Members of the Federal Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted unanimously to approve the application for emergency use authorization for Johnson and Johnson booster shots in a hearing on Oct. 15.
Johnson and Johnson is currently a single dose shot, authorized for people aged 18 and older. The company application requested a single 0.5 ml dose booster shot administered at six months or after vaccination, although it could be administered as early as two months later.
MORE: FDA Panel Begins Testimony for Moderna Booster shots
Dr. Penny Heaton, presenting for J&J, told the panel members their request was based on the outcome of a trial. She said a booster administered at two months resulted in 94% protection. A booster shot at six months resulted in a 12-fold increase in antibodies against all variants that were included in the trial, including the delta variant.
The 19 members of the panel voted unanimously to approve the application.
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It followed the outcome of the Oct. 14 session in which the panel unanimously approved the application for EUA for booster shots filed by Moderna. The vaccine is currently authorized for people aged 18 and older.
The company said the booster dose would be 0.25 ml, which is half the 0.5 dose 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 booster shot would be administered at least six months after patients completed their original, two dose regiment.
Pfizer won EUA for booster shots last month. During the Pfizer presentation corporate officials said, 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.
The panel’s vote goes to the FDA next week to decide whether to follow the recommendation. Generally, the agency does follow the panel recommendations, but they are not obligated to do so.
If approved, the FDA decision will then go to the Centers for Disease Control and Prevention for final authorization. That decision could come by Friday, Oct. 22.
Dana Lynn McIntyre is a Staff Reporter with The Augusta Press. You can reach her at dana@theaugustapress.com
