The FDA has approved Pfizer’s RSV vaccine, Abrysvo, for adults aged 18 to 59 who are at increased risk of lower respiratory tract disease caused by RSV, expanding its previous indication for adults aged 60 and older.
The FDA has approved Pfizer’s RSV vaccine, Abrysvo, for adults aged 18 to 59 who are at increased risk of lower respiratory tract disease caused by RSV, expanding its previous indication for adults aged 60 and older.
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The FDA has approved and authorized updated Moderna and Pfizer-BioNTech COVID-19 vaccines for the 2024-2025 season, designed to target current variants.
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The vaccine candidate showed strong responses against influenza A and COVID-19 but did not meet its goal for influenza B.
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Pfizer’s Abrysvo demonstrated a strong immune response and favorable safety profile in immunocompromised adults at high risk of severe RSV.
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After five years, 60% of patients remain alive without disease progression, compared to 8% on the crizotinib treatment arm.
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The Cleveland Clinic ReCOVer Clinic is enrolling Long COVID patients in the NIH RECOVER-VITAL clinical study.
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The vaccine was approved for older adults and infants through maternal immunization.Â
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The FDA approved the combination therapy—previously approved for certain metastatic melanoma patients—for the treatment of metastatic non-small cell lung cancer with a BRAF V600E mutation.
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Members of the Advisory Committee on Immunization Practices voted 11-1 to recommend the maternal RSV vaccine for pregnant people to prevent RSV lower respiratory tract infection in infants.Â
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The mRNA vaccines are formulated to more closely target currently circulating variants by including a monovalent component that corresponds to the Omicron variant XBB.1.5.
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The companies also filed an application with the FDA requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older.
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The US FDA expanded Pfizer’s Abrysvo (RSV vaccine) for use during pregnancy to prevent LRTD caused by RSV in infants from birth through 6 months of age.
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The FDA approved Abrysvo for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years and older.Â
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Pfizer’s Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
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The vaccine builds on the company’s previously approved vaccine by including seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases.Â
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The FDA expanded emergency use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent as a single booster dose for children 6 months through 4 years of age.
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FDA panel favors approval for two RSV vaccines, ‘Tripledemic’ hits US households, and a monoclonal antibody may be ready for next season—here are five RSV stories you should check out this week.
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The FDA accepted Biologics License Applications and granted priority review for both Pfizer and GSK’s RSV older adult vaccine candidates last year following positive data from phase 3 trials.Â
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The FDA has authorized bivalent COVID-19 vaccines from Moderna and Pfizer-BioNTech as a single booster dose in younger age groups, according to the agency.
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The FDA authorized updated bivalent COVID vaccines from Moderna and Pfizer-BioNTech for use as single booster doses at least two months following primary or booster vaccination.
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Updated Covid booster shots targeting omicron’s BA.5 subvariant should be here within in the next three weeks.
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The FDA approved the Pfizer/BioNTech SARS-CoV-2 vaccine (Comirnaty) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age.
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COVID-19 vaccines reduced the potential global death toll during the pandemic by more than half in the year following their implementation, a mathematical modeling study published in The Lancet Infectious Diseases estimates.
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The FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 for in children as young as 6 months old.Â
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