Moderna asked the Food and Drug Administration on Thursday to allow adults to receive a fourth dose of its COVID-19 vaccine.
The company said it is making the request “to provide flexibility” for the Centers for Disease Control and Prevention and healthcare providers to determine when a person may need an additional COVID-19 booster shot, such as people at higher risk of severe illness “due to age or comorbidities.”
Moderna said the submission is partly in response to new research following the emergence of the omicron variant of COVID-19.
We have submitted a request to the U.S. FDA for an amendment to the emergency use authorization to allow for a fourth dose of our #COVID19 vaccine in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. pic.twitter.com/aDV71C7DA1
— Moderna (@moderna_tx) March 18, 2022
“Real-world evidence continues to confirm the effectiveness and robust safety profile of the Moderna COVID-19 vaccine,” Moderna’s announcement reads. “Clinical trials are ongoing for Moderna’s Omicron-specific booster (mRNA-1273.529) and a bivalent Omicron-specific booster (mRNA-1273.214).”
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Moderna’s request comes on the same day Dr. Anthony Fauci predicted that people will eventually need to get a fourth COVID-19 vaccine dose. Pfizer and its partner, BioNTech, filed Tuesday for an emergency authorization of a fourth dose of their COVID-19 vaccine for people 65 and older.
The CDC recommends that everyone ages 5 and older get vaccinated against COVID-19.
Pfizer-BioNTech’s COVID-19 vaccine is a two-dose regimen, same as Moderna’s, while Johnson & Johnson’s only requires a single shot. The CDC currently urges anyone 18 years and older who received the Moderna vaccine to get a booster after five months, recommending either the Pfizer or Moderna vaccines.
Around 81.6% of those eligible to get vaccinated in the United States have received at least one dose of the COVID-19 vaccine, while 69.4% were fully vaccinated as of Thursday, according to the CDC.
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A total of 44.4% of U.S. residents who are fully vaccinated have received at least one booster shot. Around 46% of fully vaccinated people who are at least 18 years old have received a booster, while 66.9% of fully vaccinated people 65 and older have done the same, per CDC data.
