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.
(LUBBOCK, Texas) — An unvaccinated school-aged child in Texas has died of measles, the first associated with an outbreak in the western part of the state that has infected more than 100 people.
Lubbock city spokesperson Lauren Adams confirmed the death to ABC News on Wednesday.
In a press release, the Texas Department of State Health Services (DSHS) said the child was hospitalized in the northwestern city of Lubbock last week and tested positive for measles.
As of Wednesday, 124 cases of measles have been confirmed associated with the outbreak, according to data from DSHS.
Almost all of the cases are in unvaccinated individuals or individuals whose vaccination status is unknown, and 18 people have been hospitalized so far, DSHS said.
Children and teenagers between ages 5 and 17 make up the majority of cases with 62, followed by 39 cases among children ages 4 and under.
The outbreak began in Gaines County, which has become the epicenter, with 80 cases confirmed among residents, according to DSHS.
The outbreak has since spread to several counties in the region and is “suspected” to have spread into New Mexico, according to New Mexico Department of Health (NMDOH). Nine cases have been confirmed in Lea County, which borders Texas. Of the nine cases, four are among children, according to NMDOH.
“This death underscores the real danger of measles — it’s a severe disease that can take lives despite being preventable with vaccination,” said Dr. John Brownstein, an epidemiologist and ABC News contributor. “Every new case is a reminder of why vaccination is critical. Tragically, with an outbreak of this scale, a fatal case was not unexpected, especially among those unvaccinated. Given how contagious measles is, we anticipate more cases in the coming weeks.”
During Tuesday’s Cabinet meeting, Health and & Human Services Secretary Robert F. Kennedy Jr. responded to a question about the outbreak, saying the agency was following the cases in Texas.
Kennedy appeared to downplay the outbreak, noting there have been four outbreaks so far this year compared to 16 last year. However, the number of cases in Texas alone amount to nearly half of the 285 cases confirmed in 2024.
“It’s not unusual; we have measles outbreaks every year,” he said.
Measles is one of the most contagious diseases known to humans. Just one infected patient can spread measles up to nine out of 10 susceptible close contacts, according to the Centers for Disease Control and Prevention (CDC).
Health officials have been urging anyone who isn’t vaccinated to receive the measles, mumps, rubella (MMR) vaccine.
The CDC currently recommends people receive two vaccine doses, the first at ages 12 to 15 months and the second between 4 and 6 years old. One dose is 93% effective, and two doses are 97% effective. Most vaccinated adults don’t need a booster.
Measles was declared eliminated from the U.S. in 2000, due to the highly effective vaccination program, according to the CDC. However, vaccination rates have been lagging in recent years.
About 93% of kindergarteners nationwide received select routine childhood vaccines, including the MMR vaccine, for the 2022-23 school year, according to a November 2023 CDC report.
This is about the same as the previous school year, but lower than the 94% seen in the 2020-22021 school year and the 95% seen in the 2019-2020 school year, prior to the COVID-19 pandemic. The latter percentage had been the standard for about 10 years.
ABC News’ Youri Benadjaoud contributed to this report.
(NEW YORK) — Outpatient health care visits for flu illnesses are at their highest levels in 15 years, according to data updated Friday by the Centers for Disease Control and Prevention.
Nearly 8% of outpatient health care visits for respiratory illnesses are due to flu-like illness, which is the highest seen since the 2009-10 flu season, during the swine flu pandemic, data shows.
During the week ending Feb. 1, 8% of emergency department visits were due to flu compared with 3.2% the same time last year, according to the CDC data.
Additionally, 31.6% of tests came back positive for flu during the week ending Feb. 1 compared to a peak of 18.2% last season, CDC data shows.
“Given the sharp rise [of flu illnesses] particularly among young children and in key regions like New York City, this is a stark reminder of how unpredictable flu seasons can be,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor.
“With [influenza-like illness] rates exceeding 10% in several states and hospitalization rates climbing in older adults, this wave could put significant pressure on our health systems in the coming weeks,” he added.
What’s more, the rate of people dying from flu is now equal to the rate of people dying from COVID-19, likely for the first time since the COVID pandemic began.
The CDC estimates there have been at least 24 million illnesses, 310,000 hospitalizations and 13,000 deaths from flu so far this season.
At least 57 pediatric flu deaths have been reported so far this season, with 10 reported during the week ending Feb. 1.
Flu vaccines are available for both children and adults, but vaccination coverage remains low, meaning “many children and adults lack protection from respiratory virus infections provided by vaccines,” according to the CDC.
Data shows only 45% of adults aged 18 and older have been vaccinated against flu this season as have 45.7% of children.
CDC data also shows that overall respiratory illness activity is listed as “very high” nationwide. Currently, 12 states are listed as “very high” and 19 states are listed as “high.”
By comparison, seven states were listed as “very high” and 20 states were listed as “high” last week.
Although COVID-19 activity is “elevated” in many areas of the U.S., CDC data shows emergency department visits are at low levels and the number of laboratory tests coming back positive is falling.
Respiratory syncytial virus activity was also described as “elevated” but declining in most areas of the U.S., according to the CDC.
