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FDA panel meeting to consider approval of Moderna vaccine

An FDA advisory panel is weighing approval of Moderna's COVID-19 vaccine Thursday.

If the panel votes in favor of the vaccine, it is expected to become the second to be approved for widespread use in the U.S.


Moderna's scientists presented phase three data in the morning, reporting a 94.1% efficacy rate with only a few participants getting sick with mild cases after the first dose and no one getting sick after they had the second dose.

The company said the primary side effects were mild to moderate pain, fatigue and headache for one to three days, with symptoms getting slightly more severe after the second dose. No major side effects were reported among the trial group.

Outside doctors and scientists are also giving testimony, mostly in favor of the vaccine.

"I have personally seen the devastation COVID-19 has caused for our patients, both directly and indirectly. Clearly the vaccine is a welcome relief for our elderly patients and those with chronic medical conditions," said Dr. Renu Dhanasekaran, a researcher at Stanford.

But Dr. Diana Zuckerman, President of the National Center for Health Research said the median two month follow up period for trial participants was too short and had concerns about the vaccine.

Unlike the Pfizer vaccine, the Moderna vaccine does not require ultra-cold storage and therefore is expected to be easier to distribute and store. If the panel gives its approval, the FDA is expected to follow within a few days. Moderna is seeking approval for widespread use in people 18 and older.

California leaders are expecting Moderna to deliver 672,000 doses of its vaccine to the state by the end of the month, but that cannot happen until the vaccine gets regulatory approval.