ACT NOW AMERICA: The FDA Failed Our Children. Tell the CDC That Proof Of Safety Is Not Negotiable For Children Ages 5-11.
Our Stand: At-A-Glance
“We’re all concerned about the myocarditis issue…we are not going to get the data unless we start to use this vaccine,” said Dr. Mark Sawyer before voting yes to recommend authorizing Pfizer’s vaccine in kids as young as 5 years old.
“We simply do not have the data right now to make those decisions,” said Dr. Michael Kurilla, the only FDA committee member who abstained from voting to expand Pfizer’s EUA to children ages 5-11.
- Now that the FDA has expanded Pfizer’s vaccine EUA to kids as young as 5, the CDC’s ACIP (Advisory Committee on Immunization Practices) will do a separate risk-benefit analysis to determine whether the vaccine should be recommended for all kids age 5-11 on November 2-3, 2021.
- CDC can choose NOT to recommend the jab for young kids, or can recommend more narrow use than FDA opened the door to (say, only for high risk children, or those who do not have natural immunity). CDC is not bound by FDA authorization to recommend for all children.
- Citizens can make public comment through November 3, 2021, that will go on record.
- For extra impact for your voice, comments received by end of day Friday October 29th will be sent to ACIP members before the meeting.
- SHF advocates made over 19,000 public comments for the FDA’s meeting this past week. Lets triple that number here!
- Once again Stand for Health Freedom cannot give you a script because duplicate comments get screened and deleted. However, we can arm you with inspiration from some of our most salient talking points.
- One very important point VRBPAC missed was, parents can already access the vaccine in an off-label use. ACIP needs to be reminded of this so they do not make unnecessary recommendations.
- They need to be reminded that natural immunity needs to be part of the risk-benefit analysis. Dr. Paul Offit pointed out FDA risk-benefit analysis did not include natural immunity. “That is another piece of information that is lacking.” Other VRBPAC members questioned whether children need less dosing, or no vaccine at all if they have natural immunity.
- They need to be reminded that vaccine injury is “real, not rare” as one vaccine injured trial participant went on record to tell FDA today.
- There have been allegations, on federal record, by Dr. David Wiseman and colleague Dr. Josh Guetzkow that Pfizer data is obscured or simply not given to the FDA. How can the FDA consider the risk benefit analysis if data is being withheld?
- A number of public commenters on record shared anecdotal evidence of trial participants being dropped from studies once they had a reaction, and no data showing vaccine reaction in study publications. In other words, Pfizer (and others) are seeing reactions after vaccines and dropping those participants from the study (or claiming AEs are unrelated to the vaccine) instead of reporting a reaction due to the vaccine.
- Neurological reactions are not being collected as an Adverse Event of Significant Interest (AESI).
- These talking points from the FDA meeting still apply as well:
- Transmission of COVID-19 among children in schools and daycares is very rare.
- According to published data by the CDC, 99.99815% of children who contract COVID-19 survive.
- Children are not a significant threat to the elderly and vulnerable as most COVID cases are spread from adults to children.
- There are no adequate long-term safety studies of mRNA covid vaccines because the placebo group was “unblinded” and allowed to get the vaccine.
- This is NOT a FDA approved vaccine they are looking to give children, the FDA will expand the Emergency Use Authorization to include children as young as five. In other words, any mandate for children is of an experimental drug.
- According to the data available from the Vaccine Adverse Event Reporting System (VAERS) as of Oct. 8, there have been a total of 21,652 reports of adverse events, including 1,304 serious reactions and 24 deaths in the 12- to 17-year-old age group.
- Healthy adolescents aged 12-17 who have been given covid vaccines have experienced blood clots, myocarditis, neurologic symptoms and extreme fatigue.
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