By LINDA BOYLE
During his Senate confirmation, FDA Commissioner Dr. Martin Makary said that no more mRNA Covid boosters would be approved without adequate scientific data.
Gone were the days when the Centers for Disease Control and Prevention would just rubber-stamp the newest and greatest booster jabs Big Pharma had developed.
And no longer would the Covid booster be recommended for children, pregnant women, or perfectly healthy adults unless over the age of 65. The jab would still be available for those at high risk, and it would be a shared decision between the patient and the doctor.
I was caught off guard when on July 10 the FDA gave full approval to Moderna’s Covid-19 jab (Spikevax) for children aged six months to 11 years old. It became the first Covid jab for kids that would no longer be given under emergency authorization. It could be used in children who have at least one medical condition that puts them at risk for a severe Covid infection.
This became the first vaccine in the US to gain full FDA approval despite the increased evidence of adverse reactions, including myocarditis, pericarditis, allergic reactions, and even seizures in young recipients.
Dr. Robert Malone, a member of the Advisory Committee on Immunization Practices, said the FDA’s full approval of Spikevax blindsided RFK Jr. while RFK Jr. was on vacation. The next day, after passing this update to Spikevax, Moderna’s shares rose by at least 3.8%.
Then Moderna’s shares rose 8.83% after six medical organizations sued Kennedy over changes to Covid-19 vaccine recommendations for pregnant women and healthy children.
I know. It isn’t about the money. Or is it?
There are unanswered questions as described by Dr. Robert Malone, an inventor of mRNA vaccines and DNA vaccines and also a speaker at our first Alaska Covid Alliance Conference in 2021:
- Why approve Moderna’s Spikevax for this indication and not provide similar approval for the Pfizer product?
- Did FDA Commissioner Dr. Marty Makary know and endorse this decision, or was it decided and acted upon at the level of FDA Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad?
- Was the timing of this decision occurring while both Secretary Kennedy and his Deputy Chief of Staff Stephanie Spear were on vacation coincidental?
- What are the pre-existing conditions that FDA considers as placing “children aged 6 months through 11 years at increased risk for severe COVID-19 disease”? In other words, using plain language, what are the specific diseases of childhood that your child may have that would make them eligible for this FDA-licensed product?
- What and where are the data that demonstrate that the benefits of receiving this product outweigh the risks for children with these specific diseases? Are medical practitioners and parents going to be allowed to see the risk/benefit analysis data, which (presumably) the FDA used to justify this decision?
- What is the number of “children aged 6 months through 11 years at increased risk for severe COVID-19 disease” that need to be treated with this product to prevent one death or one avoidable hospitalization unambiguously due to severe COVID-19 disease?
I especially find it interesting that Big Pharma named the vaccine Spikevax. We know the spike protein is what causes the damage. Are they subtly telling us what we already know?
While Big Pharma and Mainstream Media are “high-fiving,” there are still a lot of questions and concerns:
Why submit children to a drug that can do harm to them with no guarantee it will stop the child from getting Covid? Who are we concerned about — our children or the Big Pharma stockholders? Are their bottom lines more important than our children’s health?
Linda Boyle, RN, MSN, DM, was formerly the chief nurse for the 3rd Medical Group, JBER, and was the interim director of the Alaska VA. Most recently, she served as Director for Central Alabama VA Healthcare System. She is the director of the Alaska Covid Alliance/Alaskans 4 Personal Freedom.