FDA accuses DeSantis of causing ‘unecessary deaths’

A war of words has broken out between federal health officials and Ron DeSantis’ vaccine-skeptic doctors over the Covid shots.

Last month Florida issued guidance to physicians telling them it was their duty to warn patients the vaccines may cause heart attacks, based on widely disputed research.

Today the FDA and CDC angrily hit back at the new order, saying antivaxx rhetoric will cause ‘unnecessary death, severe illness and hospitalization’ if elderly and vulnerable Floridians are now put off getting the shot.

The letter takes aim at Dr Joseph Ladapo, the state’s controversial surgeon general who has taken a hard line on Covid vaccines, once saying: ‘far less attention has been paid to safety [of the shots] and the concerns of many individuals have been dismissed.’

Florida Health officials report a 1,700 percent increase in adverse events to the vaccines in the state in 2021, the first year the Covid vaccine was made available. They are now recommending doctors warn patients of the increased risk of adverse events when recommending the Covid vaccine

Florida Health officials report a 1,700 percent increase in adverse events to the vaccines in the state in 2021, the first year the Covid vaccine was made available. They are now recommending doctors warn patients of the increased risk of adverse events when recommending the Covid vaccine

The FDA replied to an advisory by Florida officials telling doctors to warn Covid vaccine recipients that they could suffer a heart attack as a result of receiving the shot. They say that misinformation could be potentially deadly (file photo)

The FDA replied to an advisory by Florida officials telling doctors to warn Covid vaccine recipients that they could suffer a heart attack as a result of receiving the shot. They say that misinformation could be potentially deadly (file photo)

Dr Joseph Ladapo (pictured), had been an the center of a vaccine skepticism campaign in Florida. The FDA addressed Friday's letter to the Sunshine State's Surgeon General

Dr Joseph Ladapo (pictured), had been an the center of a vaccine skepticism campaign in Florida. The FDA addressed Friday’s letter to the Sunshine State’s Surgeon General

‘Unfortunately, the misinformation about COVID-19 vaccine safety has caused some Americans to avoid getting the vaccines they need to be up to date,’ the letter, signed by FDA Commissioner Dr Robert Califf and CDC Director Dr Rochelle Walensky, reads.

‘This has led to unnecessary death, severe illness and hospitalization.’

The letter comes in response to a notice sent to doctors in the state by the department of health on February 14. The letter was first reported by DailyMail.com, and later picked up by local media outlets.

It warned that reports of adverse events following vaccination in Florida had increased 1,700 percent from 2020 to 2021. 

Among them was a massive spike in life-threatening conditions linked to vaccines, including include heart attacks and other cardiovascular issues. 

This is despite only a 400 percent in the number of vaccines administered in Florida that year. This suggests the increase in shots administered is not the sole reason for this increase. 

The system cited by Florida officials uses self-reported information and does not require verification. 

Some reports may not be true, and others could be caused by Covid itself – which is known to cause long-term heart symptoms in some sufferers. 

‘The COVID-19 pandemic brought many challenges that the health and medical field have never encountered,’ a notice from state officials reads.

‘Although the initial response was led by a sense of urgency and crisis management, the State Surgeon General believes it is critical that as public health professionals, responses are adapted to the present to chart a future guided by data.’

The notice references reports to the Vaccine Adverse Event Reporting System (VAERS), a system run by the US Department of Health and Human Services to log vaccine-related injuries.

In 2021, 41,473 vaccine-related injuries were reported in Florida, a massive increase from the 2,466 a year earlier.

VAERS data is self-reported, and cases submitted to the system do not need to be verified by a physician.

‘The claim that the increase of VAERS reports of life-threatening conditions reported from Florida and elsewhere represents an increase of risk caused by the COVID-19 vaccines is incorrect, misleading and could be harmful to the American public,’ the letter reads.

‘Reports of adverse events to VAERS following vaccination do not mean that a vaccine caused the event.’

The FDA cites a study published last week by researchers from Mount Sinai, in New York City. 

In the study, data from nearly 2million American adults was gathered to gauge the risk of suffering a heart attack, stroke or major heart issues after vaccination.

They found that people who received the shot were less likely to experience cardiovascular problems. 

They credit this to the vaccine preventing Covid infections – which have been linked to serious heart problems in some cases.

This research was peer-reviewed and published in the Journal of the American College of Cardiology, a prestigious medical journal.

Gov DeSantis and Dr Ladapo have been criticized in the past for using studies that were not peer reviewed and did not include listed authors.

In October, the pair used such data to stand up their recommendation against teenagers receiving the vaccine, a first for any state in the US.

