Pfizer/BioNTech has asked the Federal Food and Drug Administration (FDA) to expand the use of their COVID-19 vaccine for young children.
Under the FDA guidelines, a product must meet the following criteria to obtain EAU:
- There must be an emergency
- A vaccine must be at least 30-50 percent effective
- The known and potential benefits of the product must outweigh the risks of the product
- There can be no approved, alternative treatments available
At least three of these criteria have not been met. There is no emergency among young children, the data shows no level of effectiveness, and based on the side effects observed in older children, the risks far outweigh the benefits!
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on February 15th to evaluate the emergency use authorization (EAU) application. That means we have 2 weeks to try and stop the approval.
If approved, the vaccine is likely to be mandated for school attendance in many states, so we need your help. Please tell the FDA that COVID vaccines for children under five years old is a bad idea!
Talking points, which explain more about the problems with the vaccines, are below the Take Action section. Be sure to personalize your comments for optimum success.
- Submit your comments for consideration by the FDA by February 10th if possible. (The final deadline is February 14, but they won’t be provided to the advisory committee if sent after the 10th)
You can submit comments online at: https://www.regulations.gov/commenton/FDA-2022-N-0082-0001
- Contact your U.S. Senators and Representative and encourage them to ask the FDA to deny approval for COVID-19 vaccines to children under five years of age.
You can find who represents you at: https://www.govtrack.us/congress/members/map
You can share your comments to the FDA with your elected officials, and urge them to weigh in.
I urge the FDA to deny emergency use authorization of COVID-19 vaccines for children under five years of age.
There is no reason approve experimental vaccines for children who have extremely low risk of hospitalization and death from COVID-19.
Pfizer’s clinical trial in 2-to-5-year-olds showed that their vaccines do not work. This is in addition to the real-world evidence that, even when the clinical trials showed effectiveness in older age groups, the vaccines have failed to protect adults and youth.
Data from the Department of Defense shows that 70 percent of hospitalizations for COVID-19 are in fully vaccinated and boostered people.[i]
The FDA should not approve a vaccine for children when there is no data on the vaccine’s efficacy to support authorization and the vaccines are known to cause harm.
If the Pfizer vaccine is approved for children under five years old, most parents will falsely assume that it has been shown to be effective and safe. This is not the case.
Be sure to explain why this issue is important to you. You may wish to use a couple of the talking points below, but don’t simply copy them – just use them as ideas to help structure your own message.
TALKING POINTS for comments:
- Share why this is personal to you. Do you or a family member have a history of vaccine reactions? Are you at risk for autoimmune conditions or other potential side effects of COVID-19 shots?
- There is no evidence of medical necessity for COVID-19 shots in children. A rapidly growing body of data indicates that the vaccines have serious side effects and do more harm than good in children.
- No one knows in advance whom a vaccine will harm. Each of us may respond differently as we have different medical histories, genes, epigenetics, and microbiomes.
- Vaccines are medical procedures that carry risk of serious injury. The U.S. Supreme Court recognizes vaccines to be “unavoidably unsafe” and to cause injury and death in some recipients. The U.S. Government has paid out $4.4 billion to the victims of vaccine injury. Hundreds of thousands have reported an adverse reaction to vaccination to VAERS. http://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/
- COVID-19 vaccine manufacturers and providers are shielded from liability through the Public Readiness and Emergency Preparedness Act, or PREP Act. The only option for compensating people injured by COVID-19 shots is the Countermeasures Injury Compensation program (CICP). Only eight percent of all petitioners since 2010 have been awarded compensation through the CICP. No legal or medial expert fees are covered, no pain and suffering is awarded, lost wages are capped at $50,000, and there is no judicial appeal. In other words, the victims will be severely undercompensated while the pharmaceutical companies get rich.
- The claimed justification – that unvaccinated individuals pose a health risk to others – has been shown to be false. Vaccinated individuals can become infected and transmit COVID to others.
- COVID-19 vaccines carry the risk of injury and death for some so there must be informed consent and the right to refuse the vaccine without penalty. As of January 21st, there had already been 740,000 COVID-19 vaccine adverse events and 10,316 COVID-19 vaccine deaths in the U.S. reported to the Vaccine Adverse Events Reporting System.
- Vaccine manufacturers such as Pfizer, Merck and GlaxoSmithKline have paid billions of dollars in criminal penalties and settlements for research fraud, faking drug safety studies, failing to report safety problems, bribery, kickbacks and false advertising.[ii],[iii] Pfizer paid $2.3 billion in 2009 alone to resolve criminal and civil allegations. [iv]
- According to the American Academy of Pediatrics, less than 2% of children known to be infected by the coronavirus are hospitalized, and less than 0.03% of those who are infected die. The risks of vaccination do not outweigh the potential benefits.
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