- An independent panel of advisors at the U.S. Centers for Disease Control and Prevention recommended Pfizer’s maternal vaccine to protect infants from respiratory syncytial virus.
- CDC Director Mandy Cohen must agree with this recommendation before mothers can be vaccinated to protect their infants from RSV.
- The committee’s recommendations put Pfizer’s maternal jab on track to reach the general public as RSV begins to circulate at higher levels.
Doctor vaccinating an infant against respiratory syncytial virus (RSV) in the treatment room of a pediatric clinic.
Swen Pfortner | Picture Alliance | Getty Images
The U.S. Centers for Disease Control and Prevention’s independent advisory committee on Friday recommended Pfizer’s maternal vaccine to protect infants from respiratory syncytial virus. Major cause Infant hospitalization rates in the United States
The 11 advisors recommended that pregnant women between 32 and 36 weeks pregnant be vaccinated between September and January to protect children from RSV. One of the advisors voted against this recommendation.
CDC Director Mandy Cohen would have to agree to that recommendation before giving the vaccine to mothers. Pfizer’s vaccine, called Abrysvo, has already been approved and is available in the United States for adults 60 and older.
The committee’s recommendations put Pfizer’s maternal vaccination on track to become more widely available as RSV begins to circulate at higher levels. Public health officials hope that vaccines and other treatments will help the United States better fight the virus this fall and winter, especially after facing an unusually severe RSV outbreak last year.
RSV usually causes mild cold-like symptoms. However, young children and the elderly are particularly vulnerable to more severe RSV infections.
The virus kills hundreds of children under age 5 and 6,000 to 10,000 older adults each year, according to the CDC. According to the CDC, RSV causes approximately 58,000 to 80,000 hospitalizations among children under 5 years of age each year.
Pfizer said the maternal vaccine could: prevent When vaccinations become available in the U.S. this fall and winter, up to 16,000 people are expected to be hospitalized and more than 300,000 seen for RSV.
“This fall, the annual respiratory infection season begins in the Northern Hemisphere. We are preparing vaccines for multiple infectious diseases and, for the first time in history, an RSV vaccine to help prevent disease in two at-risk populations. ” said Dr. Louis Jodard, Pfizer’s chief medical officer for vaccine medical development.
The company’s single-dose vaccine is the first RSV treatment that leverages maternal immunity. When a pregnant woman is vaccinated, antibodies are induced and passed on to the fetus. This protects newborns from the virus from birth until they are six months old.
When the Food and Drug Administration approved the vaccine, it specified a 32- to 36-week treatment period.
Over the summer, the FDA and CDC approved RSV antibody shots from Sanofi and AstraZeneca for infants, but the treatment is administered directly to infants. The CDC recommended the shot, known as Bayfortus, for all infants under 8 months of age and some older children.
a subgroup CDC Medical Officer Dr. Jefferson Jones said at an advisory meeting Friday that members of the CDC’s advisory committee “feel strongly” that most infants will not need both Bayfortas and Pfizer’s Abrisvo. . That subgroup will review published and unpublished data to develop recommended options to the panel.
“Pregnant women and prenatal care providers need to make decisions during pregnancy about which RSV prevention products to use,” Jones said.
The CDC panel’s recommendation for Pfizer’s maternal vaccine is based on data from a Phase 3 trial of approximately 7,400 participants. However, in this trial, mothers were vaccinated between 24 and 36 weeks of pregnancy, which is a wider period than the approved dosing period.
During the first 90 days of life, the vaccine was nearly 82% effective at preventing severe RSV disease in newborns and 57% effective at preventing infants from visiting the hospital due to RSV-related breathing problems.
Its effectiveness appears to decline slightly over time, so that by six months of age, the Pfizer shot was about 70% effective at preventing serious illness and 51% effective at avoiding visits to the doctor. Ta.
The FDA’s advisory committee generally praised the effectiveness of Pfizer’s maternal vaccine, but expressed concerns about potential safety risks.
In the phase 3 trial, a slightly higher number of preterm births occurred in mothers who received the vaccine compared to mothers who received a placebo: 5.7% vs. 4.7%, respectively.
Pfizer, FDA and CDC staff said the difference was not statistically significant.
Pfizer also sent unpublished data to the CDC advisory committee suggesting that preterm birth rates were reduced in women vaccinated only within the approved dosing window of 32 to 36 weeks of pregnancy, said pediatrician Catherine.・Dr. Fleming Dutra said. The CDC’s National Center for Immunization said at an advisory meeting Friday.
Professor Fleming-Dutra said mothers who received the vaccine during that period had a preterm birth rate of 4.2%, compared with 3.7% for mothers given a placebo.
“The rate of preterm births decreased because there was a reduced chance of premature birth and the approved dosing interval also reduced the disparity between the vaccine and placebo groups,” Fleming-Dutra said.
Still, the prescription label for Pfizer’s vaccine will include a warning not to administer the vaccine before 32 weeks of pregnancy, citing “numerical disparities” in preterm births, the FDA said at the time of its approval.
The FDA is asking Pfizer to investigate the risk of premature birth in post-marketing studies of its vaccine. Postmarket refers to research conducted on a product after it receives FDA approval.
Alejandra Grutman, Pfizer’s senior vice president of vaccine clinical research and development, told CNBC last month that Pfizer’s testing also includes evaluating pregnancy-related complications after vaccination.
This includes eclampsia, which refers to seizures that occur during pregnancy or shortly after birth.
Gartman said Pfizer plans to launch a pregnancy registry that will allow women and their obstetricians to call and report any adverse events that occur after a patient receives the vaccine.
