Drug maker Moderna has released encouraging interim results from a phase 1 trial of its experimental vaccine against Covid-19. They argue that vaccination has the potential to cause immunity to the pathogen in humans.
What is the vaccine and how does it work? Moderna specializes in vaccines that elicit an immune response based on mRNA, i.e. the genetic instructions by which a virus reproduces in the host organism. Novel vaccines such as that from Moderna against Covid-19 can be quickly prepared. So far, however, none of them have been approved for sale.
The study: In phase 1 clinical studies, it should be determined whether the investigated active ingredient is safe or not – the effectiveness has not yet been specifically tested. Nevertheless, the first insights into the therapeutic potential are sometimes obtained. Moderna’s ongoing study started in March and included 105 participants. Everyone receives either two injections of 25 micrograms or 100 micrograms of the vaccine candidate (four weeks apart) or a single dose of 250 micrograms.
The new results: Moderna has published antibody data for eight subjects aged 18-55 years, four of them with doses of 25 and 100 micrograms. Accordingly, the participants with the lower dose trained about as many neutralizing antibodies as recovered corona patients; at the higher dose the level was “significantly higher”. Negative effects were also observed, but according to Moderna they were “temporary and subsided”.
Next Steps: The results are encouraging, but one cannot draw far-reaching conclusions from a phase 1 study, especially not with data from only eight subjects. The FDA has already approved Moderna a phase 2 study testing biological effects on patients; there should also be an average dose of 50 micrograms. Phase 3 could follow in July. The authority could issue an emergency release for the vaccine in the fall, reports the Wall Street Journal – but only if all studies go as hoped, which is far from clear.