Moderna says will begin Phase 3 trials with 30,000 participa
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Moderna has finalised the Phase 3 study protocol, which will include approximately 30,000 participants enrolled in the US to test its COVID-19 vaccine's effectiveness on a larger scale.

• The randomized, placebo-controlled trial is expected to begin in July.

• "The company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year" the company said in a press release.

• On May 6, the US Food and Drug Administration (FDA) completed its review of the company’s investigational new drug (IND) application for mRNA-1273 and on May 11, the FDA granted it fast track designation.

• On May 18, Moderna announced initial data from the Phase 1 study of mRNA-1273 led by National Institute of Allergy and Infectious Diseases (NIAID).

• The Phase 1 study is ongoing with the original cohorts in long-term follow-up and enrollment in 9 of 12 cohorts complete. The National Institutes of Health (NIH) will be submitting the Phase 1 data to a peer-reviewed clinical publication.

• This Phase 2 study is evaluating the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.

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Good move
Jun 13, 2020Like