Florida Surgeon General responds to COVID-19 subcommittee on child vaccines

Today, Rep. James E. Clyburn, Chairman of the Select Subcommittee on the Coronavirus Crisis, issued a statement after a staff briefing held yesterday with Florida Surgeon General Dr. Joseph Ladapo and other representatives of the Florida Department of Health. Chairman Clyburn requested the staff briefing in a June 17 letter to Governor DeSantis, after it was revealed that Florida was the only state in the country that had failed to pre-order coronavirus vaccines for children under five, which were authorized earlier this month.

“The steps Governor DeSantis has taken to impede access to lifesaving coronavirus vaccines for Florida’s young children have made it harder for parents across the state to get their children vaccinated, and his promotion of anti-vaccine misinformation is making it harder for parents to make fully informed decisions on how best to protect children’s health. Coronavirus vaccines have proven to be extremely safe and highly effective at reducing the risk of severe illness, hospitalization, and death. Now that they have been authorized for young children, all parents must be given accurate information on the vaccines’ benefits and must have the freedom to vaccinate their children without needless barriers put in place by politicians like Governor DeSantis. I urge the governor to abandon this dangerous, anti-scientific approach, and I strongly encourage all parents of young children to provide them with the lifesaving protection of coronavirus vaccines as soon as possible.”

Dr. Ladapo provided the following information during the briefing:

Florida’s Intentional Failure to Pre-Order Coronavirus Vaccines for Young Children-A Decision Made with Governor DeSantis’s Involvement-May Have Delayed Vaccinations.

• Dr. Ladapo confirmed that the Florida Department of Health decided not to pre-order vaccines for young children by the June 14, 2022 deadline provided by the federal government, explaining the state found the pre-ordering system to be “inefficient” and “unnecessary” after having concluded that there was “very little demand.”
• When asked whether Governor DeSantis was apprised of the state’s decision not to pre-order vaccines, Dr. Ladapo replied that they had made the decision “together.”
• Dr. Ladapo confirmed that Florida did not allow pediatricians and other health care providers to place orders for vaccines for young children through Florida SHOTS, the state’s vaccine ordering system, until after the Food and Drug Administration (FDA) granted emergency use authorization on June 17, 2022. He explained that providers’ ability to order vaccines was always “contingent on some form of authorization” from FDA, suggesting that press reports that Florida reversed its decision and only allowed providers to order vaccines following public outcry were incorrect.
• Although he acknowledged the Biden Administration was able to “very promptly” deliver vaccines to health care providers across the state, Dr. Ladapo said that Florida’s decision to block providers from putting in orders until June 17 may have caused a short “delay” that impacted the prompt administration of vaccines.

Governor DeSantis and the State of Florida Continue to Promote Anti-Vaccine Misinformation.

• Dr. Ladapo doubled down on Governor DeSantis’s prior public statements that Florida is “affirmatively against” vaccines for young children, stating: “In Florida, we don’t recommend” coronavirus vaccines for children under 18. Contrary to consensus scientific views confirmed by the Centers for Disease Control and Prevention, FDA, and top scientists and public health experts throughout the country, Dr. Ladapo claimed there is “little data” on whether children and adolescents-who he asserted are at “low risk” from the coronavirus-benefit from the COVID-19 vaccines.
• When asked whether it was his assessment that the risks to children from the coronavirus are lower than risks to children from coronavirus vaccines, Dr. Ladapo replied that it was “a perverse question.” He said that he believes that the proper question is to compare risk of vaccination to the risk of not vaccinating, implying that risks of infection should not be considered.

More than 30,000 Florida Children Under Five Still May Not Have Access to Coronavirus Vaccines.

