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 ...
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...
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 Files FDA Application for the JN.1 Targeting ...
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 Full U.S. FDA Approval for COVID-19 ...
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 ...
Moderna’s Mixed Performance: Strong Spikevax Sales Drive Q3 …
Nov 7, 2024 · The company exceeded expectations with its Spikevax revenue, notably due to an earlier approval that allowed for a rapid uptake in retail channels. This success drove Moderna’s Q3 sales to $1.8 ...
Spikevax (previously COVID-19 Vaccine Moderna)
Jan 6, 2021 · Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.
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...
Moderna Gets Better-Than-Expected Q3 COVID-19 Vaccine Sales …
6 days ago · Moderna reported diluted earnings-per-share of $0.03 in Q3 versus analysts’ expectations of a $1.91-per-share loss. Moderna’s Q3 beat was driven by a surprise surge in sales of its COVID-19 vaccine Spikevax, which brought in $1.8 billion in the quarter, representing 3.5% year-on-year growth. Spikevax also comfortably exceeded the consensus ...