![]() ![]() "Certainly, in our eyes, there is no definitive evidence to suggest there is a risk of prematurity," said Dr. Representatives from Pfizer also pushed back on the safety concerns, emphasizing the benefits of the shot outweigh the risks. Daniel Feikin, a scientific advisor and respiratory diseases consultant, who voted in favor of the shot's safety. Am I convinced that it's real? No," said Dr. "Am I concerned about the preterm birth imbalance? Yes. ![]() There's an interaction between the two."īut some panel members cast doubt on whether there's a clear causal relationship between the vaccine and preterm births. "So, this is a very complex thing because now the harm actually makes the benefit less so. "The problem is if the child is born earlier, that also reduces the efficacy of the treatment because earlier birth means less antibodies are transferred," he said. Portnoy added preterm deliveries could potentially dampen the benefits of the shot. "If GSK truly abandons a program on a similar, almost identical vaccine, that is going to hang over program," he said during the meeting. ![]() Offit also said GSK's trial is "hanging over" Pfizer's own RSV shot for infants. Pfizer's rival GSK halted its own trial on its RSV shot for newborns after noticing concerning data on preterm births and neonatal deaths, or when a baby dies during the first 28 days of life. Premature deliveries aren't a new issue when it comes to RSV vaccines for infants. Hana El Sahly, who chairs the FDA advisory committee, said "even if it is late preterm delivery, the fact that we're putting them into preterm delivery while we're sitting here debating the matter intellectually is not trivial." Most infants, even when born prematurely, were also delivered after 34 weeks of pregnancy, just a few weeks shy of their due dates.īut Dr. The shot was also about 70% effective during the first six months of the baby's life.īut the advisory panel's concerns stemmed from safety data in that trial.Ī slightly higher number of premature births occurred among mothers who took the shot compared to those who received a placebo: 5.7% versus 4.7%, respectively.īoth Pfizer and the FDA said the difference does not appear to be statistically significant. Weighing safety and efficacy dataĪ phase three trial found Pfizer's shot was nearly 82% effective at preventing severe disease from RSV in newborns during the first 90 days of life. The single-dose vaccine triggers antibodies that are passed to the fetus, which provides it with protection against RSV from birth through the first six months of life. Pfizer's shot for infants is administered to expectant mothers in the late second or third trimester of their pregnancy. Older adults and younger children are particularly vulnerable to more severe RSV infections.Įach year, the virus kills 6,000 to 10,000 seniors and a few hundred children younger than 5, according to the Centers for Disease Control and Prevention. About one out of every 100 children younger than 6 months of age with an RSV infection may need to be hospitalized, the CDC said. RSV is a common respiratory infection that causes cold-like symptoms. The agency is expected to make a decision within weeks on Pfizer's other RSV shot for that same age group. The FDA earlier this month approved the first RSV shot for adults ages 60 and older from GlaxoSmithKline. If approved, Pfizer's jab would become the world's first vaccine that protects infants against RSV, a goal scientists have been working toward for decades. The agency is slated to make a final decision on the shot in August, right before RSV season in the fall. The FDA typically follows the advice of its advisory committees but is not required to do so. Personal Loans for 670 Credit Score or Lower Personal Loans for 580 Credit Score or Lower Best Debt Consolidation Loans for Bad Credit ![]()
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