Moderna says COVID vaccine trial produced robust immune response in all patients

Tl dr; Moderna vaccine exits Phase 1 trials successfully.

"Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety."

">30% of drugs entering phase II studies fail to progress, and >58% of drugs entering phase III studies go on to fail"

Link to the actual study: https://www.nejm.org/doi/full/10.1056/NEJMoa2022483

The significance here is that a paper with data has been published regarding the phase 1 trial[1]. Previously, Moderna had only reported some of the study results, and no study data.

A later study had been delayed, raising questions about what might have happened in the unreported cases during Phase 1.

It should be pointed out that the significance of the Moderna approach extends beyond COVID-19. If approved, it would mark the first time for an mRNA vaccine. Such vaccines don't need to gain entry into the nucleus, just the cell membrane. They don't modify the genome, just cause ribosomes to start making viral protein. Given that many diseases are caused by lack of functional protein, this could have implications for medicine beyond vaccines.

[1] https://www.nejm.org/doi/full/10.1056/NEJMoa2022483

> Moderna’s potential vaccine to prevent Covid-19 produced neutralizing antibodies in all 45 patients in its early stage human trial, according to newly released data.

> Earlier Tuesday, Moderna announced it would begin its late-stage trial for its vaccine on July 27. The trial will enroll 30,000 participants across 87 locations, according to ClinicalTrials.gov. Participants in the experimental arm will receive a 100 microgram dose of the potential vaccine on the first day and another 29 days later. Some patients will also receive a placebo.

Looks promising.