Moderna (MRNA) has taken the rare step of publishing the clinical protocols for its late-stage Covid-19 vaccine trials. The company also announced that it is planning to produce roughly 20M doses of its vaccine candidate, mRNA-1273, this year.
According to the published protocol, Moderna is carrying out a Phase 3, randomized, stratified, observer-blind, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of mRNA-1273 against the SARS-CoV-2 vaccine in adults aged 18 and over.
The study will target adults who have no known history of SARS-CoV-2 infection but whose locations or circumstances put them at risk of catching the virus.
Its primary endpoint is to demonstrate the efficacy of mRNA-1273 to prevent the first occurrence of Covid-19 starting 14 days after the second dose.
Here Covid-19 is defined as symptomatic disease based on the following criteria: at least two of fever (≥ 38ºC), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least one of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia; and a positive coronavirus test.
It will also evaluate the safety and reactogenicity of 2 injections of mRNA-1273 given 28 days apart.
Secondary endpoints include evaluating the efficacy of mRNA-1273 to prevent severe Covid-19, asymptomatic Covid-19, to evaluate vaccine efficacy (VE) to prevent death caused by the virus, and to evaluate the efficacy of mRNA-1273 to prevent Covid-19 in all study participants, regardless of evidence of prior SARS-CoV-2 infection.
Approximately 30,000 participants will be randomly assigned in 1:1 ratio to receive either mRNA-1273 100 µg or placebo, says Moderna. At least 25%-40% of enrolled participants will be either over 65, or under 65 and at risk at screening.
Moderna’s candidate mRNA-1273 is an mRNA vaccine against Covid-19 encoding for a prefusion stabilized form of the Spike (S) protein and is being co-developed with investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center.
The biotech company recently reiterated that it remains on track to deliver about 500 million doses of the potential vaccine per year, and up to 1 billion doses per year, beginning in 2021. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 was secured from investors in the company’s most recent public equity offering in May 2020.
Shares in Moderna have exploded 257% so far this year. Due to the extreme rally, Wall Street analysts have a cautiously optimistic Moderate Buy consensus on the stock’s outlook. Looking ahead, the $92 average price target suggests additional 31% upside potential lies ahead.
JPMorgan analyst Cory Kasimov said that although the vaccine candidate appears to be showing a “promising profile”, he still wants to see “the Phase 3 results with mRNA-1273, which are anticipated sometime this fall, to see how the data evolves.”
Kasimov maintains a Hold rating on the stock and $89 price target as he is skeptical of Moderna’s “ability to generate long-term meaningful revenues that justify prevailing market values.” (See MRNA stock analysis on TipRanks)