Connect with us

Lifestyle

FDA Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants Younger Than Two Months of Age

U.S. Food and Drug Administration approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age.

Published

on

woman in mask sitting and doctor applying syringe with vaccine
Photo by SHVETS production on Pexels.com

The U.S. Food and Drug Administration approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age. 

“Pertussis disease is a highly contagious respiratory illness affecting all age groups. However, babies are at highest risk for getting pertussis and having serious complications from it,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.” 

Pertussis is a common respiratory disease in the United States, resulting in frequent outbreaks. It is also called whooping cough because of the “whooping” sound that someone makes when gasping for air after a fit of coughing. Most serious pertussis cases, hospitalizations and deaths occur in infants younger than two months of age who are too young to be protected by the childhood pertussis vaccine series. According to the Centers for Disease Control and Prevention (CDC), 4.2% of the total cases of pertussis reported in the United States in 2021 were in infants younger than 6 months of age and approximately 31% required hospitalization. When the Boostrix vaccine is given during pregnancy, it  boosts antibodies in the mother, which are transferred to the developing baby. 

Boostrix was initially approved by the FDA in 2005 as a single dose for booster immunization against tetanus, diphtheria and pertussis in individuals 10 through 18 years of age. Subsequently, the FDA also approved Boostrix to include use in individuals 19 years of age and older and to include use of an additional dose 9 years or more after the initial dose of a Tdap vaccine. The FDA’s approval of Boostrix has always included its use during pregnancy to protect the vaccinated individual. Today’s approval is specific to use in pregnancy to prevent pertussis in infants younger than 2 months of age. Since 2012, the CDC has recommended the use of Tdap vaccines during the third trimester of each pregnancy.

The determination of effectiveness of Boostrix administered during the third trimester to prevent pertussis among infants younger than 2 months of age was based on a re-analysis of the Boostrix-relevant data from an observational case-control study of Tdap vaccine effectiveness.  The FDA found these real-world data as providing real-world evidence to support this approval. In this re-analysis, data from 108 cases of pertussis in infants younger than 2 months of age (including four cases whose mothers received Boostrix during the third trimester) and 183 control infants who did not have pertussis (including 18 whose mothers received Boostrix during the third trimester) resulted in a preliminary estimate of Boostrix as 78% effective in preventing pertussis among infants younger than 2 months of age, when administered during the third trimester of pregnancy. This preliminary estimate of effectiveness was updated using data from published observational studies. These statistical analyses provided estimates of effectiveness that are consistent with the preliminary estimate of 78%. 

The safety of Boostrix administered during the third trimester of pregnancy was assessed in a randomized, placebo-controlled study with a non-U.S. formulation of Boostrix. The FDA considers the safety data with the non-U.S. formulation relevant because it contains the same components as the U.S. formulation of Boostrix, except that the non-U.S. formulation contains more aluminum per dose. The study included approximately 680 pregnant individuals of whom about 340 received the non-U.S. formulation of Boostrix and of whom about 340 received saline placebo. After childbirth, the placebo recipients were then vaccinated with the non-U.S. formulation of Boostrix. The rates of reported side effects following receipt of the non-U.S. formulation of Boostrix administered during pregnancy were consistent with the rates following receipt of the non-U.S. formulation of Boostrix administered to study participants after childbirth. 

The study did not identify any vaccine-related adverse effects on pregnancy or on the fetus/newborn.

In previous clinical studies, the most commonly reported side effects by individuals who received Boostrix were pain, redness at the injection site, headache, fatigue and gastrointestinal symptoms. 

Advertisement
image 101376000 12222003

Boostrix is administered as a single 0.5-mL dose. 

The FDA granted the approval to GlaxoSmithKline Biologicals. 

Source: FDA

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

Author


Discover more from Daily News

Subscribe to get the latest posts sent to your email.

child education

Why history instruction is critical for combating online misinformation

Published

on

file 20250313 62 hrqks4.jpg?ixlib=rb 4.1
Students ask questions during a social studies class on American politics. AP Photo/John Minchillo
Lightning Jay, Binghamton University, State University of New York Can you tell fact from fiction online? In a digital world, few questions are more important or more challenging. For years, some commentators have called for K-12 teachers to take on fake news, media literacy, or online misinformation by doubling down on critical thinking. This push for schools to do a better job preparing young people to differentiate between low- and high-quality information often focuses on social studies classes. As an education researcher and former high school history teacher, I know that there’s both good and bad news about combating misinformation in the classroom. History class can cultivate critical thinking – but only if teachers and schools understand what critical thinking really means.

