New Site Demands Sh*t for Babies Regardless of Disappointing Performance and Lack of Data
aka The Side Effects of Tunnel Vision
Back in February, thousands of parents took to social media, made calls and joined letter-writing campaigns to ask FDA VRBPAC (Vaccine and Related Biological Products Advisory Committee) members to vote NO to fast-tracking Pfizer’s Covid jab for kids under 5. Clinical trials showed disappointing results and science continues to demonstrate that healthy children don’t need these shots.
But as the next FDA VRPAC meeting approaches (April 6), rumors are circulating that its members may bypass a vote altogether and instead just extend the EUA to include children under 5.
This is an idea that a new organization called ProtectTheirFuture has been pushing aggressively. The organizations website is dedicated entirely to demanding immediate access to COVID-19 shot for kids under 5.
I smell astroturf.
The website states:
Our children have their futures ahead of them; they deserve the chance to live to their fullest potential, without lifelong health conditions to navigate. They deserve to be protected. We cannot wait for the next Covid variant to ravage a generation of kids again. The time for the FDA to grant children under 5 vaccine access is NOW.
Agree. Children “deserve the chance to live to their fullest potential, without lifelong health conditions to navigate.”
It’s why some parents insist that our children deserve better than a new and unnecessary experimental gene therapy that has performed poorly in clinical trials, has known side effects and doesn’t last.
#ParentsAreWatching asks that the FDA OPPOSES a fast-tracked EUA for these shots since there is no emergency and no data to demonstrate that they work. Children are not at risk for serious illness and death from COVID. You can find their Call to Action here.
However, ProtectTheirFuture asserts that the need for vaccination access for children under 5 is “urgent,” and suggests two primary “solutions” in their Letter to the FDA from Physicians:
Solution #1
Allow providers and parents the option of joint decision-making to immunize children with off-label use of the Pfizer 10ug vaccine…
Solution #2
Remove the age de-escalation barrier to vaccine approval. The de-escalation requirement is understandable in regular trials, but it is unacceptable during a raging pandemic. Removing this red tape would allow approval of Pfizer’s 3ug dose for children aged six months to two years, which trials found to be safe and effective. Delaying distribution and administration to children simply because of procedure is unethical and immoral in light of our current circumstance. As children re-enter daycare centers, preschools, and other unavoidable group settings, we all know that the number of young children infected with Omicron will soar exponentially, creating the largest health risk that kids have faced collectively throughout the entire pandemic.
I'm trying to understand how this would work. If the decision is returned to the realm of doctor-patient relationship, but doctors remain under the medical establishment stronghold that prevents an honest risk/benefit conversation from taking place, can there ever really be informed consent? And are pediatricians willing to assume legal liability should something go wrong? (Apparently, about 270 doctors are cool with that, since they signed the letter. Interestingly, ProtectTheirFuture’s letter from scientists has zero signatures as of this writing.)
The CDC’s Covid-19 vaccine provider agreement states that when using “federally purchased Covid-19 vaccines” the “age of the vaccine recipient must align with . . . FDA Emergency Use Authorization or Approval of the administered vaccine.” The CDC also suggests that providers who violate this agreement risk losing liability protection among other things.
According to the article, Pediatric Off-Label Use of Covid-19 Vaccines: Ethical and Legal Considerations:
The U.S. Covid-19 vaccination program departs from policy and practice norms for off-label vaccination. The Centers for Disease Control and Prevention's (CDC's) vaccine provider agreement (VPA) sets the terms and conditions for the use of federally purchased Covid-19 vaccines and therefore of all Covid-19 vaccines administered in the United States outside of clinical trials, since all Covid-19 vaccines for U.S. residents have been purchased and supplied by the U.S. government. According to the VPA, administering vaccines to individuals younger than the ages for whom the FDA has approved or authorized use is prohibited and risks repercussions to providers, including legal liability, loss of payment, and removal from the Covid-19 vaccine program. The VPA effectively prevents providers from even considering recommending or administering pediatric Covid-19 vaccines off-label. The prohibition reveals a tension between health policy and individual health care choices and options, as well as the distinct ethical considerations that contribute to each.
A press release from the American Academy of Pediatrics explains:
“We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” Dr. Maldonado said. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”
There’s good reason for this. To date, NO ONE has determined an effective dose for children under 5. We know that two of the 3 mcg doses demonstrated disappointing results. Clinical trials testing a 3rd dose are still in progress. We also know that the dosage is important. Too weak an immune response won’t offer protection, but too strong a response can amplify the adverse event profile and dramatically change the risk/benefit picture.
A September 2020 article entitled, COVID-19 Discovery in Children May Inform Vaccines, Treatments noted that “new discoveries about the immune response made against a particular part of the COVID-19 virus in children who have the rare but dangerous Multisystem Inflammatory Syndrome in Children (MIS-C) may have important implications for the development of vaccines and immune therapies for COVID-19.”
Rostad and colleagues found that children with MIS-C had substantially higher levels of antibodies against a particular part of the COVID-virus known as the receptor binding domain (RBD), part of the virus’ spike protein that lets the virus invade cells. While not definitive proof, the findings suggest that a stronger immune response against RBD may be associated with MIS-C, either as simply an indicator or potentially in some sort of causal relationship.
The discovery that high levels of antibodies against RBD are associated with MIS-C could prove helpful in diagnosing MIS-C, Zeichner and Cruz note. But there may also be other implications. If antibodies against RBD – or some subset of antibodies against RBD – contribute to causing MIS-C, there may be some subtype or amount of antibodies against RBD that are unhelpful, or even dangerous…
…RBD is a component of many of the COVID-19 vaccines in development, Zeichner and Cruz write, so the new findings may prove important there as well. If some antibodies against RBD are associated with MIS-C or increased inflammation, it would be essential to carefully evaluate subjects enrolled in the vaccine clinical trials for evidence of increased inflammatory responses, particularly if and when those research subjects are exposed to and infected with the COVID-19 virus.
The possibility is an important reminder, they write, that the urgent desire for a vaccine must not eclipse the need for thoughtful, thorough testing.
What kind of antibodies are produced from mRNA jabs? From another article…
Researchers tested the antibodies elicited from mRNA vaccination and compared them to those from natural SARS-CoV-2 infection. They found the vaccine did not have antibodies to the virus nucleocapsid protein but had potent RBD antibodies.
Have we had time to properly evaluate this? Reports of MIS-C have already surfaced among vaccinated children. Are doctors even equipped to determine off-label use without a recommended dosage rooted in clinical trial data that demonstrates a balance of safety and efficacy?
And I worry that pushing for off-label use on the most vulnerable populations would make it very easy to dismiss adverse reactions and deaths as attributable to "underlying conditions", since that is a common denominator among the most vulnerable.
This "better than nothing" approach in pushing the off-label use of the COVID shots for young kids, while we only have disappointing data and no clear dose recommendation is frankly bizarre. The FDA and mainstream media spent a year discouraging and even restricting the off-label use of ivermectin while hundreds of thousands of people were deprived of early treatment and died, despite the fact that is a Nobel prize winning drug that has been used safely throughout the world for decades.
Double standards continue to prevail.