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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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State Department

Democracy Forward files FOIA request for State Department bathroom policy records

April 20 memo outlined anti-transgender rule

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(Photo courtesy of the Library of Congress)

Democracy Forward on Tuesday filed a Freedom of Information Act request for records on the State Department’s new bathroom policy.

A memo titled “Updates Regarding Biological Sex and Intimate Spaces, Including Restrooms” that the State Department issued on April 20 notes employees can no longer use bathrooms that correspond with their gender identity.

“The administration affirms that there are two sexes — male and female — and that federal facilities should operate on this objective and longstanding basis to ensure consistency, privacy, and safety in shared spaces,” State Department spokesperson Tommy Piggot told the Daily Signal, a conservative news website that first reported on the memo. “In line with President Trump’s executive order this provides clear, uniform guidance to the department by grounding policy in biological sex as determined at birth.”

President Donald Trump shortly after he took office in January 2025 issued an executive order that directed the federal government to only recognize two genders: male and female. The sweeping directive also ordered federal government agencies to “effectuate this policy by taking appropriate action to ensure that intimate spaces designated for women, girls, or females (or for men, boys, or males) are designated by sex and not identity.”

Democracy Forward’s FOIA request that the Washington Blade exclusively obtained on Tuesday is specifically seeking a copy of the memo that details the State Department’s new bathroom policy. Democracy Forward has also requested “all” memo-specific communications between the State Department’s Bureau of Global Public Affairs and the Daily Signal from April 1-21.

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Federal Government

House Republicans push nationwide ‘Don’t Say Gay’ bill

Measures would restrict federal funding for LGBTQ-affirming schools

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(Washington Blade photo by Michael Key)

Republicans have been gaining ground in reshaping education policy to be less inclusive toward LGBTQ students at the state level, and now they are turning their focus to Capitol Hill.

Some GOP lawmakers are pushing for a nationwide “Don’t Say Gay” bill, doubling down on their commitment to being the party of “traditional family values” by excluding anyone who does not identify with their sex at birth.

The largest anti-LGBTQ education legislation to reach the House chamber is House Bill 2616 — the Parental Rights Over the Education and Care of Their Kids Act, or the PROTECT Kids Act. The PROTECT Kids Act, proposed by U.S. Rep. Tim Walberg (R-Mich.), and co-sponsored by U.S. Reps. Burgess Owens (R-Utah), Mary Miller (R-Ill.), Robert Onder (R-Mo.), and Kevin Kiley (R-Calif.), would require any public elementary and middle schools that receive federal funding to require parental consent to change a child’s gender expression in school.

The bill, which was discussed during Tuesday’s House Rules Committee hearing, would specifically require any schools that get federal money from the Elementary and Secondary Education Act of 1965 — which was created to minimize financial discrepancies in education for low-income students — to get parental approval before identifying any child’s gender identity as anything other than what was provided to the school initially. This includes getting approval before allowing children to use their preferred locker room or bathroom.

It reads that any school receiving this funding “shall obtain parental consent before changing a covered student’s (1) gender markers, pronouns, or preferred name on any school form; or (2) sex-based accommodations, including locker rooms or bathrooms.”

LGBTQ rights advocates have criticized both national and state efforts to require parental permission to use a child’s preferred gender identity, as it raises issues of at-home safety — especially if the home is not LGBTQ-affirming — and could lead to the outing of transgender or gender-curious students.

A follow-up bill, HB 2617, proposed by Owens, one of the bill’s co-sponsors, prevents the use of federal funding to “advance concepts related to gender ideology,” using the definition from President Donald Trump’s 2025 Executive Order 14168, making that an enshrined definition in law of sex rather than just by executive order. There is also a bill making its way through the senate with the same text— Senate Bill 2251.

Advocates have also criticized this follow-up legislation, as it would restrict school staff — including teachers and counselors — from acknowledging trans students’ identities or providing any support. They have said that this kind of isolation can worsen mental health outcomes for LGBTQ youth and allows for education to be politicized rather than being based in reality.

David Stacy, the Human Rights Campaign’s vice president of government affairs, called this legislation out for using LGBTQ children as political pawns in an ideology fight — one that could greatly harm the safety of these children if passed.

“Trans kids are not a political agenda — they are students who deserve safety and affirmation at school like anyone else,” Stacy said in a statement. “Despite the many pressing issues facing our nation, House Republicans continue their bizarre obsession with trans people. H.R. 2616 does not protect children. It targets them. This bill is cruel, and we’re prepared to fight it.”

This is similar to Florida House Bills 1557 and 1069, referred to as the “Don’t Say Gay” bill and “Don’t Say They” bill, respectively, restricting classroom discussions on sexual orientation and gender identity, prohibiting the use of pronouns consistent with one’s gender identity, expanding book banning procedures, and censoring health curriculum.

The American Civil Liberties Union is tracking 233 bills related to restricting student and educator rights in the U.S.

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National

BREAKING NEWS: Shots fired at the White House Correspondents’ Dinner

Shooter reportedly opened fire inside hotel

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(Washington Blade photo by Joe Reberkenny)

Four loud bangs were heard in the International Ballroom of the Washington Hilton during the annual White House Correspondents’ Dinner on Saturday.

According to the Associated Press, a shooter opened fire inside the hotel outside the ballroom.

Attendees could hear four loud bangs as people started to duck and take cover. During the chaos sounds of salad and glasses were dropped as hotel employees, and guests ducked for cover.

The head table — which included President Donald Trump, Vice President JD Vance, first lady Melania Trump, and White House Correspondents Association President Weijia Jiang — were rushed off stage.

“The U.S. Secret Service, in coordination with the Metropolitan Police Department, is investigating a shooting incident near the main magnetometer screening area at the White House Correspondents’ Dinner,” the U.S. Secret Service said in a statement. “The president and the First Lady are safe along all protects. One individual is in custody. The condition of those involved is not yet known, and law enforcement is actively assessing the situation.”

Trump held a press conference at the White House after he left the hotel.

“A man charged a security checkpoint armed with multiple weapons and he was taken down by some very brave members of Secret Service,” said Trump.

Trump said the shooter is from California. He also said an officer was shot, but said his bullet proof vest “saved” him.

D.C. Mayor Muriel Bowser, interim D.C. police chief Jeffrey Carroll, U.S. Attorney for D.C. Jeanine Pirro, and other officials held their own press conference at the hotel.

Carroll said the gunman who has been identified as Cole Tomas Allen was armed with a shotgun, handgun, and “multiple” knives when he charged a Secret Service checkpoint in a hotel lobby. Carroll also told reporters that law enforcement “exchanged gunfire with that individual.”

Both he and Bowser said the gunman appeared to act alone.

“We are so very thankful to members of law enforcement who did their jobs tonight and made sure all guests were safe,” said Bowser. “Nobody else was involved.”

The Washington Blade will update this story as details become more available.

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