Not just a ‘skill’

First, the bad news. When people demand that schools teach critical thinking, it’s not always clear what they mean. Some might consider critical thinking a trait or capacity that teachers can encourage, like creativity or grit. They could believe that critical thinking is a mindset: a habit of being curious, skeptical and reflective. Or they might be referring to specific skills – for instance, that students should learn a set of steps to take to assess information online. Unfortunately, cognitive science research has shown that critical thinking is not an abstract quality or practice that can be developed on its own. Cognitive scientists see critical thinking as a specific kind of reasoning that involves problem-solving and making sound judgments. It can be learned, but it relies on specific content knowledge and does not necessarily transfer between fields. Early studies on chess players and physicists in the 1970s and ’80s helped show how the kind of flexible and reflective cognition often called critical thinking is really a product of expertise. Chess masters, for instance, do not start out with innate talent. In most cases, they gain expertise by hours of thoughtfully playing the game. This deliberate practice helps them recognize patterns and think in novel ways about chess. Chess masters’ critical thinking is a product of learning, not a precursor.
Two young women sit at a table with a chess board between them, and other pairs of players at tables in the background.
Nurman Alua of Kazakhstan, left, and Lee Alice of the U.S. during the 45th Chess Olympiad in Budapest, Hungary, on Sept. 22, 2024. AP Photo/Denes Erdos
Because critical thinking develops in specific contexts, it does not necessarily transfer to other types of problem-solving. For example, chess advocates might hope the game improves players’ intelligence, and studies do suggest learning chess may help elementary students with the kind of pattern recognition they need for early math lessons. However, research has found that being a great chess player does not make people better at other kinds of complex critical thinking.

Historical thinking

Since context is key to critical thinking, learning to analyze information about current events likely requires knowledge about politics and history, as well as practice at scrutinizing sources. Fortunately, that is what social studies classes are for. Social studies researchers often describe this kind of critical thinking as “historical thinking”: a way to evaluate evidence about the past and assess its reliability. My own research has shown that high school students can make relatively quick progress on some of the surface features of historical thinking, such as learning to check a text’s date and author. But the deep questioning involved in true historical thinking is much harder to learn. Social studies classrooms can also build what researchers call “civic online reasoning.” Fact-checking is complex work. It is not enough to tell young people that they should be wary online, or to trust sites that end in “.org” instead of “.com.” Rather than learning general principles about online media, civic online reasoning teaches students specific skills for evaluating information about politics and social issues. Still, learning to think like a historian does not necessarily prepare someone to be a skeptical news consumer. Indeed, a recent study found that professional historians performed worse than professional fact-checkers at identifying online misinformation. The misinformation tasks the historians struggled with focused on issues such as bullying or the minimum wage – areas where they possessed little expertise.

Powerful knowledge

That’s where background knowledge comes in – and the good news is that social studies can build it. All literacy relies on what readers already know. For people wading through political information and news, knowledge about history and civics is like a key in the ignition for their analytical skills. Readers without much historical knowledge may miss clues that something isn’t right – signs that they need to scrutinize the source more closely. Political misinformation often weaponizes historical falsehoods, such as the debunked and recalled Christian nationalist book claiming that Thomas Jefferson did not believe in a separation of church and state, or claims that the nadir of African American life came during Reconstruction, not slavery. Those claims are extreme, but politicians and policymakers repeat them. For someone who knows basic facts about American history, those claims won’t sit right. Background knowledge will trigger their skepticism and kick critical thinking into gear.
A sunny classroom full of students at long tables, with a female teacher in a dress pacing in front as she talks.
A teacher in North Carolina conducts a lesson about the D-Day invasion of Normandy in an Advanced Placement class. AP Photo/Gerry Broome

Past, present, future

For this reason, the best approach to media literacy will come through teaching that fosters concrete skills alongside historical knowledge. In short, the new knowledge crisis points to the importance of the traditional social studies classroom. But it’s a tenuous moment for history education. The Bush- and Obama-era emphasis on math and English testing resulted in decreased instructional time in history classes, particularly in elementary and middle schools. In one 2005 study, 27% of schools reported reducing social studies time in favor of subjects on state exams. Now, history teachers are feeling heat from politically motivated culture wars over education that target teaching about racism and LGBTQ+ issues and that ban books from libraries and classrooms. Two-thirds of instructors say that they’ve limited classroom discussions about social and political topics. Attempts to limit students’ knowledge about the past imperil their chances of being able to think critically about new information. These attacks are not just assaults on the history of the country; they are attempts to control its future. Lightning Jay, Assistant Professor of Teaching, Learning and Educational Leadership, Binghamton University, State University of New York This article is republished from The Conversation under a Creative Commons license. Read the original article.

