Moderna submitting its COVID-19 vaccine to the FDA for emergency approval

Moderna submitting its COVID-19 vaccine to the FDA for emergency approval
Photo via Shutterstock.

It's a day we've waited for: Moderna is applying for Food and Drug Administration emergency use authorization for its coronavirus vaccine. The drug manufacturer announced updated data on the vaccine trial, showing 94.1% effectiveness, in line with earlier results showing 94.5% effectiveness. Of 196 COVID-19 cases found among people in the trial, 185 had gotten the placebo and just 11 had gotten the vaccine. There were 30 severe cases among people who had gotten the placebo, one of whom died, and not one severe case among people who got the vaccine.

The EUA application will undergo final review on December 17, and the first vaccinations could be administered by December 21. Moderna expects to have 20 million doses—enough for 10 million people—by the end of December. Those doses are expected to go to healthcare workers, other essential workers, and employees and residents of nursing homes. But since Donald Trump will still be in charge of the federal government for the first month of vaccine distribution, don't expect a smooth rollout.

Perhaps predictably, Trump has punted vaccine distribution decisions to the states. States will get doses in proportion to their population, and have to make tough decisions about who's first in line.

"States are going to have to pick and choose who gets the first doses," Josh Michaud, an associate director for global health policy at Kaiser Family Foundation, told Politico. "It's very obvious that states are in different places when it comes to planning and identifying who those people are." But Trump is building in an ability to deflect blame for distribution disasters—while taking credit for the existence of the vaccine.

A vaccine is a huge, huge step forward. But vaccinations are what ultimately matters, and there will be a month of Trump-era vaccinations before President-elect Joe Biden can start to get the process under control.

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