La Commissione Europea avrebbe la possibilità di acquistare ulteriori 80 milioni di dosi per un totale fino a 160 milioni di dosi
Moderna , la società di biotecnologia che sta sperimentando terapie e vaccini con RNA messaggero (mRNA) per creare una nuova generazione di farmaci trasformativi per i pazienti, ha annunciato oggi che la Società ha concluso colloqui esplorativi avanzati con la Commissione Europea per fornire 80 milioni di dosi di mRNA-1273, il candidato vaccino di Moderna contro la COVID-19, come parte dell'obiettivo della Commissione Europea di garantire un accesso anticipato a vaccini COVID-19 sicuri ed efficaci per l'Europa.
L'accordo potenziale con la Commissione Europea per l'acquisto di 80 milioni di dosi prevede la possibilità per gli Stati membri di acquistare ulteriori 80 milioni di dosi per un totale fino a 160 milioni di dosi.
The discussions are intended to ensure that Member States have access to Moderna’s
vaccine. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000
participants is ontrack to complete inSeptember. Moderna is scaling up global manufacturing to be
able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year,
beginning in 2021. In Europe, the Company is working with its strategic manufacturing partners,
Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside of the United
States. This is a dedicated supply chain to support Europe and countriesother than the United States
that enter into purchase agreements with Moderna.
“We appreciate the European Commission’s collaboration in helping to ensure that Europeans will
have access to a safe and effective vaccine, and we are proud that the European Commission has
recognized the potential of our mRNA vaccine technology. European partners, investors and citizens
have been part of Moderna from the beginning of the company and have played an important role
in Moderna’s progress,” said Stéphane Bancel, CEO of Moderna. “We are scaling up our
international manufacturing capacity outside of the United Stateswith our strategic partners, Lonza
in Switzerland and Rovi in Spain, to be in a position to address this global health emergency with a
vaccine that is widely available once approved for use.”
Over the past nine years, Moderna has invested in creating and developing a novel platform for
designing and manufacturing a new class of mRNA-based vaccines. The investments in this
proprietary platform have enabled Moderna to expeditiously create, manufacture and clinically
develop mRNA-1273 to potentially address the current COVID-19 pandemic. A summary of the
company’s work to date on COVID-19 can be found here.
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilizedform of the
Spike (S) protein, which was co-developed byModerna and investigators from the National Institute
of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center. The first clinical batch,which
was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7,
2020 and underwent analytical testing; itwas shipped to the National Institutes of Health (NIH) on
February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1study of
mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On
May 12, the FDA granted mRNA-1273Fast Track designation. On May 29, the first participants in
each age cohort: healthy adults ages 18-55 years (n=300) and older adults ages 55 yearsand above
(n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 studycompleted
The Phase 3 COVE study of mRNA-1273, being conducted in collaboration with the NIH and the
Biomedical Advanced Research and Development Authority (BARDA), began on July 27; enrollment is
on track tocomplete in September. Results from a non-human primate preclinical viral challenge
study evaluating mRNA-1273 were recently publishedin TheNew England Journal of Medicine. On
July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was
publishedinThe New England Journal of Medicine.