SPIKEVAX XBB.1.5 (andusomeran) / Moderna - LARVOL DELTA

Short-Term Safety and Adverse Event Risk Profiles for SARS-CoV-2 Booster Vaccine Doses in Australian Adults: A Survey Study. (PubMed, Med J Aust) - "The results of this study confirm the short-term safety and low impact on daily living of SARS-CoV-2 booster vaccine administration to Australian adults."

Adverse events • Journal • Fatigue • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE (clinicaltrials.gov) - P=N/A | N=4207 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2028 ➔ Mar 2029 | Trial primary completion date: Dec 2028 ➔ Mar 2029

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection. (clinicaltrials.gov) - P=N/A | N=4206 | Recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Dec 2026 ➔ Dec 2028

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran (clinicaltrials.gov) - P=N/A | N=15196685 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed | N=10000000 ➔ 15196685

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Andusomeran and raxtozinameran for prevention of COVID-19 disease. (PubMed, Aust Prescr) - No abstract available

Journal • Review • Infectious Disease • Novel Coronavirus Disease

Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran (clinicaltrials.gov) - P=N/A | N=10000000 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection. (clinicaltrials.gov) - P=N/A | N=3300 | Recruiting | Sponsor: ModernaTX, Inc.

New trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran (clinicaltrials.gov) - P=N/A | N=10000000 | Recruiting | Sponsor: ModernaTX, Inc.

New trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5 (European Medicines Agency) - "EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant...The vaccine — known as Spikevax XBB.1.5 — is to be used for preventing COVID-19 in adults and children from 6 months of age.....In line with previous recommendations by EMA and the European Centre for Disease Prevention and Control (ECDC), adults and children from 5 years of age who require vaccination should have a single dose, irrespective of their COVID-19 vaccination history. Children from 6 months to 4 years of age may have one or two doses depending on whether they have completed a primary vaccination course or have had COVID-19....In its decision to recommend the authorisation, the CHMP considered all the available data on Spikevax and its other adapted vaccines. In addition, the committee assessed laboratory data showing that the adapted vaccine is able to trigger an adequate immune response against XBB.1.5."

European regulatory • Novel Coronavirus Disease

MODERNA RECEIVES HEALTH CANADA AUTHORIZATION FOR UPDATED COVID-19 VACCINE FOR AGES SIX MONTHS AND OLDER (Canada Newswire) - "Moderna Biopharma Canada Corp. today announced Health Canada has authorized its updated COVID-19 vaccine, SPIKEVAX® XBB.1.5, to prevent COVID-19 in individuals 6 months of age and older.i Now approved for use, Moderna's updated COVID-19 vaccine will be available to provinces and territories to coordinate their fall vaccination campaigns....Moderna's submission to Health Canada contained clinical data showing an immune response against SARS-CoV-2 XBB sublineages including XBB.1.5 and XBB.1.16. In addition to the data included in the submission, Moderna has recently released further clinical trial data concerning the ongoing evaluation of SPIKEVAX XBB.1.5 against circulating subvariants like BA.2.86, EG.5, and FL.1.5.1."

Canadian regulatory • Infectious Disease • Novel Coronavirus Disease