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Comirnaty News
CDC Says COVID-19 Cases Rising in 25 States
MONDAY, July 14, 2025 — COVID-19 cases are on the rise again across the United States, with the biggest increases in parts of the South, Southeast and West Coast. The U.S. Centers for Disease Control ...
FDA Medwatch Alert: FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination
FDA Safety Communication June 25, 2025 Purpose: To inform the public and healthcare providers that FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Va...
COVID Vaccine Protects Against Kidney Damage During Infection
MONDAY, June 16, 2025 — Kidney damage is common during a severe case of COVID-19, but vaccination appears to protect people against this life-threatening side effect, a new study says. Unvaccinated C...
RFK Jr. Ends COVID Vaccine Urging for Healthy Kids, Pregnant Women
WEDNESDAY, May 28, 2025 — The top U.S. health agency will no longer recommend the COVID-19 vaccine for healthy children and pregnant women. Tuesday's announcement by U.S. Health and Human Services S...
FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines
THURSDAY, May 22, 2025 — The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines. The updated warnings highlight a rare risk of h...
Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine
NEW YORK & MAINZ, Germany--(BUSINESS WIRE) August 22, 2024 – Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the U.S. Food and Drug Administration (“...
Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine
This season’s vaccine is tailored to the SARS-CoV-2 XBB.1.5 sublineage and indicated as a single dose for most individuals 5 years of age and older Pre-clinical data show that the updated COVID-19 v...
Pfizer and BioNTech Announce U.S. FDA Approval of Their COVID-19 Vaccine Comirnaty for Adolescents 12 Through 15 Years of Age
Comirnaty® is the first and only COVID-19 vaccine to be granted FDA approval for adolescents 12 years and older, following emergency use authorization in May 2021 Approval of the two-dose primary ...
FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older
Comirnaty is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than...