Members of Congress Demand Answers
The use of COVID vaccines for babies and children is about to be decided based on?
Eighteen sitting Congressional members wrote a strong letter to the FDA demanding answers prior to the decision by regulators to approve COVID-19 vaccines for babies and young children aged 6 months to 4 years old. The FDA VRBPAC advisory panel is scheduled to meet on June 15 to discuss authorization and this letter addresses the fact that there are questions and facts that the FDA must consider prior to EUA authorization.
COVID-19 poses little risk to young children, the vaccines have little effectiveness against new variants and there is evidence of significant adverse events. Therefore, the lawmakers ask the panel why they are necessary for this age cohort.
“The broad approach of the CDC and FDA to date has been a one-size fits all policy—get the vaccine regardless of age, risk factors, the underlying health of the individual, or previous infection,” the members wrote to FDA Commissioner Robert Califf and members of the advisory panel in a June 7 letter obtained by The Epoch Times. “Yet, to date there remain many unanswered questions about these EUA-approved COVID-19 vaccines and only a small percentage of the safety data about these vaccines that are in the possession of the FDA and the manufacturers has been released for review.”
The letter clearly states that COVID-19 poses little risk to babies and young children, that the vaccines have little effectiveness against new variants, that there are many unanswered questions about the safety of the vaccines and that there is evidence of significant adverse events. Therefore, the lawmakers queried the FDA panel as to why these vaccines are necessary for this age cohort.
“The broad approach of the CDC and FDA to date has been a one-size fits all policy—get the vaccine regardless of age, risk factors, the underlying health of the individual, or previous infection,” the members wrote to FDA Commissioner Robert Califf and members of the advisory panel in a June 7 letter obtained by The Epoch Times. “Yet, to date there remain many unanswered questions about these EUA-approved COVID-19 vaccines and only a small percentage of the safety data about these vaccines that are in the possession of the FDA and the manufacturers has been released for review.”
The document states that 68% percent of children aged 1 to 4 have recovered from COVID-19 and that those rates are even higher for older children, according to a cited May 2022 CDC study. The lawmakers note that the rates for natural immunity are even higher now than when the study was conducted, with an estimated 80% of children across all age cohorts being seropositive against COVID. As natural infection yields better protection than vaccination against COVID, plus children who contract COVID-19 have a high survival rate and have little risk of experiencing severe disease, there is little reason to vaccinate at this time.
The lawmakers want the FDA to answer a series of questions before issuing its decision on the EUA requests from Moderna and Pfizer.
The questions below are taken directly from the letter to the FDA (a link to the full letter can be found at the end of this post). Please make your own interpretations:
1. Why has the FDA been slow to release the hundreds of thousands of pages of data from pre-approved manufacturers studies, post-approval adverse events state, other post-approval manufactures data submitted to the FDA as required by law??
2. What is the FDA doing to expedite the release of this data and when can we expect all of the data in the FDA’S possession on these vaccines to be publicly released?
3. Should the FDA approve EUA COVID vaccines for children under age 5, will the FDA release the data to the public with 14 days of approval that served as the basis for FDA EUA approval? If not, why not? If not within 14 days, when will the FDA release all of this data to the public?
4. When will the FDA and CDC provide the public with more details on those children who have had the most serious adverse outcomes from COVID-19 infections?
As of ‘April 2022, the CDC reported 484 COVID-related deaths among children ages five and under (over a two+ year period). According to the CDC there are about 24,000"deaths overall in children ages 0-5 annually. Each of these deaths is tragic for these families and society. As the FDA and CDC consider COVID vaccine policies, we believe it is important to understand facts related to these COVID-related deaths, including any underlying conditions that may have been a factor in their death. This is important data for parents, health care providers and public health officials so that they can make fully informed decisions about the best healthcare decision for each child, particularly if the child is seropositive and has no other known risks for adverse outcomes from COVID. It is also noteworthy that as the older population has seen increasing hospitalizations and death with waves of COVID cases, CDC cumulative data show significantly less adverse impact on children under age five even during such waves.
5. What are the cardiac risk factors in administering these EUA COVID vaccines to children? As COVID vaccines were administered to larger numbers of those ages 5-18, public health officials began to notice a previously unknown risk factor related to cardiac inflammation, pericarditis and myocarditis in particular. Not only have there been a number of deaths but the long-term effects of those who suffered cardiac-related inflammation are as yet unquantified by public health officials.
