National
Biden administration shifts monkeypox vaccine approach amid shortage
Health experts sees new guidance as mixed bag
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.”
National
Medical groups file lawsuit over Trump deletion of health information
Crucial datasets included LGBTQ, HIV resources
Nine private medical and public health advocacy organizations, including two from D.C., filed a lawsuit on May 20 in federal court in Seattle challenging what it calls the U.S. Department of Health and Human Services’s illegal deletion of dozens or more of its webpages containing health related information, including HIV information.
The lawsuit, filed in the United States District Court for the Western District of Washington, names as defendants Robert F. Kennedy Jr., secretary of the Department of Health and Human Services (HHS) and HHS itself, and several agencies operating under HHS and its directors, including the Centers for Disease Control and Prevention, the National Institutes of Health, and the Food and Drug Administration.
“This action challenges the widespread deletion of public health resources from federal agencies,” the lawsuit states. “Dozens (if not more) of taxpayer-funded webpages, databases, and other crucial resources have vanished since January 20, 2025, leaving doctors, nurses, researchers, and the public scrambling for information,” it says.
“These actions have undermined the longstanding, congressionally mandated regime; irreparably harmed Plaintiffs and others who rely on these federal resources; and put the nation’s public health infrastructure in unnecessary jeopardy,” the lawsuit continues.
It adds, “The removal of public health resources was apparently prompted by two recent executive orders – one focused on ‘gender ideology’ and the other targeting diversity, equity, and inclusion (‘DEI’) programs. Defendants implemented these executive orders in a haphazard manner that resulted in the deletion (inadvertent or otherwise) of health-related websites and databases, including information related to pregnancy risks, public health datasets, information about opioid-use disorder, and many other valuable resources.”
The lawsuit does not mention that it was President Donald Trump who issued the two executive orders in question.
A White House spokesperson couldn’t immediately be reached for comment on the lawsuit.
While not mentioning Trump by name, the lawsuit names as defendants in addition to HHS Secretary Robert Kennedy Jr., Matthew Buzzelli, acting director of the Centers for Disease Control and Prevention; Jay Bhattacharya, director of the National Institutes of Health; Martin Makary, commissioner of the Food and Drug Administration; Thomas Engels, administrator of the Health Resources and Services Administration; and Charles Ezell, acting director of the Office of Personnel Management.
The 44-page lawsuit complaint includes an addendum with a chart showing the titles or descriptions of 49 “affected resource” website pages that it says were deleted because of the executive orders. The chart shows that just four of the sites were restored after initially being deleted.
Of the 49 sites, 15 addressed LGBTQ-related health issues and six others addressed HIV issues, according to the chart.
“The unannounced and unprecedented deletion of these federal webpages and datasets came as a shock to the medical and scientific communities, which had come to rely on them to monitor and respond to disease outbreaks, assist physicians and other clinicians in daily care, and inform the public about a wide range of healthcare issues,” the lawsuit states.
“Health professionals, nonprofit organizations, and state and local authorities used the websites and datasets daily in care for their patients, to provide resources to their communities, and promote public health,” it says.
Jose Zuniga, president and CEO of the International Association of Providers of AIDS Care (IAPAC), one of the organizations that signed on as a plaintiff in the lawsuit, said in a statement that the deleted information from the HHS websites “includes essential information about LGBTQ+ health, gender and reproductive rights, clinical trial data, Mpox and other vaccine guidance and HIV prevention resources.”
Zuniga added, “IAPAC champions evidence-based, data-informed HIV responses and we reject ideologically driven efforts that undermine public health and erase marginalized communities.”
Lisa Amore, a spokesperson for Whitman-Walker Health, D.C.’s largest LGBTQ supportive health services provider, also expressed concern about the potential impact of the HHS website deletions.
“As the region’s leader in HIV care and prevention, Whitman-Walker Health relies on scientific data to help us drive our resources and measure our successes,” Amore said in response to a request for comment from the Washington Blade.
“The District of Columbia has made great strides in the fight against HIV,” Amore said. “But the removal of public facing information from the HHS website makes our collective work much harder and will set HIV care and prevention backward,” she said.
The lawsuit calls on the court to issue a declaratory judgement that the “deletion of public health webpages and resources is unlawful and invalid” and to issue a preliminary or permanent injunction ordering government officials named as defendants in the lawsuit “to restore the public health webpages and resources that have been deleted and to maintain their web domains in accordance with their statutory duties.”
