Florida Surgeon General tells US Senate there is ‘inadequate data’ regarding efficacy of pediatric COVID vaccine

The statement made by Ladapo came in a letter regarding false information disseminated through through a recent subcommittee press release.

"Separate from ordering, I recommended against pediatric COVID-19 vaccines for children under 5," Ladapo wrote. "There are no data that prove this vaccine is more effective than the placebo in reducing severe illness and other clinically meaningful outcomes un this age group."

"There is also inadequate data regarding the safety of the COVID-19 vaccine," he added.

Ladapo continued on to say that "a recent pre-print study shows a higher risk of serious adverse events of special interest run the treatment group versus the placebo group in adults, for example."

"Additionally, since the release of the COVID-19 vaccines, studies continue to show a risk of myocarditis and pericarditis across several age groups, especially in adolescents and young men," Ladapo wrote.

Ladapo said that manufacturers failed to meet the burden of proof in showing that the vaccine "may be effective" at preventing disease, "especially for those ages 6 months through 4 years."

"The burden of proof for vaccine efficacy and safety does not fall on the Florida Department of Health. This burden falls squarely on drug manufacturers. It is the responsibility of the US Food and Drug Administration (FDA) and CDC to review a manufacturer’s data, and the Department disagrees with their recommendation."

In the letter, Ladapo also slammed the subcommittee for "blatantly false statements perpetuated by a misleading press release issued by [Clyburn’s] office."

Ladapo clarified that "at no point did the Florida Department of Health limit vaccine access in Florida."

He said that over two years into the pandemic, the state determined that pre-ordering vaccines was an "unnecessary relic," and one that was "implemented when supply was low and demand was high among high-risk populations."

Ladapo noted that in the case of pediatric vaccines, demand remains low.

He added that while the Florida Department of Health chose not to engage in the pre-ordering process, the state never stopped pediatricians and doctors from ordering the vaccine, some of which did so the day that the vaccine was approved.

"It is unfortunate that the information you released is perpetuating confusion among the public," Ladapo wrote. "Parents are in the best position to make these decisions for their children. Florida remains committed to making recommendations and decisions based on data and science — not ideology."