Moderna awarded $590M to help accelerate development of mRNA-based bird flu vaccine: HHS
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(NEW YORK) — Moderna has been awarded approximately $590 million from the federal government to help speed up the development of an mRNA-based bird flu vaccine, alongside other influenza vaccines, health officials announced Friday.
The U.S. Department of Health and Human Services (HHS) said in a press release that the funding will allow the pharmaceutical company to accelerate the development of an H5N1 mRNA influenza vaccine “that is well matched to strains currently circulating in cows and birds and expands the clinical data supporting the use of mRNA vaccines that may be needed if other influenza strains emerge with pandemic potential.”
Moderna said the funding will support the expansion of clinical studies “for up to five additional subtypes of pandemic influenza.”
The U.S. government previously awarded the vaccine manufacturer $176 million in July 2024 to help expedite the development of an mRNA vaccine that could be used for bird flu.
mRNA technology is the same type that was used in the development of some COVID-19 vaccines. While some vaccines use a weakened or inactive virus to stimulate an immune response, mRNA vaccines teach the body how to make proteins that can trigger an immune response and fight off an infection.
Researchers can often design mRNA vaccines more quickly than they can produce the live or weakened pathogens needed for a live-attenuated or inactivated vaccine.
The federal government already has two bird flu vaccine candidates, which use traditional vaccine technology, available in the nation’s stockpile. Officials previously noted they’d have 10 million ready-to-use doses within the beginning of 2025. Vaccines were being stockpiled as a precaution.
“Avian flu variants have proven to be particularly unpredictable and dangerous to humans in the past. That is why this response has been a top priority for the Biden-Harris Administration and HHS,” HHS Secretary Xavier Becerra said in a statement on Friday. “Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe.”
Bird flu cases in humans have been spreading across the country since April 2024 with 67 confirmed cases as of Friday, according to the Centers for Disease Control and Prevention (CDC).
The first death of a human bird flu patient was reported in Louisiana earlier this month. The patient was over the age of 65 and had underlying medical conditions, according to health officials.
Most human cases have occurred after coming into contact with infected cattle, infected poultry farms or other culling operations.
The CDC and other public health officials say there is currently no evidence of human-to-human transmission and the risk to the general public is low.
ABC News’ Mary Kekatos contributed to this report.
(WASHINGTON) — Vice President Kamala Harris said former President Donald Trump will roll back health care protections if he wins the presidential election.
Speaking to reporters on Thursday in Madison, Wisconsin, Harris said Trump unsuccessfully tried to repeal the Affordable Care Act (ACA), the landmark law signed by then-President Barack Obama in 2010, while he was president.
“Insurance companies could go back to a time where they would deny you coverage for health insurance based on pre-existing conditions, such being a survivor of breast cancer, asthma, diabetes,” Harris said. “The American people, regardless of who they are voting for, know the importance of Obamacare in terms of expanding coverage to health care, based on the fundamental principle I hold deeply: access to health care should be a right and not just a privilege for those who can afford it.”
“Health care for all Americans is on the line in this election,” Harris continued.
In a post on his social media platform Truth Social, Trump falsely claimed not wanting to end the ACA, even though he repeatedly tried to do so while president.
Here is what we know about Trump’s health care agenda if he is elected to a second term:
‘Concepts’ of a heath care plan
During the ABC News presidential debate in September, Trump said he was interested in replacing the ACA — also known as “Obamacare” — but implied that he didn’t have any specific plans in place.
“Obamacare was lousy health care. Always was,” Trump said. “It’s not very good today and, what I said, that if we come up with something, we are working on things, we’re going to do it and we’re going to replace it.”
When asked to clarify if he had a health care plan, the former president said he had “concepts of a plan” to replace the ACA but provided no details.
“If we can come up with a plan that’s going to cost our people, our population, less money and be better health care than Obamacare, then I would absolutely do it,” Trump said.
After Harris’ press conference on Thursday, Trump took to Truth Social to deny wanting to end the ACA.
“Lyin’ Kamala is giving a News Conference now, saying that I want to end the Affordable Care Act. I never mentioned doing that, never even thought about such a thing,” he wrote Thursday morning.
Trump made several attempts to repeal the ACA during his presidency but failed to do so.
He attempted to partially repeal the ACA by passing the American Health Care Act (ACHA). The plan would have repealed the individual mandate and the employer mandate, amended Medicaid eligibility and weakened protections for patients with pre-existing conditions.
