Moderna becomes second company to request emergency FDA authorization for COVID-19 vaccine candidate

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Moderna will apply Monday for an emergency use authorization from the FDA after receiving more good news about the safety and effectiveness of its candidate COVID-19 vaccine.

Pfizer and Moderna have both announced promising results in the phase 3 trials of their COVID-19 vaccines. Here's how they differ.

Of the 30 participants who suffered severe disease, all were in the placebo group, which suggests the vaccine prevents both mild and serious disease. One placebo recipient died.Effectiveness was consistent across age groups, as well as race and ethnicity. The 196 participants with cases of COVID-19 included 33 adults over 65 and 42 who identified as Hispanic, Black, Asian American or multiracial.

Moncef Slaoui, who co-leads the government's Operation Warp Speed, which has overseen the development of Moderna's vaccine and helped finance production of Pfizer's, also was impressed with the results and the novel mRNA technology behind both. Moderna's president, Dr. Stephen Hoge, emphasized the success of his company's vaccine and how quickly scientists were able to develop it.Hoge said the company decided to file for FDA authorization at this point, because"there's nothing more we would do. ... We passed the baton."The trial has been the same size and scope as for any vaccine.

To win FDA authorization, companies have to show three things: their vaccine is safe, it's more than 50% effective, and it can be produced reliably and safely. Pfizer/BioNTech showed earlier this month that its candidate vaccine, BNT162b2, was 95% effective and submitted a request for FDA authorization Nov. 20.

Novavax, another vaccine developer, which targets the spike protein in a different way, provided an update early Monday on its clinical trials. Without masks and a vaccine, we could reach Herd Immunity from COVID-19, but deaths would skyrocket. We break down the science of it.

 

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