Moderna (MRNA +7.1%) rallies, albeit on below-average volume, on the heels of this morning’s presentation on COVID-19 vaccine candidate mRNA-1273 before the CDC’s Advisory Committee on Immunization Practices. Highlights:
The vaccine, administered in two 10 microgram doses 28 days apart, stimulated an immune response in older adults (n=20), inducing similar antibody titers as younger adults. Neutralizing antibody levels were higher than those in convalescent sera but the specific titers were undisclosed.
No serious adverse events were reported. The majority of minor symptoms, including fatigue, chills, headache and pain, resolved within two days.
Shares jumped at almost the precise time the presentation started.
Update: Additional points from the company’s slide presentation:
Neutralizing antibodies were observed in all participants on day 14 following the second dose. Lowest responses were in the 25 mcg dose arm. Responses in the 100 mcg and 250 mcg arms were similar to the upper half of the range in convalescent sera. All participants receiving two doses of 100 mcg seroconverted.
Th1-biased CD4+ T cell responses were noted across all age groups receiving 100 mcg. Th2 phenotype response was rare.
Phase 2 study fully enrolled. About 13 months for each participant (28 days for inoculation plus 12 months follow-up). Three cohorts (18 – <55, sentinel at least 55 years old, full at least 55 years old). Randomized 1:1:1 to receive either 50 mcg, 100 mcg or placebo.
Large-scale Phase 3 trial, COVE, started July 27. Three groups: at least 65 years old, less than 65 years old at increased risk of COVID-19 complications, less than 65 years old and not at risk. Dose: 100 mcg. Study duration will be ~25 months (24-month follow-up).
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