If there’s one thing the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have taught us since COVID-19 began, it’s that we should proceed with caution when it comes to their proclamations on public health. This is a sad reality that we must acknowledge if we wish to keep our nation’s youngest and most innocent citizens safe, especially since the FDA’s advisory panel just voted unanimously to recommend the Pfizer and Moderna vaccines for babies and toddlers.
Alarmingly, the FDA essentially announced recently that it no longer approves of the use of the Johnson and Johnson (J&J) COVID-19 vaccine due to “rare” but “potentially life-threatening” side effects. This embarrassing and disturbing proclamation comes after the shot had been available and encouraged—and in some cases, required for the public to take—for over 14 months. Now, the FDA says the shot should only be used if an individual is unable to get the Pfizer or Moderna shot—a ringing endorsement from the “trust the science” crowd.
A little over a year ago, the FDA told us that the J&J vaccine “meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use.” The vaccine apparently held up to the FDA’s “rigorous standards for safety, effectiveness and manufacturing quality,” although authorized in a grossly truncated timeline that was alone concerning to cautious observers.
So how can we possibly trust an FDA that just over a year ago gave the J&J vaccine a glowing review to now ensure that the proper safety and efficacy standards are met and implemented when it comes to our country’s youngest children and babies?
We recently sent a letter to FDA Commissioner Robert Califf expressing our serious concerns over Big Pharma’s rush to see that the Pfizer and Moderna COVID-19 vaccines be authorized under emergency use for young children (which, as anyone paying attention knows, will almost certainly lead to widespread COVID-19 vaccine mandates for children, particularly given that the U.S. government has already purchased millions of doses for them).
This is a virus with a 99.995 percent survival rate for children under 18 years of age. According to the CDC, more than 70 percent of this population have already had COVID-19 and recovered. Why, then, the urgency to authorize its use for kids when the long-term side effects are completely unknown and the risk of adverse events, particularly myocarditis in young boys, appears to be a real issue? An April study in JAMA Cardiology shows how devastating myocarditis can be for young men aged 16 to 24. To date, there have been over 10,000 reports of adverse reactions for children aged 5 to 11 who received COVID-19 vaccines.
In fact, myocarditis is prevalent enough in our young children post-vaccination that the CDC recently announced that it may consider experimenting with spacing out the time between vaccine doses to attempt to prevent heart inflammation cases in kids who receive the shots.
A study released in February found that the Pfizer vaccine was only 12 percent effective in children 5 to 11 years old after 30 days. How will a third dose boost this large of a decline in efficacy, and what is the decline in efficacy for 0-to-4-year-olds? Even more importantly, what are the risks to the children who take these shots? The answer is, the FDA doesn’t know.
Last week, we sent another letter to the FDA and its Vaccines and Related Biological Products Advisory Committee highlighting critical questions that we wished to see answered before the vaccines were authorized for emergency use for babies and toddlers. For instance:
- Why has the FDA recently lowered the efficacy bar for COVID-19 vaccines for the youngest children?
- If approved and widely used among children aged 5 and under, how many lives does the FDA estimate will be saved in this age group over the next year? Given the injuries reported in the FDA’s own Vaccine Adverse Event Reporting System, or VAERS, how will the FDA evaluate potential tradeoffs of serious vaccine injuries versus serious COVID-19 outcomes?
- How many healthy children aged 5 and under without preexisting medical conditions have died or been hospitalized from the original SARS-CoV-2 virus or its variants?
- Why has the FDA been so slow to release the hundreds of thousands of pages of data from preapproval manufacturer studies, post-approval adverse events data, and other post-approval manufacturer data submitted to the FDA as required by law?
There are numerous questions that need to be answered by the FDA and CDC. It’s quite possible that the risks outweigh the benefits when it comes to using these experimental vaccines with a questionable safety profile on our children—and our government barely seems to care.
Views expressed in this article are the opinions of the author and do not necessarily reflect the views of The Epoch Times.