UPDATED: Analysis of Florida Department of Health: Guidance on Childhood Vaccines
Does Florida's Health Department recommendations in direct opposition with ACIP, CDC, and American Academy of Pediatrics hold up to scrutiny?
On March 8th, 2022 the Florida Department of Health released a press release titled: "New Guidance Regarding COVID-19 Vaccination Recommendations for Children."
The Florida Surgeon General Dr. Joseph A. Ladapo, MD stated: “Based on currently available data, the risks of administering COVID-19 vaccination among healthy children may outweigh the benefits.”
UPDATE: As of April 2023 a Freedom of Information Act request showed that Joseph Ladapo, MD personally altered a Florida State Study about COVID-19 Vaccines, falsifying data to make vaccines appear more dangerous:
“Ladapo’s changes, released as part of a public records request, presented the risks of cardiac death to be more severe than previous versions of the study. He later used the final document in October to bolster disputed claims that Pfizer-BioNTech and Moderna vaccines were dangerous to young men.”
News references and additional details:
“Florida surgeon general altered key findings in study on Covid-19 vaccine safety”
“Report: Florida officials cut key data from vaccine study”
“Hiding important information is not science”
“Data Omitted From FL Vax Report? No Evidence of Fraud in Stanford President's Paper”
“In a public records request, the Times asked for all previous versions of the state analysis made public in October. Before the final version was released, at least five drafts had been produced, the article stated. The conclusion in four of the drafts "provided a counterpoint to Ladapo's assertion about the vaccine."
Study alterations omitting key data are detailed here. Ladapo himself manipulated of scientific studies and used this to make recommendations against getting vaccinated.
The press release issued by the Florida Department of Health contains quotes from three researchers, Dr. Martin Kulldorff, Dr. Joseph Fraiman, and Dr. Tracy Høeg. Each of them focuses only on mortality in children.
Dr. Tracy Høeg stated: “We need to look at children who have already been infected – and we know according to the CDC that that's at least 58% of children, it’s probably more by now. Especially for healthy children, we don't know if they've benefitted from being vaccinated on top of already having infection. That's actually true for adults. That's been shown with data from the CDC out of New York and California.” Disregarding rapid re-infection with new variants repoted earlier in 2022.
Dr. Martin Kulldorff stated: “For children, the story is very, very different. I think in public health, it's important to be honest, not only about what we know, but also what we don't know. If you go back and look at the randomized trials for children of the Pfizer vaccine that we used for the emergency use authorization, what those trials showed – and they had about a little over 4,000 people in total in these two trials – is that there is the reduction in mild infections. If you look at serious disease, the hospitalization and deaths, there was none.”
Dr. Joseph Fraiman stated: “The question is, if you have a child who's at risk or has co-risk factors for COVID-19, that's a discussion with your pediatrician, but if you have a healthy child, the chances of that child dying are incredibly low, essentially close to zero, if not actually zero. Then the next part of the analysis that you would have to think about are the side effects of the vaccine and the symptoms of COVID-19. The vaccine causes severe symptoms in children and adults.”
Together, these statements disregarded morbidity in children and adolescents post COVID-19 infection as well as research demonstrating that repeat infections in adults can occur at rapid intervals if distinct variants are in circulation: Occurrence and significance of Omicron BA.1 infection followed by BA.2 reinfection, Increased risk of SARS-CoV-2 reinfection associated with emergence of Omicron in South Africa. Repeat infection leads to compounding organ damage in adults and reinfection in children can be common: Burden of SARS-CoV-2 and protection from symptomatic second infection in children.
The Guidance for Pediatric COVID-19 Vaccines issued by Dr. Ladapo references research based on unconfirmed VAERS reports. In addition, the guidance references a publication in pre-print form at the time of guidance issuance. Relying on one to two research research studies that have not been peer reviewed and, or have made significant controversial statements relative to better controlled, larger studies is not standard practice in making medical and health recommendations. At the time of this writing, this article has yet to be published with peer review. In the pre-print the authors showed that despite waning protection from infection in children and adolescents significant protection persisted against both Delta and Omicron. “The risks of infection and hospitalization were elevated for unvaccinated vs vaccinated children aged 5 to 11 and 12 to 17 years, although the risk declined as Omicron became more prevalent. Protection declined with time since vaccination. These results complement recent findings of reduced vaccine effectiveness for adolescents against the Delta variant and the dual effects of the variant and waning protection against infection, with sustained protection against hospitalizations.”
