This week, a U.S. Food and Drug Administration panel unanimously (with one abstention) approved Pfizer’s COVID vaccine to be given to 5- to 11-year-old children.
In doing so, the FDA betrayed the expanded mission Congress gave it in the early 1960s after the morning sickness drug thalidomide caused thousands of birth defects in newborn infants in over 40 foreign countries (though exactly how thalidomide caused these defects was not fully understood until just a few years ago).
In 1962, because of thalidomide’s devastating impact, Congress added what were known as the “Kefauver Amendments” to the original bill which created the FDA in 1938. In laymen’s terms, the agency’s fundamental focus became (Page 3 at link) “better extremely safe than sorry.” Those amendments’ most critical elements (Page 5 at link) “authorized the FDA to deny a new drug application (NDA) if there was not substantial evidence that the drug would have its claimed effect.”
The FDA panel’s decision completely and indefensibly abandoned the agency’s posture during the past 60 years by approving the use of the vaccine for 28 million children in the 5-11 age group despite the clear lack of legally required “substantial evidence” of safety, or even efficacy.
The current uncertainty surrounding the use of the vaccine on young children is so severe that one panelist, Dr. Eric Ruben, clearly determined to skip the complete set of clinical trials and other steps ordinarily involved in NDAs for vaccines, asserted that “We’re never gonna learn about how safe the vaccine is until we start giving it. That’s the way it goes.”
They’re also apparently not done. In June, a Cleveland TV station reported (as seen in the final seconds of the video at the link, but not in its transcript) that the “next steps” are “looking at 2- to 5-year-olds, and also the 6 months to two-year-olds.” Pfizer’s own “Clinical Trials in Children” page confirms that the company has been conducting trials on children as young as 6 months old.
We are being led down a dangerous path, as Kaylee McGhee White explained at the Washington Examiner on Wednesday. In her article titled “FDA wants to use children as guinea pigs for COVID-19 vaccines,” she wrote:
It’s one thing to expect grown adults capable of making responsible decisions to get the shot; it’s another to ask minors to become test subjects for a vaccine, especially when the virus this vaccine combats is not a threat to children’s health in the first place.
Families who want to get their children vaccinated against COVID-19 should be free to do so. That’s their choice. The problem, however, is that it’s only a matter of time before they lose that choice and vaccination becomes mandatory.
In California, it’s not even a matter of time. Governor Gavin Newsom has already mandated that all schoolchildren get the shot when it becomes available. This mandate ignores the reality that “approximately double … (the number) of children have died of pneumonia” than have died from COVID since the virus appeared in the U.S. early last year. Absent public pushback, Newsom’s move will surely be followed by similar measures in other blue states governed by control freaks.
In an October 23 letter to the U.S. Catholic Conference of Bishops, Archbishop Carlo Maria Viganó, former Apostolic Nuncio to the USA, wrote:
How Joe Biden, who also defines himself as “Catholic,” could impose vaccination on 28 million children aged 5 to 11, is absolutely inconceivable, if only for the fact that there is practically zero risk of them developing the SARS-CoV-2 disease. The Holy See and the Bishops’ Conferences have the duty to express a firm condemnation in this regard, and also in relation to the very serious side effects that can result for children who are inoculated with the experimental gene serum.
When will Catholics, people of other faiths, and other Americans from all walks of life wake up, see what’s happening in plain sight, and scream, “STOP!”? Time is running short.