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.
Last Updated on November 9, 2024 by Daily News Staff
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.
Boostrix is administered as a single 0.5-mL dose.
The FDA granted the approval to GlaxoSmithKline Biologicals.
Source: FDA
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Food and Beverage
A Lesson in Kindness, Inclusion and How Kids Eat Differently
Kids Eat Differently: The school year brings new classmates, routines and opportunities for children to learn about people whose experiences may be different from their own. They could include friends who use a wheelchair, carry an inhaler or even receive nutrition through a feeding tube.
A Lesson in Kindness, Inclusion and How Kids Eat Differently
(Feature Impact) The school year brings new classmates, routines and opportunities for children to learn about people whose experiences may be different from their own. They could include friends who use a wheelchair, carry an inhaler or even receive nutrition through a feeding tube.
Watch this video to learn more
For families who rely on tube feeding, it is an essential part of daily life but is often understood only by those who experience it. That limited awareness can leave children who are tube fed and their families feeling isolated or unseen, according to Gerard Minor, a pediatric gastroenterology and hepatology specialist.
Parents can use everyday questions as opportunities to help children understand there are many ways people receive nourishment. Teachers, classmates, caregivers and communities can also help make tube feeding part of the everyday conversation around childhood rather than something that separates children from it.
“Helping children understand those differences early can encourage curiosity, kindness and inclusion,” Minor said.
To help bring greater awareness, understanding and representation to children and families who experience tube feeding every day, Compleat, a leader in tube feeding formulas, launched “What Is Better Than How,” featuring “Sesame Street’s” Elmo and his signature warmth and curiosity. The original song celebrates the many ways people eat. Some people eat with a fork, some use a spoon and some use a tube, reinforcing a simple message: What matters is not how you eat. What matters is that you are nourished, loved and included.
To hear the song, create a personalized version and learn more about the campaign, visit Compleat.com/WhatIsBetterThanHow.
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Consumer Corner
5 Hidden Ways to Save on Home Insurance Costs
Lowering Home Insurance Costs? Many home improvements offer an added bonus of unlocking insurance discounts, but these savings opportunities can easily fly under the radar when you aren’t actively on the lookout for them.
5 Hidden Ways to Save on Home Insurance Costs
(Feature Impact) When you’re planning home improvements, you’re often thinking about improving the comfort, safety, aesthetic or value of your home. Many changes and renovations have the added bonus of unlocking insurance discounts, but these savings opportunities can easily fly under the radar when you aren’t actively on the lookout for them.
“Homeowners tend to think about their insurance when they buy the house or when they have a claim, but a lot can change in between,” said Larry Anderson, director of underwriting operations at Mercury Insurance. “Something as simple as reviewing your policy with your agent once a year can help make sure your coverage still reflects your home today and identify improvements or other factors that may qualify you for additional savings.”
The experts at Mercury Insurance, a multiple-line insurance carrier emphasizing competitive rates and excellent customer service, encourage homeowners to consider these five ways to save on home insurance costs.
Updating Older Parts of the Home
As a home ages, it’s wise to look at what parts and systems may be deteriorating and need upgrades for modernity or safety reasons. Replacing older electrical, plumbing or other major systems can protect your home from emergencies and loss risks. Depending on the state you live in, your specific policy and the improvements you made, it can also qualify your property for an updated-home insurance discount.
Keep records of major improvements – including receipts, work permits and information about when the work was completed – and plan to discuss the upgrades during your next insurance review.
Adding Protective Technology
Beyond replacing the batteries in your smoke detectors, you can outfit your home with a variety of protective devices that make a difference to insurers. Consider options like monitored burglar and fire alarms, smart water sensors and automatic water shutoff systems designed to detect problems before they become major losses. Remember, while security upgrades can make your home less risky to insure, they won’t save you money if your insurer doesn’t know you’ve installed them.
Improving Resilience to Damage
If you live in an area prone to extreme weather or other hazards, resilience upgrades could both safeguard your home and access insurance savings. Depending on your location, qualifying improvements could include a stronger roof, wildfire mitigation measures or flood defense options. Local insurance agents can provide more specific guidance on ways to make your home less vulnerable to damage – or whether you’re eligible for discounts because of work you’ve already completed.
Qualifying for Community Programs
Even if you haven’t personally made renovations to your home, certain changes in your community could help you save on insurance. That could include local wildfire mitigation measures, membership in a qualifying homeowners association or other neighborhood characteristics that affect coverage options, but specific programs vary by location.
