Moderna seeks EUA for fourth dose of COVID-19 vaccine for all adults
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Moderna announced that it is seeking an emergency use authorization from the FDA for an additional booster dose of its COVID-19 vaccine for all adults.
The company applied for the EUA for anyone aged 18 years or older who has already received a booster dose of any authorized COVID-19 vaccine.
The submission was based partly on data from Israel and the United States following the emergence of the omicron variant that demonstrated the benefits of an additional dose of the vaccine, according to a press release.
The company did not specify what the data showed, but a recently published study in The New England Journal of Medicine that assessed a fourth dose of either the Pfizer-BioNTech or Moderna messenger RNA vaccine among health care workers showed it was safe and boosted antibody levels similarly to levels observed after a third dose. Although the trial is ongoing, researchers noted that, so far, a fourth dose did not appear any more effective at preventing infection with the omicron variant.
If approved, the EUA for Moderna’s vaccine would be broader than the one requested by Pfizer and BioNTech this week, which seeks authorization of a fourth dose for adults aged 65 years or older.
Moderna said the broader request would “provide flexibility” to the CDC and health care workers to determine the “appropriate use” for populations at higher risk of COVID-19 because of age or comorbidities.
References:
Regev-Yochay G, et al. N Engl J Med. 2022;doi:10.1056/NEJMc2202542.
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