The agency said it couldn’t exclude the possibility that one death, in a baby born very prematurely 10 days after its mother was vaccinated, was related to the vaccine.Aerial view of Six Flags Discovery Kingdom in 2012

The FDA agreed with Pfizer that four of the five deaths in the immunized group were probably unrelated to the vaccine. There were 17 deaths in the main study: five in the group that got the vaccine and 12 in the group whose moms got a placebo. By six months after birth, the vaccine was 69% effective at preventing severe RSV disease and 51% effective at preventing a doctor’s visit for RSV-related breathing problems.Īfter six months, the vaccine was about as effective as the placebo at preventing RSV that became severe enough to send babies to the doctor’s office.įor the most part, the vaccine appeared to be safe, with reactions and serious adverse events balanced between the vaccine and placebo groups. CDCįDA approves first vaccine for RSV, a moment six decades in the makingįor the first three months after birth, the vaccine was 82% effective at preventing severe RSV disease and 57% effective at keeping babies from needing to see the doctor because of an RSV infection. Using indirect immunofluorescence microscopy, this photomicrograph revealed the presence of the respiratory syncytial virus (RSV) in an unidentified tissue sample, RSV is the most common cause of bronchiolitis and pneumonia among infants and children under 1 year of age. In terms of efficacy, FDA reviewers said the vaccine was most effective for the youngest infants, and its protection waned over time. The FDA’s Vaccine and Related Biological Products Advisory Committee, or VRBPAC, will meet Thursday and vote on whether to recommend approval for Pfizer’s maternal RSV vaccine. There were also 13 neonatal deaths in the vaccine arm, compared with three in the placebo group, according to a recent report in the BMJ. There were 238 preterm births among 3,496 vaccinated moms (6.8%) compared with 86 among 1,739 pregnant women (4.9%) in the placebo group. GSK later reported that there was a higher risk of preterm births among vaccinated mothers in its study compared with those who got a placebo. Late-stage trials of a similar maternal vaccine for RSV being tested by the drug company GSK were stopped last year over safety concerns. Still, this finding will probably spur discussion this week at meeting of a group of independent experts who advise the US Food and Drug Administration on its vaccine decisions. And most infants, even when born prematurely, were delivered after 34 weeks of pregnancy, just a few weeks shy of their due dates.

Rates of preterm births in both groups were lower than the rates of early birth reported in the general population, which is about 10%. The difference between the groups was not statistically significant, meaning it could have been due to chance. Late-stage RSV vaccine trials show 'exciting promise,' some scientists say RSV is the most common cause of bronchiolitis and pneumonia among infants and children, under 1-year of age. The virion is variable in shape, and size, with an average diameter between 120-300nm.

This highly-magnified, 1981 transmission electron microscopic (TEM) image, reveals some of the morphologic traits exhibited by a human respiratory syncytial virus (RSV). Safety data published in an agency analysis Tuesday also showed a slightly higher proportion of preterm birth in babies whose moms got the experimental RSV vaccine compared with those who got a placebo: 5.7% vs. Scientists have been working on an effective RSV for young children for roughly 60 years, so there’s plenty of excitement around the prospect of having a candidate get so close to the finish line.īut the news isn’t all rosy. RSV is a major cause of hospitalization in infants and the elderly each year, and it typically hits hardest during the winter months. Many parents have been eagerly anticipating this news, particularly after last year’s long and severe RSV season. Pfizer’s vaccine to protect newborns from respiratory syncytial virus, or RSV, by vaccinating their moms late in pregnancy cuts the risk that infants will need to see a doctor or be admitted to the hospital with a moderate to severe infection before 6 months of age, according to a new analysis by government regulators.

Sixflags discovery kingdom