Reviewing Insurance Products and Discounts
Whether something significant has changed in your home or community or not, it’s always valuable to review your insurance coverage on a regular basis. For instance, there may be new products or discounts that simply didn’t exist when you originally purchased your policy. Beyond savings considerations alone, ask your agent questions to make sure your coverage still reflects your circumstances and goals.
“Finding savings is always welcome, but the bigger goal of a policy review is making sure your insurance keeps pace with your life and your home,” Anderson said. “A house isn’t static. We improve it, maintain it and protect it in new ways over time. Your insurance should keep up with those changes.”
For more information on homeowner coverage and discount eligibility, visit MercuryInsurance.com.
Questions to Consider During Your Annual Insurance Checkup
An annual insurance review is an opportunity to look for savings and update coverage. Use these questions as a jumping-off point for discussions with your agent:
- What has changed about my home?
- What has changed about my property or community?
- Have my circumstances changed?
- Are discounts available today that weren’t when I purchased my policy?
- Does my coverage still reflect what it would cost to repair or rebuild my home today?
Photos courtesy of Shuttersotck
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Health and Life Insurance
Lessons in Life Insurance: 4 Reasons Getting It May Be Easier Than You Think
Life is the most valuable thing you have – and like all valuable things, it should be insured. Even thinking about life insurance can be stressful, so it’s one of those things that’s easy to put off and tell yourself you’ll do another day. Consider these four ways to make getting life insurance simpler than you thought.
Lessons in Life Insurance: 4 Reasons Getting It May Be Easier Than You Think
(Feature Impact) Life is the most valuable thing you have – and like all valuable things, it should be insured. Even thinking about life insurance can be stressful, so it’s one of those things that’s easy to put off and tell yourself you’ll do another day.
If that’s how you feel, you aren’t alone. According to the 2026 Life Happens Life Insurance Survey, nearly half (46%) of U.S. adults have getting life insurance on their to-do list but plan to deal with it later or not at all. Confusion, procrastination and cost concerns are among the main reasons people kick this can down the road, according to 45% of respondents.
Yet the survey also uncovered an interesting disconnect: 69% of Americans said they personally know someone who had life insurance or whose family used a life insurance policy, most often a parent or parent figure (33%), but still haven’t made getting coverage a priority.
“Life insurance isn’t unfamiliar to most Americans,” Life Happens Executive Director Brian Steiner said. “The challenge is turning that awareness into action. People may think life insurance is something they can deal with later, but waiting can leave the people they love financially vulnerable. Getting started doesn’t have to be complicated, and professional guidance can help you find protection that fits your needs and budget.”
Consider these four ways to make getting life insurance simpler than you thought.
Watch this video to learn more
1. Find a policy that’s a fit.
Roughly 4 in 10 survey respondents reported feeling overwhelmed, anxious or some combination of both about planning for life insurance, with 12% citing thinking it’ll be too expensive as a reason they’ve delayed looking into, buying or updating life insurance.
The good news: There’s a policy that’s right for your current needs. It may be term life insurance, which provides protection for a specific period of time, like to cover a mortgage or tuition for children. There’s also permanent life insurance, which offers lifelong protection, as long as you pay the premiums.
2. Take advantage of digital tools
One-quarter of respondents said they’d be more likely to look into life insurance if they learned it was easier to get than they thought, and digital tools can help make that demand a reality.
It can take as little as two minutes to find out how much you need, for example, with the life insurance needs calculator from the nonprofit Life Happens. Just answer a few simple questions to estimate the amount of life insurance coverage you may need to take care of your family.
3. It’s about protection, not perfection.
Part of the anxiety around life insurance may be the perception that it should be perfect. For more than 1 in 5 survey participants, the plan is to seriously look at it when they feel more financially stable, and another 12% simply said they’ll do it when they’re older.
However, life insurance doesn’t have to check all the boxes for every stage of your life – you can find what works for your family right now then adjust as things change over time.
4. Professional help is available.
Perhaps the biggest hurdle to tackling life insurance is the feeling that you’re in it alone. Overall, 55% of respondents said if they learned life insurance may be easier to get than they expected, they’d be more likely to start the process.
With professional help only a few clicks away, you can rest assured you’re on the path to a life insurance fit that’s right for you by visiting findapro.lifehappens.org.
Photo courtesy of Shutterstock
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