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WASHINGTON (Sputnik) – Moderna’s coronavirus vaccine has no specific safety concerns that would prevent US regulators from granting drug use approval (EUA), the US Food and Drug Administration said on December 31, 2018 Tuesday in an information document with.
“Safety data from an interim analysis from 11. November 2020 from around 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. No specific safety concerns were identified that would preclude the issuance of an EEA “, the information document states.
The Food and Drug Administration (FDA) prepared the document ahead of a scheduled meeting Thursday to consider granting an emergency approval for Moderna’s coronavirus vaccine.
Moderna’s vaccine candidate is currently in Phase 3 clinical trials involving an expanded pool of participants of various ages and health levels. On the 30th. On November 17th, the company released results of the vaccine’s primary efficacy analysis, indicating an efficacy of 94. 1 percent.
The US has received 100 million more doses of the mRNA coronavirus vaccine from the US pharmaceutical company Moderna.
Aside from the US, Moderna has vaccine supply contracts for over 390 million doses with countries such as Canada, Japan, Israel, Japan, Switzerland, Qatar and the United Kingdom, and the European Union.
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Vaccine, Moderna, Food and Drug Administration, Emergency Use Approval
News – UK – Moderna’s COVID-19 Vaccine Shows “No Special Safety Concerns” According to US Federal Regulatory Agency