USA – Moderna files COVID vaccine EUA; adcomm set for 17 December

The pharmaceutical company Moderna has filed an emergency use authorization request with the US Food and Drug Administration (FDA) for the coronavirus vaccine the firm co-developed with the National Institutes of Health (NIH).

The company’s vaccine against COVID-19 will be considered at a 17 December meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee. Announcing the meeting, FDA Commissioner Stephen Hahn, MD, said that the advisory committee’s external medical, scientific and public health experts will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission. »

Like the upcoming 10 December VRBPAC meeting to consider the Pfizer/BioNTech COVID-19 vaccine, the meeting for Moderna’s candidate will be streamed live on Facebook, YouTube, and Twitter in addition to the usual FDA-hosted live webcast. RELATED: Updated: Pfizer files EUA for COVID vaccine; FDA sets adcomm for 10 December, Regulatory Focus 20 November 2020)…