The ACHA passed the House in May 2017 but failed to pass in the Senate. Perhaps mostly infamously, the Senate attempted to pass a so-called “skinny repeal” in late July 2017 but it was rejected, with Republican Sens. John McCain, Susan Collins and Lisa Murkowski siding with Senate Democrats to kill the bill.
During a closed-door campaign event for a fellow Republican House candidate earlier this week, House Speaker Mike Johnson said that there will be “no Obamacare.”
“We want to take a blowtorch to the regulatory state,” Johnson said in footage first reported by NBC News. “Health care is one of the sectors, but we need this across the board.”
“No Obamacare?” an attendee of the event asked Johnson.
“No Obamacare,” Johnson replied. “The ACA is so deeply ingrained, we need massive reform to make this work, and we got a lot of ideas on how to do that.”
Trump’s campaign has worked to separate itself from the speaker’s comments with Karoline Leavitt, national press secretary for the Trump campaign, telling ABC News in a statement that repealing the ACA is “not President Trump’s policy position.”
“As President Trump has said, he will make our health care system better by increasing transparency, promoting choice and competition, and expanding access to new affordable health care and insurance options. Kamala Harris broke our health care system, President Trump will fix it,” the statement continued.
The 2024 GOP platform currently calls for expanding access to “new” affordable health care and prescription drug access as well as protecting Medicare and increasing transparency in the health care sector.
Trump enlists Kennedy to oversee health care policy
Trump has also suggested that he intends to tap Robert F. Kennedy, Jr. — who dropped out of the presidential race in August and endorsed Trump — to help shape health care policies if he wins a second term.
During the Alfred E. Smith Memorial Foundation Dinner — an annual white-tie dinner to raise money for Catholic charities — earlier this month, Trump said Kennedy will “make us a healthier place.”
“We’re gonna let him go wild for a little while, then I’m gonna have to maybe reign him back, because he’s got some pretty wild ideas, but most of them are really good,” Trump said at the dinner. “I think he’s a — he’s a good man, and he believes, he believes the environment, the healthy people. He wants healthy people, he wants healthy food. And he’s going to do it. He’s going to have a big chance to do it, because we do need that.”
Kennedy said Trump has “promised” him “control of the public health agencies,” but Trump’s team said no decisions have been made yet on who will be leading these agencies if he wins the election.
However, Trump implied during a rally in Henderson, Nevada, on Thursday that Kennedy would play a role in shaping women’s health care policies.
“Robert F. Kennedy Jr., we have,” Trump said. “And he’s gonna work on health, and women’s health, and all of the different reasons ’cause we’re not really a wealthy or a healthy country. We’re not.”
There are currently no women’s health care issues listed in the 2024 GOP platform aside from keeping “men out of women’s sports.”
“The only thing President Trump and his campaign team are focused on is winning on November 5th. Everything after that is after that, and President Trump has made clear that Bobby Kennedy will play an important role,” Jason Miller, senior adviser to the Trump campaign told ABC News in a statement.
In response to Trump saying Kennedy will oversee women’s health, Harris reposted a clip of Trump’s comments on X with the caption “No” followed by a heart emoji.
The Harris campaign did not immediately respond to ABC News’ requests for comment.
ABC News’ Lalee Ibssa, Soorin Kim, Will McDuffie, Lauren Peller and Kelsey Walsh contributed to this report.
After more than two years of gender-affirming treatments, LW, the Tennessee teenager behind a landmark case at the U.S. Supreme Court, says, “I feel normal now.” (ABC News)
(NASHVILLE) — The transgender Tennessee teenager behind a historic hearing at the U.S. Supreme Court this week doesn’t want to show her face on television but is eager to speak about a case she says has the potential to make thousands of American kids feel “seen” for who they are.
“The court has definitely ruled in ways that would make me think that they don’t exactly value bodily autonomy, but I have heard that they’ve been a little bit better about trans cases than people would think,” said 16-year-old LW in an exclusive interview with ABC News alongside her parents Samantha and Brian Williams.
The court on Wednesday will hear the Williams family’s challenge to Tennessee’s 2023 ban on gender-affirming medical treatments for minors, including puberty-blocking medication and hormone therapies that have dramatically improved LW’s quality of life.
While the medications have been used safely to treat minors of all genders for years, they are now prohibited in Tennessee when used to treat trans kids struggling with gender dysphoria, the distress experienced when one’s gender assigned at birth is different from one’s sense of identity.
“It’s not very comfortable being trapped in [your body] because it just doesn’t feel like you,” said LW, who reports significant improvement since beginning the treatments in 2022.
Since the state law took effect, LW now has to take time away from school to make a 10-hour round trip out of state to continue receiving care. The travel has also been a costly and time-consuming burden, her parents say.
