Moderna Inc (MRNA)

[blanka]

Moderna, Inc.
December 19, 2020 9:44 PM EST
U.S. CDC Advisory Committee on Immunization Practices Recommends Vaccination with Moderna’s COVID-19 Vaccine for Persons 18 Years and Older
Recommendation follows yesterday’s U.S. FDA authorization for emergency use of the Moderna COVID-19 Vaccine

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 19, 2020-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to recommend the use of the Moderna COVID-19 vaccine in people 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). The committee is comprised of independent health experts. 11 ACIP members voted in favor of the vaccine and 0 members voted against.

Today’s ACIP recommendation follows the December 1, 2020 ACIP recommendation for a Phase 1a rollout in which the first priority for COVID-19 vaccines is given to healthcare personnel treating patients and residents in long-term care facilities. This ACIP recommendation will be forwarded to the Director of the CDC and the U.S. Department of Health and Human Services (HHS) for review and adoption.

“Since we began this journey in January, our goal has always been to protect as many people as possible and this ACIP recommendation is another step forward in our quest to address this devastating pandemic with a vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Healthcare workers have been on the front lines of the fight against the virus and are an inspiration to us all. We look forward to vaccinations of this important population starting this week.”

The ACIP advises the CDC on the populations and circumstances for which vaccines should be used. The Committee based its recommendation on clinical evidence supporting the Moderna COVID-19 Vaccine including data from Moderna’s 30,000 participant Phase 3 study and ACIP’s interim guidance on the allocation of initial vaccine doses. The Moderna COVID-19 Vaccine was authorized for distribution and use under an EUA on December 18, 2020. The EUA for the Moderna COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use, unless terminated or revoked. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021.

Under Operation Warp Speed, the U.S. Department of Defense (DoD), in partnership with HHS and the CDC, will manage allocation and distribution of the vaccine in the United States. 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.

Please see the EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.modernatx.com/covid19vaccine-eua.