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Moderna preparing for interim analysis of late-stage COVID-19 vaccine data

The company has accrued enough COVID-19 cases in the trial for interim analysis

Moderna is preparing for the first interim analysis of its COVID-19 vaccine candidate, announcing yesterday that it has accrued enough cases in the trial to submit information to the data safety monitoring board (DSMB).

The company, which is developing the mRNA-based vaccine candidate mRNA-1273, said that it has seen a ‘significant’ increase in the rate of COVID-19 case identification across its trial sites in the US over the last week.

Following the additional cases, Moderna expects that its first interim analysis will include over 53 cases, which was the original targeted figure for analysis.

The data on these cases is currently being prepared for submission to the independent DSMB for analysis and recommendation, Moderna added, although the company did not say when exactly it intends to publish the efficacy data.

In October, Moderna’s chief executive officer Stéphane Bancel said that he expects interim results from the company’s COVID-19 vaccine trial in November, according to the Wall Street Journal.

He added that the vaccine candidate could be granted an emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) in December, assuming that the data from the first analysis of its phase 3 trial is positive.

Moderna’s vaccine candidate entered the 30,000-participant phase 3 trial in July. The study, which is being conducted in collaboration with the US National Institutes of Health (NIH), is investigating two shots of the candidate at a dosage of 100 µg.

The primary endpoint of the study is the prevention of symptomatic COVID-19 disease, with key secondary endpoints including the prevention of severe COVID-19 disease and prevention of infections with SARS-CoV-2, which causes COVID-19, regardless of symptoms.

Earlier this week, Pfizer and BioNTech, which are also developing an mRNA-based COVID-19 vaccine, released the first data detailing the efficacy of their vaccine.

According to results from the interim analysis, which was conducted after 94 participants in the study contracted COVID-19, the vaccine has an efficacy rate above 90%, seven days after the second dose of the vaccine was administered.

However, Pfizer and BioNTech did add that the final vaccine efficacy percentage could change as the study continues - even so, an initial efficacy of over 90% is seen to be promising.

Article by
Lucy Parsons

12th November 2020

From: Research

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