מודרנה קיבלה אישור FDA לחיסון לקורונה בארה"ב

Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.
December 19, 2020

U.S. FDA authorizes mRNA vaccine against COVID-19 for emergency use Total of 200 million doses ordered by the U.S government to date; U.S. government retains option to purchase up to an additional 300 million doses
Approximately 20 million doses will be delivered by the end of December 2020 Moderna intends to submit a Biologics License Application for full U.S. licensure in 2021 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 18, 2020-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration’s (FDA) has authorized the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older.

The Moderna COVID-19 Vaccine is now authorized for distribution and use under an Emergency Use Authorization (EUA). Delivery to the U.S. Government will begin immediately. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021.

“I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. I want to thank the NIH and NIAID for their scientific leadership and our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. I also want to thank the Moderna team, our suppliers and our partners for their tireless work across research, development and manufacturing of our vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. 

“I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants. It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

Under Operation Warp Speed, the Department of Defense (DoD), in partnership with the Department of Health and Human Services (HHS) and the U.S. Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the United States. Allocation and distribution will be prioritized according to populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP).

Approximately 20 million doses will be delivered to the U.S. government by the end of December 2020. The Company expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the U.S. Moderna would also like to underscore the importance of the CARES Act — and thank its bipartisan Congressional champions — specifically with respect to its significant commitment in funding to enable BARDA and Operation Warp Speed to simultaneously fund development and manufacturing ahead of approval.

The FDA based its recommendation on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30. The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%. 

The most common solicited adverse reactions (ARs) after the two-dose series included injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%). While the majority of these ARs were grade 1 (mild) or grade 2 (moderate), there was a higher occurrence of grade 3 (severe) reactions after the second injection. The majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for a median of one to two days. Safety data continue to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH). All participants in the COVE study will continued to be monitored for two years for the duration of the study to assess long-term protection and safety.