Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults.

The request is broader than Pfizer and BioNTech's request earlier this week for the regulator to approve a booster shot for adults 65 and older.

What You Need To Know

  • Moderna has asked the Food and Drug Administration to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults

  • The request Thursday is broader than than Pfizer and BioNTech's request earlier this week for the regulator to approve a booster shot for adults 65 and older

  • The company says its request was made "to provide flexibility" to the CDC to determine the "appropriate use" of a second booster dose, "including for those at higher risk of COVID-19 due to age or comorbidities"

  • The FDA granted full approval of Moderna's vaccine in January of this year; More than 75 million people in the U.S. have been fully vaccinated with Moderna's two-dose regimen, with 41.5 million boosted with the shot, according to data from the CDC

In a press release, the company said its request for approval for all adults was made "to provide flexibility" to the Centers for Disease Control and Prevention and medical providers to determine the "appropriate use" of a second booster dose of the mRNA vaccine, "including for those at higher risk of COVID-19 due to age or comorbidities."

"The request to include adults over 18 years of age was made to provide flexibility for the U.S. Centers for Disease Control and Prevention (CDC) and healthcare providers to determine the appropriate use of an additional booster dose of mRNA-1273, including for those at higher risk of COVID-19 due to age or comorbidities," Moderna wrote in a release. "This submission is based in part on recently published data generated in the United States and Israel following the emergence of Omicron."

U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines' protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to "urgently" approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations.

U.S. health officials currently recommend a primary series of two doses of the Moderna vaccine and a booster dose months later.

Moderna said its request for an additional dose was based on "recently published data generated in the United States and Israel following the emergence of Omicron."

On Tuesday, Pfizer and its partner BioNTech asked U.S. regulators to authorize an additional booster dose of their COVID-19 vaccine for seniors, saying data from Israel suggests older adults would benefit.

The FDA granted full approval of Moderna's vaccine in January of this year. More than 75 million people in the U.S. have been fully vaccinated with Moderna's two-dose regimen, with 41.5 million boosted with the shot, according to data from the CDC.

More than 258 million Moderna doses have been administered in the U.S., the CDC says.