In an April 27, 2017 press release the first human proof-of-concept data from Moderna’s mRNA technology platform was released. “In addition, they are the first-ever published data demonstrating a prophylactic mRNA vaccine’s ability to elicit robust immunity in humans”.  Moderna distinguishes a “mRNA Therapeutic” from an “mRNA Vaccine” simply by the intent of the protein code, that being to “fight disease” versus “prevent disease”.

In a Cell paper, funded by Moderna Therapeutics, looking at the “immunogenicity by mRNA Vaccines” against H10N8 (mRNA-1440) and H7N9 (mRNA-1851) Influenza Viruses.  They concluded that “LNP-formulated, modified mRNA vaccines can induce protective immunogenicity with acceptable tolerability profiles” in mouse studies and a First-in-Human Phase 1 Study with 31 human subjects (23 of whom received mRNA-1440 and eight of whom received placebo) and were followed for only 43 days, but the intent is for subjects to be “followed for up to 1 year post-vaccination for safety and immunogenicity”. [1, 2, 3]

“mRNA-1440 demonstrated strong efficacy based on Hemagglutination Inhibition Assay (HAI) and Microneutralization Assay (MN) titers, two measures of immunogenicity in response to vaccination.” Achieving antibody “titers consistent with protection at day 43.”

  • Clinical trials (NCT03076385 ) began March 2, 2017
  • “Adverse events (AEs) according to FDA scale were mild or moderate with 3 subjects (13%) experiencing severe adverse events, it “demonstrated a safety profile consistent with that of approved vaccines”. [4, 5]
  • Until recently mRNA vaccines were not advanced into the clinic due to concerns around stability and production.

The paper states that mRNA vaccines “offer advantages in speed, precision, adaptability of antigen design and production control that cannot be replicated with conventional platforms,” and that until recently mRNA vaccines “were not advanced into the clinic due to concerns around stability and production.”

But now with the ever looming “concern for a potential pandemic and the need for an effective, safe, and high-speed, and scalable vaccine production platform, the mRNA-based vaccines make them ideally suited to impede potential pandemic threats.”