Tell the FDA to retract their EUA Approval for the CV-19 Vaccine for infants and children!
Over the weekend the FDA approved the Pfizer and Moderna CV Vaccine for infants 6 months old to children 4 years of age. This passed through an unanimous vote of 21-0.
Hours later, CDC Director Rochelle Walensky signed off on the decision, and the shots will become available this week.
This decision expands the nation’s vaccination campaign to children as young as 6 months.
Sign the petition to tell the FDA to retract EUA approval of the CV vaccine for children 0 to 4 years old.
Main Talking Points:
- There is no state of emergency for children. Multiple studies have shown that children without comorbidities who acquire COVID-19 have a survival rate of >99%.
- Omicron, the least virulent of all COVID-19 strains, has further reduced the risk for children.
- 68% of children ages 1-4 are already SARS-COV2 seropositive, indicating they have previously been infected with the virus and recovered. Research conducted by Johns Hopkins has found that 99% of all COVID-19 infections result in natural immunity.
- Prior to approval of the CV vaccine for ages 5-11 in October, CDC Advisory Committee Member Dr. Eric Rubin stated, “We’re never going to learn about how safe the vaccine is until we start giving it. That’s just the way it goes.” Children should not be put at risk, when there is statistically very little benefit for them.
Questions/Concerns:
- Considering the data to the contrary, what studies have the FDA conducted to ensure that the benefits of the CV vaccine outweigh the risks for young children?
- Why do CV vaccines have to reach an efficacy threshold of 50% for adults, but not for children? What is the basis for recommending a vaccine with efficacy rates as low as 12% for young children?
- Considering the increased risk of myocarditis for boys ages 12-17 , is there an increased risk for those ages 0-4?
We also request a response to the following questions proposed to the FDA by Members of Congress:
- According to the FDA, how many children ages five and under with pre-existing medical conditions have died from COVID or its variants?According to the FDA, how many healthy children ages five and under without preexisting medical conditions have died from COVID or its variants?
- According to the FDA, how many children ages five and under with pre-existing
- medical conditions have been hospitalized due to (not with) COVID or its variants?
- According to the FDA, how many healthy children ages five and under without preexisting medical conditions have been hospitalized due to (not with) COVID or its variants?
Resources:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02867-1/fulltext
https://pubmed.ncbi.nlm.nih.gov/35443078/
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4092074
https://jamanetwork.com/journals/jama/fullarticle/2788894?resultClick=1
https://www.nationalreview.com/2021/10/the-fda-shouldnt-cut-corners-on-child-vax-safety/
Tell the FDA to retract their EUA Approval for the CV-19 Vaccine for infants and children!
Over the weekend the FDA approved the Pfizer and Moderna CV Vaccine for infants 6 months old to children 4 years of age. This passed through an unanimous vote of 21-0.
Hours later, CDC Director Rochelle Walensky signed off on the decision, and the shots will become available this week.
This decision expands the nation’s vaccination campaign to children as young as 6 months.
Sign the petition to tell the FDA to retract EUA approval of the CV vaccine for children 0 to 4 years old.
Main Talking Points:
- There is no state of emergency for children. Multiple studies have shown that children without comorbidities who acquire COVID-19 have a survival rate of >99%.
- Omicron, the least virulent of all COVID-19 strains, has further reduced the risk for children.
- 68% of children ages 1-4 are already SARS-COV2 seropositive, indicating they have previously been infected with the virus and recovered. Research conducted by Johns Hopkins has found that 99% of all COVID-19 infections result in natural immunity.
- Prior to approval of the CV vaccine for ages 5-11 in October, CDC Advisory Committee Member Dr. Eric Rubin stated, “We’re never going to learn about how safe the vaccine is until we start giving it. That’s just the way it goes.” Children should not be put at risk, when there is statistically very little benefit for them.
Questions/Concerns:
- Considering the data to the contrary, what studies have the FDA conducted to ensure that the benefits of the CV vaccine outweigh the risks for young children?
- Why do CV vaccines have to reach an efficacy threshold of 50% for adults, but not for children? What is the basis for recommending a vaccine with efficacy rates as low as 12% for young children?
- Considering the increased risk of myocarditis for boys ages 12-17 , is there an increased risk for those ages 0-4?
We also request a response to the following questions proposed to the FDA by Members of Congress:
- According to the FDA, how many children ages five and under with pre-existing medical conditions have died from COVID or its variants?According to the FDA, how many healthy children ages five and under without preexisting medical conditions have died from COVID or its variants?
- According to the FDA, how many children ages five and under with pre-existing
- medical conditions have been hospitalized due to (not with) COVID or its variants?
- According to the FDA, how many healthy children ages five and under without preexisting medical conditions have been hospitalized due to (not with) COVID or its variants?
Resources:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02867-1/fulltext
https://pubmed.ncbi.nlm.nih.gov/35443078/
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4092074
https://jamanetwork.com/journals/jama/fullarticle/2788894?resultClick=1
https://www.nationalreview.com/2021/10/the-fda-shouldnt-cut-corners-on-child-vax-safety/