Category: COVID-19

FDA Approves and Authorizes 2024-2025 COVID-19 Vaccines

Posted on by Kate Smith

FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants August 22, 2024 – Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Read More …

FDA Updates Advice to 2024-2025 COVID-19 Formula

Posted on by Kate Smith

Based on the totality of the evidence, on June 6, 2024, FDA initially advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States beginning in fall 2024 should be monovalent JN.1 vaccines. FDA has continued to monitor the circulating strains of SARS-CoV-2.  Based on the most current available data, along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible. Read more

Moderna Receives U.S. FDA Approval for RSV Vaccine mRESVIA(R)

Posted on by Kate Smith

May 31, 2024 CAMBRIDGE, MA / ACCESSWIRE / May 31, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna. “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” said Stéphane Bancel, Chief Executive Officer of Moderna. “mRESVIA protects older adults Read More …

FDA Authorizes Updated Novavax COVID-19 Vaccine

Posted on by Kate Smith

October 3, 2023. Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses. Read More

Updated COVID-19 Vaccine Availability Expected Within Next Week

Posted on by Kate Smith

DOVER, Del. (Sept. 15, 2023) –  This week, the Centers for Disease Control and Prevention (CDC) issued the recommendation that everyone 6 months and older get an updated COVID-19 vaccine to protect against the potentially serious outcomes of COVID-19 illness this fall and winter.  The recommendation follows the Food and Drug Administration’s (FDA) action approving and authorizing for emergency use updated COVID-19 vaccines from Pfizer/BioNTech and Moderna formulated to more closely target currently circulating variants.  Per the CDC, vaccination remains the best protection against COVID-19-related hospitalization and death and reduces the chance of suffering from Long COVID.  Anyone who has yet to receive any type of Read More …

FDA Approves Updated COVID-19 Vaccines

Posted on by Kate Smith

Yesterday, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Read More

Five Pandemics Lead to One Million Deaths

Posted on by Kate Smith

There have really been five pandemics, J. Emory Parker shows us in grim data visualizations, and SARS-CoV-2 still leaves us with mysteries to be solved and promises to better prepare for the next pandemic. What was once a nagging suspicion has turned into solid certainty that it didn’t have to be this bad.