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The Food and Drug Administration on Monday approved a Pfizer vaccine that protects infants against respiratory syncytial virus, the leading cause of hospitalization among infants in the United States.
Pfizer’s RSV shot is now approved and available for older adults in the United States.
It is now the second treatment and first vaccine approved by the FDA to prevent RSV in infants. It uses maternal immunization, which involves vaccinating pregnant mothers so that they can pass protective antibodies to their fetuses.
Awaiting a recommendation from the Centers for Disease Control and Prevention, Pfizer hopes to make the vaccine available to the public in late October or early November, marking the start of RSV season, according to the company’s senior vice president, Alejandra Gurtman. president of clinical research and development for vaccines.
“If you think about it globally, this vaccine could potentially have a huge public health impact,” Gurtman told CNBC. “After 50 years of trying to find a way to protect babies in the first three or especially six months of life, this vaccine is something I’m very proud of.”
FDA vaccine chief Dr. Peter Marks added in a statement that the approval provides another option for health professionals and pregnant women to “protect babies from this potentially life-threatening disease.”
The FDA approved an RSV monoclonal antibody in mid-July Sanofi and AstraZeneca given directly to babies. The CDC recommends this drug for all babies younger than eight months and some older babies.
The agency’s advisory panel is expected to meet in October to review the recommendation on the Pfizer vaccine, but it is unclear how it compares to guidelines for first-time treatment because it is not given to infants.
Pfizer jab is especially applied to mothers-to-be in the second or third trimester of pregnancy. The single-dose vaccine triggers antibodies that are transferred to the fetus, which protects it from RSV for the first six months of life.
RSV usually causes mild cold-like symptoms. However, young children and older adults are particularly susceptible to more severe RSV infections.
Each year, the virus kills several hundred children under the age of 5 and 6,000 to 10,000 children, according to the CDC.
The shot will help the US deal with the upcoming RSV season, which is an unusually severe year.
Cases of the virus in children and older adults have overwhelmed hospitals across the country, largely because the public stopped practicing the Covid pandemic health measures that helped spread RSV.
Safety and efficacy data
The FDA’s approval of the Pfizer vaccine was based on data from a phase 3 trial showing that the vaccine is about 82% effective in preventing severe RSV disease in newborns during the first 90 days of life.
The vaccine was also about 70% effective during the first six months of a baby’s life.
In May, an FDA advisory panel unanimously said the data showed the Pfizer vaccine was effective.
Respiratory syncytial virus – a viral vaccine under investigation
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But some advisers have expressed concerns about security.
The number of preterm births was slightly higher among mothers who received injections compared to those who received placebo: 5.7% and 4.7%, respectively.
The FDA said after Monday’s approval that available data were “insufficient to establish or exclude a causal relationship between preterm birth” and the Pfizer vaccine.
Pfizer’s Gurtman also said the difference in preterm birth rates was “not statistically significant.”
He noted that the majority of preterm births occurred within 30 days of vaccination, meaning “a very close causal relationship between the vaccine and preterm birth could not be established.”
“We couldn’t find any reason why this actually happened,” Gurtman said.
He added that some upper-middle-income countries, including In the United States and Japan, mothers who received the vaccine did not have a higher rate of preterm births.
Still, Gurtman said Pfizer will examine the risks in a post-marketing study of the vaccine. “Post-marketing” refers to research conducted on a product after receiving FDA approval.
He added that the company’s post-marketing will also include evaluating any pregnancy-related complications after the vaccine. This includes eclampsia, which refers to seizures that develop during pregnancy or shortly after birth.
According to Gurtman, Pfizer will launch a pregnancy registry that will allow women and midwives to call and report any adverse events after receiving the vaccine.
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