FDA officials say Pfizer’s infant RSV vaccine has positive safety data
Blood sample for respiratory syncytial virus (RSV) testing.
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This was announced by employees of the US Food and Drug Administration on Tuesday Pfizers Vaccine that protects infants from respiratory syncytial virus “generally cheap” security data.
The FDA staff came to the conclusion briefing documents before a meeting on Thursday when a panel of external advisors to the Agency will discuss whether to recommend full approval of RSV vaccination.
The consultants will vote whether Pfizer’s late clinical trial data on the vaccine demonstrates its safety and efficacy. The FDA generally follows the advice of its advisory committees, but is not required to do so.
The agency is expected to decide whether to clear the shot in August ahead of the fall RSV season. If approved, Pfizer’s vaccine would be the world’s first vaccine to protect infants from RSV.
RSV usually causes mild, cold-like symptoms. But infants and older adults are particularly susceptible to more severe cases.
Every year the virus kills According to the Centers for Disease Control and Prevention, there are 6,000 to 10,000 seniors and a few hundred children under the age of 5.
The FDA approved an RSV vaccine earlier this month GlaxoSmithKline for adults over 60 years.
The agency is expected to make a decision on Pfizer’s other RSV vaccine for the same age group within a few weeks.
Pfizer’s RSV vaccine for infant protection is given to expectant mothers in the late second or third trimester of their pregnancy.
The single-dose vaccine elicits antibodies that are passed to the fetus, protecting it from RSV from birth until the first six months of life.
In addition to safety information, staff also reviewed vaccine efficacy data.
Pfizer’s study found that vaccination was 82% effective in preventing severe RSV disease in newborns in the first 90 days of life. The effectiveness of the vaccination was about 70% in the first six months of the baby’s life.
Most of the more than 3,000 mothers who received the vaccine in a phase III trial experienced mild to moderate side effects, according to the FDA’s data review.
The most common reactions were fatigue, myalgia, headache and injection site pain. Most reactions disappeared within three to four days after vaccination, the staff assessment said.
According to the staff assessment, mothers who took the vaccine had a higher number of preterm births than mothers who received a placebo.
However, they said the difference did not appear to be statistically significant.
Some of the participants’ children also had low birth weight, according to the staff assessment.
A total of 18 peripartum fetal deaths were reported in the study, including infants who survived shortly after birth and fetuses who died during pregnancy.
However, FDA officials said those deaths were unlikely to be related to Pfizer’s vaccination.
https://www.cnbc.com/2023/05/16/pfizer-rsv-shot-for-infants-has-favorable-safety-data-fda-staff-say.html FDA officials say Pfizer’s infant RSV vaccine has positive safety data