Regulatory FDA greenlights Pfizer's RSV vaccine for administration during pregnancy

FDA greenlights Pfizer’s RSV vaccine for administration during pregnancy


In a significant stride toward safeguarding the health of newborns, the Food and Drug Administration (FDA) has granted approval for Pfizer’s groundbreaking vaccine, Abrysvo, to be administered during pregnancy. This move responds to the alarming rate of respiratory syncytial virus (RSV) infections in infants, especially during their first few months of life, when their developing immune systems are most vulnerable. The vaccine, previously authorized for use in older adults, has demonstrated a remarkable ability to transmit immunity to infants from their mothers.

RSV is a common virus recognized for causing cold-like symptoms in the majority of instances. Nevertheless, in infants, the virus can progress to a lower respiratory tract illness, leading to hospitalization for tens of thousands of young children each year. Moreover, adults aged 60 and above are also vulnerable to severe RSV infections. The authorization of Abrysvo in May for utilization among older adults has set the stage for this recent achievement in its use during pregnancy.

Unlike previous attempts that have fallen short, Pfizer’s success with Abrysvo results from a scientific breakthrough that has revolutionized vaccine design. Rigorous clinical trials have substantiated the vaccine’s efficacy and safety profiles in both older adults and pregnant individuals.

Executive director of Pfizer’s vaccine clinical research and development, Iona Munjal shared before FDA’s decision, “A lot is going on in the mom’s life and the baby’s life after birth, and so the ability to just have protection gifted from birth, that’s just really, really magical.”

One of the most remarkable aspects of Abrysvo is its potential to provide maternal immunization. By administering the vaccine to pregnant women between 24 and 36 weeks gestation, Pfizer’s researchers were able to demonstrate that Abrysvo not only protects expectant mothers from the virus but also bestows immunity upon their offspring.

The research, which was made available in The New England Journal of Medicine, unveiled that babies born to mothers who had been vaccinated showed defense against serious lower respiratory tract illness linked with RSV in the first 90 to 180 days following birth. Nonetheless, the vaccine’s effectiveness against less severe variations of the ailment did not meet the initial objective.

Despite this success, the FDA’s approval does come with certain limitations. The vaccine is approved for administration exclusively during weeks 32 to 36 of pregnancy. While the data currently available do not establish a causal relationship between preterm birth and the vaccine, caution is advised, and healthcare providers are advised to refrain from administering the vaccine to pregnant individuals before the 32-week mark. Furthermore, the FDA has stipulated follow-up testing to assess potential risks such as preterm birth and other reported side effects, including pre-eclampsia.

This achievement also marks a turning point in RSV research, as Pfizer’s success is echoed by the approval of GSK’s RSV vaccine. While GSK’s efforts encountered a setback, Pfizer’s breakthrough serves as a beacon of progress, motivating the medical community to explore new avenues for safeguarding vulnerable populations.

With the proven effectiveness and safety of Abrysvo, a panel of advisors for the Centers for Disease Control and Prevention will assemble to formulate usage guidelines. Moreover, scientists are exploring the viability of giving the vaccine to infants born to vaccinated mothers, potentially offering extra safeguarding.

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