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On Monday, the Food and Drug Administration (FDA) gave its nod to a vaccine developed by Pfizer, designed to safeguard infants against respiratory syncytial virus (RSV), which stands as the primary cause of hospitalizations among infants in the United States. This move follows the prior approval and availability of Pfizer’s RSV vaccine for older adults within the country.
This marks the second FDA-approved treatment aimed at preventing RSV in infants, and notably, it is the first vaccine for this purpose. The approach involves maternal immunization, wherein pregnant mothers are vaccinated to transmit protective antibodies to their developing fetuses.
Subject to a recommendation from the Centers for Disease Control and Prevention (CDC), Pfizer envisions the vaccine’s availability to the public by either the end of October or the start of November. This timeline coincides with the commencement of the RSV season, as indicated by Alejandra Gurtman, Pfizer’s Senior Vice President of Clinical Research and Development for Vaccines. Gurtman shared with CNBC that on a global scale, this vaccine could potentially yield substantial public health benefits. She expressed her pride in this achievement, highlighting that after five decades of striving to find a solution for protecting infants, especially within their initial three to six months of life, this vaccine stands as a remarkable accomplishment.
Dr. Peter Marks, leading the FDA’s vaccine efforts, further emphasized in an official statement that this approval introduces an additional choice for healthcare professionals and expectant individuals to shield infants from the risks posed by this potentially fatal ailment. In the middle of July, the FDA granted approval for an RSV monoclonal antibody developed by Sanofi and AstraZeneca. This antibody is directly administered to infants. Subsequently, the CDC extended its endorsement of this medication to encompass all infants below the age of eight months, as well as certain older infants.
The advisory panel of the agency is scheduled to convene in October to evaluate and potentially provide a recommendation for Pfizer’s vaccine. However, the extent to which this recommendation aligns with the guidelines established for the initial treatment remains uncertain, given that Pfizer’s vaccine is not administered directly to infants. Instead, it is specifically given to expectant mothers during the later stages of their second or third trimester of pregnancy. This single-dose vaccine induces the production of antibodies that are subsequently transferred to the fetus, furnishing protection against RSV from birth throughout the initial six months of life.
Typically, RSV induces mild symptoms resembling a common cold. Nevertheless, it poses a heightened risk of more severe infections, particularly in younger children and elderly individuals. The CDC reports that annually, the virus claims the lives of several hundred children under the age of 5, as well as between 6,000 to 10,000 senior citizens. Given that the U.S. is emerging from an exceptionally intense RSV year, this vaccine would play a pivotal role in fortifying the nation against the impending RSV season.
