FDA Updates Advice to 2024-2025 COVID-19 Formula

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)

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

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

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

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

CDC Raises Delaware’s COVID-19 Community Levels to High in All Counties

CDC RAISES DELAWARE’S COVID-19 COMMUNITY LEVELS TO HIGH IN ALL COUNTIES; DPH ENCOURAGES MASKING IN INDOOR PUBLIC SETTINGS AND VACCINATION DOVER, DE (July 29, 2022) – The Centers for Disease Control and Prevention (CDC) raised Delaware’s COVID-19 community levels to the High category (red) in all three counties on July 28, 2022.    As a result, the Division of Public Health (DPH) is asking Delawareans to follow the CDC’s key strategies at this level of community spread:    ·       Wear a well-fitting mask in indoor public settings, regardless of vaccination status. ·       Stay home if you are sick and get tested if you have symptoms or Read More …

DPH Encourages Eligible Delawareans to Get Boosted Now

DOVER, DE (July 15, 2022) – The Delaware Division of Public Health (DPH) reports that COVID-19 cases experienced an uptick in the daily 7-day average for the percentage of positive tests since the previous monthly COVID-19 update released on June 17, 2022. Since that time, Delaware has also exceeded 3,000 COVID-related deaths. According to the Centers for Disease Control and Prevention’s (CDC) COVID-19 Community Levels data tracker, which was last updated on June 14, case levels in Kent County are considered high, while case levels in New Castle and Sussex Counties are listed as medium. Many people are expressing concerns about getting vaccinated Read More …

Five Pandemics Lead to One Million Deaths

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. 

FDA Limits J&J COVID-19 Vaccine

The FDA yesterday set limits on Johnson & Johnson’s Covid-19 vaccine because of the risk of a clotting disorder discovered weeks after the vaccine was first put into use in spring 2021. The agency said its review of the available data on the risk of thrombosis with thrombocytopenia — or TTS — suggested limiting access to the vaccine is warranted. The condition, though rare, can be fatal. The single-dose vaccine will now be available only to adults 18 and older who would not otherwise agree to be vaccinated or who cannot take one of the other available vaccines for medical Read More …