Moderna Requests Emergency FDA Authorization For COVID-19 Vaccine


Moderna is making strides in getting a COVID-19 vaccine to people by applying for emergency authorization from the Food and Drug Administration (FDA). 

The pharmaceutical company is set to send its data set to the Administration showing its vaccine in preventing COVID-19 is 94.1% effective. 

Dr. Tal Zaks, Moderna’s chief medical officer, told CNN he got emotional after seeing the data on Saturday (November 28). 

“It was the first time I allowed myself to cry,” he said, “We have a full expectation to change the course of this pandemic.” 

Moderna started clinical trials in July of this year, giving 30,000 volunteers either a vaccine or a placebo. Of the 15,000 given the vaccine in the study, 11 developed COVID-19. 

Those 11 who did get COVID-19 were not severely ill according to the data, a promising step towards slowing the impact of the virus. 

Moderna is the second company to apply for FDA authorization for a COVID-19 Vaccine. Pfizer became the first, applying November 20 for a vaccine with a similar effective rate. 

In an interview with CNN, Dr. Paul Offit, a member of the FDA’s vaccine advisory committee said of Moderna’s vaccine, “This is striking. These are amazing data.”

The FDA is expected to meet in December to review both vaccine applications. 

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Americans can expect to see the first vaccines released for use “towards the latter part of December.” 

The FDA’s advisory committee will be pouring over the data presented by both companies and taking a particular close look at why some people with the vaccine still developed COVID-19. 

“Were they more likely to be older? Were they more likely to be African American or obese or have underlying medical problems like diabetes?,” Offit explained. 

If the FDA’s committee grants emergency authorization, the Centers for Disease Control and Prevention will make a recommendation on how the vaccine gets distributed. 

Some reports suggest health care frontline workers will be the first to receive the virus, along with residents of nursing homes. 

By the end of the year, Moderna expects to have 20 million doses of the vaccines manufactured and is working at a pace to have 500 million to 1 billion doses made by next year for global distribution, according to a company press release. 

Pharmaceutical companies like Moderna and Pfizer are hopeful to be able to provide millions with the vaccine to slow down the pandemic’s impact, especially for the elderly and other groups who’ve experienced disproportionate devastation of the virus. 

“The magnitude of this achievement and the implications of what it means to what’s ahead of us in the context of what’s going on around us is -- it’s just overwhelming emotionally,” Zaks said. 

Photo: Getty Images 


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