The first vaccine to protect babies from the respiratory syncytial virus (RSV) is one step closer to approval after the Food and Drug Administration’s advisory committee met to discuss the efficacy and safety of the vaccine.

If approved by the FDA later this year, this could be the first vaccine to protect infants from RSV, which is a leading cause of hospitalization for infants. The vaccine would be issued to expecting mothers during the second or third trimester of pregnancy to prevent RSV and prevent severe RSV from birth through six months of age.

The Centers for Disease Control and Prevention is also weighing recommendations for a monoclonal antibody for babies and toddlers, as well as a RSV vaccine for older adults.

Virtually all children get an RSV infection by the time they are 2 years old. RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious, especially for infants and older adults. RSV can also cause severe illnesses such as bronchiolitis and pneumonia. The risk is especially high for premature infants.

Some children require hospitalization, but most do not. Currently, there is no vaccine to prevent RSV infection. To prevent RSV infection, Cook Children’s encourages children to continue health habits learned in the pandemic, including hand hygiene, coughing/sneezing into a tissue and staying home if you or your child feel sick.

There are limited treatments for RSV; most are available only for premature infants, infants with other lung diseases, infants who are considered immunocompromised, or patients with congenital heart disease.

In fall 2022, Cook Children’s experienced an early spike in RSV and influenza A cases. Our Emergency Department and Urgent Care Centers were overwhelmed with patients. By November 2022, our patient census was full across the board due to many patients with flu, RSV and respiratory illnesses. If patients were inoculated with the RSV vaccine, this could help alleviate stress on our health care system by keeping children out of the hospital.

During the FDA’s advisory committee meeting, the discussions were complicated so the recommendations were split to vote on efficacy and safety. They unanimously approved based on the efficacy of the vaccine. However, based on available safety results, the decision was split (10 would approve, 4 would oppose).

The vaccine had serious safety concerns in the elderly patient trials that were submitted with 1 patient out of 2,500 having Guillain-Barre syndrome and another with acute disseminated encephalomyelitis (ADEM), both serious central nervous system diseases. Both diseases occur outside of trials in this population, but they are also known to be rarely related to both vaccines and due to the diseases they help prevent. There are post-marketing studies in place in elderly patients to further evaluate the exact risks of these diseases.

Additionally, a pregnancy trial was in progress but it was paused due to safety concerns. In addition to the diseases noted, there were more preterm births in the vaccine group. These were mostly babies born a week or two early which is generally safe, but due to the trend, the trial was paused while the safety is better assessed.

Nicholas Rister, M.D., of the Cook Children's Infectious Disease team, shares what parents and caregivers need to know.

Why should I consider getting the RSV vaccine? Is it safe?

Right now, the vaccine is only approved for elderly patients over the age of 60. People in this age range should talk with their doctor about the vaccine.

There is an ongoing discussion about making the vaccine available for pregnant women so that the antibodies it induces can be passed to their infants via the placenta. It has been difficult to develop an RSV vaccine for very young infants since they do not react readily to the vaccines that have been developed. However, young infants are the group most at risk for severe and prolonged disease with RSV so providing them protection via their mother is an important opportunity.

The safety questions are the issue here. Right now, the vaccine is not approved for pregnant women so it is not an option. However, the vaccine appears very effective so it may still gain approval in some form once the exact risks are better understood.

Importantly, this is not a vaccine that is going to be mandated for pregnant women. The ethical issues with having a person get a vaccine (the mother) to provide protection for someone else (the infant) and the risks assumed between them is going to make this a more nuanced discussion between OB/GYNs, pediatricians, and families.

How long and how strong is the protection against RSV infection if vaccinated?

Initial results from pregnancy trials showed 82% protection from severe RSV disease from 0-3 months of life and still 69% percent at 6 months of life. While this doesn’t prevent disease or even all severe disease, since RSV is so common in infants and particularly dangerous in preterm infants, this level of protection is very significant and dramatic.

What should parents of toddlers and young children know about the RSV vaccine since, if approved, it would only pertain to pregnant women?

RSV is a very low-risk infection for children outside of the first year or two of life and in younger adults. Until vaccine risks are clarified, there likely will be no push for using this vaccine outside of infants (via pregnant mothers) and elderly adults. Should further evaluation (or a new vaccine) emerge to show minimal risk to getting the vaccine, there may be a role in vaccinating older children to prevent the spread within families to high-risk groups. But, for now, the discussion is likely to stay with pregnant women and older adults.

Why is there a need for the vaccine? How will this impact health care systems?

