,” though he also acknowledged Talarico’s ability to harness the moment to build support as an underdog candidate. The interview was later released online and garnered millions of views, boosting Talarico’s national profile.

In November, Talarico will face the winner of the Republican primary between incumbent Sen. John Cornyn and Texas Attorney General Ken Paxton, who have been locked in a bruising GOP contest. Rep. Wesley Hunt was also in the Republican primary field. The GOP race is expected to head to a May runoff.

In a joint statement, Senate Minority Leader Chuck Schumer and Democratic Senatorial Campaign Committee Chair Kirsten Gillibrand praised Talarico’s victory and framed him as a candidate capable of broad appeal.

“As an eighth-generation Texan, former middle school teacher, and Presbyterian seminarian, James will be a fighter for Texans from all walks of life and of all political stripes,” they said. “In November, Texans will elect a champion for working people: James Talarico.”

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