Moderna is informed by FDA Chief Scientist that its Covid vaccine is “an investigational vaccine not licensed for any indication”-FDA.gov, July 7, 2021

7/7/21 Letter to Moderna from Chief Scientist, Food and Drug Administration,  Denise M. Hinton, describes Moderna vaccine as “investigational:”

“It is an investigational vaccine not licensed for any indication.”…

“ModernaTX, Inc. Attention: Ms. Carlota Vinals 200 Technology Square Cambridge, MA 02139

(p. 1) “On July 7, 2021, having concluded that revising this EUA [Emergency Use Authorization] is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA again is reissuing the letter in its entirety with revisions incorporated to clarify terms and conditions that relate to export of Moderna COVID‑19 Vaccine from the United States. Moderna COVID‑19 Vaccine is for use for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older….It is an investigational vaccine not licensed for any indication.”…

 

 

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