Moderna seeks FDA authorization for a 4th COVID vaccine shot for all adults

Moderna on Thursday requested emergency use authorization from the Food and Drug Administration for a fourth dose of its COVID-19 vaccine as a booster for people 18 and over — a broader request than Pfizer made days ago for its vaccine.

Currently, a single booster dose of Moderna's mRNA vaccine is authorized for emergency use on top of its two-dose vaccine.

The biotech company’s request comes two days after Pfizer and its collaborator BioNTech requested federal permission to provide an additional booster dose of their COVID-19 vaccine Comirnaty to people 65 and older.

Moderna 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.

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The Food and Drug Administration has not said how long it will take to review either request or whether it will convene its expert panel to review them. 

Moderna said its request for emergency use authorization is based partly on recently published data from the U.S. and Israel following the emergence of the omicron variant.

The company did not specify what the U.S. and Israeli data showed, but Israel approved a fourth COVID vaccine shot for vulnerable people over the age of 18 in January 2022. Additionally, a study of more than 1 million Israelis over 60 showed that those who got a fourth dose of the Pfizer-BioNTech vaccine were half as likely to become infected and four-times less likely to fall severely ill than those who had only three shots. That study has not been peer-reviewed. 

Other studies show that the effectiveness of mRNA vaccines, like Pfizer's and Moderna's, begins to fade after about three months following a third dose.

As of March 2022, over 216 million Americans – 65.2% of the population – have been fully vaccinated, and 44.4% have received a booster dose, according to Centers for Disease Control and Prevention data.

Contributing: Karen Weintraub, USA TODAY; The Associated Press