“It would definitely be horrible for me to have to continue to go out of state to get care,” said LW. “I feel normal now.”
Backed by the American Civil Liberties Union, the Biden administration, and major American medical associations, the Williamses sued Tennessee last year alleging the ban on certain gender-affirming treatments for minors discriminates on the basis of sex and overrides the rights of parents to make medical decisions for their children.
“Our state legislature had made such a big deal out of parents’ rights during COVID, about masks and vaccines that that’s for parents to decide these medical decisions for their children,” Samantha Williams said. “And then they made this medical decision for our child.”
State lawmakers who support the law, SB1, say it is meant to protect kids from potentially irreversible effects from treatment and that contradictory scientific evidence and uncertainty about long-term adverse consequences warrant caution.
“We made the policy decision on behalf of our constituents that in Tennessee we think this is a risky procedure,” said state Sen. Jack Johnson, the Senate GOP leader who sponsored the bill. “It is our role as policymakers here in the state of Tennessee to set those guardrails.”
The American Academy of Pediatrics says the effects of puberty blockers are not permanent if treatment is discontinued and that many effects of hormone therapy can also be reversed. Long-term risks may include fertility challenges and possible harm to bone density, but the Academy says those risks require further study.
Worldwide, several countries which had previously embraced the treatments for transgender children have subsequently reversed course, citing unclear data about their purported benefits and alleged harms. In many of those places, the treatments remain available, but on a much more limited basis.
In Tennessee, there are an estimated 3,000 transgender teenagers between ages 13 and 17, according to the Williams Institute at UCLA Law School, which has analyzed Census data. It is not known how many were receiving treatments that are now outlawed or how many suffered alleged harm.
A study published in the medical journal JAMA Pediatrics in October 2024 found the overwhelming majority of participants in a long-term survey of 220 transgender youths reported high levels of satisfaction and low levels of regret in the three to five years after receiving puberty blockers and hormone therapy.
Major American medical associations have for more than a decade endorsed the use of puberty blockers and hormone therapy as part of “individually tailored interventions” to support trans kids and affirm their sense of self.
“It all begins and ends with science. This is not about any sort of agenda,” said Dr. Ben Hoffman, president of the American Academy of Pediatrics, in an interview with ABC.
Clinical practice guidelines from the American Endocrine Society — based on more than 260 research studies — recommend consideration of medications to treat gender dysphoria in young people but waiting until a child reaches adulthood to consider gender-affirming surgery.
“It’s crucial that there be a deep understanding of both the risks and benefits, and truly informed consent,” Hoffman said. “And for that reason, it is, by definition, going to take months or years.”
The Williams family said the decision to use medication to delay LW’s puberty followed months of careful consultation with medical experts and mental health providers. They said they grew worried that masculine changes to LW’s body would compound her gender dysphoria.
“There is this time clock sitting here,” said Brian Williams. “The kids can go through puberty and it can have permanent effects on them. So these two things you’re trying to balance at the same time.”
“She’s not suicidal, but she shouldn’t have to be suicidal, right?, to get the care that she needs,” added Samantha Williams. “When that really hit me, I was like, ‘OK, let’s do blockers. Let’s get moving.'”
More than a year later, LW began receiving hormone therapy to better align her body with her gender identity. The course of treatment led to a reduction in discomfort.
“That was incredibly helpful,” LW said. “I feel amazing after that. You know, maybe it’s just because the gender dysphoria was so bad.”
The outcome of the case U.S. v. Skrmetti could have a sweeping impact on health care for the more than 300,000 American teens who identify as transgender, as well as the broader LGBTQ community.
“This is one of the most significant LGBTQ cases to ever reach the Supreme Court. I think this is an inflection point,” said Chase Strangio, the ACLU attorney representing the Williams family. He will be the first openly transgender person to argue a case before the nation’s highest court.
“Is this going to be a Bowers v. Hardwick type moment that sets off years of government legitimized discrimination against LGBTQ people? Or, is this going to be a Bostock moment that clarifies what we all have been assuming all this time, which is that LGBTQ people are protected under the Constitution and civil rights laws,” Strangio said.
In its 1968 decision in Bowers, the court upheld state laws criminalizing private same-sex conduct; it was overturned in 2003. The Court’s 2020 decision in Bostock v. Clayton County found that employment discrimination on the basis of sexual orientation and gender identity is illegal.
Twenty-six states have laws banning gender-affirming treatments for minors, according to the Human Rights Campaign, an LGBTQ advocacy group.
