Moderna Confirms Discussions with U.S. Government for Additional 100 Million Doses of the Moderna COVID-19 Vaccine
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today confirmed that the Company is in discussion with the U.S. government to purchase an additional 100 million doses of the Moderna COVID-19 Vaccine for delivery in the third quarter of 2021.
To date, the U.S. government has agreed to purchase 200 million doses of the Moderna COVID-19 Vaccine. This new purchase would bring the U.S. government’s confirmed order commitment to 300 million doses.
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Moderna will continue to leverage the Company’s U.S.-based manufacturing infrastructure to supply the Moderna COVID-19 Vaccine to the U.S. government. The Moderna COVID-19 Vaccine received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) on December 18, 2020 and Moderna began supplying to the government shortly thereafter.
AUTHORIZED USE IN THE UNITED STATES:
The Moderna COVID-19 Vaccine has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) 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.
- 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 (https://www.cdc.gov/vaccines/covid-19/).
- Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine.
- The Moderna COVID-19 Vaccine may not protect all vaccine recipients.
- Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.
- Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
- There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.
- Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.
- Vaccination providers must complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words " Moderna COVID- 19 Vaccine EUA " in the description section of the report.