The Centers for Disease Control and Prevention reports that per year, there are between 58,000 and 80,000 hospitalizations for RSV among children under 5. Because so many children get RSV every year, the actual number of children with severe disease is very high. This leads to a massive use of health care resources each year. That’s why there is so much effort into evaluating the vaccine despite some significant safety questions that need answering.

Go here to view more info about RSV from the CDC.

According to the CDC, those at greatest risk for severe illness from RSV include:

• Premature infants
• Infants, especially those 6 months and younger
• Children younger than 2 years old with chronic lung disease or congenital (present from birth) heart disease
• Children with weakened immune systems
• Children who have neuromuscular disorders, including those who have difficulty swallowing or clearing mucus secretions

As parents, we want to make the best decisions for our baby. We’ve been asked a lot lately if it’s safe for pregnant women, or women planning on becoming pregnant, to get the COVID-19 vaccine. We met with Shanna Combs, M.D., a gynecologist, to answer some of our most frequent questions.

Dr. Combs oversees the Cook Children’s Pediatric and Adolescent Gynecology department. She is the Obstetrics and Gynecology Clerkship Director with the TCU and UNTHSC School of Medicine and has been an assistant professor for the Texas College of Osteopathic Medicine since completing her residency.

Q: What are the differences between the vaccines?

A: All three of them have been shown to be efficacious at preventing worse outcomes with the COVID-19 infection. Two of them are what we call the messenger RNA vaccines, which is a newer process for vaccination and requires a two-shot series. And then the other one is the Johnson & Johnson vaccine, which is a one-shot series to fight off the infection.

Q: What should I know about the Johnson & Johnson (J&J) vaccine?

A: With the Johnson & Johnson vaccine, one of the biggest things that has come out is a concern for higher risk of blood clots, and so there is a warning about that. That being said, there are many things in life that can also cause blood clots such as smoking, or even being pregnant or having a baby actually increases your risk for blood clots. So while there is that increased risk with the vaccine overall, it's still a very low risk.

Q: If I decide to get a COVID-19 vaccine, what should I expect?

A: It’s a shot, so I always say your arm is going to be sore the next day. I usually tell people to get it in the hand they write with, so they move it around and it's not quite as sore. What has been seen, especially with the two-shot vaccine series, Pfizer and Moderna, vaccines is that you do get a little bit of rundown feeling after the second vaccine. Some have it with the first shot, but more so with the second shot where you just kind of feel body aches, maybe a little feverish, just kind of run down. But that usually goes away within the first couple of days after receiving the vaccine.

Q: I have heard rumors about how the vaccines can affect my body. What is the truth?

A: It has no impact on your genetic makeup. Basically what is in your cells, the way you are, that doesn't change. All it's doing is teaching your body how to fight the infection. It's a normal, natural response. With the vaccine, when you feel that bad is your immune system learning the process. It just means that your immune system is working really hard to figure out how to fight off this virus, but we're not actually giving you COVID with the vaccine.

Q: Should I get a COVID-19 vaccine if I am trying to get pregnant?

A: There has been no evidence to show that it affects your fertility. I know there have been reports that it causes infertility. That has not been shown at all. There’s a continuous registry and nothing has been reported regarding infertility. And so we do recommend it, even if you are considering getting pregnant or planning on getting pregnant, as well as once you are pregnant. We highly recommend the vaccine.

Q: Should I get a COVID-19 vaccine during pregnancy?

A: When you are pregnant, if you get infected with COVID, unfortunately you are more likely to get sicker. So, you know, we're seeing patients who are healthy young, pregnant women in the ICU with COVID infection. So being intubated, not being able to breathe on their own, or if they are able to breathe on their own requiring a large amount of oxygen. Unfortunately with pregnancy, if you get COVID, you are at much higher risk of getting sick. The unfortunate thing is you're growing your baby. And so if you get sick, there's risks that you may have to deliver your baby early, causing a lot more problems than not getting vaccinated.

Q: Should I be worried about getting the shot during the first trimester?
A: Thus far, we have not seen any fetal abnormalities or developing abnormality in babies of moms who got the COVID vaccine. So even in the first trimester, we still recommend it. One of the things that we've known from prior vaccines that we recommend in pregnancies, such as the whooping cough vaccine or flu vaccine, is when you, as a woman, build your antibodies, the things that fight infection, after a vaccine when you're pregnant, you actually give those antibodies to your baby through the placenta. So when your baby is born, you're actually giving them a little bit of protection in those first couple months of life. You are actually doing something good for yourself by making yourself be able to fight off the virus, but you're also doing something for your baby.

Q: Is ther e enough research to know my child will not have any long-term effects?