“What concerns me as a physician is that legislators are going to be able to make decisions about a diagnosis, which is very unusual. I mean, that really hasn’t happened,” said Dr. Susan Lacy, a physician who specializes in hormone management and transgender care for teens and adults at her private practice in Memphis.
Lacy, who is also a party to the Supreme Court case, agrees with Tennessee lawmakers that more research is needed on gender-affirming treatments for minors, but that a debate over the data shouldn’t deny patients the chance to make an informed decision of their own.
“I think the most compelling thing is to listen to the patients,” Lacy said. “I have about 700 transgender patients out of about 3,000 total patients, and I have not seen anybody have a serious complication — not one.”
“I think we’re just at a point where we’re still in the process of treating people and having studies that will give us more and more data to support this treatment,” she said.
Johnson said he hopes the Supreme Court will uphold an appeals court ruling that affirmed Tennessee’s right to impose restrictions on treatments for transgender minors.
“States should be the laboratories of democracy,” he said. “We should be making the vast majority of decisions about what’s best for our people, our constituents here in the statehouse.”
The Williams family says care that has improved the life of their daughter should not be up for political debate.
“I want to listen to the doctors. I want to listen to my kid. I want to take care of her, you know?” Brian Williams said.
(NEW YORK) — Women are stocking up on birth control and asking for long-term contraception methods following President Donald Trump being elected to a second term last week, doctors say.
Searches for “birth control” and “Plan B” doubled between Nov. 2 and the two days after the election, with a notable spike the day after the election, Google Search data shows.
Doctors told ABC News that patients are worried that access to birth control and contraception might be limited after Trump takes office due to efforts made during his first term and comments made on the campaign trail.
Dr. Brittany Cline, an OB-GYN at Northwestern Medicine, in Chicago, said she has seen an increase in the number of appointments being made for contraceptive or birth control counseling as well as appointments for long-acting contraceptives being either inserted or replaced or exchanged.
“We have, in clinic, seen many patients coming in for their [intrauterine device] replacements, even this week,” she told ABC News. “On Monday, I used all of our intrauterine devices that the clinic had, and I think that this is going to continue over the next few months and even years down the line, as people try to take some control over their bodies.”
Cline said she also received a message from a patient this week requesting four years of her birth control prescription be sent to a pharmacy.
‘That’s something that I have not, you know, seen before. Usually, we supply, you know, 12 months, one year at a time,” she said. “We do know that as many medications, there is a shelf life, and so it would not be safe for me to prescribe four years’ worth of contraception to a patient because of the shelf life.”
Dr. Leslie Kantor, professor and chair of the Department of Urban Global Public Health at the Rutgers School of Public Health, in New Jersey, told ABC News that she has heard anecdotal reports of more traffic to websites that have information about birth control.
She said patients may be worried because of the federal contraceptive coverage guarantee. Under a provision of the Affordable Care Act, most private insurance plans must cover the full cost of most contraceptives, such as birth control, without making patients pay out-of-pocket costs.
If the incoming Trump administration allows employers and schools to use religious and moral exemptions to prevent coverage of contraceptives, as the White House did during Trump’s first term, this may lead to out-of-pocket costs that make contraceptives unaffordable to some, experts previously told ABC News.
The experts say patients may be concerned due to comments Trump made on the campaign trail suggesting he’s open to restricting contraceptives.
During an interview with Pittsburgh TV station KDKA-TV, Trump was asked if he supports any restrictions on a person’s right to contraceptives.
“Well, we’re looking at that and we’re going to have a policy on that very shortly,” Trump responded. “And I think it’s something you’ll find interesting and it’s another issue that’s very interesting.”
When asked to clarify if he was suggesting he was open to supporting some restrictions on contraceptives, “like the morning-after pill,” Trump dodged, saying. “Things really do have a lot to do with the states — and some states are going to have different policy than others.”
Some states have also taken it upon themselves to provide contraception access. In Michigan, Gov. Gretchen Whitmer launched Take Control of Your Birth Control, a program to provide Michigan families access to free contraception including over-the-counter oral birth control pills, emergency contraception, condoms and family planning.
Both Cline and Kantor recommended that patients speak to their health care providers about the best birth control method for them as well as what options are available for them down the road.
“The advice that I would give to people right now is this is a great time to figure out the best birth control method for you, and you can do that in a variety of ways,” Kantor said. “It’s a terrific time to find an ongoing method of birth control that will work. …There’s no reason, however, to panic. Access to birth control is not going away tomorrow, and in fact, it’s not going away on the day that Trump becomes president.”
ABC News’ Lalee Ibssa, Soo Rin Kim and Kelsey Walsh contributed to this report.
