The Food and Drug Administration (FDA) has granted approval for a new vaccine developed by Pfizer to protect infants from respiratory syncytial virus (RSV), which is the leading cause of hospitalization among babies in the U.S. Pfizer’s RSV shot is already available for older adults. This vaccine is the second treatment approved by the FDA to prevent RSV in infants and the first vaccine. It utilizes maternal immunization, where pregnant mothers are vaccinated to pass protective antibodies to their fetuses.
Pending a recommendation from the Centers for Disease Control and Prevention (CDC), Pfizer aims to make the vaccine available to the public by the end of October or the beginning of November, coinciding with the start of the RSV season. Alejandra Gurtman, Pfizer’s senior vice president of clinical research and development for vaccines, states that this vaccine could have a significant global public health impact. Dr. Peter Marks, the FDA’s vaccine head, believes that this approval provides another option to protect infants from this potentially life-threatening disease.
In July, the FDA approved an RSV monoclonal antibody from Sanofi and AstraZeneca that is directly administered to infants. The CDC recommended this drug for all infants under eight months of age and some older babies. The CDC’s panel of advisors is expected to meet and consider a recommendation for Pfizer’s vaccine in October. However, since Pfizer’s vaccine is not given to infants, it remains unclear how it will compare to the guidelines set for the first treatment.
Pfizer’s vaccine is specifically administered to expectant mothers in the late second or third trimester of pregnancy. It is a single-dose vaccine that triggers antibodies passed to the fetus, offering protection against RSV from birth through the first six months of life. Although RSV typically causes mild cold-like symptoms, it poses a greater risk to younger children and older adults.
The virus causes several hundred deaths in children under five and thousands of deaths in seniors each year. Pfizer’s vaccine can help the U.S. combat the upcoming RSV season, which follows an unusually severe year. The spread of RSV overwhelmed hospitals across the country as the public discontinued COVID-19 health measures.
The FDA based its approval of Pfizer’s vaccine on data from a phase three trial, which showed the vaccine to be nearly 82% effective at preventing severe RSV disease in newborns during the first 90 days of life. The vaccine also showed an effectiveness of approximately 70% during the first six months. The FDA’s panel of advisors unanimously agreed in May that the data demonstrated Pfizer’s vaccine’s effectiveness.
However, some advisors expressed concerns about safety. The data showed a slightly higher rate of premature births among mothers who received the vaccine compared to those who received a placebo: 5.7% versus 4.7%, respectively. The FDA stated that the available data are insufficient to establish or exclude a causal relationship between preterm birth and Pfizer’s vaccine.
Pfizer’s Gurtman emphasized that the difference in premature birth rates was not statistically significant. She pointed out that most premature births occurred 30 days after vaccination, and a direct causal relationship could not be identified. Countries like the U.S. and Japan, which fall into the upper-middle-income category, did not observe a higher rate of premature births among mothers who received the vaccine.
Nevertheless, Pfizer plans to conduct a post-marketing study on the vaccine to examine any potential risks. Additionally, the company will launch a pregnancy registry to gather information on any adverse events following vaccination. This registry will offer a platform for women and obstetricians to report any complications or concerns related to the vaccine.
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