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.”
Florida
Gay Fla. Democrat Elijah Manley sees opportunity in Trump’s second term
State’s 20th Congressional District’s includes Broward, Palm Beach Counties
Just over two and a half miles from President Donald Trump’s primary residence lies one of Florida’s most reliably Democratic congressional districts. There, a 27-year-old progressive is mounting a campaign centered on resisting what he calls the Trump-Vance administration’s attacks on civil rights, immigrants, and LGBTQ Americans.
Elijah Manley, an openly gay Democrat, sat down with the Washington Blade to discuss why he is running for Florida’s 20th Congressional District, why he believes this moment calls for a new generation of leadership, and what he hopes to accomplish if elected to Congress.
Born and raised in Fort Lauderdale’s historic Sistrunk neighborhood — the city’s oldest African American community — Manley was raised by a single mother who struggled to make ends meet. His family experienced housing insecurity and, at one point, homelessness, experiences he says continue to shape both his politics and his policy priorities.
For Manley, those experiences are precisely what he believes Congress is missing.
“I think now the country is in need of somebody like me, with my story, my lived experience, the struggles I’ve been through in my life. We’re going through a really dark time in the country with the Trump administration coming for our civil rights and an economy that is not working for everybody. In a time where we have MAGA fascism, we need progressive leadership, and we need people who are really going to do the work of fighting back and resisting and obstructing Donald Trump and MAGA Republicans’ agenda in Congress.”
Manley said his campaign is also about ensuring people from marginalized communities — those without wealth, political connections, or institutional backing — have a voice in Congress.
“I think my story sets me aside from everyone else. I’m the only one in this race who has a story to tell voters that lines up with their lived experiences and their struggles. Growing up in poverty and experiencing homelessness was instrumental in developing my worldview and how I fight for people, and I think that’s something that’s absent on Capitol Hill.”
He argues that lived experience offers a perspective often missing on Capitol Hill.
“There are too many lawyers and people coming from professional and political backgrounds. Then you have somebody like me who is rooted in the story of this district. That’s what sets me apart from everyone else in this race.”
According to his campaign website, Manley’s interest in public service dates back to childhood. He cites the election of President Barack Obama as a defining moment that inspired him to pursue politics.
“He was inspired by Barack Obama’s historic election, igniting his passion for public service. He began writing to elected officials, speaking at school board and city council meetings, and advocating for issues affecting his community,” the website states. It goes on to describe his involvement in criminal justice and law magnet programs, Navy JROTC, and hundreds of hours of volunteer service while in high school.
As an openly gay candidate running during Trump’s second administration, Manley said Congress must take a far more aggressive approach to protecting LGBTQ Americans, particularly as Republican-led states continue passing restrictions targeting transgender people.
“I think we need to bring the hammer down on some of these states. I’m not one of these states’ rights people — Congress has the power to preempt laws that states pass through the Supremacy Clause. There’s never been a more important time in our history when we’re seeing fascism, we’re seeing an administration out of control, and we need Congress to act.”
His campaign has also drawn criticism from both Republicans and establishment Democrats for his positions on Gaza, immigration, and his call to abolish U.S. Immigration and Customs Enforcement.
Manley said abolishing ICE does not mean eliminating immigration enforcement altogether.
“I’m not saying there should be no immigration laws. We want laws around immigration, but we want dignity. We don’t need a hypermilitarized, paramilitary group chasing people through the streets, terrorizing communities, churches, schools, and families.”
His personal experiences also inform his healthcare agenda.
“When we talk about healthcare, my experience growing up on Medicaid is seeing the failure of the government to expand Medicaid here in Florida, and now we’re seeing cuts from the Trump administration. I’m not just looking at statistics or numbers on paper — this is based on lived experience. I know how the people in this district are going to be hurt by these policies because I’ve lived it.”
California Democratic Congressman Ro Khanna, who has generated early buzz as a potential 2028 presidential contender for his “progressive capitalist” approach to governing, has endorsed Manley’s campaign, giving the first-time congressional candidate one of his highest-profile endorsements.
Manley faces six other Democrats in the primary, including U.S. Rep. Debbie Wasserman Schultz and former U.S. Rep. Sheila Cherfilus-McCormick, along with four Republican candidates in the general election field. Cherfilus-McCormick resigned from Congress ahead of a potential expulsion and is running again while facing federal criminal charges.
Despite running as the youngest candidate in the field, Manley said he hopes voters leave the race remembering one thing above all else.
“I want people to remember bold and authentic leadership. I want them to know I’m running because I’ve been through what people are going through right now — and it’s not that I’ve been through it, I’m actually still going through it. We need bold people who are going to fight for everybody and stand up for what’s right, and that’s what I hope voters see when they go to the polls.”
