Moderna Highlights Publication of Antibody Persistence Data of its COVID-19 Vaccine out to 6 Months in the New England Journal of Medicine
Moderna, Inc. (Nasdaq: MRNA) announced the publication of data in The New England Journal of Medicine showcasing the persistent antibody response achieved by its COVID-19 vaccine six months post-second dose. The study involved 33 participants from a Phase 1 trial, confirming robust antibody levels, aligning with prior findings on natural COVID-19 immunity. Ongoing studies will further evaluate immune responses. Moderna is also advancing its clinical strategy to combat emerging variants and enhance vaccine efficacy as part of its commitment to addressing the pandemic.
- Publication of antibody persistence data underscores vaccine efficacy.
- Evidence of antibody persistence for up to six months post-vaccination.
- Ongoing studies enhance confidence in vaccine's protective capabilities.
- None.
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today highlighted the publication of antibody persistence data out to 6 months following the second dose of the Moderna COVID-19 Vaccine in The New England Journal of Medicine.
“We are pleased that this new data shows antibody persistence through 6 months following the second dose of our COVID-19 vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “This gives us further confidence in the protection afforded by our COVID-19 vaccine. We remain committed to continuing to address the COVID-19 pandemic.”
This study analyzed 33 healthy adult participants in the NIH-led Phase 1 study of Moderna’s COVID-19 Vaccine at 6 months following the second 100 μg dose (day 209). As detected by three distinct serologic assays, antibodies elicited by the Moderna COVID-19 vaccine persisted through 6 months after the second dose. Antibody decay was estimated using two approaches and was consistent with published observations of convalescent patients with COVID-19 through 8 months after symptom onset.
Studies monitoring immune responses beyond 6 months are ongoing. Out of an abundance of caution, Moderna is also pursuing a clinical development strategy against emerging variants. Additionally, NIAID, part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial to assess the monovalent and multivalent modified mRNA-1273 vaccines as a primary series in naïve individuals and as a booster vaccine in those previously vaccine with mRNA-1273.
About the Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 2020, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing. On May 12, 2020, the U.S. FDA granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, 2020, the first participants in each age cohort were dosed in the Phase 2 study of the vaccine. On July 8, 2020, the Phase 2 study completed enrollment.
Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29, 2020 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization.
The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.
AUTHORIZED USE
Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
IMPORTANT SAFETY INFORMATION
- Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
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Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (
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FAQ
What does the latest Moderna press release say about the COVID-19 vaccine?
Moderna highlights data showing antibody persistence for six months after the second dose of its COVID-19 vaccine, indicating strong immune response.What are the implications of the antibody persistence data for MRNA stock?
The data could boost investor confidence in MRNA's vaccine efficacy and long-term prospects, positively impacting stock performance.When was the antibody persistence data published by Moderna?
The data was published in The New England Journal of Medicine following the completion of a study analyzing 33 participants.How does Moderna plan to address emerging COVID-19 variants?
Moderna is pursuing a clinical development strategy focused on adapting its vaccines to effectively combat emerging variants.