A: As a physician (and) a woman’s health specialist and OB-GYN, I would not recommend something to my patients if I thought it was going to endanger them or their child. I say follow the science. This has been studied. This has been approved. It's gone through the normal FDA processes. The only difference with this vaccine right now is it's under emergency use authorization, which does not mean it's experimental, because there is a category for that. It's gone through all the usual processes, it’s just expedited some of the FDA processes to get it out. But it's been studied in many, many people and I highly, highly recommend it for women.

To learn more about the COVID-19 Vaccines While Pregnant or Breastfeeding, click here for information from the Centers for Disease Control and Prevention (CDC).

Contracting COVID-19 near your delivery date could impact how you will care for your baby in significant ways.

Here are some tips to help prepare you and your new baby:

• Follow the advice of your doctor. Things are changing rapidly and they will be the best resource for up-to-date information.
• Contact your delivery hospital in advance to understand their policies regarding your partner and other visitors.
• Call your Cook Children’s Pediatrician for a Virtual Prenatal Consultation. You can meet your pediatrician in advance, and they can talk you through the policies we have in place to keep your baby safe and provide you the best possible care.

So before your child arrives, it’s important try to be as prepared as possible.

Prior to Delivery

1. Every mother should get a Tdap vaccine in the third trimester of pregnancy to protect her baby against whooping cough. Any other family members who will be spending time with your newborn should also get a Tdap vaccination. If it’s flu season, family members should also receive the flu vaccine to protect your child from getting the flu, since babies are unable to receive the flu vaccine themselves until they are 6 months old.
2. Pack a to-go bag for the hospital with clothes, toiletries, and a camera (or at least have your phone charged and ready to go), as well as anything that you may want to have during delivery such as soothing music. Formula, diapers and wipes are readily available in the hospital and do not need to be packed. Don’t forget to bring your baby’s car seat, as your family won’t be allowed to leave the hospital without having one.
3. If possible, before delivery, ensure that car seat/car seat base is installed tightly. If it can be moved more than an inch side to side or front to back, it’s not tight enough. All infants and toddlers should ride in a rear-facing car seat for as long as possible, until they reach the highest weight or height allowed by the car seat manufacturer, which is usually about 40 pounds. Most children can stay rear-facing until after 2 years old. Rear-facing is the safest way for babies/toddlers to ride.
4. Make sure your baby has a safe sleeping space at home. This may be a crib or bassinet with a firm, flat surface for your baby to sleep on. Besides a tight-fitting sheet over a mattress, there should not be anything else in the crib/bassinet. No loose blankets, stuffed animals/toys, pillows or bumpers in the sleep space. It’s recommended that babies share a room with parents. The bassinet or crib should be close to your bed for at least the first 6 months of life, but preferably the first year of life. This has been shown to decrease the risk of SIDS.

After Delivery

1. After delivery, your child will be examined by a pediatrician within the first 24 hours of life, and then each day your baby is in the hospital.
2. Every baby will receive a vitamin K shot and erythromycin eye ointment soon after they are born.
3. After your baby is born, he or she should be fed on demand, which is usually every 2-3 hours. Every baby loses weight in the first week of life, and then usually gains back to their birth weight by about 2 weeks of life. Until that time moms, be prepared to feed at least every 3 hours.
4. Breastfeeding: In the first few days after birth, a mother’s body will produce nutrient rich colostrum for her baby. Breast milk usually comes in 3-5 days after the birth. It’s helpful to breastfeed often to stimulate milk production. Breastfeeding is a learning process for both mother and baby. It’s very helpful to utilize lactation consultants in the hospital. They are a wonderful resource for parents.
5. Babies should receive their first hepatitis B vaccine prior to discharge from the hospital. Babies will also have a hearing screen, congenital heart screen, and newborn screen done prior to discharge from the hospital.
6. When placing your baby in the car seat after leaving hospital: Harnesses should be at or below the baby’s shoulders. When testing the harness strap over your baby’s shoulders, you should not be able to pinch any slack between your fingers. The harness chest clip should be at the center of the chest, even with your baby’s armpits.
7. Your baby should have a follow-up appointment with your pediatrician 2-3 days after discharge from the hospital, or sooner if needed.
8. Keep the umbilical cord clean and dry. Only give sponge baths until the umbilical cord has fallen off. If there is any redness/swelling or foul smelling discharge, call your pediatrician.
9. Try to keep yourself and your baby away from people who are sick. Wash your hands with soap and warm water often. If you are not near water, use an alcohol-based hand cleaner. Call your pediatrician if your baby has a fever, which is 100.4 degrees F. The most accurate way to check a baby’s temperature is rectally.

Argh! I know. It seems like a lot. But by taking a few precautionary steps now, you will have more time to enjoy your baby and this exciting time in your lives!

I have to start with an apology.

