Respiratory syncytial virus – a viral vaccine under study
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Food and Drug Administration Independent Advisory Board on Thursday encourage Full approval of by Pfizer that vaccine protect infants from RSV, but raises concerns about the safety of preterm births that may be associated with injections.
The committee unanimously said the vaccine’s efficacy data were adequate. Ten of the advisors said Pfizer’s injection safety data were adequate, while four said no.
“If the vaccine really matches the data that we see today, I can guarantee that many babies and their parents will breathe easier in the years to come.” City, after voting in favor of the safety and effectiveness of the shot.
Dr Paul Offit, a vaccine specialist at Children’s Hospital of Philadelphia, said he did not believe there was enough data to show the vaccine’s safety was “reliable”.
Offit, who voted against the vaccine’s safety data, said: “If you’re going to risk a premature birth with this vaccine, I think you’re going to pay a heavy price.”
Adam Berger, director of healthcare and clinical research policy at the National Institutes of Health, voted in favor of the injection’s safety and effectiveness but said Pfizer’s post-marketing studies needed consider the risk of preterm birth.
Postmarketing refers to studies performed on a product after receiving FDA approval.
The FDA generally follows the advice of its advisory committees but is not required to do so. The agency is expected to make a final decision on vaccinations in August, just before respiratory syncytial virus season in the fall.
If approved, Pfizer’s vaccine would become the world’s first vaccine to protect infants against RSV – a goal scientists have been aiming for for decades.
FDA earlier this month approved first RSV shot for adults age 60 and older GlaxoSmithKline. The agency is expected to make a decision within weeks Another Pfizer RSV Shot for the same age group.
RSV is a common respiratory infection that causes cold-like symptoms. But older adults and young children are especially susceptible to severe RSV infections.
Every year virus kill 6,000 to 10,000 elderly people and several hundred children under the age of 5, according to the Centers for Disease Control and Prevention. About one in 100 children under 6 months of age with RSV infection may require hospitalization, the CDC says.
Pfizer Infant Injection is given to expectant mothers at the end of the second or third trimester of pregnancy. The single-dose vaccine activates antibodies that are passed on to the fetus, which protects the fetus from RSV from birth until the first six months of life.
Safe and Effective Data Consideration
ONE phase three testing found that Pfizer’s vaccine was nearly 82 percent effective in preventing serious infant RSV illness during the first 90 days of life. The shot is also about 70% effective for the first six months of a baby’s life.
But the advisory panel’s concerns stemmed from the safety data in that trial.
The number of preterm births that occurred in mothers who received the vaccine was slightly higher than in mothers who received the placebo: 5.7% versus 4.7%, respectively.
Both Pfizer and the FDA said the difference did not appear to be statistically significant.
Most babies, even premature, are born after 34 weeks of pregnancy, just a few weeks away from their due date.
But Dr. Hana El Sahly, chair of the FDA’s advisory committee, said “even if it’s a late preterm birth, it’s up to us to put them in preterm while we’re sitting here debating the issue. This subject intellectually is no small matter.”
Premature birth is not a new issue when it comes to the RSV vaccine for babies.
Pfizer rival GSK halted infant RSV vaccine testing after noticing Related data about premature birth and neonatal death, or when a baby dies within the first 28 days of life.
Offit also says that the GSK trial is “hanging” on Pfizer’s own infant RSV injection.
“If GSK actually abandoned a similar, almost identical vaccine program, that would stall. [Pfizer’s] program,” he said during the meeting, “I think it needs to be addressed.”
Portnoy added that being born prematurely is likely to reduce the benefit of the shot.
“The problem is that if the baby is born earlier, that also reduces the effectiveness of the treatment because earlier birth means fewer antibodies are passed on,” he said. “So this is a very complicated thing because now the harm actually makes the benefit less. There’s an interaction between the two.”
But some panel members doubted whether there was a clear cause-and-effect relationship between the vaccine and preterm birth.
Dr Daniel Feikin, scientific adviser and respiratory diseases consultant, who voted in favor of the injection’s safety, said: “Am I worried about imbalances in preterm birth? Yes . Do I believe that to be true? No.”
Pfizer representatives also pushed back on safety concerns, stressing that the benefits of vaccination outweigh the risks.
“Certainly in our eyes, there is no definitive evidence that there is an increased risk of preterm birth,” said Dr William Gruber, senior vice president of clinical research and vaccine development at Pfizer. “So the question is do you hold the potential benefits of vaccines hostage to something you’re not statistically significant at this point?”
Some of the participants’ children also had low birth weights and had developmental delays, the FDA staff review said.
According to an FDA staff review of data, most of the more than 3,000 mothers injected in the trial experienced mild to moderate adverse reactions.
The most common reactions were fatigue, muscle pain, headache, and pain at the injection site. Most reactions resolved within three to four days of vaccination, staff reviews noted.
