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Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S.

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01-Jun-2021
Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for the Moderna COVID-19 Vaccine
CAMBRIDGE, Mass. (BUSINESS WIRE) Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older.
“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.” ....

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Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern

Published: May 05, 2021
CAMBRIDGE, Mass. (BUSINESS WIRE) Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced initial data from its Phase 2 study showing that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil). A booster dose of mRNA-1273.351, the Company’s strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273. A manuscript describing these preliminary results has been submitted as a preprint to ....

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Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern

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Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern
Single booster dose of 50 µg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two variants of concern (B.1.351, P.1) in previously vaccinated clinical trial participants
Booster dose of mRNA-1273.351, a strain-matched candidate, achieved higher titers against B.1.351 than a booster dose of mRNA-1273
mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated
Evaluation of a multivalent vaccine booster candidate, mRNA-1273.211, is ongoing; data expected shortly
CAMBRIDGE, Mass. (BUSINESS WIRE) Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced initial data from its Phase 2 study showing that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutra ....

United Kingdom , South Africa , Republic Of South Africa , Lavina Talukdar , Colleen Hussey , Us Department Of Defense , National Institute Of Allergy , Coalition For Epidemic Preparedness Innovations , European Union , Moderna Inc , Centers For Disease , Vaccine Research Center , Company Phase , Us Department Of Health , Biomedical Advanced Research , National Institutes Of Health , Human Services , World Health Organization , Development Authority , Exchange Commission , Corporate Communications , Office Of The , European Medicines Agency , Chief Executive Officer , National Institute , Infectious Diseases ,

Moderna Announces Additional Investments to Increase Global Supply for COVID-19 Vaccine to up to 3 Billion Doses in 2022

Press release content from Business Wire. The AP news staff was not involved in its creation.
Moderna Announces Additional Investments to Increase Global Supply for COVID-19 Vaccine to up to 3 Billion Doses in 2022
April 29, 2021 GMT
CAMBRIDGE, Mass. (BUSINESS WIRE) Apr 29, 2021
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it is making new funding commitments to increase supply at its owned and partnered manufacturing facilities, which it expects will increase global 2022 capacity to up to 3 billion doses of its COVID-19 vaccine, depending upon the mix between the authorized Moderna COVID-19 Vaccine at the 100 μg dose level and potentially lower doses of the Company’s variant booster candidates and pediatric vaccines, if authorized. The Company will use its cash balance to fund these investments. ....

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Moderna (MRNA) Announces Additional Investments to Increase Global Supply for COVID-19 Vaccine to up to 3 Billion Doses in 2022

Moderna (MRNA) Announces Additional Investments to Increase Global Supply for COVID-19 Vaccine to up to 3 Billion Doses in 2022
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