Moderna Inc has submitted a request to the US FDA to amend its emergency use authorization (EUA) to allow for a second booster (fourth dose) of its COVID-19 vaccine (mRNA-1273) in all US adults. Adults 18 years of age and older who have received an initial booster of any authorized or approved COVID-19 vaccine would be eligible to receive the second Moderna booster, if the request is authorized.
The request comes two days after Pfizer/BioNTech requested FDA authorization for a second booster (fourth dose) of its COVID-19 vaccine (Comirnaty) for adults age 65 and older.
The current approvals/authorizations for the Moderna vaccine or booster doses is as follows:
- The two-dose Moderna vaccine (Spikevax) is FDA-approved for individuals 18 years of age and older as of January 31, 2022.
- In addition, a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level is authorized for emergency use in the US for adults 18 years and older.
- A third dose of the Moderna COVID-19 vaccine at the 100 µg dose level is authorized for emergency use in immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
“Moderna continues to collect and monitor real-world data on its COVID-19 vaccine. Real-world evidence continues to confirm the effectiveness and robust safety profile of the Moderna COVID-19 vaccine. Clinical trials are ongoing for Moderna’s Omicron-specific booster (mRNA-1273.529) and a bivalent Omicron-specific booster (mRNA-1273.214),” the company said in a press release.