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.”
The Comings & Goings column is about sharing the professional successes of our community. We want to recognize those landing new jobs, new clients for their business, joining boards of organizations and other achievements. Please share your successes with us at [email protected].
Congratulations to Gil Pontes III on his recent appointment to the Financial Advisory Board for the City of Wilton Manors, Fla. Upon being appointed he said, “I’m honored to join the Financial Advisory Board for the City of Wilton Manors at such an important moment for our community. In my role as Executive Director of the NextGen Chamber of Commerce, I spend much of my time focused on economic growth, fiscal sustainability, and the long-term competitiveness of emerging business leaders. I look forward to bringing that perspective to Wilton Manors — helping ensure responsible stewardship of public resources while supporting a vibrant, inclusive local economy.”
Pontes is a nonprofit executive with years of development, operations, budget, management, and strategic planning experience in 501(c)(3), 501(c)(4), and political organizations. Pontes is currently executive director of NextGen, Chamber of Commerce. NextGen Chamber’s mission is to “empower emerging business leaders by generating insights, encouraging engagement, and nurturing leadership development to shape the future economy.” Prior to that he served as managing director of The Nora Project, and director of development also at The Nora Project. He has held a number of other positions including Major Gifts Officer, Thundermist Health Center, and has worked in both real estate and banking including as Business Solutions Adviser, Ironwood Financial. For three years he was a Selectman, Town of Berkley, Mass. In that role, he managed HR and general governance for town government. There were 200+ staff and 6,500 constituents. He balanced a $20,000,000 budget annually, established an Economic Development Committee, and hired the first town administrator.
Pontes earned his bachelor’s degree in political science from the University of Massachusetts, Dartmouth.
Kansas
ACLU sues Kansas over law invalidating trans residents’ IDs
A new Kansas bill requires transgender residents to have their driver’s licenses reflect their sex assigned at birth, invalidating current licenses.
Transgender people across Kansas received letters in the mail on Wednesday demanding the immediate surrender of their driver’s licenses following passage of one of the harshest transgender bathroom bans in the nation. Now the American Civil Liberties Union is filing a lawsuit to block the ban and protect transgender residents from what advocates describe as “sweeping” and “punitive” consequences.
Independent journalist Erin Reed broke the story Wednesday after lawmakers approved House Substitute for Senate Bill 244. In her reporting, Reed included a photo of the letter sent to transgender Kansans, requiring them to obtain a driver’s license that reflects their sex assigned at birth rather than the gender with which they identify.
According to the reporting, transgender Kansans must surrender their driver’s licenses and that their current credentials — regardless of expiration date — will be considered invalid upon the law’s publication. The move effectively nullifies previously issued identification documents, creating immediate uncertainty for those impacted.
House Substitute for Senate Bill 244 also stipulates that any transgender person caught driving without a valid license could face a class B misdemeanor, punishable by up to six months in jail and a $1,000 fine. That potential penalty adds a criminal dimension to what began as an administrative action. It also compounds the legal risks for transgender Kansans, as the state already requires county jails to house inmates according to sex assigned at birth — a policy that advocates say can place transgender detainees at heightened risk.
Beyond identification issues, SB 244 not only bans transgender people from using restrooms that match their gender identity in government buildings — including libraries, courthouses, state parks, hospitals, and interstate rest stops — with the possibility for criminal penalties, but also allows for what critics have described as a “bathroom bounty hunter” provision. The measure permits anyone who encounters a transgender person in a restroom — including potentially in private businesses — to sue them for large sums of money, dramatically expanding the scope of enforcement beyond government authorities.
The lawsuit challenging SB 244 was filed today in the District Court of Douglas County on behalf of anonymous plaintiffs Daniel Doe and Matthew Moe by the American Civil Liberties Union, the ACLU of Kansas, and Ballard Spahr LLP. The complaint argues that SB 244 violates the Kansas Constitution’s protections for personal autonomy, privacy, equality under the law, due process, and freedom of speech.
Additionally, the American Civil Liberties Union filed a temporary restraining order on behalf of the anonymous plaintiffs, arguing that the order — followed by a temporary injunction — is necessary to prevent the “irreparable harm” that would result from SB 244.
State Rep. Abi Boatman, a Wichita Democrat and the only transgender member of the Kansas Legislature, told the Kansas City Star on Wednesday that “persecution is the point.”
“This legislation is a direct attack on the dignity and humanity of transgender Kansans,” said Monica Bennett, legal director of the ACLU of Kansas. “It undermines our state’s strong constitutional protections against government overreach and persecution.”
“SB 244 is a cruel and craven threat to public safety all in the name of fostering fear, division, and paranoia,” said Harper Seldin, senior staff attorney for the ACLU’s LGBTQ & HIV Rights Project. “The invalidation of state-issued IDs threatens to out transgender people against their will every time they apply for a job, rent an apartment, or interact with police. Taken as a whole, SB 244 is a transparent attempt to deny transgender people autonomy over their own identities and push them out of public life altogether.”
“SB 244 presents a state-sanctioned attack on transgender people aimed at silencing, dehumanizing, and alienating Kansans whose gender identity does not conform to the state legislature’s preferences,” said Heather St. Clair, a Ballard Spahr litigator working on the case. “Ballard Spahr is committed to standing with the ACLU and the plaintiffs in fighting on behalf of transgender Kansans for a remedy against the injustices presented by SB 244, and is dedicated to protecting the constitutional rights jeopardized by this new law.”
National
After layoffs at Advocate, parent company acquires ‘Them’ from Conde Nast
Top editorial staff let go last week
Former staff members at the Advocate and Out magazines revealed that parent company Equalpride laid off a number of employees late last week.
Those let go included Advocate editor-in-chief Alex Cooper, Pride.com editor-in-chief Rachel Shatto, brand partnerships manager Erin Manley, community editor Marie-Adélina de la Ferriére, and Out magazine staff writers Moises Mendez and Bernardo Sim, according to a report in Hollywood Reporter.
Cooper, who joined the company in 2021, posted to social media that, “Few people have had the privilege of leading this legendary LGBTQ+ news outlet, and I’m deeply honored to have been one of them. To my team: thank you for the last four years. You’ve been the best. For those also affected today, please let me know how I can support you.”
The Advocate’s PR firm when reached by the Blade said it no longer represents the company. Emails to the Advocate went unanswered.
Equalpride on Friday announced it acquired “Them,” a digital LGBTQ outlet founded in 2017 by Conde Nast.
“Equalpride exists to elevate, celebrate and protect LGBTQ+ storytelling at scale,” Equalpride CEO Mark Berryhill said according to Hollywood Reporter. “By combining the strengths of our brands with this respected digital platform, we’re creating a unified ecosystem that delivers even more impact for our audiences, advertisers, and community partners.”
It’s not clear if “Them” staff would take over editorial responsibilities for the Advocate and Out.
-
Federal Government5 days agoTwo very different views of the State of the Union
-
Virginia5 days agoVa. activists preparing campaign in support of repealing marriage amendment
-
Opinions4 days agoThe global cost of Trump’s foreign aid ideology
-
Opinions4 days agoCriteria for supporting a candidate in D.C.
