FDA verifies safety, efficacy data for Moderna COVID-19 vaccine candidate

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FDA verifies safety, efficacy data for Moderna COVID-19 vaccine candidate
tjordan_drupal
Dec 15, 2020

Ahead of a Dec. 17 meeting of its Vaccines and Related Biological Products Advisory Committee, the Food and Drug Administration released a briefing document confirming Moderna’s data on the safety and efficacy of the mRNA-1273 COVID-19 vaccine candidate. FDA said mRNA-1273 is 94.1% effective in preventing severe COVID-19, with “no specific safety concerns identified that would preclude issuance of an (emergency use authorization).” Like the Pfizer vaccine approved last week, the Moderna candidate requires two doses, albeit 28 days apart, compared with Pfizer’s 21. Once approved for emergency use, Moderna is expected to supply 200 million vaccine doses to the U.S. through the end of 2021.

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FDA verifies safety, efficacy data for Moderna COVID-19 vaccine candidate
tjordan_drupal
Dec 15, 2020

Ahead of a Dec. 17 meeting of its Vaccines and Related Biological Products Advisory Committee, the Food and Drug Administration released a briefing document confirming Moderna’s data on the safety and efficacy of the mRNA-1273 COVID-19 vaccine candidate. FDA said mRNA-1273 is 94.1% effective in preventing severe COVID-19, with “no specific safety concerns identified that would preclude issuance of an (emergency use authorization).” Like the Pfizer vaccine approved last week, the Moderna candidate requires two doses, albeit 28 days apart, compared with Pfizer’s 21. Once approved for emergency use, Moderna is expected to supply 200 million vaccine doses to the U.S. through the end of 2021.

Novel Coronavirus (SARS-CoV-2/COVID-19)
COVID-19: Vaccines and Therapeutics
COVID-19: CDC, FDA and CMS Guidance

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