FDA documents reveal Moderna booster side effects

Moderna COVID-19 Vaccines
Moderna COVID-19 Vaccines(waff)
Published: Oct. 12, 2021 at 4:41 PM EDT
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RALEIGH, N.C. (WNCN) – The FDA was scheduled to hear debates from Moderna this week regarding their COVID-19 booster this week. The company was authorized to boost the immunocompromised a few months ago. They are now hoping to expand that.

Ahead of its meeting, the FDA has published more information on its additional dose including side effects for a Moderna booster.

The company conducted two separate studies to support the need for a booster. Overall, the company says of all trial participants:

  • 38% felt mild fatigue
  • 34% felt mild muscle pain
  • 37% felt mild headache
  • 16% felt mild nausea
  • 18% felt mild chills
  • 18% felt mild joint pain
  • 9% felt mild fever

Moderna is pushing for a booster shot with half the dosing of the original vaccine. The company said trial findings were almost identical for trial participants who had the full dosing versus the half dosing.

Moderna said a half dose “would result in a substantial increase in the worldwide vaccine supply.”

The company said in documents submitted to the FDA that a booster created 15 times more neutralizing antibodies after dose 2. Moderna said those levels were 66 times higher than before dose 1.

The FDA was scheduled to discuss Moderna’s booster on Thursday and Johnson and Johnson’s booster on Friday.

The CDC plans to meet next week to discuss booster data as well.

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