BARCELONA, Spain – Researchers from the Amsterdam University Medical Center made a groundbreaking announcement this week of the results of a major study to be presented at the 2024 European Congress of Clinical Microbiology and Infectious Diseases, which will be held April 27-30 in Barcelona.

A team led by Dr. Elena Herrera-Carrillo using a gene-editing tool known as Crispr-Cas, were able to eliminate HIV DNA, removing all traces of the virus from infected cells. In the press release Tuesday, Dr. Herrera-Carrillo alongside team members Yuanling Bao, Zhenghao Yu and Pascal Kroon, said that utilizing the gene-editing tool they focused on parts of the virus that stay the same across all known HIV strains.

“These findings represent a pivotal advancement towards designing a cure strategy,” the team said.

Herrera-Carrillo’s team works in developing a cure for HIV infection based on novel CRISPR-Cas methods.  CRISPR-Cas is a powerful gene editing tool working like genetic scissors but can also be used to selectively attack and inactivate integrated HIV DNA genomes in infected cells.

Herrera-Carrillo’s team eliminated HIV from cells in a laboratory, raising hopes of a cure, but cautioned that for now their work represents proof of concept, and will not become a cure for HIV tomorrow. According to the researchers the next steps involve optimizing the delivery route to target the majority of the HIV reservoir cells within the body.

The hope the research team points out, is to devise a strategy to make this system as safe as possible for future clinical applications, and achieve the right balance between efficacy and safety. “Only then can we consider clinical trials of ‘cure’ in humans to disable the HIV reservoir,” they stated adding, “While these preliminary findings are very encouraging, it is premature to declare that there is a functional HIV cure on the horizon.”

FOSTER CITY, Calif. — Gilead Sciences this week announced it has given $4 million in grants to 35 organizations in Latin America and the Caribbean that fight HIV/AIDS.

A press release notes Asociación Panamericana de Mercadeo Social (Pan-American Association of Social Marketing) in Nicaragua, Fundación Genesis (Genesis Foundation) in Panama, Fundación por una Sociedad Empoderada (Foundation for an Empowered Society) in Argentina, Associação Nacional de Travestis e Transexuais (National Association of Travestis and Transsexuals) in Brazil and Caribbean Vulnerable Communities are among the groups that received grants. Gilead notes this funding through its Zeroing In: Ending the HIV Epidemic in Latin America and the Caribbean will “improve access to care, increase health equity and reduce HIV-related stigma for populations most affected by HIV.”

“The HIV prevention and care needs of people throughout Latin America and the Caribbean are incredibly diverse, and each of these programs addresses a unique community challenge,” said Gilead Vice President of Corporate Giving Carmen Villar. “Our grantees are deeply embedded in their communities and best positioned to provide needed HIV care and support services.” 

“Their expertise will be essential to achieve the Zeroing In program’s goals of improving access to comprehensive care among priority populations, decreasing HIV-related stigma and reducing HIV and broader health inequities,” she added.

The pandemic disproportionately affects Transgender people and sex workers, among other groups, in the region. Activists and HIV/AIDS service providers in the region with whom the Washington Blade has previously spoken say discrimination, stigma, poverty, a lack of access to health care and criminalization laws are among the myriad challenges they face.

First Lady Jill Biden in 2022 during a trip to Panama announced the U.S. will provide an additional $80.9 million in the fight against HIV/AIDS in Latin America through the President’s Emergency Plan for AIDS Relief. 

Cuba in 2015 became the first country in the world to eliminate mother-to-child transmission of HIV. The Cuban government until 1993 forcibly quarantined people with HIV/AIDS in state-run sanitaria.

Antigua and Barbuda, St. Kitts and Nevis, Barbados and Trinidad and Tobago in recent years have decriminalized consensual same-sex sexual relations. 

The Inter-American Commission on Human Rights in 2021 ruled Jamaica must repeal its colonial-era sodomy law. The country’s Supreme Court last year ruled against a gay man who challenged it.  

WASHINGTON – UNAIDS dubbed this year’s World AIDS Day theme as “Let Communities Lead.” This is how conversations around HIV and AIDS should be structured, Duante’ Brown said, who manages two programs at NMAC — a nonprofit dedicated to working to end the AIDS epidemic. People living with HIV need to be considered the subject matter experts, he said. 