Florida
Former Fla. gubernatorial candidate Andrew Gillum arrested on drug charges
Democrat narrowly lost to DeSantis in 2018, later came out as bisexual
Andrew Gillum, the former Democratic nominee for governor of Florida and former mayor of Tallahassee, was arrested on drug possession charges in Alabama last week.
Police in Daphne, Ala., said they pulled Gillum over for erratic driving and found marijuana and methamphetamine in his vehicle. He was charged with possession of marijuana and unlawful possession of a controlled substance, according to the Daphne Police Department. Jail records show he was arrested on July 2 and released on July 3, the Associated Press reports.
Gillum, the first Black nominee of a major political party for governor in Florida, lost the 2018 election to current Republican Gov. Ron DeSantis in a highly contentious race.
Once considered a rising star in national politics, Gillum served in Tallahassee’s local government, first as a city commissioner and then as mayor of Florida’s capital from 2014- 2018.
The Daphne Police Department said officers stopped Gillum’s vehicle around 10:45 p.m. and initiated a probable cause search after one officer noticed a glass pipe on the center console.
During the search, officers found several rolled marijuana cigarettes and three packages containing a substance that tested positive for methamphetamine, police said.
The day after his arrest he was charged with possession of dangerous drugs, use or possession of drug paraphernalia, and possession of marijuana.
In 2020, Gillum was involved in a similar incident when he was found in a Miami Beach, Fla., hotel room with a man identified as an escort who had apparently overdosed on drugs. Police also found three bags of suspected crystal methamphetamine in the room. The man survived, and no one was ever charged with a crime.
Later that year, Gillum came out as bisexual during an appearance on “The Tamron Hall Show,” where he discussed his struggles with drug and alcohol addiction and his decision to seek treatment following the 2020 incident.
In the same interview he shed light onto this, saying his substance use was a byproduct of the emotional struggles he experienced after losing the 2018 gubernatorial race to DeSantis.
This is not the first time Gillum has faced legal scrutiny.
During his 2014 mayoral campaign, he faced allegations of misconduct after hiring private equity investor Adam Corey as his campaign treasurer, raising questions about a potential conflict of interest. However, the FBI ultimately concluded there was no conflict of interest.
Pennsylvania
Philadelphia murder suspect remains at large
Two killed, one injured in attacks motivated by victims’ sexual orientation
Police seek the public’s support in finding a suspect wanted in connection with three Philadelphia shootings, including two murders, who may have targeted his victims because they were gay. All three shootings took place near Hunting Park Recreation Center between May 29 and June 26.
The suspect is 21-year-old Jahylin Melchur, who has not been located by police and is not in police custody as of July 7. Police seek the public’s support in tracking down the suspect, whose image was captured on surveillance cameras. Previous reporting underlined that Melchur should be considered armed and dangerous.
Each of the victims was found partially clothed between 10 and 11 p.m.
On May 29, a 55-year-old in Juniata Park was found two miles from the rec center. The victim, who survived the encounter with critical injuries, said a man approached him and announced his intention to rob him, before shooting him in the elbow and torso.
Martin Higgins, 45, was pronounced dead on the bleachers of the rec center’s baseball field on June 20, suffering from a gunshot wound to the abdomen. Sharef Holman, 29, was found near the basketball courts on June 26, suffering from multiple gunshot wounds. He was transported to Temple University Hospital but died shortly thereafter.
Deputy Police Commissioner Frank Vanore declined to answer the Philadelphia Inquirer’s question regarding whether the victims may have met Melchur on a dating app, citing the ongoing investigation. Sources told the Philadelphia Inquirer that investigators are exploring this possibility
Although robbery may be at least part of the motive in the first shooting, other movies are unclear.
NBC10 reported that law enforcement sources told the station all three victims were targeted because they were gay, but the Philadelphia Police Department did not confirm this.
The Philadelphia Police Department replied to PGN’s questions with an email stating, “This remains a very active investigation, and investigators are looking at all aspects of the case, including underlying motivations for committing these crimes.
“At this point, we can confirm that Melchur is wanted for two homicides by shooting and one non-fatal shooting, all of which occurred in the Hunting Park area.
“The investigation has not established that the victims were specifically targeted because of their sexual orientation.”
The Philadelphia Police Department is urging anyone with information to contact the Homicide Unit at 215-686-3334 or submit an anonymous tip by calling the PPD Tip Line at 215-686-TIPS (8477).
(This story is republished with permission of the Philadelphia Gay News.)
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