The FDA is responsible for evaluating the safety and efficacy of drugs and biologics that come to market. American parents rely on that. But many vaccines and drugs have been recalled because they hurt people they were supposed to help, even after they were recommended by VRBPAC and put through years of evaluation before approval by the FDA. The COVID shots went through research and development in an astounding four months, a process that generally takes up to a decade for vaccines. The first trial in adults began April 23, 2020. Trials in children as young as 6 months started March 24, 2021. As of June 15, 2022, when VRBPAC will meet to evaluate the data from Pfizer and make a recommendation to the FDA on whether the EUA for Pfizer’s COVID shots should be extended to children as young as 6 months, there will only be just over two years of data for adults and one year of data for children. In this short amount of time, there is already significant data about adverse events that has not yet been properly analyzed from VAERS, which is a huge safety signal that these shots are not safe.
Already, hundreds of adverse events have been reported to VAERS for children ages 0-5 after COVID shots given to breastfeeding mothers. One 6-month-old infant died within 24 hours of breast milk exposure following his mother’s second shot (VAERS ID 1166062-1). Another infant suffered a seven-minute seizure after breastfeeding and reports a permanent disability – no medical history or other complicating factors were found (VAERS ID 1415059-1). Many other breastfed infants suffered anaphylaxis, blisters, rashes, fevers, racing heartbeats, and more, requiring hospitalizations, emergency care, and visits to their doctors.
There have been 1,492 reports to VAERS after COVID shots in 3–5-year-olds as of June 2, 2022. One 5-year-old died (VAERS ID 1890705-1), four report life threatening events, five report permanent disability. Most of the adverse events reported were from a Pfizer shot, the very manufacturer that has submitted an application to extend their EUA experimental shots into children as young as 6 months old.
Do we know that the spike protein stays in the place it is injected, or does it travel through the body and end up being found in places like sex organs? If the spike protein travels, would it be more likely to end up in the brain and CNS of infants and toddlers since the blood brain barrier is not as developed? One Canadian immunologist and vaccine researcher, Bryam Bridle, believes the spike protein does not stay at the vaccination site, but instead can travel through the body in the blood.[i] Do the unique differences in the immune systems of infants change the analysis for immediate safety and long-term safety – clearly it has already been demonstrated that the efficacy of the jab is not the same, and it is logical to assume the safety profile would be different in undeveloped immune systems, as well. Babies have different ratios of fat to muscle, as well as different metabolisms – are these things taken into consideration in the trials?
Should we be vaccinating children to (possibly) protect adults? Dr. James Hildebrant, who sits on VRBPAC, does not think so, but he voted yes for the shots in children as young as 5. Is there enough evidence that children transmit the COVID virus to adults? Does it make sense that our smallest humans would get doses of an experimental drug that has only a couple years’ worth of post-market safety data in other age groups?
Despite all these questions, the White House has been waiting for this authorization since January. Jeffrey Zientz, former White House COVID-19 Response Coordinator, told the press the administration was ready to “hit the ground running” to vaccinate infants and toddlers as soon as they get the authorization.
We need to remind VRBPAC and the FDA their job isn’t to approve something because parents are scared. Their job isn’t to move a political agenda down the line or make good on the White House’s advance purchase contracts. Their job is to keep American families safe and only allow effective products to market.
The FDA must take into consideration public comment as well as the advice of VRBPAC when making decisions about novel biologics that enter the U.S. market. Commenting in the Federal Register (the publication for all federal agency actions) is a simple yet powerful way to make your voice heard.
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