Pfizer's infant RSV vaccine receives FDA Advisory Committee's support

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The FDA Advisory Committee recently voted in support of approval for Pfizer's maternal immunization vaccine to help prevent RSV in infants. In this Contemporary Pediatrics® interview, Tina Tan, MD, FAAP, FIDSA, FPIDS, pediatric infectious diseases attending, Ann & Robert H. Lurie Children's Hospital, Chicago, explains what this means for this patient population ahead of an expected FDA decision in August, 2023.

Transcription edited for clarity.

Contemporary Pediatrics®:

Hi, thanks so much for joining us. I'm Joshua Fitch of Contemporary Pediatrics®.

Tina Tan, MD

Hi, I'm Dr. Tina Tan I'm editor-in-chief of Contemporary Pediatrics® and a professor of pediatrics at the Feinberg School of Medicine of Northwestern University and a pediatric infectious diseases attending at Lurie Children's Hospital of Chicago.

Contemporary Pediatrics®:

Dr. Tan, good to see you as always, thanks for taking the time. Recently, the FDA Advisory Committee voted in support for Pfizer's RSV vaccine for infants. Your initial reaction:

Tina Tan, MD

I think it's fabulous. I mean, we know that RSV is a major cause of upper and lower respiratory tract infection in persons of all ages. We know that it is one of the major respiratory viruses that leads to hospitalization in individuals, especially those under five years of age, because in the US, we basically see anywhere from 60,000 to 80,000 infants and children under five years of age, hospitalized each year and RSV causes on average greater than 2 million infections in that younger age group each year. What we saw this past RSV season, which was very unusual, is that we had surges of RSV infection that were occurring in older individuals, because normally it's the younger infants and children, usually under two years of age that have the most problems, but we were seeing kids 4, 5, 6, and 7 [years of age] being hospitalized with severe RSV infection. So, I think that this is really a fabulous progress with regards to getting a vaccine out there that's going to provide protection for the younger infants.

Contemporary Pediatrics®:

You mentioned getting it out there, according to Pfizer an FDA decision as expected August 2023. Can you speak to the timeframe of this whole pipeline?

Tina Tan, MD

I think it should be really good timing. But again, we cannot predict when RSV season is going to start because the seasons are a little bit off kilter right now. You know, last year, we did see a surge of RSV during the summertime, which is very, very unusual. So we're going to have to see what this year brings, but it's going to be fabulous, because we know that this maternal vaccine provides really significant protection for infants during the first six months of life, which is usually the time period when we get the most severe RSV disease, hospitalization, complications occurring.

Contemporary Pediatrics®:

According to Pfizer, the Committee voted 14 to 0 on effectiveness and 10 to 4 on safety for this RSV vaccine, what are those numbers telling you? Can you break them down?

Tina Tan, MD

I mean, I think, you know, that's telling you that they have a lot of confidence in the vaccine being effective and providing protection, not only for the mom, but also for the young infants during the first six months of life. I think the safety breakdown was broken down that way, primarily because we don't have a lot of safety data with regards to the vaccine effect on the younger infants. But in general, if you look at the clinical trials data, the vaccine was actually very, very safe.

Contemporary Pediatrics®:

Dr. Tan, thank you so much. Anything else you would like to add based on this news?

Tina Tan, MD

No. I mean, I think this is great news and again, I encourage everyone to make sure that their patients are up to date on their vaccination because we continue to see lags with regards to individuals receiving their routine recommended vaccines, and we've already seen some consequences of that with outbreaks of vaccine preventable disease. So, we definitely need to make sure that all our patients are up to date on their routine vaccines.

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Tina Tan, MD, FAAP, FIDSA, FPIDS, editor in chief, Contemporary Pediatrics, professor of pediatrics, Feinberg School of Medicine, Northwestern University, pediatric infectious diseases attending, Ann & Robert H. Lurie Children's Hospital of Chicago
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