• Dr. Ladapo confirmed that, given the state’s view that children should not be vaccinated against the coronavirus, county health departments in Florida “cannot” order or administer coronavirus vaccines to young children, a decision that he said he discussed with Governor DeSantis. Dr. Ladapo also confirmed that approximately 3% of the more than 1.1 million children under five who live in Florida receive their primary care at county health departments, leaving approximately 33,000 young children in Florida without access to coronavirus vaccines at their normal point of care.
• When asked whether the Florida Department of Health had analyzed whether parents whose children receive primary care at county health departments may have difficulty getting their children vaccinated against the coronavirus at other locations, Dr. Ladapo asserted: “We don’t believe it should be offered at all and we’ve communicated that to Floridians.” However, he added that the state has done “some research” on how to connect parents who are interested in vaccinating their children with federally qualified health centers and other providers that are offering vaccinations.
• Dr. Ladapo was not able to provide an immediate answer as to whether coronavirus vaccines for young children are currently offered in all counties across the state or what percentage of the population can easily access the vaccines. He noted that he does not believe that the Florida Department of Health “should be on the back” of health care providers to provide access to “a product we don’t agree with.”

“Dear Chairman Clyburn:

While we were initially pleased with the opportunity to meet on June 28, 2022, with staff of the House Committee on Oversight and Reform, and the House Select Subcommittee on the Coronavirus Crisis, we have become aware of the blatantly false statements perpetuated by a misleading press release issued by your office. It is unfortunate that staff used this educational meeting as a launching pad for politically charged attacks. The purpose of the meeting was to discuss:

1) Misinformation regarding ordering versus pre-ordering in Florida,
2) Ability for private providers to order the COVID-19 vaccine for children as young as six months,
3) Pediatric COVID-19 guidance,
4) Vaccine availability and access.

Information regarding the meeting released to media outlets earlier today mischaracterizes the conversation and we welcome the opportunity to clarify.

Vaccine Ordering

At no point did the Florida Department of Health limit vaccine access in Florida. While responding to COVID-19 for over two years, Florida determined the following:

1) Pre-ordering is an unnecessary relic and was implemented when supply was low and demand was high among high-risk populations, including those 65 and older. There continues to be a low demand for pediatric COVID-19 vaccines.

2) Inefficiencies were observed by the Department during pre-ordering of previous vaccine
authorizations, and the Department determined that the process is cumbersome and no longer needed.

3) By simply allowing providers to determine their individual needs, rather than assuming demand,
direct ordering allows for more efficient resource management and distribution.

The Department permitted private providers to order the vaccine as soon as the Emergency Use Authorization (EUA) was issued on June 17, 2022. In fact, some pediatricians ordered vaccines on that day. While the Department chose not to engage in the pre-ordering process, providers were never restricted from ordering. Moreover, they cannot order any vaccines from the Centers for Disease Control and Prevention (CDC) that have not been authorized or approved.

Providers started receiving orders as early as June 21, 2022, which is further evidence for why the preordering process is not needed.

Pediatric COVID-19 Vaccine Guidance

Separate from ordering, I recommended against pediatric COVID-19 vaccines for children under 5. There are no data that prove this vaccine is more effective than the placebo in reducing severe illness and other clinically meaningful outcomes in this age group. There is also inadequate data regarding the safety of the COVID-19 vaccine. A recent pre-print study shows a higher risk of serious adverse events of special interest in 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.

To receive an EUA, a manufacturer must show that a product “may be effective” at preventing a disease or condition, and the FDA must determine that the benefits outweigh the risks. The manufacturers failed to meet this burden of proof, 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 U.S. Food and Drug Administration (FDA) and CDC to review a manufacturer’s data, and the Department disagrees with their recommendation.

Data

Florida has always ensured COVID-19 vaccines and treatments are widely available, but never mandated.

The FloridaHealthCOVID19.gov website provides the public with:

1) Reports including county-level data and vaccination rates.

2) Vaccine, treatment, and testing locators.

As to your inquiry about data on pediatric COVID-19 uptake, these data can be seen in the reports on this website. You can find data we referenced that show the low demand for pediatric vaccines here. Additionally, page 21 of the Kaiser survey shows that demand dropped significantly from 31% in January 2022 to 18% in April 2022. This drop may be attributed to a loss in confidence after the original application for EUA was withdrawn.

Last year, the State of Florida transitioned from an emergency COVID-19 response to an endemic phase which shifts health care back to private providers and the normal stream of health care. We expect health care providers to manage COVID-19 care, especially when caring for young patients, through prevention and treatment, on a case-by-case basis.

It is unfortunate that the information you released is perpetuating confusion among the public. 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.”