“Bringing those people into the room, showing them that they have a voice and that there’s not just this group of people who are making a decision for them … is definitely the way that you go about this.”

Brown manages the ESCALATE program at NMAC, which aims to empower people to address HIV stigma, and the ELEVATE program, which is a training program for people with HIV to be more involved in the planning and delivery of the Ryan White HIV/AIDS Program, which is the largest federal program designed specifically for people with HIV. 

In the United States, it’s estimated 1.2 million people are living with HIV, according to HIV.gov. About 13% are unaware they have HIV.

HIV also continues to disproportionately affect certain populations. Men who have sex with men accounted for 70% of the 32,100 estimated new HIV infections in 2021. And Black individuals accounted for 40% of the new infections that year, while only comprising 12% of the population of the United States, according to the CDC. 

In 2023, stigma is a key inhibitor to ending the epidemic, Brown said. When stigma gets out of the way, there could be a day when there are no new cases of HIV transmissions, he said. To get around that stigma, people need to have meaningful and productive conversations about AIDS. 

“Not treating it as taboo, making sure that we are empowering people living with HIV and AIDS to tell their stories and to be empowered to feel that it’s OK,” Brown said. “And that nothing is wrong with you.”

And there are events in the locally and nationally to recognize World AIDS Day, many of them aimed at abolishing the stigma that comes with talking about HIV.

At a national level, Janet Jackson is set to headline the World AIDS Day concert on Dec. 1 — an annual fundraiser sponsored by the AIDS Healthcare Foundation. The concert will be at the NRG Arena in Houston, and will also honor actor and activist Blair Underwood with its lifetime achievement award. 

“[The concert] really is a way to commemorate World AIDS Day in a way that is both remembrance of those that we’ve lost, recognizing where we’re at, but also really celebrating and connecting the work that’s yet to be done. And having folks still leaving uplifted and elevated about what the future could hold,” said Imara Canady, AHF’s national director for communications and community engagement. 

Jackson has long been an outspoken advocate for people living with HIV. Her song, “Together Again,” is a tribute to a friend she lost to AIDS, as well as a dedication to patients around the world. 

The AIDS Healthcare Foundation, the largest nonprofit HIV/AIDS service organization and advocacy group, has several health care centers in the region and many across the nation and world. AHF also has a free HIV test locater online at freehivtest.net. 

AIDSWatch, the electronic memorial to people lost to HIV and AIDS, will be viewable on www.AIDSWatch.org and on the City of West Hollywood’s WeHoTV broadcast and streaming channels, including Spectrum Channel 10 within West Hollywood, beginning at 12:01 a.m. on Thursday, Dec. 1, for 24 hours.

The City of West Hollywood will join STORIES: The AIDS Monument and APLA Health in a World AIDS Day event on Friday, Dec. 1. The evening will begin at 5:30 p.m. with a reception at the West Hollywood Park Aquatic and Recreation Center (ARC) Respite Deck, located at 8750 El Tovar Place.

After a short program with refreshments, attendees will descend the grand staircase of the ARC at 6:30 p.m. in a candlelight procession through West Hollywood Park and along N. Robertson, Santa Monica, and N. San Vicente Boulevards to the City’s Council Chambers/Public Meeting Room, located at 625 N. San Vicente Boulevard. There, the evening will continue with a screening of the award-winning 2023 documentary “Commitment to Life.” Doors will open at 7 p.m. and the screening will begin promptly at 7:15 p.m. 

Events are free to attend and open to the public. Limited validated parking will be available at the West Hollywood Park 5-Story structure. 

Advance RSVP is requested by reserving a spot on Eventbrite.

WASHINGTON — U.S. Rep. Maxine Waters (D-Calif.) on Wednesday sharply criticized House Republicans over their proposed cuts to HIV/AIDS prevention programs.

The California Democrat who represents the state’s 43rd Congressional District in a speech she delivered at the U.S. Conference on HIV/AIDS noted the House Appropriations Committee’s Fiscal Year 2024 Labor, Health, Human Services, Education and Related Agencies Appropriations Bill would cut $767 million from domestic HIV/AIDS programs.

