Blood sample for respiratory syncytial virus (RSV) test
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U.S. Food and Drug Administration staff on Tuesday said Pfizer’s vaccine that protects infants from respiratory syncytial virus has “generally favorable” safety data.
The FDA staff made the conclusion in briefing documents ahead of a meeting on Thursday when a panel of external advisors to the agency will discuss whether to recommend full approval of the RSV shot.
The advisors will vote on whether Pfizer’s late-stage clinical trial data on the vaccine supports its safety and efficacy. The FDA typically follows the recommendation of its advisory committees, but shouldn’t be required to achieve this.
The agency is slated to make a choice on whether to clear the shot in August before RSV season in the autumn. If approved, Pfizer’s jab would change into the world’s first vaccine that protects infants against RSV.Â
RSV often causes mild, cold-like symptoms. But infants and older adults are particularly vulnerable to having more severe cases.
Annually the virus kills 6,000 to 10,000 seniors and a number of hundred children younger than 5, in response to the Centers for Disease Control and Prevention.
The FDA earlier this month approved an RSV shot from GlaxoSmithKline for adults ages 60 and older.
The agency is anticipated to make a choice inside weeks on Pfizer’s other RSV shot for that very same age group.
Pfizer’s RSV vaccine that protects infants is run to expectant moms within the late second or third trimester of their pregnancy.Â
The only-dose vaccine triggers antibodies which might be passed to the fetus, which provides it with protection against RSV from birth through the primary six months of life.Â
Together with safety information, the staff also reviewed the vaccine’s efficacy data.
Pfizer’s trial found the shot was 82% effective at stopping severe disease from RSV in newborns through the first 90 days of life. The shot was about 70% effective through the first six months of the infant’s life.
Many of the greater than 3,000 moms who received the shot in a phase three trial experienced mild to moderate antagonistic reactions, in response to the FDA staff’s review of knowledge.
Probably the most common reactions were fatigue, muscle pain, headache and pain on the injection site. Most reactions resolved inside three to 4 days after vaccination, the staff review noted.
A better variety of premature births occurred amongst moms who took the vaccine in comparison with those that received a placebo, in response to the staff review.
But they said that difference doesn’t seem like statistically significant.Â
A number of the participants’ children also had low birth weights, the staff review said.Â
The trial reported a complete of 18 peripartum fetal deaths, which incorporates infants who survived briefly after birth and fetuses that died while pregnant.Â
However the FDA staff said it’s unlikely that those deaths are related to Pfizer’s shot.