FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines …
Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is...
FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better …
Approval of Spikevax (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, a change to a single dose for individuals 18 years of age and older, and approval of a single dose for individuals...
Spikevax (COVID-19 Vaccine, mRNA) 2024-2025 Formula - Moderna
Learn about Moderna's Spikevax® (COVID-19 Vaccine, mRNA) 2024-2025 Formula and how it helps protect against emerging variants, following ACIP recommendation.
News Details
Aug 22, 2024 · CAMBRIDGE, MA / ACCESSWIRE / AUGUST 22, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above.
The Updated COVID Vaccines Are Here: 9 Things to Know
Apr 19, 2024 · The Food and Drug Administration (FDA) authorized the updated vaccines by Pfizer-BioNTech and Moderna for infants and children ages 6 months to 11 years, and approved them for everyone ages 11 years and older. It also authorized an updated Novavax vaccine for those 12 and older in the fall of 2023.
Moderna Files FDA Application for the JN.1 Targeting COVID-19 …
Jun 7, 2024 · CAMBRIDGE, MA / ACCESSWIRE / June 7, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1.
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine
Sep 11, 2023 · SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
Coronavirus (COVID-19) Update: FDA Takes Key Action by …
Jan 31, 2022 · Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for...
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine Spikevax
Jan 31, 2022 · Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine Spikevax. Approval based on a comprehensive submission package including efficacy and safety data approximately six months after second dose. SPIKEVAX has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel. 807 ...
MHRA approves Spikevax JN.1 COVID-19 vaccines for adults and …
Sep 2, 2024 · The MHRA has approved an adapted Moderna COVID-19 vaccine (Spikevax) that targets the JN.1 COVID-19 subvariant. On 2 September 2024, The Medicines and Healthcare products Regulatory Agency (MHRA...