(WASHINGTON) — Some major medical associations are pushing back against the Department of Health and Human Services’ updated definitions of biological sex in federal policy in the wake of President Donald Trump’s executive order.
HHS issued new guidance on Feb. 19 where it said it “recognizes there are only two sexes: male and female,” adding: “HHS will use these definitions and promote policies acknowledging that women are biologically female and men are biologically male.”
“There is extensive scientific research that supports the complexity of sex and gender beyond binary classifications,” American Psychological Association CEO Arthur C. Evans Jr., Ph.D., told ABC News in a statement. “The new restrictive definition of sex ignores decades of science, increasing harm to youth and families, while undermining critical mental health outcomes.”
The new HHS guidance for the federal government defines “sex” as “a person’s immutable biological classification as either male or female.” It further defines “female” as “a person of the sex characterized by a reproductive system with the biological function of producing eggs (ova)” and “male” as “a person of the sex characterized by a reproductive system with the biological function of producing sperm.” It additionally defines the definition of a “woman” as “an adult human female” and a “man” as “an adult human male.”
The updated HHS guidance also includes definitions for “father” as describing a “male parent” and “mother” as describing a “female parent.”
The HHS guidance doesn’t mention intersex individuals — people born with sex characteristics that don’t fit typical definitions of male or female. The National Institutes of Health estimates that about .018% of the population is considered intersex.
The federal government previously defined “sex” in broader terms.
The Centers for Disease Control and Prevention, one of HHS’ agencies, defines sex as “an individual’s biological status as male, female, or something else. Sex is assigned at birth and associated with physical attributes, such as anatomy and chromosomes.”
The CDC’s website defines gender as “the cultural roles, behaviors, activities and attributes expected of people based on their sex.”
After Trump took office, the administration ordered the CDC and the Food and Drug Administration to remove certain public health websites, including the CDC’s page with more gender-inclusive definitions, which were then taken offline. A judge granted a temporary restraining order to restore the pages after organizations filed lawsuits.
A banner at the top of the CDC page currently states: “Per a court order, HHS is required to restore this website as of 11:59PM ET, February 14, 2025. Any information on this page promoting gender ideology is extremely inaccurate and disconnected from the immutable biological reality that there are two sexes, male and female.”
The HHS did not include its own definition of gender in its updated guidance posted Feb. 19.
The second Trump administration has issued a number of executive orders targeting the transgender population, and a number of lawsuits have been filed to challenge them.
Human biology is complex, and not all individuals fit neatly into binary categories, Evans told ABC News.
“We cannot just ignore the biological science that some people are born with a difference of sex development (DSD),” Evans said in his statement. “DSD are congenital conditions where the development of anatomical, chromosomal or gonadal sex is atypical. It is important that we support access to psychological and medical interventions for such individuals who do not fall into the male or female category, putting them at a higher risk of depression and anxiety.”
Evans also said the new HHS definitions excluded the concept of gender identity.
“It is crucial to recognize the psychological science on the validity of gender identity, as it allows for a more accurate understanding of individual experiences beyond the binary framework of biological sex,” he said. “Research consistently shows that affirming both sex and gender identity is vital for promoting mental health and well-being.”
In its updated guidance, HHS Secretary Robert F. Kennedy Jr. said the Trump administration “is bringing back common sense and restoring biological truth to the federal government. The prior administration’s policy of trying to engineer gender ideology into every aspect of public life is over.”
The American College of Obstetricians and Gynecologists said in a statement that it will not change its current definitions of sex and gender, and will use inclusive language “to recognize and affirm all people who seek and receive care from obstetrician-gynecologists.”
The ACOG also called on researchers to diversify studies by including gender-expansive participants and to report study participant characteristics inclusively by using language beyond traditional binary descriptors.
The American Academy of Family Physicians noted its long-standing policy on care for transgender and nonbinary patients, saying in a statement that it will continue to recognize that “diversity in gender identity and expression is a normal part of human existence and does not represent pathology.” It further asserted that “medical decisions are best made by patients, their families and their physicians, supported by medical evidence.”
The American Academy of Pediatrics said it will comply with all applicable executive orders as the law requires. “The AAP continues to hold that medical decisions are best made by patients, their families and their physicians, supported by medical evidence,” the organization said in a statement.
The American Medical Association’s policy on the Medical Spectrum of Gender, first enacted in 2018, appears to remain unchanged. It “affirms that an individual’s genotypic sex, phenotypic sex, sexual orientation, gender and gender identity are not always aligned or indicative of the other, and that gender for many individuals may differ from the sex assigned at birth,” according to the policy.
HHS spokesperson Andrew Nixon told ABC News the department has no comment.
ABC News has reached out to the White House for comment.
White House press secretary Karoline Leavitt said on Thursday, a day after HHS updated its guidance, that Trump “reestablished the scientific and biological truth that there are only two sexes in this country — male and female — that those are biologically based determinations. They are not based and can never be based on gender identity.”
Dr. Allia Vaez is a family medicine resident at Southern Regional AHEC and a member of the ABC News Medical Unit.
