The biotechnology has reached it COVID-19 case accrual mark, and announced plans to submit data to an independent review board.
Moderna is nearing presentation of phase 3 data for its coronavirus 2019 (COVID-19) vaccine candidate, and could shortly thereafter apply for US Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
Late last week, the biotechnology company announced it had reached case accrual necessary for the first interim analysis of phase 3 COVE study outcomes comparing vaccine candidate mRNA-1273 to placebo in preventing COVID-19 in real-world volunteers.
After new daily COVID-19 cases skyrocketed in the last week—most notably in the US, where daily cases surpassed 180,000—Moderna shared anticipation that their first interim analysis will include “substantially more” than the necessary 53 cases of COVID-19 among COVE trial volunteers that would trigger the analysis.
The data on such positive COVID-19 cases is being prepared for submission to the Data Safety Monitoring Board (DSMB), an independent analysis and advisory committee. Moderna remains unaware to whether these participants received either mRNA-1273 or placebo.
The news of this benchmark—which may quickly lead to Moderna’s own announcement of preliminary prophylactic outcomes—shortly follow the announcement from Pfizer and BioNTech that their COVID-19 vaccine candidate BNT162 was associated with a 90% or better efficacy in preventing coronavirus among dosed patients in their ongoing phase 3, 44,000-patient trial.
Though such data is yet to be presented as peer-reviewed findings with addition of safety outcomes, anticipation is that Pfizer is nearing an EUA application later this month, and is prepared to immunize up to 20 million patients with BNT162 by the end of the year.
The Moderna and Pfizer candidates have been linked since their conceptualization near the very beginning of the pandemic, as both vaccines come from the mRNA platform and have progressed quickly through early-stage assessment.
In an interview with sister publication HCPLive® as part of the Lungcast podcast series last month, Anthony Fauci, MD, director of the National Institutes of Allergy and Infectious Disease (NIAID), explained genetic platforms including mRNAs are which allowed vaccine developers to complete in months what normally takes years.
Though Fauci also alluded to discussions with both Pfizer and Moderna teams about completing long-term safety data for both candidates, he stressed the need for full demographic representations in ongoing clinical trials—as COVID-19 has discriminately burdened differing populations, and showing vaccine efficacy and safety in particularly effected groups is crucial.
The phase 3 COVE trial, designed in collaboration with the FDA and NIAID parent organization the National Institutes of Health (NIH), included US persons at greatest risk of COVID-19 severity—including 7000-plus volunteers aged ≥65 years old and 5000-plus with high-risk chronic conditions.
According to Moderna, these high-risk groups represent 42% of the total study participants.