COVID-19 hasn't been the only threat to parents and their children since 2020. Concerns about the flu and the respiratory syncytial virus (RSV) have also escalated during recent winters, leading to what was termed a "tripledemic" last year. However, with upcoming advancements in RSV vaccines, the approaching winter may finally have a sense of calm — that is, if anti-vax misinformation doesn't get in the way.
The FDA estimates that each year about 60,000 adults over the age of 65 are hospitalized with RSV; 6,000 to 10,000 die from the virus. Infants also face an increased risk. According to the Centers for Disease Control and Prevention (CDC), each year nearly 80,000 kids under 5 are hospitalized with RSV, and an estimated 300 die.
Last month, the FDA approved Pfizer's vaccine against RSV for adults age 60 and older, marking the second shot approved that month. The GSK vaccine was previously approved by the FDA. This month, the FDA will reconvene to discuss an upcoming pediatric vaccine that would pass immunity to fetuses by vaccinating pregnant women.
"For a long time, we thought of RSV as just being of concern to younger infants and causing mild illness, like colds, in older adults but we're finding that it's not quite as severe as something like influenza, but it causes about a quarter of the deaths and hospitalizations compared to influenza," Dean Blumberg, chief of pediatric infectious diseases and associate professor in the Department of Pediatrics at the University of California, Davis, told Salon.
"And that's still pretty significant."
The approaching winter may finally have a sense of calm — that is if anti-vax misinformation doesn't get in the way.
Indeed, the FDA is clearing the path for approval to protect both the elderly and young infants. Two weeks ago, FDA advisers showed unanimous support for the Pfizer vaccine that would immunize pregnant women during the second or third trimester. A clinical study involving 7,400 people found that the vaccine had 81.8% efficacy in preventing severe illness caused by RSV up to three months after birth, and 69.4 percent efficacy in the first six months of life.
In an op-ed published in STAT News, Sallie Permar, pediatrician-in-chief at NewYork-Presbyterian Komansky Children's Hospital, and Karen Acker, hospital epidemiologist at NewYork-Presbyterian Komansky Children's Hospital, emphasized the urgency for RSV vaccines to be approved by the FDA as soon as possible.
"If we could wave a magic wand to ameliorate the all-but-certain confluence of a high-volume respiratory virus season, ongoing behavioral health patient needs, staffing shortages, and dwindling pediatric capacity, we would all run — not walk — to deliver this to children, families, and providers," the authors wrote. "Globally, RSV is the second leading cause of death during the first year of a child's life, after malaria."
And while the magic wand appears to have been delivered, there are fears it could be intimidated by misinformation — especially among pregnant women.
As Salon has reported before, online pregnancy forums are rife with health misinformation, especially around vaccines. In mid-May, Children's Health Defense, Robert F. Kennedy, Jr.'s anti-vax nonprofit, called the progress with the pediatric vaccine a "sad day for babies and mums," emphasizing concerns about pre-term births. The framing is yet another example of how anti-vaxxers repeatedly decontextualize information to fit an anti-vaccine agenda. FDA's reviewers of Pfizer's international study of nearly 7,400 pregnant women agreed "the safety data seem generally favorable."
However, they did raise concerns about a small difference — 5.7 percent versus 4.7 percent — in premature births between vaccinated mothers and unvaccinated moms. On average in the U.S., one in 10 babies are born prematurely. The FDA advisors said the difference wasn't statistically significant. A total of 17 infants did die during the study, five of whom were born to vaccinated mothers. The FDA panel said none of the deaths were related to the vaccine, with the exception of one, as it was "unable to exclude the possibility" that one of the infant's deaths could be related.
Previously, Dr. Melissa Simon, an obstetrician-gynecologist and professor at Northwestern University's Feinberg School of Medicine, told Salon the fact that a lot of the misinformation clouds pregnancy stems from "structural issues," such as "excluding pregnant and birthing and lactating persons" from research. "And that's really unfortunate because when certain groups are left behind from being included in clinical trials, there is relatively less data." But now, more data is here as pregnant people are being included in more studies.
An American College of Obstetricians and Gynecologists (ACOG) spokesperson told Salon via email that "there are a number of details that need to be determined that will impact the implementation of the vaccine and integration into the practice setting and routine obstetric care."
In other words, it hasn't been approved just yet and advisors and scientists are doing their job to only approve it if it's safe for pregnant women and their children.
"These include details around optimal timing of administration, co-administration, vaccine storage, other access considerations," the spokesperson said. "Obstetrician-gynecologists recognize and appreciate the importance of preventing RSV in infants younger than six months of age and other populations at highest risk for severe illness, and immunizations are an essential part of preventive care for adults, including pregnant individuals."
It also doesn't help that the RSV vaccine has a worrisome history. One that was developed in the 1960s induced a more severe reaction to the virus in vaccinated kids.
"That was when there was much less known about the pathophysiology of RSV disease in infants," Blumberg said. "For decades, nobody wanted to come near RSV vaccines with a 10-foot pole because of that experience, until people learned more about why that happened and really learned from that mistake and resulted in an immune response that was predicted to protect against disease not result in that risk of worsening disease."
There is another vaccine in the works, nirsevimab, which could vaccinate children directly. In a real-world clinical trial, the vaccine reduced infant hospitalizations by 83 percent.
"The reason to vaccinate during pregnancy is so the mother develops antibodies that get passed on to the child, but now that there's an alternative that's on the horizon to vaccinate the child themselves directly, that just makes much more sense," Blumberg said. "And then you don't have to worry about the issue of possible preterm delivery or any other effects during pregnancy."