6. Why has the FDA recently lowered the efficacy bar for COVID vaccines for youngest children? This change significantly lowers the expected benefits from any COVID vaccination recommendation for young children and of particular concern given that over 70% of this age cohort are already seropositive. Recall that when FDA gave EUA approval to COVID vaccines for those ages16 and older, it did so based on data demonstrating over 90%’ effectiveness in “preventing confirmed COVID infection.” We now know that the efficacy is considerably lower.
7. The FDA decided to evaluate effectiveness of this vaccine on a measurement of neutralizing antibodies to the original SARS-CoV2 spike protein. What evidence does FDA have if any that “immunobridging” is an adequate surrogate to the disease prevention metrics used for previous EUAs? Please explain and provide us with FDA data that demonstrates the correlation between immunobridging and disease prevention comparisons between vaccinated and unvaccinated children.
8. Is it a possibility that administering the proposed COVID vaccines in young children could predispose them for increased risk from future novel COVID variants? These COVID vaccines were developed using the original SARS-CoV-2 strain and published studies indicate that vaccine efficacy wanes after subsequent doses and as new COVID variants arise in the population.
9. World renowned immunologists have raised concerns about the possibility of antibody dependent enhancement phenomenon (ADE) resulting form COVID vaccines, noting that ADE was a problem in unrelated COV vaccine trials. What studies has the FDA relied upon when examining the possibility of ADE resulting from EUA COVID vaccines in children ages five and under, or any age group for that matter? Will the FDA affirm with 100% certainty that ADE is not a risk factor for children receiving this vaccine?
10. If approved and widely used amount children age five and under, how many lives does the FDA estimate will be saved in the age group over the next year? Given the injuries reported in the FDA’s own VAERS system, how will the FDA evaluate potential tradeoffs of serious vaccine injuries versus serious COVID outcomes?
11. If approved, what does FDA estimate will be the cost of administering these vaccines to this age group?
12. CDC reports ”seropositivity of 68% of children 1-4 years, 77% for those 5-11, and 74% children ages 12-17. With two additional COVID waves since this data was reported and corresponding increases in seropositivity, what percentage does the FDA consider herd immunity?
13. According to the FDA, how many children ages five and under with pre-existing medical conditions have died from COVID or its variants?
14. According to the FDA, how many healthy children ages five and under without pre- ‘existing medical conditions have died from COVID or its variants?
15.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?
16. According to the FDA, how many healthy children ages five and under without pre- existing medical conditions have been hospitalized due to (not with)COVID or its variants?
17. According to the FDA, how many children ages five and under with pre-existing medical conditions that have required treatment due to COVID or its variants?
18. According to the FDA, how many healthy children ages five and under without pre- existing medical conditions have required treatment due to COVID or its variants?
19.Please list the medical emergencies of children 0 to 4 years old that enables the FDA to approve the COVID vaccine for children using its EUA.
The data show that the risk of serious adverse outcomes of r COVID for shiclren five and under is very low and as such the standard for evaluating EUA interventions must be very high.
We believe each question raised about is not just important, but essential questions for the FDA, VRBPAC and the CDC when it comes to doing a thorough job of evaluating the potential benefits and potential risks of thes vaccines for which you have been asked to consider granting an Emergency Use Authorization.
Signed by:
the following Members of Congress:
_______
That this letter is necessary and that it is signed by 18 sitting members of Congress is a strong inditement about the state of the FDA. It is shocking that such a letter should be needed.
These members of Congress have the integrity to do what is right. These are elected officials who represent us, who have the courage to stand up and try to make a difference. I am sure most of these members of Congress need Pharma dollars to get elected - it is not in their personal interest to write such a letter. They are doing this because it is important and the right thing to do.
Now let’s hope that the FDA actually listens to their “supervisors,” that is - Congress.
Congressional oversight refers to the power of the United States Congress to monitor and, if necessary, change the actions of the executive branch, which includes many federal agencies. The primary goals of congressional oversight are to prevent waste, fraud, and abuse and to protect civil liberties and individual rights by ensuring that the executive branch complies with the laws and the Constitution. Derived from its “implied” powers in the U.S. Constitution, public laws, and House and Senate rules, congressional oversight is one of the key elements of the American system of checks and balances of power among the three branches of government: executive, congressional, and judicial.
Let us hope that the FDA answers the questions posed honestly and forthrightly. That they then actually use these questions and the obvious answers to make the decision to not grant an EUA for COVID vaccines for babies and young children. The FDA should do this on the clear and compelling evidence that these vaccines are not needed, as clearly documented in the letter. It is time to put the “emergency use authorization” powers away.
The emergency over -
