Moderna COVID-19 Vaccine Spikevax® XBB.1.5 Clinical Trials, Dosage, Efficacy, News, Side Effects
Moderna Inc.'s Spikevax® COVID-19 Vaccine is a Messenger RNA (mRNA) vaccine targeted against the SARS-CoV-2 betacoronavirus to prevent severe COVID-19. SpikeVax encodes for a prefusion stabilized form of the Spike (S) protein selected by Moderna Inc. in collaboration with U.S. NIAID Vaccine Research Center investigators. SpikeVax's active ingredient is CX-024414 (single-stranded, 5’-capped mRNA), produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the S protein of the SARS-CoV-2 virus.
Moderna Inc. designs its mRNA vaccines using the virus's sequence but not the virus itself. mRNA is a single-stranded molecule that carries genetic code from DNA in a cell's nucleus to ribosomes, the cell's protein-making machinery. The mRNA instructs a patient's cells to produce proteins that prevent, treat, or cure disease. Moderna says mRNA plays a fundamental role in human biology, transferring the instructions stored in DNA to make the proteins required in every living cell.
On December 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA). SpikeVax (elasomeran mRNA vaccine) Accession Number: DB15654; Preferred Substance Name: CX-024414; UNII: EPK39PL4R4; MedlinePlus a621002. On January 24, 2023, the FDA published a Briefing Document, Future Vaccination Regimens Addressing COVID-19. During the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) digital meeting on January 26, 2023, Moderna's Antonella Lozito, PharmD Executive Director, presented COVID-19 Bivalent Vaccines Primary Series and Booster. The FDA published a Briefing Document on June 15, 2023.
On September 6, 2023, Moderna announced its updated COVID-19 vaccine mRNA-1273.815, which generated an 8.7-fold increase in neutralizing antibodies in humans against the BA.2.86 (Pirola) variant. On September 11, 2023, the FDA approved the supplemental Biologics License Application(sBLA) for Spikevax® for ages 12 years and above. An EUA for the Moderna COVID-19 Vaccine was also received for individuals six months through 11 years of age. Health Canada and the European Medicines Agency (EMA) have authorized the Spikevax XBB.1.5 COVID-19 vaccine for people six months of age and older in September 2023.
On January 5, 2024, The Lancet Infectious Diseases published results from a study - Short-term effectiveness of the XBB.1.5 updated COVID-19 vaccine against hospitalization in Denmark: a national cohort study - The early results from cohort analyses with national health registry data in Denmark indicate a high level of protection from the XBB.1.5 vaccine, vaccination was associated with a 76·1% reduced risk of COVID-19 hospitalization in a population vaccinated with a booster dose the previous season.
On May 2, 2024, Moderna Inc. reported total revenue for the first quarter of 2024 was $167 million, compared to $1.9 billion in the same period in 2023. The decline was primarily due to reduced sales of the Company's COVID-19 vaccine. The Company reported $2.8 billion in Spikevax® (COVID-19 vaccine) sales in the fourth quarter of 2023, which includes $0.8 billion in U.S. sales and $2 billion in international sales. This led to $6.7 billion in vaccine sales for fiscal 2023.
Moderna, Inc. is advancing mRNA science to create a new transformative medicine class for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane, or secreted proteins that can have a therapeutic or preventive benefit and potentially address a broad spectrum of diseases. They are headquartered in Cambridge, MA. Moderna Inc.'s 10-Q SEC filing on January 4, 2021, indicates that 'mRNA is considered a gene therapy product by the U.S. FDA' (pINN elasomeran). To learn more, visit www.modernatx.com.
SpikeVax XBB.1.5 Vaccine Dosage
Moderna's COVID-19 vaccines are offered in various doses, subject to country-based authorizations. On June 5, 2024, Frances Priddy, MD MPH Executive Director, Clinical Development Moderna, Inc., presented the Safety and Effectiveness of Moderna 2023-2024 (XBB.1.5) COVID-19 Vaccine. On November 1, 2023, the FDA issued an advisory for healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals six months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial so that the correct dose is administered to the vaccine recipient. To provide clarification, the Dosage and Administration section of the Fact Sheet for Healthcare Providers Administering Vaccines has been revised.
SpikeVax Vaccine History
The first clinical batch of the Moderna vaccine candidate (CX-024414), funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020.
SpikeVax News
April 22, 2024 - "We are proud to partner with the Ministry of Health to provide our mRNA COVID-19 vaccine for the first time in Brazil as part of the national vaccination campaign," said Stéphane Bancel, Chief Executive Officer of Moderna.
COVID-19 Vaccine (Moderna) Clinical Trials
Moderna continues to run clinical trials to evaluate the safety, immunogenicity, and reactogenicity of its COVID-19 vaccine.
Moderna's Phase 3 clinical trial of its next-generation COVID-19 vaccine (mRNAhich is designed to be refrigerator-stable, and it is fully enrolled. The Company anticipates data from the study in the first half of 2024.
