FDA Panel Begins Testimony for Moderna Booster shots

Date: October 15, 2021

Members of the Federal Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend a booster shot of the Moderna vaccine during the first of two days of hearings.

During the Oct. 14 session, the 19 members of the committee took up the application for Emergency Use Authorization filed by Moderna. The vaccine is currently authorized for people aged 18 and older.

Pfizer won EUA for booster shots last month. From the presentation, “While highly effective at preventing disease in the months immediately after someone is fully vaccinated, tests indicate the vaccine begins to lose potency against severe infection and hospitalization of COVID-19.”

MORE: Reviewing Boosters and Vaccinations for Younger Children

However, a recent study by the Centers for Disease Control and Prevention showed Moderna’s vaccine effectiveness holds up better protecting against hospitalization.

The report said, “VE against COVID-19 hospitalizations was higher for the Moderna vaccine (93%) than for the Pfizer-BioNTech vaccine (88%). VE for both mRNA vaccines was higher than that for the Janssen vaccine (71%).”

Dr. Peter Marks opened the hearing by explaining vaccine effectiveness.

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“It’s important to remember the vaccines still provide strong protection against serious outcomes, especially for younger age groups,” said Marks. “Vaccine effectiveness against mild and moderate disease appears to wane over time for the different vaccines.”

That was the argument made by Moderna; that booster shots are needed to prevent the mild to moderate cases of the virus. The company said the booster dose would be 0.25 ml, which is half the 0.5 dose administered in its first two shots. Moderna said participants in the study showed an antibody level 1.8 times higher after receiving the booster shot.

The members voted unanimously in favor. It would be administered at least six months after patients completed their original, two dose regiment.

The panel’s decision now goes to the FDA to decide whether to follow the recommendation. Generally, the agency does follow the panel recommendation, but they are not obligated to do so.

The panel convenes again on Oct. 15 to review the EUA application to authorize booster shots from Johnson and Johnson.

Dana Lynn McIntyre is a Staff Reporter with The Augusta Press. You can reach her at dana@theaugustapress.com

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The Author

Dana Lynn McIntyre is an award-winning reporter who began working in radio news in her hometown of Johnstown, Pennsylvania. She also worked as a television news photographer for a station in Altoona, Pennsylvania. Dana moved to Savannah, Ga. in 1984 to join the news team at WIXV-FM/I95 Radio. In early 1986, WBBQ Radio in Augusta invited her to interview for a position with the news department. Within three weeks, Dana was living in Olde Town and working at a legendary radio station. Dana left WBBQ in 1996 to join WJBF NewsChannel 6 as assignment manager. In 1998 she became a reporter/anchor covering law enforcement, crime and courts as well as witnessing two executions, one in Georgia, the other in South Carolina. She also spent time as an assignment manager-editor in Atlanta, metro New York City, and back in Augusta at WRDW Television. Dana joined The Augusta Press team in April 2021. Among Dana’s awards from the Georgia Associated Press Broadcasters Association are for Excellence in General Assignment Reporting, Spot News and Specialized Reporting. Dana also received an award for Public Service Reporting from the West Augusta Rotary Club for a story with actor LeVar Burton on his PBS Television show “Reading Rainbow."

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