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

Continue Reading

Lifestyle

Planning for a Positive Economic Future: Financial literacy tips for teens

Published

on

Financial literacy (Family Features) Financial literacy is a critical skill that helps set the foundation for a stable and prosperous future. By understanding the basics of money management, teens can make informed decisions and avoid common financial pitfalls. According to the annual Teens and Personal Finance survey, a study of teens ages 13-18 conducted by Wakefield Research on behalf of Junior Achievement and MissionSquare Retirement’s Foundation, 45% of high schoolers took a personal finance or financial literacy class at school. This is up from 31% in 2024, indicating the nation’s youth are interested in building a strong financial foundation. What’s more, of the students who took their school’s curriculum, 64% found it extremely or very helpful, yet despite this increase, data reveals knowledge gaps remain. In fact, 42% of teens surveyed are terrified they won’t have enough money to cover their future needs and goals. “There is so much for teens to absorb when learning about finances and planning for their future, they often struggle to envision what lies ahead,” said Andre Robinson, president and CEO of MissionSquare Retirement. “Offering engaging programs that can boost financial knowledge and decision-making skills can only help to inspire young individuals to build a strong foundation of lifelong financial resilience.” Consider discussing these economic topics with your teen to help make a positive impact on students’ financial readiness and get them ready for financial decisions they’ll face in adulthood. Mastering Saving and Budgeting A good starting point for teens is to create a simple budget that tracks income and expenses. Because only 36% of teens surveyed save a part for their futures when they receive money, this can help them understand where money is going and identify areas they may be able to save for the future. This is particularly important considering 68% of teens agree that saving for retirement is something they can think about later in life. Understanding Credit Credit is a powerful tool but can also be a source of financial trouble if not managed properly. It’s essential to understand how financial behaviors, like paying bills on time and keeping credit card balances low, impact their credit scores. A higher FICO score, which 80% of teens surveyed had never heard of or did not fully understand, can lead to better interest rates and more favorable loan terms. Managing Common Debt Pitfalls According to the survey, 43% of teens believe an interest rate of 18% on debt is manageable and can be paid off over time. However, it’s important to understand the true cost of debt and how interest rates can accumulate over time and lead to significant financial strain. Establishing good debt management habits early, such as avoiding high-interest debt and paying off balances quickly, can lead to a healthier financial future. Investing and Planning Ahead According to the survey, teenagers’ most appealing investing strategies are savings accounts, side hustles and keeping cash at home, and only 13% invest a portion of their money. Encouraging teens to learn about different types of investments, such as stocks, bonds and mutual funds, can help them make informed decisions and begin to build long-term wealth. For more information on how to help teens improve their financial knowledge, visit ja.org.   Photo courtesy of Shutterstock   collect?v=1&tid=UA 482330 7&cid=1955551e 1975 5e52 0cdb 8516071094cd&sc=start&t=pageview&dl=http%3A%2F%2Ftrack.familyfeatures SOURCE: Junior Achievement  

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

Continue Reading

family fun

Easter and School Holiday Escapes, A Family-Friendly Retreat at Sheraton Bali Kuta Resort

Published

on

BALI, IndonesiaApril 4, 2025 /PRNewswire/ — Celebrate Easter and the upcoming school holidays with an unforgettable beachfront getaway at Sheraton Bali Kuta Resort. With a refreshed lobby, a vibrant social lounge at &More by Sheraton, and the newly renovated “PlayHouse” kids club, the resort blends premium comfort with family-friendly fun in the heart of Kuta.

Wake up to the gentle sound of waves and breathtaking ocean views from your private balcony, setting the perfect tone for a memorable family escape. The Suite Experience package offers spacious comfort with a sofa bed, kids’ tent amenities, a one-time minibar, VIP perks, and a special family room setup. Begin your day with a lavish buffet breakfast, fueling adventures for the little ones at PlayHouse, where 20+ activities keep them entertained, while parents unwind by the infinity pool or enjoy curated moments with the Side by Side program. Afternoons invite relaxation and indulgence with the Jewelry Box Afternoon Tea, a delightful treat for the whole family. Families can also enjoy 15% off dining, including the famous Sunday Social Brunch, where kids dine free. As the sun sets, the revitalized lobby offers a warm, inviting space for coffee, pastries, and social gatherings, while &More by Sheraton sets the scene for a perfect evening with live music, handcrafted cocktails, and stunning views of Kuta Beach. Savor authentic Italian cuisine at Bene Italian Kitchen, sip signature drinks at &More by Sheraton, or explore diverse culinary delights at Daily Social, all with panoramic ocean vistas. Just steps from Beachwalk Shopping Center, local markets, and the iconic WXYZ Bar at Aloft Bali Kuta, the resort offers the perfect balance of relaxation and excitement. Whether an Easter egg hunt by the beach or a sunset cocktail, every moment is designed for lasting memories. Ashley Lai, Cluster General Manager of Sheraton Bali Kuta Resort & Aloft Bali Kuta at Beachwalk, shares “It’s more than a place to stay, it’s a destination. With refreshed spaces, family-friendly experiences, and unmatched dining, we create moments that last a lifetime.” Enjoy the Marriott Bonvoy Fast Track program, become a member and register by April 14, 2025, to earn 1,000 bonus points and 1 Elite Night Credit per night. For more information visit Sheraton Bali Kuta Resort.   SOURCE Sheraton Bali Kuta Resort

Author

  • Rod Washington

    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

    View all posts

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

Continue Reading

Trending