A similar group of authors did publish a research letter: “Risk of Infection and Hospitalization Among Vaccinated and Unvaccinated Children and Adolescents in New York After the Emergence of the Omicron Variant”. Here, the authors themselves conclude that: “These findings support efforts to increase vaccination coverage in children and adolescents and review dosing strategies for children aged 5 to 11 years.”
Finally, in addition to citing unsubstantiated research the issued guidance fails to assess risk of childhood morbidity and reduction in severity of breakthrough infection by vaccination which is known to reduce long-COVID in adults.
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The FDA, CDC, ACIP have approved childhood vaccines based on a risk-benefit analysis of clinical trial data: FDA Comirnaty, FDA Spikevax, FDA Novavax, CDC Childhood Vaccines, ACIP COVID-19 Vaccine Recommendations. The American Academy of Pediatrics recommends COVID vaccination for healthy children ages 6 months and older: COVID-19 Vaccines in Children and Adolescents. The American Heart Association also strongly recommends vaccination for children: COVID-19 vaccine recommended for children ages 5 - 11, and adolescents: Statement Following CDC ACIP Meeting from Nation’s Leading Doctors, Nurses and Public Health Leaders on Benefits of Vaccination.
Morbidity or long-term health consequences of viral infection are known to occur with other viruses. Some examples of other viruses causing sequelae are provided here: Syncope after Influenza Virus Infection, Long term outcomes in survivors of epidemic Influenza A (H7N9) virus infection, Neurological complications of acute and persistent Epstein-Barr virus infection in pediatric patients, Neurological aspects of rubella virus infection. However, because of the pleotropic nature of the SARS-CoV-2 virus, wherein cells throughout the body are infected, significant and permanent physical damage beyond the lung tissue is well documented post COVID-19 infection: More than 50 long-term effects of COVID-19: a systematic review and meta-analysis.
COVID infection in children leads to a significantly higher rate of medical conditions and symptoms detailed below in Table 3 from MMWR Report / August 5, 2022 / 71(31); 993–999 : “Post–COVID-19 Symptoms and Conditions Among Children and Adolescents — United States, March 1, 2020–January 31, 2022.” Conditions where the statistics are significantly higher than background are highlighted in orange. Numbers above 1.00 with confidence intervals (>1 on the low end) are considered significant and indicate a negative outcome of COVID-19 infection.
A non-exhaustive set of additional research reports detailing serious medical conditions in children and adolescents post-COVID infection are linked here:
Post–COVID-19 Conditions Among Children 90 Days After SARS-CoV-2 Infection
Post COVID-19 Condition in Children and Adolescents: An Emerging Problem
Long COVID in children and adolescents
Extended coagulation profile of children with Long Covid: a prospective study
Pediatric long-COVID: An overlooked phenomenon?
Long‑COVID in children and adolescents: a systematic review and meta‑analyses (graphic below)
Studies of suspected vaccine induced myocarditis or pericarditis indicate temporary mild illness relative to COVID-19 infection:
CDC investigating rare myocarditis in teens, young adults; COVID-19 vaccine still advised for all who are eligible: Statement from the American Heart Association/American Stroke Association (“Both myocarditis and pericarditis are most often the result of an infection and/or inflammation caused by a virus…”)
Clinically Suspected Myocarditis Temporally Related to COVID-19 Vaccination in Adolescents and Young Adults: Suspected Myocarditis After COVID-19 Vaccination (“In conclusion, our case series demonstrates that myocarditis temporally related to COVID-19 vaccination is characterized by a mild illness with rapid resolution of symptoms in most patients.”)
Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021: “The major presenting symptoms appeared to resolve faster in cases of myocarditis after COVID-19 vaccination than in typical viral cases of myocarditis. Even though almost all individuals with cases of myocarditis were hospitalized and clinically monitored, they typically experienced symptomatic recovery after receiving only pain management. In contrast, typical viral cases of myocarditis can have a more variable clinical course. For example, up to 6% of typical viral myocarditis cases in adolescents require a heart transplant or result in mortality.”
Childhood vaccination against COVID-19 reduces the risk of hospitalization and post-COVID symptoms.
The SARS-CoV-2 virus has mutated, despite this vaccination still has some efficacy in reducing initial infection and also reduces hospitalization and severe disease in children.
In the United States up to 30% of children hospitalized because of COVID-19 have no underlying medical conditions with 19% of them requiring acute care: Post–COVID-19 Symptoms and Conditions Among Children and Adolescents. In one study, up to a quarter of children hospitalized with COVID have persistent symptoms for months after infection, with about 1 in 10 experiencing multi-organ system involvement. Risk factors for post-COVID-19 condition in previously hospitalized children using the ISARIC Global follow-up protocol: a prospective cohort study
Vaccination of children significantly reduces severe illness requiring hospitalization. With initial clinical trials showing 100% protection against severe disease. A recent study showed in adolescents protection remained as high as 92% against the Delta variant 23-44 weeks post vaccination, and 40% (hospitalization) 79% (against ‘critical’ COVID infections) with Omicron, a variant with an astounding 50+ mutations: BNT162b2 Protection against the Omicron Variant in Children and Adolescents. Now that the bi-valent vaccine that targets both the original Wuhan variant and the Omicron variant has been approved for 5+ this protection is likely to be significantly better with a booster this winter.
As vaccination leads to a reduction in severe illness, it is expected to reduce post-acute sequelae in children as is seen in the adult population. In addition, vaccination of adolescents is expected to reduce overall disease burden within the entire population: Vaccinating Adolescents and Children Significantly Reduces COVID-19 Morbidity and Mortality across All Ages: A Population-Based Modeling Study Using the UK as an Example
In summary, the data shared here are publicly available much of it published prior to the Florida Department of Health’s Press Release, and publication of its Childhood Vaccination Guidelines. All vaccination carries a small percentage of risk, as does any medical intervention or medication. However it is the job of skilled practitioners and expert researchers to assess the risk-benefit of medical intervention and provide a patient, or the public in the case of the Florida Surgeon General with data and informed consent rather than broad, unsubstantiated recommendations.
Childhood vaccination against the COVID virus is recommended by the vast majority of countries world wide and well supported by the clinical data as providing a strong benefit profile relative to reported risks.
This, along with the data presented above leaves researchers such as myself curious as to the data used to support such public recommendations made by J. Ladapo, MD where he stated that COVID vaccination may not be beneficial to the children of Florida. The lack of supporting data used to make those recommendations that may have significant health consequences for the children of Florida and beyond. In addition, the scientific basis supporting the risk benefit analysis performed by doctors Tracy Høeg, Martin Kulldorff, and Joseph Fraiman that led to their statements would be of great interest to the public and specialists in Vaccinology, Immunology, and Pediatric care.
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Lapado is the lap dog of Desantis here in Florida. Both of them have been extremely dangerous for public health.
Long Covid young adult premed student here. Long Covid to me it feel like brain deteriorating disease. I have memory loss, memory retention decreased, short term memory gone, for autistic that’s ruins to keep the routine. I was an athletic, ice hockey in winter and baseball in summer, daily running 5 km then walking 5km enjoying changes of weather. Yesterday or Wednesday, I thought I lost keys, I just moved organizing all in ranger rolls and some good clothings to hang up, it was a work considering with severe fatigue but missing key I had to do inside out. No key, then turned out it was back door still stuck. Remembering even days became hard, I think it was yesterday, I lost Google passwords 8 times. Right after change I wrote it down, cuz I’ll forget. But each time they say can’t use same passwords and I don’t remember what passwords I used. I hope kids doesn’t have to go through what I’m going through. I am thinking it is time for me to give up my longest hope of becoming doctor... I still want to so doing everything I can to stimulate brain extra... but uncertainty of cure, there’s darkness.