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Moderna's mRNA vaccine passes important first hurdle.

Created by Timothy Paustian on Jul 15, 2020, 4:58 PM

 

Many of you probably already heard that the Moderna vaccine raised a strong immune response in all participants that finished the initial trial. Moderna also has a press release about the results. I took the time to go read the paper in JAMA. If I had to sit down and write the ideal results I would want from a Phase 1 vaccine trial, these would be close.

  1. The vaccine doses were 25 µg, 100 µg, and 250 µg and all raised a strong antibody (Ab) response against the virus that was dose-dependent.
  2. The Ab response was as strong or stronger as that seen in convalescent plasma. It was important to run these controls using the assays they used for their vaccine since response methods have not been standardized. They included 41 plasma samples in the control tests, eliminating (in my mind) the possibility that the controls just happened to be weak plasma samples.
  3. The Ab showed a strong neutralizing effect in tests of infection with a live virus that matched that seen with convalescent serum.
  4. They also demonstrated a T-cell response of both arms of the immune system. This is a very good sign that it may be protective.

The one concern in this trial was the frequency of adverse events. A fever was detected in half of the 100 µg group after the second dose of the vaccine. Also, many participants reported chills, myalgia (felling icky), and headache. While most of these were mild I would like to know exactly what mild means. Moderna is in the process of a phase 2 trial of 600 participants with a 50  µg dose to assess if a lower dose will decrease adverse events, yet still, give a strong immune response.

In any case, the vaccine is now approved for a phase 3 trial including 30,000 participants that is scheduled to begin in July.