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FDA on Pfizer for 5-11 year-olds: We Have To Use It To Know the Risks

FDA On Pfizer Children's Shot At A Glance:

  • The FDA VRBPAC committee voted to approve the Pfizer vaccine for children ages 5-11.
  • Over 1,400 public concerns were collected on the FDA's website.
  • Pfizer acknowledged the studies weren't set up to detect concerns like myocarditis.

The FDA VRBPAC (Vaccine and Related Biological Products Advisory Committee) voted with 17 in support of the Pfizer vaccine for children age 5-11 with one abstention. The FDA now takes the committee’s input and decides whether or not to give its official approval for the EUA status. The FDA’s VRBPAC was tasked with assessing the data presented by Pfizer BioNTech to determine safety and efficacy. With that data and many hours of testimony, they were set to vote on this one question:

Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age?1

An astonishing 140,000 comments plus were submitted from the public to the FDA’s website. Concerned experts also shared testimony that the benefits did not outweigh the risks, yet the vote overwhelmingly passed. Many on the committee wanted to make the vaccines available as a possibility but didn’t consider it necessary for all children, especially the estimated 30 million kids representing 42 percent of the childhood population that likely already has natural immunity.1

The CDC’s ACIP (Advisory Committee on Immunization Practices) will meet November 2-3 to vote on whether or not they will recommend the vaccine to be used in this new age range.

Risks of Myocarditis/Pericarditis

As was stated in the meeting, the studies simply weren’t powered to detect myocarditis in this age group. According to the FDA’s briefing document for the meeting, that data won’t be available for a while:

The number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination. Long-term safety of COVID-19 vaccine in participants 5 to <12 years of age will be studied in 5 post-authorization safety studies, including a 5-year follow-up study to evaluate long term sequelae of post-vaccination myocarditis/pericarditis.2

Biden’s Push to Have Shots “Ready to Go into Arms”

The Biden administration has already raced ahead and has its eyes set on vaccinating 28 million youngsters with millions of doses ready to go within hours of approval. Last week the administration laid out a plan involving engaging 25,000 pediatricians and public health clinics. The White House’s goal is to have the vaccines ready to administer within a week of approval across the country.

Hold the Phone -- Doc’s Thoughts:

The testimony from the experts was powerful. You can listen to the full recorded meeting, and I suggest you do. Only when you know how these processes work, can you make an informed decision.

In the FDA’s briefing document prepared for the meeting, they mentioned there was an unmet need to protect these children with a vaccine. In reality, the meeting seemed to progress more like an untapped opportunity. Some of the committee members had hesitations as to whether the vaccine would need to be available for all children. That will be decided by the ACIP committee next week.

There were several experts who weighed in expressing their concerns that a vaccine just wasn’t needed in this group,  the benefits didn’t outweigh the risks. The comments by the committee before the vote was pretty eye-opening, as well. In the video link above, you can find this section at the 6:27 mark.

The fact that these doctors knew that the studies weren’t powered to detect the myocarditis concerns and were willing to go on is shown around the 6:32 mark. Myocarditis has been detected in every age bracket that has received this vaccine with over 10,304 cases of myocarditis and pericarditis reported and an addition 8,408 heart attacks. The FDA has gone as far as to put a warning on the vaccine for the heart inflammation, myocarditis back in June. In July, the FDA called on Pfizer-BioNTech and Moderna to expand their studies to include more children so that these instances could be detected. Why are they now admitting they don’t have that?

At 6:33 Dr. Eric Rubin states the vaccines appear “pretty safe” and appear to “work by immune-bridging.” Remember, they didn’t include the actual number of cases reduced to show efficacy. They did a blood serum test to see if the markers indicated a similar response to the older cohorts. He went on to mention that there were concerns regarding side effects, “they couldn’t be measured yet, but they are probably real.” He continued by questioning whether or not there was a need for the vaccine in this age group and finally concluded:

“We’re never gonna learn about how safe the vaccine is until we start giving it. That’s just the way it goes. This is how we found out about rare complications of other vaccines.”

This was his statement just before he stated that he thought the committee ought to approve the shot.

At 6:35, Dr. James E.K. Hildreth brought up the idea that likely 42% of children in the US likely have natural immunity. These 30 million kids have already “made their contributions” toward herd immunity.  Dr. Hildreth also expressed his concerns with the small percentage of minorities in the trials considering they take on the brunt of the disease.

Dr. Mark Sawyer continued on at 6:36 and said he believes the number of hospitalizations the vaccine could prevent appeared to be overestimated given the high natural immunity in children. He also believes that even the high number of possible myocarditis cases was a conservative estimate. He acknowledged that they were basing their decision for risk/benefit in these cases mostly on models and that data wouldn’t be collected until they started using the vaccine in the general child population.

Dr. A Fuller starts to ask for a further explanation as to how adverse reactions can be linked back to the vaccine. She pressed the issue that parents may need to be “comforted” by their child’s pediatrician that the reaction was indeed flagged. After an explanation by two familiar with the VAERS and other CDC reporting systems, at 6:40 she states:

“If we don’t make it available, we’ll never know what will happen with a larger group of people.”

Ignoring Concerns, Data, and Testimony

What is apparent is that these people have concerns. They don’t seem very confident in the product they are voting on. That would make sense considering the data is severely lacking, the science is lackluster, and the majority of these children had at most two months of follow-up. And nearly half of American children have natural immunity! Yet, they are willing to continue this trial into the general public using the children of America to complete the study.

We must stand up and defend our children. We know what comes next, full approval will be pushed through, the vaccine will be added to the childhood schedule and a firm legal shield will be in place so that Pfizer and BioNTech will not be held accountable for the vast number of injuries and deaths they’ll have caused. VAERS is already showing them, what makes us think the children will escape?

Parents, you need to educate yourself. You need to be prepared to stand up for your freedoms, especially as they relate to healthcare. These young children don’t have the ability to choose whether they will get this shot, that’s up to parents to decide. If the doctors who heard all the testimony and saw the available data had lingering questions and concerns, that should raise some red flags. Just because they are willing to continue collecting “data” on kids, doesn’t mean it has to be your child.

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