Moderna Wins Backing from FDA for Authorization

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US regulators and the FDA have backed the authorization of the Moderna Covid-19 vaccine.  Advisers in the FDA voted 20-0 that the benefits of the vaccine outweigh any of the risks in an attempt to speed up the process to immunize the United States. Similar to the Pfizer vaccine, priority of the Moderna Vaccine will go to health care workers. 

James Hildreth, a panel member and president of Meharry Medical College, said, “To go from having the virus sequenced in January to having two vaccines in December is a remarkable achievement.”

In the latest efficacy report, the Moderna Covid-19 vaccine was labeled as 94% effective and listed side effects such as “headache, fatigue and muscle aches typical of a vaccine.”  However, something to keep in mind is that some recipients of the vaccine are developing allergic reactions, in which case the FDA and the CDC are ensuring facilities distributing the vaccine also have proper medication for any allergic reactions to the vaccine.

Doran Fink, deputy director of FDA’s division of vaccines and related products applications said, “As we continue to evaluate and investigate the data, we will determine whether additional recommendations need to be made.”

Internally Moderna is considering offering the vaccine to anyone in their studies that were part of the placebo group.  However according to Steven Goodman, the associate dean of clinical and translational research at Stanford University School of Medicine, said on the subject, “The images of young low-risk trial participants being knowingly vaccinated before much higher-risk community members could adversely affect trust in the fairness of the vaccine testing and allocation system.”

As soon as the FDA and US officials approve the Moderna Vaccine is will be sent out nationwide with nearly 6 million doses ready.  By the end of the year, it is expected that up to 20 million people could be vaccinated between the Moderna and Pfizer vaccines.  For more updates be sure to check back with the ABN Blog regularly.

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