- Moderna’s experimental COVID-19 vaccine, mRNA-1273 was found to be 94.5% effective against SARS-CoV-2 in an interim analysis of a Phase 3 study.
- The Company aims the submission of an Emergency Use Authorization (EUA) with the US FDA in the next few weeks.
- Moderna stated that mRNA-1273 has a longer shelf-life at refrigerated temperatures and can remain stable for up to a month.
US biotech firm Moderna Inc (NASDAQ:MRNA) on 16 November 2020 announced that its experimental vaccine against COVID-19, mRNA-1273 was 94.5% effective, marking a significant breakthrough in the quest to end the ongoing pandemic. The interim data from the late-stage clinical trial buoyed the hopes of millions across the globe.
Following the significant announcement, Moderna shares closed at US$97.95, up by 9.58% on 16 November 2020 on NASDAQ.
Let us look at the interim analysis of the Phase 3 trial in detail:
Moderna’s COVID-19 Vaccine Meets Primary Endpoint
On 16 November 2020, Moderna announced that the Phase 3 COVE study for mRNA-1273 met the statistical criteria pre-specified in the study protocol, with an efficacy of 94.5% for the vaccine candidate.
The primary endpoint of the ongoing Phase 3 study is based upon an analysis of COVID-19 confirmed cases beginning two weeks after the vaccine’s second dose.
The first interim analysis included 95 subjects with confirmed COVID-19. The preliminary assessment indicates a largely consistent safety and efficacy profile in all evaluated subgroups.
Based on the interim safety and efficacy data, the Company aims for the submission of an Emergency Use Authorization (EUA) with the US FDA in the upcoming weeks. Moreover, Moderna also anticipates informing the EUA for the final safety and efficacy data with at least a 2-month median duration.
Image Source: © Kalkine Group 2020
The biotech player also plans submission of applications to global regulatory agencies for authorizations.
Moderna anticipates having almost 20 million doses of mRNA-1273 ready for shipment in the US by the end of 2020. Moreover, the Company remains on track to manufacture 500 million-1 billion doses worldwide in 2021.
Moderna’s vaccine update comes hot on the heels of Pfizer and BioNTech’s last week announcement that their vaccine was over 90% effective. The vaccine has thus become the second vaccine demonstrating high efficacy against coronavirus in the Phase 3 clinical trial.
Stéphane Bancel CEO of Moderna said-
Moderna’s vaccine candidate expected to remain stable at 2-8°C
Moderna also highlighted the longer shelf-life for mRNA-1273 at refrigerated temperatures. It said that new data demonstrated that the vaccine remains stable at standard refrigerator temperatures of 2-8°C (36°-46°F) for up to 30 days.
Moreover, COVID-19 vaccine of Moderna remains stable at -20° C (-4°F) for nearly six months at refrigerated conditions for up to a month and at room temperature for approximately 12 hours. No dilution is necessary before mRNA-1273 vaccination.
The vaccine can be distributed using broadly available vaccine delivery and storage infrastructure.
Chief Technical Operations and Quality Officer at Moderna, Juan Andres commented-
Moderna’s vaccine success has given the world more hope in fight against the pandemic. Together with Pfizer and BioNTech’s COVID-19 vaccine, that has further safety information and regulatory review pending, the US could potentially have two COVID-19 vaccines authorized for emergency use by December 2020 to combat the deadly pandemic.