The leading public health agencies also cite CDC data estimating that a person who is fully vaccinated and has received a bivalent Covid booster is 9.8 times less likely to die from the virus.

The bivalent booster was developed by Pfizer and Moderna to target the Omicron variant. It has replaced the original Covid vaccine, developed to fight the original Wuhan strain.

It also notes that uptake of bivalent booster among the elderly in Florida – a state known for its retired population – falls well short of the national average.

‘As the leading public health official in state, you are likely aware that seniors in Florida are under-vaccinated, with just 29 percent of seniors having received an updated bivalent vaccine, compared to the national average of 41 percent coverage in seniors,’ the letter reads.

‘It is the job of public health officials around the country to protect the lives of the populations they serve, particularly the vulnerable. Fueling vaccine hesitancy undermines this effort.’

The Florida Department of Health did not immidiately reply to a DailyMail.com request for comment. 

Last month, Florida officials cited studies of their own to dispute the safety of the vaccines.

An American study published in September found one in every 550 recipients of the Covid vaccine suffered an adverse event.

‘Which is much higher than other vaccines,’ the notice says.

The study focused on clinical trials held for the Pfizer and Moderna vaccines to initially earn FDA approval in late-2020.

Across all the trials gathered for the study – which included tens of thousands of patients – 52 Pfizer vaccine recipients and 87 who got the Moderna shot had a significant adverse reaction.

This is compared to 33 and 64, respectively, among people who did not receive the shot, indicating that the existing risk is still relatively small.

This data was considered by the FDA and CDC before they issued emergency use authorization – and eventually full approval – for the shots in recent years.

Florida Health also cites a 2022 study by Israeli researchers, which found a 25 percent increase in cardiac events in the Middle-Eastern nation in the months following the shot’s rollout.

Researchers note that it is unclear whether any of these events had any link to the vaccine.

‘While not establishing causal relationships, the findings raise concerns regarding vaccine-induced undetected severe cardiovascular side-effects and underscore the already established causal relationship between vaccines and myocarditis, a frequent cause of unexpected cardiac arrest in young individuals,’ researchers wrote.

Gov Ron DeSantis (pictured) has proved to be a staunch opponent of vaccines and Covid related mandates over the past two years

Gov Ron DeSantis (pictured) has proved to be a staunch opponent of vaccines and Covid related mandates over the past two years

The FDA and CDC cite a recent study from Mount Sinai that found people who had received the vaccine were less likely to suffer issues such as a heart attack or stroke (file photo)

The FDA and CDC cite a recent study from Mount Sinai that found people who had received the vaccine were less likely to suffer issues such as a heart attack or stroke (file photo)

A Norwegian study cited by the Florida health department showed that the AstraZeneca vaccine was linked to blood clotting in the brain and low blood platelet counts – both of which are life-threatening.

The vaccine is not available in America, though, and could not be responsible for the uptick in VAERS reports in 2021.

The shots do not come without some relatively small risks, though.

Early in 2021, the CDC warned that young males who had received the mRNA vaccines – either the Pfizer or Moderna shot were at an increased risk of suffering heart inflammation.

The agency warned that myocarditis was appearing more frequently in males 16 and older within seven days of receiving the shot.

Despite the warning, officials also continued to recommend the vaccine to this age group.

Earlier this year, the FDA and CDC also issued a warning linking the Pfizer’s bivalent shot to ischemic stroke three to four weeks post-vaccination.

The possible link between Pfizer’s jab and the elevated stroke risk was detected by the CDC’s Vaccine Safety Datalink (VSD), a real-time surveillance system.

Two weeks later, it was noted the risk was minimal, but getting the bivalent shot on the same data as a flu shot could pose some issue.

Global health officials have given widespread approval to the Covid vaccines.

Despite existing risks, they have determined the benefits of the shots outweigh any risks.

Floridian officials have stood out among other US leaders in their continued criticism of the Covid vaccines.

In December, Gov Ron DeSantis called for a grand justy to investigate ‘wrongdoing’ related to the shots.

‘We’ll be able to get the data whether they want to give it or not,’ DeSantis said.

‘In Florida, it is illegal to mislead and misrepresent, especially when you are talking about the efficacy of a drug.’

He continued, ‘today, I’m announcing a petition with the Supreme Court of Florida to enpanel a statewide grand jury to investigate any and all wrongdoing in Florida with respect to Covid vaccines.’

Dr Ladapo was present too. He drew criticism last year after recommending against teens receiving the shots, despite FDA approval.

‘The data that’s coming in on this is showing for healthy kids very little benefit in terms of what the vaccine is doing and that’s weighed against the fact that they’re at very, very low risk,’ he said.

‘Individuals can make their own decision… but I think the data is in line with what the surgeon general recommended.’

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