RSV Vaccine?! Well, yes... And no. And maybe. Parents are starting to ask about the new RSV vaccine and when they can get it for their babies. RSV vaccine is a new product and a bit confusing because, as you may not realize, there are actually several anti-RSV products moving into the market this year including: 1) RSV vaccine for older adults and pregnant moms and 2) a new monoclonal antibody product for infants. To reduce the confusion, let’s break it down. Yes, there is a RSV vaccine. Earlier this year the FDA approved a RSV vaccine from GSK for use in adults above age 60. Pfizer just received approval for its adult RSV vaccine as well. Then there’s the AstraZeneca RSV vaccine product, that *may* make it to market this year but looks like it will be in use for next winter. Why vaccinate older adults? On average, there are more than 60,000 hospitalizations of people above age 60 per year and more than 6,000 deaths per year in the US from RSV. Pediatricians aren’t involved in giving this particular RSV vaccine or managing those patients, but RSV spreads very easily through both families and daycares, so protecting all the vulnerable, namely older adults and younger infants is key. Many families who went through our terrible RSV season in 2022-2023 noticed that not only younger children but the elderly get very ill with RSV. In fact, while RSV is the #1 cause of hospitalization in infants in the winter in the US, last year we had a similar rate to adults of 60,000 hospitalizations of children less than age 5 with (thankfully) far, far fewer deaths in children. In pediatrics we also have a robust system of providing outpatient care for children with moderate to severe RSV disease, including our Utah Suction Clinic system where children can visit the ER daily for checks with a respiratory therapist. This reduces the reported hospitalization numbers for RSV in infants compared to adults: trust me, there were hundreds of thousands of very ill infants with RSV in the US last winter. In fact, the CDC estimates that in winter 2022-23 1 in 10 families in the US had a child with RSV disease that was at least moderately severe. So the RSV vaccine- which isn’t for children- has been thoroughly tested in older adults, is ready for a fall vaccine campaign, and hopefully will make a major difference in winter hospitalizations, illness, and deaths in adults this year. If you have someone in your family above the age of 60, definitely ask your doctor about how to get vaccinated for RSV. As part of the testing program for the adult RSV vaccine, pregnant women were also enrolled. Around 7,000 women were given the vaccine between 24 and 36 weeks of pregnancy. The vaccine was remarkably successful: only 6 infants with vaccinated moms developed severe RSV disease compared to 33 in the unvaccinated group in the first three months of life. Yet there are a few concerns still about this vaccine in pregnant women:
1) The rate of premature birth increased by 1% in the vaccinated group. Premature birth is a major source of illness and disability in infants and so this risk is not to be taken lightly. In fact, Dr. Paul Offit of Children’s Hospital of Philadelphia went on record with a no vote for the vaccine because of concerns about the increased risk of premature birth. (DIsclaimer: Dr. Offit is a hero of mine and about as pro-vaccine as they get.) But the data in the test group is not representative of our pregnant US women as a whole. We usually expect 10% of women to deliver prematurely in the US but in the study the rate of premature birth increased from 4% to 5%. That is not a comparable group to the general US population. We also can’t do a comparison yet because...
2) The numbers for the GSK study in pregnant women are small. Testing in only 7,000 women in no way shape or form can give us good data on unusual or rare side effects or complications of a vaccine. (Compare this number to the more than 7,000,000 doses of COVID vaccine in children, which is a great number and has given us accurate info on remarkable safety and efficacy.) Both GSK and Pfizer agreed to release data to the FDA this fall as their vaccines roll out, but the numbers are just small.
3) The vaccine, when given to pregnant women, protects babies from severe RSV disease for about 90 days. As you may know, RSV causes severe disease in children much older than that, so the vaccine will really be protecting the youngest and sickest infants only. That’s great and I endorse that idea: Synagis provided the same kind of benefit.
No, it is not for use in children. It will be fascinating to watch the data from the RSV vaccine rollout this fall and see how well they work at protecting older adults and the youngest infants from RSV disease. Regardless of the initial data, this really is a game-changing moment in pediatrics.The amazing accomplishments of our scientists in producing a COVID vaccine that is safe and effective less than 18 months after the pandemic started can not be underestimated. But I think that the combination of products now emerging for RSV disease are also going to radically change for the better how winter illness looks in the US. We use monoclonal antibodies to prevent RSV in children. There was Synagis. Now there is Beyfortus. In the past, we have used Synagis (palivizumab), a monoclonal antibody made by the SOBI corporation to protect children. Typically pediatricians keep a running list of our infants who are at highest risk for severe RSV disease who are eligible for Synagis. These include (as of 2022-2023) 1) infants who were born before 35 weeks and are less than 6 months of age at the start of RSV season, 2) babies with bronchopulmonary dysplasia or chronic lung disease resulting from extreme prematurity and 3) infants with congenital heart disease of types that make them more at risk with RSV. We notify the insurance company of those patients, help to arrange coverage, and then see those babies throughout the winter season to get them their Synagis shots in the office. This is not a large number in any one pediatric practice, but last year Synagis was used to prevent severe RSV in thousands of infants nationwide. It’s extremely effective at preventing
severe RSV, but requires a monthly shot given to the infant throughout the season and is remarkably expensive (thousands of dollars per dose). Because Synagis is so pricey and there are risks with using monoclonal antibody products, insurance companies and the FDA have limited use of Synagis to the most at risk and sickest infants.
But now there is an affordable monoclonal antibody product made by Pfizer that may be ready to use this winter in *all* young infants. The product is called nirsevimab (Beyfortus) made by Pfizer and is safe and effective. (Ii’ll review the data for you later when/if it is widely available.) It will probably replace Synagis in prevention of RSV in infants. This past week the FDA approved Beyfortus for use in all infants less than 8 months of age at the start of RSV season. But. But. But. There are a few interesting logistical hurdles to clear before we see the Beyfortus product made widely available. They include:
ACIP/Medicaid and insurance coverage. Beyfortus is a preventative product but not a vaccine so the US insurance companies and our state and federal governments agencies are duking it out right now to figure out who pays for it. If it is labeled as a preventative product/treatment that would be covered by the ACA, then your insurance company will probably have to pay for it. If Medicaid and the federal insurance plans cover it, private insurance companies will have to pay for it. But until then- surprise!- private insurance companies seem to be arguing that *you* should pay for the product and they shouldn’t.
Beyfortus and RSV vaccine. If a pregnant woman has had the vaccine, then (at this point we think) infants should *not* get Beyfortus. Can you picture the logistical nightmare challenge of coordinating communication from OBs, hospital records, parent insurance companies, nurseries, pediatricians, and child insurance programs to make this decision a clear one? A new administrative structure to manage a new medical product requires time to be built and implemented. Pediatricians wonder if we’ll be able to do that in our fragmented US medical system in the next eight weeks. Systems like Kaiser Permanente and Intermountain, of course, have an administrative advantage in coordinating this massive effort and getting it done in time for winter, but we’ll see.
Cost and availability. The price is TBD but will probably be in the $300-500 range. Infants receive it once and will be protected for the season. This is an unbelievably cost effective way to prevent hospitalizations, missed parental work, and two weeks of a moderate to severely ill infant. But right now, we are waiting to hear how doctors will buy it, how insurance companies will reimburse us, and what cost will be passed on to patients. News to follow.
In summary: RSV Vaccine?! Well, yes...The RSV vaccine is ready this winter for older adults and pregnant women. And no. RSV prevention in children will be a new monoclonal antibody named Beyfortus, not a vaccine.
