THURSDAY, May 18, 2023 (HealthDay News) — The first RSV vaccine designed to protect infants is under consideration by a panel of advisers to the U.S. Food and Drug Administration.

An independent committee of experts will vote Thursday on whether to recommend the shot for pregnant mothers at 24 to 36 weeks gestation.

“Before the pandemic, RSV was the No. 1 cause of infant hospitalization in the United States, so this is a big deal,” Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, told NBC News. Levy is a temporary voting member of the panel, but not one who will vote on this vaccine.

If the panel recommends the vaccine, the FDA would still need to approve it, a process that could take months. The agency is not obligated to follow its advisers’ recommendations, but it usually does.

The Pfizer-made vaccine would only be the second one ever approved in the United States for RSV (respiratory syncytial virus). A vaccine made by pharmaceutical company GSK was approved for adults ages 60 and up earlier this month. However, 11 RSV vaccines for various age groups are being tested in ongoing clinical trials.

When a mother-to-be receives the vaccine, protective antibodies transfer to infants through the placenta.

Safety data for the infant vaccine is “generally favorable,” according to the FDA. 

Trial participants had a slightly elevated rate of preterm births compared to the control group, according to the news report. However, that rate was still lower than that seen in the general population. The rate of preterm births among the 7,400 trial participants was 5.7% for those who received the vaccine compared to 4.7% of those who received a placebo and 10% in the general population. A trial by GSK for an infant vaccine was halted last year because of a higher preterm birth rate.

RSV generally causes mild, cold-like symptoms. It is a minor illness in healthy adults, but can be severe in more vulnerable groups, including babies and older adults.

Up to 300 children younger than 5 years die from RSV in the United States each year. Up to 10,000 people age 65 and older also die from the virus, according to the U.S. Centers for Disease Control and Prevention.

In a clinical trial for the vaccine, infants had an 82% lowered risk of severe disease in the first three months after birth, NBC News said. That dropped to 69% by six months. Infants also had 51% lowered risk of developing respiratory disease so severe that it required a doctor’s visit.

“Maternal immunization looks like an important piece of the puzzle, but we’re going to need more to shield into the second half of the first year [of infancy] and beyond,” Levy said.

Vaccines given in pregnancy are always concerning, he said.

“There’s always the background concern: Are you inducing some inflammation that could be a problem? Because the body reads inflammation as, ‘The woman’s no longer safe, let’s get the baby out.’ So you want a fairly bland vaccine,” Levy said.

Pfizer also has a proposal for an RSV vaccine used by older adults before the FDA panel this month. That is for the same vaccine, but for use in people ages 60 and up.

Another option, a monoclonal antibody injection, has already been approved in Canada, Europe and the United Kingdom for infants. An application for that shot is also being reviewed by the FDA. 

Vaccine side effects including fatigue, headache, muscle pain and injection site pain in pregnant women.

More information

The U.S. Centers for Disease Control and Prevention has more on RSV.

SOURCE: NBC News

Following the recommended schedule for well-child visits can help protect your child’s long-term health and well-being. These appointments also give you an opportunity to talk to your pediatrician about growth, development, and behavior.

Here are seven questions to help you get the most out of your appointments:

1. Is my child growing and developing at a healthy rate?

At each visit, your pediatrician will measure your child’s height and weight. Babies and toddlers often experience rapid growth, while gaining too much weight may be an issue for older children and teens.

2. Are my child’s vaccines up to date?

Recommended vaccinations protect children from serious diseases, including hepatitis, measles, tetanus, and polio. It’s important to get vaccines on schedule because sometimes it can take multiple doses before a child is fully protected. Make sure you understand what each vaccine protects against, and remember that children age six months and older should receive an annual flu shot.

3. What foods and beverages should my child eat?

Good nutrition is essential for healthy growth and development. For babies and toddlers, you might have questions about breastfeeding or when to introduce solid foods. As children grow up, it’s important to establish healthy eating habits. Ask your doctor about foods and beverages your child should avoid and what to do if you have a picky eater.

4. How can I keep my child safe?

Talk to your pediatrician about steps you can take to child-proof your home, protect kids from exposure to the sun, and protect against infectious diseases. Depending on the age of your children, you might have questions about when it’s time to graduate from a car seat or how much screen time is appropriate.

5. Do you have any concerns about my child’s mental health?

Mental health is important at every age. Whether your child is struggling at school or having trouble making friends, identifying an issue gives your pediatrician a chance to address it. Depression and anxiety are common among children and adolescents, so don’t be afraid to bring up these issues.

6. Ask about any specific concerns you have.

Make a list of your questions before the appointment, and put the most important ones at the top. That way, you won’t forget to ask about something that has been on your mind.

7. When should I schedule our next well-child visit?

Book your next appointment before you go home. You can change the date later, if needed, but scheduling your next visit while you’re at the doctor’s office can help you stay on track.