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Moderna Requests Emergency Use Authorization of Fourth COVID Vaccine Dose

Unlike Pfizer, which seeks an EUA for adults 65 and older, Moderna is seeking authorization for all adults over age 18

On Thursday, Moderna announced it had submitted a request to the Food and Drug Administration (FDA) for emergency use authorization of a second booster dose of its COVID-19 vaccine for all adults aged 18 and over.

This move follows Pfizer’s and BioNTech’s request on Tuesday for the same authorization for a second booster dose of their vaccine for adults age 65 and older.

In a press release, Moderna stated that its request for the emergency authorization for all adults intends to provide the flexibility for the “U.S. Centers for Disease Control and Prevention (CDC) and healthcare providers to determine the appropriate use of an additional booster.”

Similar to the Pfizer submission, Moderna based its request partly due to data from Israel following the surge of the highly contagious Omicron variant.

The companies said a second booster administered at least four months after an initial booster dose could restore antibody levels to peak post-third dose level. 

Moderna also stated that evidence indicates the vaccine’s efficacy against symptomatic infection and severe illness caused by COVID-19 drops roughly three to six months after receiving the third dose.

On Thursday, Dr. Anthony Fauci spoke to House Democrats during a weekly Democratic Whip meeting. He had been invited to address members by Whip Jim Clyburn to outline the needs related to the White House’s continued request for additional COVID-19 funding. 

Fauci pointed to the need for a fourth dose of the vaccine. Additional boosters would be covered by government funding to ensure vaccinations are available to all Americans. 

According to a letter sent to Congress from the White House, the U.S. has not ordered enough shots to give all Americans the fourth dose if needed. Fauci indicated that protection against hospitalization appears to wane four or five months after a third dose and could be expected to drop further.

“I would project that sooner or later, we will need a fourth,” Fauci said.

The U.S. may follow Israel’s example. The nation became the first country to approve the fourth dose of COVID-19 vaccines after Prime Minister Naftali Bennett announced that the additional dose would be available to people ages 60 or older and at-risk groups.

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