The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of Moderna’s Covid-19 vaccine in adults under the Emergency Use Authorisation (EUA) issued by the US Food and Drug Administration (FDA).
Eleven ACIP members voted in favour of the vaccine and with none voted against.
Moderna and NIAID Vaccine Research Center investigators co-developed the mRNA vaccine, earlier known as mRNA-1273, which encodes for a prefusion stabilised form of the Spike (S) protein.
FDA authorised the vaccine for distribution and use under an EUA and the delivery to the US government will start soon.
Under the EUA, the vaccine will be used for active immunisation to prevent Covid-19 in individuals aged 18 years or older.
The latest suggestion follows the ACIP recommendation in December for a Phase Ia rollout in which the first priority will be given to healthcare workers who are treating patients and residents in long-term care facilities.
This recommendation will be sent to the Director of the CDC and the US Department of Health and Human Services (HHS) for review and adoption.
Moderna CEO Stéphane Bancel said: “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.
“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 committee’s recommendation is based on clinical data supporting the vaccine which comprises results from Moderna’s 30,000 participant Phase III study and ACIP’s interim guidance on the allocation of first doses.
The company will continue to collect additional data and intends to submit a Biologics License Application (BLA) to the FDA requesting full licensure next year.
Moderna plans to supply 20 million doses to the US government by the end of this year.
Last week, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) supported the grant of an EUA to Moderna’s Covid-19 vaccine candidate, mRNA-1273.
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December 21, 2020 at 02:16PM
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US CDC panel recommends Moderna's Covid-19 vaccine for use in adults - pharmaceutical-technology.com
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