"Safety data from a 11 November 2020 interim analysis of approximately 30,350 participants ≥18 years of age randomized 1:1 to vaccine or placebo with a median of 7 weeks of follow-up after the second dose supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA," the briefing document said.
The Food and Drug Administration (FDA) prepared the document in advance of a scheduled meeting on Thursday to consider granting emergency approval for Moderna's coronavirus vaccine.
Moderna's candidate vaccine is underway with phase 3 clinical trials, involving an expanded pool of participants of different age and health condition. On 30 November, the company released results of the vaccine's primary efficacy analysis indicating efficacy of 94.1 percent.
The United States has secured 100 million more doses of the mRNA coronavirus vaccine by US pharmaceutical company Moderna.
Aside from the US, Moderna has vaccine supply contracts for over 390 million doses with such countries as Canada, Japan, Israel, Japan, Switzerland, Qatar and the United Kingdom, as well as the European Union.