It’s not that I didn’t care, or wasn’t concerned.

I asked about feedings and dirty diapers. I asked about sleep positioning. I asked about your plans for vaccination. I educated on how to take a temperature and what a fever is, whom you should call when you are concerned.

I know a lot about your baby from our little time together.

But, I often forgot to ask about you.

Sometimes, if you looked particularly tearful, concerned … I don’t know, maybe distraught, I asked how you were doing. You might have said “fine” and I probably left it that.

Recent news reports reminded me that I should be doing better.

Depression affects about 30 percent of women between 18 and 44 years of age. I don’t want to get bogged down with more stats, but about 15 percent of women in their reproductive years take antidepressants. Most experts agree that untreated depression carries much more risk to babies than medications for depression. Studies have shown mixed results with most indicating that they are safe and others indicating a slight increase in risk for birth defects.

A special US Preventative Service Task Force report stated that all adults should be screened for depression but placed particular emphasis on the importance of screening pregnant and new moms. They conclude that screening should be implemented “with adequate systems in place to ensure accurate diagnosis, effective treatment, and appropriate follow-up.”

If new moms should be screened for depression, who is going to do it if I don’t? Many don’t go back to their obstetricians until six weeks. What doctor are they seeing in the mean time? Who is going to screen them for postpartum depression? It has to be me.

Many pediatricians do this very well. They have built a system in place and screening has been part of their process for years.

Those of us who didn’t have many reasons…

Other priorities took over.

Checkup times are too short.

We’re not sure what we would do when we identified someone with postpartum depression.

But none of those are good excuses.

Because of this, I promise to work to develop a system that works.

I have to.

For you and for your baby.

I will report back with more soon.

Sincerely,

PS. Symptoms of postpartum depression can include:

• Increased irritability
• Loss of patience
• Quick mood changes
• Excessive energy or extreme fatigue
• A sense of feeling hopeless or overwhelmed

If you are someone you know is suffering from these symptoms, please ask for help from someone. Start with a friend or a doctor but do not suffer in silence. There are resources available.

So why did the Tarrant County Health Department just announce that there is a case of rubella in a Texas Christian University student?

Unfortunately, the student returned from a part of the world where rubella continues to be an ongoing concern. The World Health Organization states that rubella continues to cause infection in Africa, the Eastern Mediterranean and Southeast Asia. Despite the fact that rubella is no longer transmitted in the United States, an average of 10 cases of rubella are diagnosed here each year from travelers who bring it back from affected areas.

Don’t get me wrong, rubella is a big deal. Prior to the vaccination, it used to cause millions of cases per year around the world. The most severe complication from rubella is congenital rubella syndrome (CRS) which can affect the babies of women who contract rubella during the first three months of their pregnancy. Children born with CRS are at risk for growth problems, developmental delays and other birth defects.

We should definitely be aware that there is a case of rubella in our area, but I’m advising parents not to panic about their children getting rubella.

Here are the 2 main reasons why I’m choosing not to panic:

1. Rubella is a mild illness in children. It can start with a mild fever (but often doesn’t) and then causes a rash that starts on the face and spreads downward. Other complications from rubella are very rare and are more likely to happen in teenagers and adults.

2. Rubella vaccine works very well. After the first dose of the rubella vaccine (given at 1 year), 90-95 percent of children are protected. After the 4-year booster dose, protection gets much closer to 100 percent. If your child is vaccinated, they are most likely protected. As with anything, the vaccination is not perfect so we are relying on each individual person getting vaccinated to help protect their neighbors from an outbreak. Despite the fact that cases of rubella have been imported into the United States, no outbreaks have occurred, thanks to our relatively high immunization levels.

Children (or adults) who are infected by rubella can spread the disease via droplets spread by sneezing or coughing. We recommend all children be vaccinated against rubella. The vaccination helps prevent children from getting the disease and it also helps protect anyone they may come in contact with, including pregnant women.

Pregnant women with rubella run the risk of potentially having a baby with congenital rubella syndrome.

As always, if you are pregnant (especially in the first three months), use caution around sick individuals especially those with a rash. If you already have a baby, you were likely checked for rubella immunity at the delivery and your doctor should have the results of that test. If you are thinking about becoming pregnant, a doctor can check your immunity level now so that you can be vaccinated prior to getting pregnant.

Let’s not panic about rubella at TCU. If your child is starting classes there, feel free to send them on (I’ll be on campus for a meeting today if that gives you any peace of mind). Let’s be aware. We’ll follow the story and notify you if there are any updates or new reasons to be concerned.

More resources:

• Rubella
• Frequently asked questions about immunization
• Measles: Just a plane ride away
• Should you immunize?