Waters said the bill would cut funds to fight HIV/AIDS among underrepresented groups by 53 percent and “completely eliminates” funding for “Minority AIDS Initiative activities within the Substance Abuse and Mental Health Services Administration.” Waters also noted the appropriations measure “eliminates funding” for the Centers for Disease Control and Prevention’s Ending the HIV Epidemic Initiative, the Ryan White HIV/AIDS Program and community health centers.

“The cuts to the Minority AIDS Initiative will exacerbate racial disparities and the elimination of the (Ending the) HIV Epidemic Initiative,” said Waters.

Waters also criticized House Republicans for “refusing to authorize” the President’s Emergency Plan for AIDS Relief.” The California Democrat said ending PEPFAR “would endanger the lives of millions of people around the world who are living with HIV and endanger the lives of millions more who are at risk.” 

“Moreover, it would compromise United States leadership on global health issues,” added Waters. “These programs used to have widespread support. It’s shameful that House Republicans are now trying to eliminate them. We cannot allow these cuts to pass. We cannot compromise. We will not give up.”

U.S. Reps. Jim Jordan (R-Ohio) and Marjorie Taylor Greene (R-Ga.) are among those who Waters criticized by name in her speech.

“I will speak truth to power. I want to use words that they will understand. Hell no! We won’t go! We are not going to give up,” said Waters. “That’s the people’s money. You can’t decide who you’re going to spend it on and not who you’re going to spend it on.”

More than 3,000 people are expected to attend the National Minority AIDS Council-organized conference that will end on Saturday. This year’s theme is “A Love Letter to Black Women.”

“We need a love letter to Black women,” said Waters. “We need it not only from this conference. We need it from our families often times. We need it from our communities. We need it from the churches that we give so much attention to and give our resources to and don’t really get it back. We need a love letter coming from all over this country for what we have suffered, for what we have endured, for the way that we have been denied and for the way that we have been ostracized.” 

Waters in her speech specifically praised former Massachusetts Congressman Barney Frank and the late U.S. Sen. Ted Kennedy (D-Mass.) for their work in support of LGBTQ+ rights and efforts to combat HIV/AIDS. Waters also thanked Jewel Thais-Williams, who opened Catch One, a bar and restaurant on Pico Boulevard in Los Angeles that became a refuge for people with HIV/AIDS.

“They had nowhere to gather, nowhere to go, nowhere to be recognized as people who needed support,” said Waters.

B. Kaye Hayes, deputy assistant secretary for infectious disease in the Office of the Assistant Secretary for Health who is also the executive director of the Presidential Advisory Council on HIV/AIDS, is among those who are expected to speak at the conference. Mark S. King, an HIV/AIDS activist and blogger who published “My Fabulous Disease: Chronicles of a Gay Survivor” on Sept. 1, is scheduled to talk on Thursday.

Cal Benn contributed to this story.

WASHINGTON – The American Red Cross announced a historic change in the organization’s policies regarding blood donations by gay and bisexual men. Under this new donor screening process, all donors answer the same eligibility questions regardless of gender or sexual orientation and will be assessed for blood donation based on individual risk factors, not on sexual orientation.

This change by the Red Cross falls within the U.S. Food and Drug Administration finalized guidelines for blood donation issued this past May that will use a uniform individualized risk assessment questionnaire for respondents regardless of their sexual orientation, sex, or gender.

In a statement the Red Cross noted:

“This change means many healthy individuals who previously could not give will now be able to support their community through the gift of blood donation.

Andrew Goldstein, a cancer researcher from Los Angeles, was a regular blood donor in his younger years before the FDA’s previous policies made him ineligible to donate as a gay man. His desire to influence change compelled him to register as a participant in the FDA funded ADVANCE Study in 2021, which sought to gather data to evaluate the possibility of moving to an individual donor assessment. He is proud he was able to be part of the study that led to this change and is excited to finally be able to give blood again.

“There’s so much in the world that you can’t help with, and you sometimes have to see people going through difficult times, but something like giving blood feels like something so small that you can do, and it means a lot to me that I’ll be able to do that again,” said Andrew. Now, Andrew and many others are able to share their good health with patients in need of lifesaving transfusions.”

The FDA’s new protocols issued in May note that prospective donors who have had a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be ineligible.

So would those who are “taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP),” because these drugs can delay the detection of HIV.

Blood donation rules have changed to be more inclusive! All donors will answer the same eligibility questions regardless of gender or sexual orientation, and more people can give lifesaving blood with the Red Cross while keeping the blood supply safe.

