HomeMy WebLinkAbout12.12.25 Board Correspondence - FW_ FDA May Slap COVID Vaccines With Black Box Warning, CNN Reports • Children's Health Defense.ATTENTION: This message originated from outside Butte County. Please exercise judgment before opening
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Subject:Board Correspondence - FW: FDA May Slap COVID Vaccines With Black Box Warning, CNN Reports • Children"s
Health Defense
Date:Monday, December 15, 2025 11:39:41 AM
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Subject: FDA May Slap COVID Vaccines With Black Box Warning, CNN Reports • Children's Health
Defense
Public Record
“Because of the censorship of science and media echo chambers, a black box
warning may be the first time a physician or patient reads of a potential for harm, and
a lot of harm has manifested from these shots,” he added.
Black box warnings, also called “boxed” warnings, are the FDA’s most serious
warning label, used to indicate that a drug is associated with a serious hazard, often
including death or life-threatening reactions.
For example, some opioids have boxed warnings for addiction, overdose and death.
Several antidepressants carry a boxed warning because they are linked to
suicidality in young people.
Boxed warning speculation follows recent probes into vaccine safety
The report comes days after the FDA announced it is expanding its probe into
COVID-19 vaccine-related deaths to adults, after initially confirming that the agency
was investigating the deaths of 10 children who died after receiving the shot.
In September, the FDA initiated an “intense investigation” into the deaths of children
who received the COVID-19 vaccine. The investigation drew from reports filed in the
VAERS
by the FDA and the Centers for Disease Control and Prevention (CDC).
As of Dec. 5, there were 38,913 reports of deaths following COVID-19 vaccines filed
in VAERS among all age groups, according to OpenVAERS. More recent numbers
are not publicly available.
However, the actual number of deaths is likely much higher. VAERS historically has
been shown to report less than 1% of all adverse events.
A 2022 audit by React19, an organization advocating on behalf of COVID-19 vaccine
injury victims and their families, found that 1 in 3 COVID-19 vaccine adverse event
reports in VAERS were not posted publicly or were deleted.
In April, the FDA issued letters to Pfizer and Moderna, informing them they
must revise their COVID-19 vaccine labels to include more detailed warnings
about the risks of heart damage, including myocarditis.
The FDA told vaccine makers in May they must expand the age group they say is at
risk for vaccine-related myocarditis and pericarditis, and warn that myocardial injury
can be lasting among those who suffer it, the agency said.
The warnings mandated at that time were limited to those adverse events.
Is boxed warning too little too late?
After a leaked memo confirmed that the FDA was investigating child deaths
associated with the COVID-19 vaccine, former FDA officials denounced the
claims and said the FDA had responded to safety concerns with the vaccine as they
arose.
However, Freedom of Information Act requests by CHD and others have shown that
HHS officials under the Biden administration avoided issuing a formal warning to the
American public — ignoring safety signals indicating the COVID-19 vaccines could
cause myocarditis and pericarditis, especially in young men.
Well before the public health agencies informed the public of the possible risk, the
CDC, FDA, U.S. Department of Defense, Pfizer and the Israeli Ministry of Health had
documented evidence of myocarditis shortly after vaccination, predominantly in 16-
to 24-year-old males. However, they didn’t publicly share that information.
They also ignored warnings in VAERS, documents showed.
Earlier this month, FDA Commissioner Marty Makary acknowledged that the
agency sat on the data under his predecessor.
Dr. Peter McCullough, a cardiologist who sounded the alarm early on about the risks
of myocarditisand pericarditis from the vaccines, said in an email to The
Defender that adding a boxed warning to the shots now is “far too late.”
McCullough said:
“HHS and the White House had fatal cases reported to them in early 2021 and
worked to hide the evidence from the public. This was revealed in the May 21, 2025,
US Senate Hearing by the Homeland Security and Governmental Affairs, Permanent
Subcommittee on Investigations led by Senator Ron Johnson.
“‘The Corruption of Science and Federal Health Agencies: How Health Officials
COVID-19 Vaccines’ generated a report that was ignored by the current FDA for
over six months!
“The public should be asking, why the change now? More importantly, why aren’t all
COVID-19 vaccines pulled from the market to protect the public from more fatal
injuries?”
For years, scientists, researchers and members of the public have been calling on the
FDA to pull the shots from the market as evidence that the vaccines
are potentially harmful continues to grow.
https://childrenshealthdefense.org/defender/fda-potential-covid-vaccine-black-box-
warning-cnn-adverse-effects/
diana dreiss