It also calls on the court to require defendant government officials to “file a status report with the Court within twenty-four hours of entry of a preliminary injunction, and at regular intervals, thereafter, confirming compliance with these orders.”
The health organizations that joined the lawsuit as plaintiffs include the Washington State Medical Association, Washington State Nurses Association, Washington Chapter of the American Academy of Pediatrics, Academy Health, Association of Nurses in AIDS Care, Fast-Track Cities Institute, International Association of Providers of AIDS Care, National LGBT Cancer Network, and Vermont Medical Society.
The Fast-Track Cities Institute and International Association of Providers of AIDS Care are based in D.C.
U.S. Federal Courts
Federal judge scraps trans-inclusive workplace discrimination protections
Ruling appears to contradict US Supreme Court precedent
Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas has struck down guidelines by the U.S. Equal Employment Opportunity Commission designed to protect against workplace harassment based on gender identity and sexual orientation.
The EEOC in April 2024 updated its guidelines to comply with the U.S. Supreme Court’s ruling in Bostock v. Clayton County (2020), which determined that discrimination against transgender people constituted sex-based discrimination as proscribed under Title VII of the Civil Rights Act of 1964.
To ensure compliance with the law, the agency recommended that employers honor their employees’ preferred pronouns while granting them access to bathrooms and allowing them to wear dress code-compliant clothing that aligns with their gender identities.
While the the guidelines are not legally binding, Kacsmaryk ruled that their issuance created “mandatory standards” exceeding the EEOC’s statutory authority that were “inconsistent with the text, history, and tradition of Title VII and recent Supreme Court precedent.”
“Title VII does not require employers or courts to blind themselves to the biological differences between men and women,” he wrote in the opinion.
The case, which was brought by the conservative think tank behind Project 2025, the Heritage Foundation, presents the greatest setback for LGBTQ inclusive workplace protections since President Donald Trump’s issuance of an executive order on the first day of his second term directing U.S. federal agencies to recognize only two genders as determined by birth sex.
Last month, top Democrats from both chambers of Congress reintroduced the Equality Act, which would codify LGBTQ-inclusive protections against discrimination into federal law, covering employment as well as areas like housing and jury service.
The White House
Trump travels to Middle East countries with death penalty for homosexuality
President traveled to Saudi Arabia, Qatar, and United Arab Emirates
Homosexuality remains punishable by death in two of the three Middle East countries that President Donald Trump visited last week.
Saudi Arabia and Qatar are among the handful of countries in which anyone found guilty of engaging in consensual same-sex sexual relations could face the death penalty.
Trump was in Saudi Arabia from May 13-14. He traveled to Qatar on May 14.
“The law prohibited consensual same-sex sexual conduct between men but did not explicitly prohibit same-sex sexual relations between women,” notes the State Department’s 2023 human rights report, referring specifically to Qatar’s criminalization law. “The law was not systematically enforced. A man convicted of having consensual same-sex sexual relations could receive a sentence of seven years in prison. Under sharia, homosexuality was punishable by death; there were no reports of executions for this reason.”
Trump on May 15 arrived in Abu Dhabi, the capital of the United Arab Emirates.
The State Department’s 2023 human rights report notes the “penalty for individuals who engaged in ‘consensual sodomy with a man'” in the country “was a minimum prison sentence of six months if the individual’s partner or guardian filed a complaint.”
“There were no known reports of arrests or prosecutions for consensual same-sex sexual conduct. LGBTQI+ identity, real or perceived, could be deemed an act against ‘decency or public morality,’ but there were no reports during the year of persons prosecuted under these provisions,” reads the report.
The report notes Emirati law also criminalizes “men who dressed as women or entered a place designated for women while ‘disguised’ as a woman.” Anyone found guilty could face up to a year in prison and a fine of up to 10,000 dirhams ($2,722.60.)
Trump returned to the U.S. on May 16.
The White House notes Trump during the trip secured more than $2 trillion “in investment agreements with Middle Eastern nations ($200 billion with the United Arab Emirates, $600 billion with Saudi Arabia, and $1.2 trillion with Qatar) for a more safe and prosperous future.”
Former President Joe Biden traveled to Saudi Arabia in 2022.
Saudi Arabia is scheduled to host the 2034 World Cup. The 2022 World Cup took place in Qatar.
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