We’ve worked for years… pic.twitter.com/htnLg3AHOm

— American Red Cross (@RedCross) August 7, 2023

Related:

NEW YORK – The Rocket Fund is the Elton John AIDS Foundation’s latest transformative $125 million campaign to redouble the fight against AIDS everywhere. Growing levels of stigmatization, marginalization, and poverty have led to high rates of HIV and low access to healthcare globally. 

“For years, HIV/AIDS has caused enormous pain across the world, but I pray that soon this epidemic will be a thing of the past” said Sir Elton John. “More than 30 years after I launched the Elton John AIDS Foundation, my passion for reaching everyone, everywhere with education and compassionate care is still as strong as ever. The Rocket Fund will turbo-charge our mission and reach those most at risk from this terrible disease. Now is the time. This epidemic has gone on too long. We must all act together to see AIDS defeated in our lifetimes.”

Money from the fund will go towards supporting access to HIV prevention and treatment services, including providing access to HIV tests, antiretroviral therapies, and Pre-Exposure Prophylaxis (PrEP), according to the press release. Donatella Versace, one of the Rocket Fund’s co-chairs — alongside Furnish, Tani Austin, and David Geffen — has also pledged to match donations to the fund up to $300,000 during the month of June.

Throughout Pride Month, Sir Elton John and the co-chairs of The Rocket Fund are challenging supporters to let their #InnerElton out. Letting your #InnerElton out is about proudly expressing your authentic self, showing love for others and taking compassionate action. Supporters are encouraged to join the movement by posting photos of themselves on social media wearing their own take on Elton’s signature looks – or whatever makes them feel their true self – with the hashtag #InnerElton. Many notables are joining to let their #InnerElton out, including Dolly Parton, Michaela Jaé Rodriguez, JoJo Siwa, Heidi Klum, Smokey Robinson and more. Learn more here. The Let Your Inner Elton Out campaign was created by advertising agency Invisible Man and produced in partnership with global communications agency BCW.

The Foundation launched this critical initiative on June 5, the day in 1981 when the Centers for Disease Control released its first report on what would become the AIDS epidemic. This inaugural Rocket Day commemorates the early days of the fight against HIV/AIDS, while committing to accelerate progress towards ending AIDS for all.

“The end of the HIV/AIDS epidemic is within sight, and The Rocket Fund is the push we need to finally cross the horizon,” said David Furnish, Chairman of the Elton John AIDS Foundation. “To end AIDS, we must make targeted investments that can level the playing field, by tackling the inequalities and stigma that prevent people from accessing the care they desperately need. By joining The Rocket Fund and our mission, you can help transform the future for millions of people globally.”

“As we’ve learned through the global fight to stop COVID-19, epidemics do not recognize state borders, economic or cultural differences. If left unchecked, they only worsen with devastating impacts on the most vulnerable,” said Anne Aslett, Chief Executive Officer of the Elton John AIDS Foundation. “It is critical that we meet this moment to connect vulnerable people with the care and resources they need to live vibrant, healthy lives and we welcome all who want to see an end to this disease to join us.”

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ATLANTA – Data published Tuesday. by the Centers for Disease Control and Prevention shows a significant decline in new HIV infections, but suggests the impact of prevention efforts was far less substantial for Black and Latino populations.

From 2017 to 2021, as rates of HIV testing, treatment, and the use of pre-exposure prophylaxis (PrEP) medication rose, new cases dropped by 12 percent overall and by as much as 34 percent among gay and bisexual males aged 13 to 24.

The numbers show a “move in the right direction,” CDC Director Rochelle Walensky said in a press release.

However, when broken down by race, the CDC found new infections were down by 27 percent and 36 percent, respectively, among Black and Hispanic-Latino populations, compared with 45 percent of whites.

Similarly, by 2021 about one third of those who are considered eligible were taking PrEP for HIV prevention, but the CDC noted this number includes “relatively few Black people or Hispanic/Latino people” despite the significant increase in prescriptions up from just 13 percent in 2017.

“Longstanding factors, such as systemic inequities, social and economic marginalization and residential segregation,” Walensky noted, continue to act as barriers “between highly effective HIV treatment and prevention and people who could benefit from them.”

She added, “Efforts must be accelerated and strengthened for progress to reach all groups faster and equitably.”

