WASHINGTON (AP) — A first-of-its-kind RSV vaccine for pregnant women guards their newborns against the scary respiratory virus -– and federal health advisers debated Thursday if Pfizer's shot is ready to roll out.
RSV fills hospitals with wheezing babies each fall and winter, and the virus struck earlier than usual and especially hard in the U.S. this past year..
Vaccinating moms-to-be "would have a major impact," said Dr. Alejandra Gurtman, Pfizer's vaccine research chief.
The idea: Give women a single injection late in pregnancy, between 24 weeks and 36 weeks, so they develop RSV-fighting antibodies that pass through the placenta — just like they pass protection against other bugs to their babies.
In Pfizer's international study of nearly 7,400 pregnant women, maternal vaccination proved 82% effective at preventing severe RSV during babies' most vulnerable first three months of life. At age 6 months, it still was proving 69% protective against severe illness.
Pfizer said there were no signs of safety problems and in an analysis posted ahead of Thursday's meeting, FDA's reviewers agreed "the safety data seem generally favorable." But the FDA did ask its scientific advisers to consider whether a slight difference in premature birth between the two groups was of concern.
If the Food and Drug Administration ultimately approves the maternal shot, it would mark a second milestone in the decades-long quest to prevent the respiratory syncytial virus. Earlier this month the FDA approved the world's first RSV vaccine, rival GSK's shot for older adults, who also are at high risk. There isn't a vaccine yet for children, but Pfizer is about to begin testing one.
Here are some things to know:
RSV IS A COMMON THREAT
For most healthy people, RSV is a cold-like nuisance. But it can be life-threatening for the very young –- infecting deep in the lungs to cause pneumonia or impeding babies' breathing by inflaming their tiny airways. In the U.S. alone, between 58,000 and 80,000 children younger than 5 are hospitalized each year, and between 100 and 300 die, according to the Centers for Disease Control and Prevention.
"All young infants are at risk of severe disease with RSV," but postponing infection even by a few months lessens that risk, said CDC's Dr. Katherine Fleming-Dutra.
VACCINE'S POTENTIAL IMPACT
Pfizer's vaccine isn't intended to prevent RSV infection but to avoid the worst outcomes. In late-stage testing, six infants born to vaccinated mothers had a severe RSV illness in their first three months of life compared to 33 infants whose mothers received a dummy shot. In addition, the vaccine cut in half the chances of needing any medical attention for an RSV infection by age 6 months.
The company predicts the U.S. could prevent as many as 20,000 infant hospitalizations a year, and 320,000 doctor visits, if enough pregnant women were vaccinated.
Vaccine reactions included typically mild injection-site pain and fatigue. As for the prematurity question, vaccinated mothers had slightly more preterm infants –- 5.7% versus 4.7%. The vast majority were born just a few weeks early. That's better than the nation's preterm birth rate -- overall in the U.S., 1 in 10 babies were born premature last year –- and the study imbalance wasn't statistically significant, meaning it could be due to chance.
A total of 17 infants died during the study, five born to vaccinated mothers and 12 to those given a dummy shot. Researchers deemed none of the deaths related to the vaccine but FDA said it "is unable to exclude the possibility" that one infant's death, stemming from extreme prematurity, might be related.
Vaccines always get close safety scrutiny but regulators are especially mindful of a major setback in the 1960s when an experimental RSV shot worsened infections in children. Eventually scientists figured out the problem and the RSV vaccines in the pipeline today are made with safer, modern methods -- yet still were tested first in older adults.
WHAT HAPPENS NEXT?
FDA's advisers already have recommended approving Pfizer's vaccine for older adults, and the agency is expected to make a decision by month's end. Whether to use the same shot in pregnant women will be a separate FDA decision, expected in August.
Meanwhile, rival GSK is gearing up for fall immunizations with its RSV vaccine for seniors. First, the CDC's advisers will debate next month whether all older adults or only those at high risk need vaccination.
Vaccines aren't the only advance in the pipeline. High-risk infants often get monthly doses of a protective drug during RSV season but European regulators recently approved the first one-dose option, from Sanofi and AstraZeneca. FDA's advisers will debate that drug next month, too.