May 18, 2022

Ladapo Says ‘Lack of Data’ Behind Biden Booster Authorization for Children

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By Lydia Nusbaum

May 18, 2022 Updated 4:31 P.M. ET

TALLAHASSEE (FLV) – Florida Surgeon General Joseph Ladapo said there is a “lack of data” behind the U.S. Food and Drug Administration’s decision to authorize the first COVID boosters for children ages 5 to 11 Tuesday.

“Dr. Ladapo finds the lack of supporting data disappointing. The question should be whether or not the booster improves clinical outcomes, and there is no evidence that it does in this population,” Florida Department of Health Spokesperson Jeremy Redfern said.

The FDA analyzed antibody responses in 67 study participants who received a booster dose seven to nine months after completing a two-dose primary series of the Pfizer vaccine. The FDA said it resulted in antibody levels increasing. 

The FDA said it also assessed the safety of the booster in about 400 children. The most common side effects were pain, redness and swelling where the shot took place, as well as fatigue, headache, muscle or joint pain, chills and fever. 

“The data is based purely on antibody levels,” Redfern said. “It’s not based on clinical outcomes.”

The recent approval allows 5 to 11-year-olds to receive the booster shot from the Pfizer-BionTech vaccine after receiving the first two shots five months previously. 

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, M.D. “Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe.”

The FDA did not consult with the Vaccines and Related Biological Products Advisory Committee before approving the booster. The committee was established to provide advice to the Commissioner to help ensure safe and effective vaccines.

The FDA said Pfizer’s emergency use authorization request “did not raise questions that would benefit from additional discussion by committee members.” Instead, the agency said it previously had met with the committee for “extensive discussions” regarding the use of booster doses. 

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