Robyn Neblett Fanfair, acting director of the CDC’s Division of HIV Prevention, said that “At least three people in the U.S. get HIV every hour—at a time when we have more effective prevention and treatment options than ever before.”

“These tools must reach deep into communities and be delivered faster to expand progress from some groups to all groups,” she said.

The HIV+Hepatitis Policy Institute issued a press release following the CDC’s announcement of the new data, noting both the encouraging progress and need for improvement.

“It appears that our investments in HIV prevention are providing some positive results, but the persistent high number of new diagnoses and the low usage of PrEP among the communities most impacted by HIV point to the need for increased resources, particularly for a national PrEP program,” said the group’s executive director, Carl Schmid.

President Joe Biden’s FY24 budget requested $237 million for a national PrEP program along with $850 million to support the U.S. Department of Health and Human Services’ “Ending the HIV Epidemic in the U.S.” initiative.

WASHINGTON – The President’s Emergency Plan for AIDS Relief (PEPFAR) marks its twenty year anniversary today, marking the largest commitment by any nation to address a single disease in the world.

The initiative which was personally led and launched by former President George W. Bush in 2003,  its funding has totaled more than $110 billion to date, including funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), to which the U.S. government is the largest donor.

PEPFAR is credited with saving millions of lives and helping to change the trajectory of the global HIV epidemic.  The White House today released a statement by President Joe Biden marking the 20th Anniversary:

Twenty years ago today, President George W. Bush declared that preventing and treating HIV/AIDS was a foreign policy priority of the United States. At a time when nearly 30 million people were HIV positive, but very few were receiving life-saving medicines, the President’s Emergency Plan for AIDS Relief (PEPFAR) transformed the global AIDS response and laid a marker for America’s commitment to countries that were impacted the hardest by the AIDS epidemic. Helping lead the bipartisan effort in Congress to authorize PEPFAR is among my proudest achievements from my time in the Senate. To this day, PEPFAR remains a powerful example of America’s unmatched ability to drive progress and make life better for people around the world.
 
Since 2003, PEPFAR has saved more than 25 million lives and dramatically improved health outcomes in more than 55 partner countries. AIDS-related deaths have declined by 68 percent since their peak in 2004, and new HIV infections are down 42 percent. PEPFAR investments have ensured that 5.5 million babies have been born HIV-free. And two decades of investment in partner nations’ health systems played a critical role in countries’ ability to respond to other health crises such as COVID-19, Mpox, and Ebola.    
 
Today, PEPFAR continues to support 20.1 million people around the world with HIV/AIDS treatment, and my Administration is committed to continuing to lead the global HIV/AIDS response. We will build on our decades of progress to reach the Sustainable Development Goal of ending AIDS by 2030, work to eliminate the stigma and inequities that keep people from accessing care, and keep the voices of people living with HIV/AIDS at the center of our response.  I look forward to working with Congress on PEPFAR’s reauthorization this year.

PEPFAR is overseen by the U.S. Global AIDS Coordinator, who is appointed by the President, confirmed by the Senate, and reports directly to the Secretary of State, as established through PEPFAR’s authorizing legislation.

PEPFAR’s original authorization established new structures and authorities, consolidating all U.S. bilateral and multilateral activities and funding for global HIV/AIDS. Several U.S. agencies, host country governments, and other organizations are involved in implementation.

Dr. John Nkengasong, the current coordinator was sworn in on June 13, 2022, and holds the rank of Ambassador leading the Office of the Global AIDS Coordinator (OGAC) at the U.S. Department of State.

Twenty years ago this month, President George W. Bush announced #PEPFAR during his State of the Union address. Since then, the U.S. government has invested $100B+ in the global HIV/AIDS response through PEPFAR, saving 25M lives & bringing us closer to #EndAIDS2030. #PEPFAR20 pic.twitter.com/SMAOHWPZ03

— PEPFAR (@PEPFAR) January 11, 2023

Nobel Prize winning scientist Harold Varmus, who served as Director of the National Institutes of Health (NIH) from 1993 to 1999 and currently the Lewis Thomas University Professor of Medicine at Weill Cornell Medicine in New York City, wrote in an article honoring World Aids Day 2013:

