Happy February! If you're coming off of dry January and hoping to maintain a healthy relationship with alcohol, we have some tips and tricks.
 |  | By Anisa Arsenault, Associate Editorial Director | | | Happy February! If you're coming off of dry January and hoping to maintain a healthy relationship with alcohol, we have some tips and tricks. | | | Today's Top Story | | What's the Difference Between FDA 'Emergency Use Authorization' and 'Approval'? |  | Yesterday, the FDA granted full approval to Moderna's COVID-19 vaccine for people 18 and older. It's now the second COVID-19 vaccine in the U.S. with full approval, joining the ranks of Pfizer.
Previously, Moderna's vaccine was available thanks to an emergency use authorization (EUA) from the FDA. What makes an approval any different? More data.
A formal vaccine approval begins with a biologic licensing application, which requires much more clinical trial data—and time—than an EUA application. Approval is more rigorous, consisting of high standards for safety, effectiveness, and manufacturing quality.
"That is not to say that the clinical trials are compromised in design," said LJ Tan, chief strategy officer of the Immunization Action Coalition. "It's just that the EUA is issued earlier than licensure, so we will not have as much data accumulated for the trial yet."
The FDA can grant an EUA to a treatment or vaccine if: | | • | The product may reasonably prevent, diagnose, or treat serious or life-threatening disease or condition. | | • | The known and potential benefits outweigh the known and potential risks. | | • | There is no adequate, approved, and available alternative. | | | Once health officials declare a public health emergency over, an EUA is no longer valid, and full approval is necessary to continue the use of the product. | | Know More | | With full approval comes a new name: Moderna will be marketed as Spikevax. But don't expect this name to take hold. Pfizer's vaccine is fully approved for those ages 16 and older under the brand name Comirnaty, and nobody's really calling it that. | | Feel Better | | Studies, clinical trials, and safety plans for any adverse effects are also necessary for a company to earn an EUA. It's not as if Moderna wasn't safe before. | | |  | | Has Omicron peaked? Potentially. COVID-19 case counts in the U.S. typically follow the trajectory of cases in the U.K., and U.K. cases have been on the decline since the end of December. |  |  | | Undiagnosed Dyslexia in Adults Exacerbated by Pandemic | | Reading, writing, or spelling can be difficult for adults with dyslexia, whether they're diagnosed or not. While many adults have learned how to compensate over the years in their careers, an abrupt switch to remote work during the pandemic exposed a need for help. Learn how to identify signs of dyslexia and how treatment can fit into different lifestyles. | | | | FDA Scales Back Use of 2 Monoclonal Antibody Treatments | | The FDA is advising against the use of monoclonal antibodies from Eli Lilly and Regeneron to treat the Omicron COVID-19 variant because they are not very effective against this strain of the virus. The treatments, typically given via IV infusion, are intended for people with mild-to-moderate COVID who are at high risk for a severe case and poor outcomes. Effective treatments are still available for these patients, like antiviral pills from Merck and Pfizer. | | | | | | | In Other News | | | ■ | The Rise, Fall and Curious Revival of Vaseline. Bloomberg | | | | | ■ | Vaccine for Kids Under 5 Could Come Earlier than Expected. Axios | | | | | ■ | Olympian Brittany Bowe on Recovering From a Concussion. Self | | | | | | | | |  |     | You are receiving this newsletter because you subscribed to the Verywell Health newsletter. If you wish to unsubscribe, please click here.
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