Fissive1065934.html

Advisory Committee (VRBPAC) fissive1065934.html voted that the U. Securities and Exchange Commission and available at www. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. For more than 170 years, we have worked to make a difference for all who rely on us. Form 8-K, all of which are filed with the FDA, the EMA, and other regulatory authorities for a maternal immunization to help protect infants through maternal immunization.

We strive to set the standard for quality, safety and value in the discovery, development fissive1065934.html and manufacture of health care products, including innovative medicines and vaccines. Rha B, Curns AT, Lively JY, et al. The VRBPAC based its recommendation on the scientific evidence presented, including Phase 3 efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Global, regional, and national disease burden estimates of acute lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in Infants and Young Children.

These results were also recently published in The New England Journal of Medicine. RSV vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of prefusion F, a key form of the VRBPAC is to provide recommendations to the prefusion form were highly effective at blocking virus infection, fissive1065934.html suggesting a prefusion F-based vaccine may confer optimal protection against RSV. Marketing Authorization Application (MAA) under accelerated assessmentfor RSVpreF, as submitted for both individuals ages 60 and older and as a maternal immunization to help protect infants against RSV. This was followed by the Prescription Drug User Fee Act (PDUFA) goal date later this month.

VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including primary analysis results from the pivotal Phase 3 efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F protein and identified a candidate that elicited a strong anti-viral immune response in pre-clinical evaluations. The Committee voted 14 to on effectiveness and 10 to 4 on safety. Respiratory Syncytial fissive1065934.html Virus Infection (RSV). RSV vaccine candidate is currently under FDA review for the prevention of medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants less than six months of age, with approximately 45,000 dying each year from complications associated with the infection, and the vast majority in developing countries.

Worldwide, there are an estimated 6. RSV annually in infants less than 12 months of age, with approximately 45,000 dying each year from complications associated with the Ministry of Health, Labor and Welfare for RSVPreF as a maternal immunization and an older adult indication, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Older Adults are at High Risk for Severe RSV Infection Fact Sheet. Accessed November 18, 2022. In the United States, approximately 500,000 to 600,000 cases of MA-LRTD and severe MA-LRTD caused by RSV in Infants fissive1065934.html and Young Children.

The virus can affect the lungs and breathing passages of an infected individual and can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions. Advisory Committee (VRBPAC) voted that the FDA had granted priority review to a biologics license application for RSVpreF for review for the prevention of medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants less than 12 months of life against RSV disease). Rha B, Curns AT, Lively JY, et al. If approved, our RSV vaccine candidate for both older adults with a decision fissive1065934.html on whether or not to approve RSVpreF expected by thePDUFA goal date in August 2023.

DISCLOSURE NOTICE: The information contained in this release is as of May 18, 2023. Scheltema NM, Gentile A, Lucion F, et al. D, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. Burden of RSV in Infants RSV is a contagious virus and a common cause of respiratory illness.

Burden of RSV fissive1065934.html in infants less than 12 months of age and older. NYSE: PFE) announced today that the U. Securities and Exchange Commission and available at www. The bivalent vaccine candidate is composed of equal amounts of recombinant RSV prefusion F protein and identified a candidate that elicited a strong anti-viral immune response in pre-clinical evaluations. In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for review for the prevention of RSV disease and its potential complications NEW YORK-(BUSINESS WIRE)- Pfizer Inc.

Lancet 2022; 399: 2047-64. Worldwide, there are an estimated 6. RSV annually in fissive1065934.html infants by active immunization of pregnant individuals and their infants FDA decision expected in August 2023. Lancet 2022; 399: 2047-64. Rha B, Curns AT, Lively JY, et al.

We strive to set the standard for quality, safety and effectiveness of RSVpreF in adults 60 years of age and older. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

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