[…] “the PEPFAR story must begin with George W. Bush and his wife, Laura, and their interests in AIDS, Africa, and what Bush termed “compassionate conservatism.” According to his 2010 memoir, Decision Points, the two of them developed a serious interest in improving the fate of the people of Africa after reading Alex Haley’s Roots and visiting The Gambia in 1990.³ In 1998, while pondering a run for the U.S. presidency, he discussed Africa with Condoleezza Rice, his future secretary of state; she said that, if elected, working more closely with countries on that continent should be a significant part of his foreign policy. She also told him that HIV/AIDS was a central problem in Africa but that the United States was spending only $500 million per year on global AIDS, with the money spread across six federal agencies, without a clear strategy for curbing the epidemic.”

Key Facts (As provided by Kaiser Health & Family Foundation)

• Although the U.S. has been involved in efforts to address the global AIDS crisis since the mid-1980s, the creation of the President’s Emergency Plan for AIDS Relief (PEPFAR) in 2003 marked a significant increase in funding and attention to the epidemic.
• PEPFAR is the largest commitment by any nation to address a single disease in the world; to date, its funding has totaled more than $110 billion, including funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), to which the U.S. government is the largest donor. PEPFAR is credited with saving millions of lives and helping to change the trajectory of the global HIV epidemic.
• U.S. funding for PEPFAR grew from $2.2 billion in FY 2004 to $7.0 billion in FY 2022; FY 2022 funding includes $5.4 billion provided for bilateral HIV efforts and $1.6 billion for multilateral efforts ($50 million for UNAIDS and $1.56 billion for the Global Fund).
• As the COVID-19 pandemic continues to have profound effects across the world, PEPFAR has acted to respond to COVID-19 in countries that receive support in order to minimize HIV service disruptions and leverage the program’s capabilities to address COVID-19 more broadly.
• Looking ahead, PEPFAR faces several issues and challenges, including how best to: address the short- and long-term impacts of COVID-19 on PEPFAR and the HIV response; accelerate progress toward epidemic control in the context of flat funding; support and strengthen community-led responses and the sustainability of HIV programs; define its role in global health security and broader health systems strengthening efforts; and continue to coordinate with other key players in the HIV ecosystem, including the Global Fund.

Key Activities and Results (As provided by Kaiser Health & Family Foundation)

PEPFAR activities focus on expanding access to HIV prevention, treatment, and care interventions. These include provision of antiretroviral treatment, pre-exposure prophylaxis, voluntary male circumcision, condoms, and other commodities related to HIV services. In addition, PEPFAR has launched specific initiatives in key strategic areas. For example, in 2015, PEPFAR launched DREAMS, a public-private partnership that aims to reduce HIV infections in adolescent girls and young women.

The latest results reported by PEPFAR indicate that it has:

• supported testing services for 63.4 million people in FY 2021;
• prevented 2.8 million babies from being born with HIV, who would have otherwise been infected;
• provided care for more than 7.1 million orphans and vulnerable children (OVC);
• supported training for nearly 300,000 new health care workers; and
• supported antiretroviral treatment for 18.96 million people.
• In the 15 countries implementing the DREAMS initiative, new diagnoses among adolescent girls and young women have declined with most DREAMS areas (96%) experiencing declines greater than 25% and nearly two-thirds with declines greater than 40%.

The achievements of the PEPFAR program have been remarkable, well-documented by outside evaluators, and hugely applauded throughout the advocacy community and the developing world. In general, milestones have been met, the program has been enlarged (for instance, to include some research on implementation of medical assistance), the roster of PEPFAR countries has grown and spending plans have not been exceeded.

SILVER SPRING, Md. – The U.S. Food and Drug Administration (FDA) introduced a proposed change to its blood donation guidelines on Friday that would ease restrictions for gay and bisexual men.

The FDA notes the proposal, news of which was first reported in November, would bring U.S. policies in alignment with those in place in countries like the U.K. and Canada. The agency is expected to formally adopt the new guidelines after a public comment period.

The move follows criticism from LGBTQ groups and organizations like the American Medical Association (AMA) who have long argued the current policy is homophobic and based on an outdated understanding of the risks associated with blood donation by men who have sex with men.

As the AMA wrote of the current policy: “a man who has protected sex with another man in the three months prior to a blood donation cannot be a donor, but a man or woman who has unprotected sex with multiple partners of the opposite sex over the same time period remains eligible.”

