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Moderna Expects To Provide Up To 125 Mln COVID-19 Vaccine Doses Globally In Q1

Moderna Inc. (MRNA) said Thursday that it expects to have between 100 million and 125 million doses of its potential COVID-19 vaccine available globally in the first quarter of 2021, with 85 million-100 million of those available in the U.S. And 15 million-25 million of those available outside of the U.S.

The expected first quarter doses are inclusive within the 500 million to up to 1 billion doses that the company expects to manufacture globally in 2021.

The company re-affirmed its expectation of having about 20 million doses available in the U.S. by the end of 2020.

Moderna said interim durability data from NIH-led phase 1 study showed that its COVID-19 vaccine candidate mRNA-1273 produced high levels of binding and neutralizing antibodies that declined slightly over time, but they remained elevated in all participants three months after the booster vaccination. The results were consistent across all age cohorts.

According to the company, the results showed that mRNA-1273 has the potential to provide durable humoral immunity, despite a slight expected decline in titers of binding and neutralizing antibodies.

It also reported that no serious adverse events were noted in the trial, no prespecified trial-halting rules were met, and no new adverse events that were considered by the investigators to be related to the vaccine occurred after day 57.

The announcement follows the company's November 30 announcement that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirmed the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%.

Also on November 30, Moderna submitted a request for an Emergency Use Authorization from the U.S. Food and Drug Administration and conditional approval from the European Medicines Agency.

Earlier this week, Pfizer and German biotech firm BioNTech SE's mRNA-based COVID-19 vaccine received a temporary authorization for emergency use in the U.K., marking the first authorization in the world for a Covid vaccine.

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