Saturday, October 16, 2021

Talk I gave on October 2 to a group in Poland meeting at their Parliament regarding testing of vaccines in children


Thank you for inviting me. 

Let me tell you about the laws regarding experimental products and research on children in the United States.

According to federal law, children require protection and their parents are supposed to provide it.  Consent is needed for a child to travel on a trip with their class, or to have their ears pierced.  Most children, even in foster care, still require their parents' consent to become medical research subjects.

Research is defined as the use of any medicinal product that has not been fully licensed. Therefore, the use of vaccines that have been authorized only for emergency use is considered experimental.  

Parental consent is absolutely required for children who receive an Emergency Use product, as well as for children who are subjects in medical experiments.

Children who with their parents chose to volunteer to be subjects in a Pfizer Covid vaccine trial are paid about $800 dollars if they complete the entire trial.  

In 1997 the FDA Modernization Act offered pharmaceutical companies an extra six months of patent exclusivity if the company tested new drugs and vaccines on children.  For a blockbuster vaccine, this could mean an additional billion dollars or more in earnings before it had to face generic competition.  Even if the drug or vaccine is never even used in children after being licensed, it will still receive an extra six months of protection if the manufacturer performs tests in children as specified by the FDA.

For the Covid vaccine, the FDA asked Pfizer to submit its protocol to test children aged 6 months to 5 years by last February. Pfizer must give FDA its protocol for testing children under 6 months of age by next January 31.

Covid vaccines are therefore being tested in younger and younger children, even though arguably the disease is so mild in children that no vaccine is needed.  Usually children just get a cold from Covid or are asymptomatic. 

We know that despite millions of cases in children, less than 30 children have died from Covid in the UK, and only 26 have died in Germany.  Our CDC does not tell the public how many US children have died from COVID.  Instead we are told how many children have died "involving" COVID. Most of these were chronically ill, and it appears that many were only diagnosed with COVID after being hospitalized for something else and undergoing routine surveillance testing. 

While COVID is not very dangerous to children, it seems the COVID vaccines themselves are dangerous to children.  Myocarditis, or inflammation of heart muscle and perhaps other regions of the heart, occurs 50 times more often in males aged 12-17 compared to males over 65, based on reports to the VAERS system.  The risk of myocarditis from an mRNA COVID vaccine rises exponentially as you get younger and younger.  Additional risks, such as pulmonary emboli, strokes and heart attacks, are elevated after COVID vaccinations, but the risk is not well quantified.  While there are also considerable risks from the disease COVID, when it is treated early with ivermectin and other appropriate drugs, these complications are extremely rare.

According to data from the UK's Office of National Statistics, deaths in teenagers have risen about 50% since June 2021, when vaccinations began to be offered to their age group.

A cynic or perhaps a wise man might say that the FDA has colluded with COVID vaccine companies to sacrifice children on the altar of 6 months of additional profits.

While our CDC produced a highly flawed estimate of risk-benefit that magnified the COVID risk in children, and minimized the myocarditis risk, others have found that the risk from the vaccine is not justified by its benefit to children.  While it is considered unethical to vaccinate children to protect adults, in fact exactly that has been called for by some politicians.  The California governor yesterday required Covid vaccinations for children to attend school, once the vaccines are licensed for their age group.  As vaccinations for 16 and 17 year olds are already approved, unvaccinated children of this age will not be able to attend school in California beginning next January.

Despite the laws I described that require parental consent, something strange has been happening in the US.  Teenagers aged 12-15 have recently been offered experimental Covid vaccines without parental consent in cities around the United States.  In fact, health departments have actively encouraged adolescents to come alone to be vaccinated, even when their parents are against it.  Staff who perform the vaccinations have been told they can decide whether a child is able to provide his or her own "assent."  

Some unknown authority has superceded our traditional laws regarding parental responsibility, presumably under new emergency rules that require no legislative votes.  Perhaps the same is true in Poland?  We seem to be operating under secret rules now, and the state seems to think it owns our children, and it can use any draconian means it likes to enforce vaccine compliance.  Instead of the state working to serve its citizens, the state now thinks we are here to serve it.  I hope the Polish authorities never stoop to enticing children to get vaccinated or to do anything else without their parents' knowledge and consent.

In the 1980s and 90s, over 500 foster children in New York were used as experimental subjects for dangerous drugs for HIV, many in research projects sponsored by the National Institutes of Health and conducted by local universities.  Over 80 of these children died in foster care, and 25 died while they were enrolled in a clinical trial.  As you might guess, there was no parental consent for many of these children.  The scandal led to hearings in Congress and widespread publicity.  Yet it seems we may be back in the same place today.  Because when you want to test a dangerous product on children, whose children do you use?  Not ours. 

Some families may be lured financially.  But the easiest way to obtain child subjects is use those who have no parent protecting them.  I hope that is not occurring in Poland.

Our federal health agencies have been captured by the pharmaceutical industry.  Our federal government seems to be captive to special interests.  Our healthcare system is no longer trusted by the citizens, who will do anything to avoid being treated in hospital if they get COVID.  Our cherished institutions are undergoing a controlled demolition.  

I urge you not to follow our path.  Protect your children.  Serve your citizens.  Be a beacon for the world.

Meryl Nass, M.D.

References (Letter from FDA to Pfizer, Aug. 23, 2021)

See below, pages 5-6: 

"Your deferred pediatric studies required under section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of these postmarketing studies must be reported according to 21 CFR 601.28 and section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments or required studies or clinical trials. 

Label your annual report as an “Annual Status Report of Postmarketing Study Requirement/Commitments” and submit it to the FDA each year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject to the reporting requirements under section 506B of the FDCA are released or fulfilled. These required studies are listed below: 

1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age. 

Final Protocol Submission: October 7, 2020 

Study Completion: May 31, 2023 

Final Report Submission: October 31, 2023 

2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of COMIRNATY in infants and children 6 months to <12 years of age.

Final Protocol Submission:  February 8, 2021

Study Completion:  November30, 2023

Final Report Submission:  May 31, 2024

3.  Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age.

Final Protocol Submission:  January 31, 2022

Study Completion:  July 31, 2024

Final Report Submission:  October 31, 2024

Submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND.  Please refer to the PMR sequential number for each study/clinical trial and the submission number as shown in this letter.

Submit final study reports to this BLA STN BL 125742.  In order for your PREA PMRs to be considered fulfilled, you must submit and receive approval of an efficacy or a labeling supplement.  For administrative purposes, all submissions related to these required pediatric postmarketing studies must be clearly designated as:

·      Required Pediatric Assessment(s)

We note that you have fulfilled the pediatric study requirement for ages 16 through 17 years for this application."