The FDA’s proposal would lift the mandatory three-month deferral period for some men who have sex with men and instead use a “gender-inclusive, individual risk-based questions relevant to HIV risk.”

Potential donors would be asked for information about their sexual history over the past three months. Respondents who indicate they have had sex with one or more new sexual partners would then be asked whether they have had anal sex during this period. Those who answer “yes” would be deferred from blood donation.

Axios noted that as of this morning, about 20 percent of the country’s community blood centers have a one-day supply or less, while the FDA’s broadened eligibility criteria would increase the annual blood supply by two to four percent, citing data from America’s Blood Centers’ daily tracker and the Williams Institute.

U.S. Sen. Tammy Baldwin (D-Wis.) issued a statement celebrating the FDA’s proposal. “As I have long advocated for, this blood donation policy takes a step forward and is better rooted in the most up-to-date science with a focus on individual risk factors, not outdated stigmas that effectively ban gay and bisexual men,” she said.

Baldwin has repeatedly urged the agency to revisit its blood donation policy over the years, including by corralling support from other members of Congress to cosign letters to the FDA in 2014 and 2016, raising the issue again in 2020 as the COVID-19 pandemic exacerbated shortages in the blood supply.

The Congressional LGBTQ+ Equality Caucus also acknowledged the move in a statement by its chair, Rep. Mark Pocan (D-Wis.): “I am glad the FDA is finally moving toward an individual risk-based assessment model, but recognize, based on existing reporting, that many LGBTQI+ people may still be barred from donating,” he said. “I look forward to taking a closer look at the proposed guidelines once they are published and working with the FDA to ensure that any unnecessary barriers are removed.”

Several LGBTQ groups also issued statements celebrating the FDA’s new guidance.

“These changes are 40-plus years in the making, and are a tremendous leap forward toward elevating science over stigma,” said GLAAD President Sarah Kate Ellis. “GLAAD and leading medical experts have long been advocating for guidelines that see and treat LGBTQ people the same as any other person, including as potential donors who want to help others.”

“This new policy removes a decades-long barrier for many in our community – and there is more to do to ensure gay, bisexual and transgender people are no longer unfairly stigmatized when they try to donate blood,” Human Rights Campaign President Kelley Robinson said. “The assessment criteria have flaws, focusing excessively, for instance, on the number of partners a potential donor has instead of just on new partners,” she added.

Carl Schmid, executive director of the HIV+ Hepatitis Policy Institute, said: “While this long-overdue change is being made based on the science and the facts, which have been clear for years, it is the result of the leadership of the Biden administration that continues to tear down discriminatory government policies.”

BETHESDA, Md. – A clinical trial of an investigational HIV vaccine regimen, being conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) by Janssen Pharmaceutical Companies and global partners of parent company Johnson & Johnson dubbed “Mosaico,” was discontinued.

In an announcement made Wednesday, NIAID said the HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board had determined.

A spokesperson for Johnson & Johnson noted in light of the board’s determination, the Mosaico clinical trial will be discontinued. Participant notifications and further analyses of the data are underway. Throughout the trial, study investigators have ensured that any individuals who contracted HIV received prompt HIV treatment and care.

Both Johnson & Johnson and NIAID stressed that no safety issues with the vaccine regimen were identified.

“We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine. We are grateful to our Mosaico partners and the study investigators, staff and participants.”

Janssen Vaccines & Prevention sponsored the Mosaico study with funding support from NIAID, part of the National Institutes of Health. The trial was conducted by the NIAID-funded HIV Vaccine Clinical Trials Network, based at the Fred Hutchinson Cancer Research Center in Seattle. The U.S. Army Medical Research and Development Command provided additional study support.

The Phase 3 Mosaico Study:

Mosaico, a Phase 3 study of Janssen’s investigational HIV vaccine regimen, began in 2019, and completed vaccinations in October 2022. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States.

The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year. A mix of soluble proteins (Clade C/Mosaic gp140, adjuvanted with aluminum phosphate) was also administered at visits three and four.

The Mosaico DSMB analysis, based on the data available to date, indicated that the regimen does not protect against HIV and the study is not expected to meet its primary endpoint. No safety issues with the vaccine regimen were identified. In light of this, the study will be discontinued, and further analyses are underway.