The Food and Drug Administration has cleared the way for an experimental coronavirus vaccine to advance to a Phase 2 trial, CNBC reported this week. Phase 2 trials, which generally include larger groups of participants than the 20-80 people involved in Phase 1 trials, occur during the fourth of 12 steps required for drugs under review at FDA. The manufacturer, Moderna, has announced that its Phase 2 study will include 600 participants. If plans to commence Phase 3 testing in the early weeks of summer materialize, Moderna says it hopes for a 2021 approval date.
The vaccine was developed in conjunction with the National Institute of Allergy and Infectious Diseases, an agency within the National Institutes of Health. In a testimony before the U.S. Senate Committee on Health, Education, Labor and Pensions on Thursday, NIAID director Anthony Fauci cautioned against betting on the success of the effort, but also offered hope. According to CNBC, Fauci warned that “you can have everything you think that’s in place and you don’t induce the kind of immune response that turns out to be protective and durably protective. So one of the big unknowns is, will it be effective? Given the way the body responds to viruses of this type, I’m cautiously optimistic that we will with one of the candidates get an efficacy signal.”
- Sources:
- https://www.cnbc.com/2020/05/07/fda-approves-moderna-vaccine-candidate-for-phase-2-study.html
- https://www.clinicaltrials.gov/ct2/help/glossary/phase
- https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-continued
- https://www.reuters.com/article/us-health-coronavirus-moderna/modernas-experimental-coronavirus-vaccine-gets-fdas-fast-track-status-idUSKBN22O1RG
- https://www.cnbc.com/2020/05/12/fauci-tells-congress-no-guarantee-the-coronavirus-vaccine-will-be-effective.html
- https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins