Days after the FDA approved J&J’s COVID vaccine for emergency use, the company announced plans to test the vaccine on newborns, despite the vaccine’s risks and strong evidence that COVID poses virtually no risk to healthy children.
On Friday, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization for Johnson & Johnson’s (J&J) COVID vaccine, paving the way for the one-shot vaccine to be administered beginning this week.
The Centers for Disease Control and Prevention (CDC) also recommended the vaccine for people 18 and older. On Sunday, J&J revealed plans to test its one-shot vaccine on infants, including newborns, pregnant women and the immunocompromised. The expanded clinical trials were laid out in the company’s application for emergency use approval and in briefing materials provided to the FDA and discussed briefly during the meeting.
According to the New York Times, the plan for expanded clinical trials met the approval of Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the FDA’s advisory committee that reviewed the company’s vaccine data.
When Levy saw the outlines of the planned trials, he said: “They did not get into a lot of detail about it but did make it clear they will be pursuing pediatric and maternal coronavirus immunization studies.”
A spokesperson for Janssen Biotech, a J&J subsidiary, confirmed the company plans to extend clinical trials to children –– first to children between the ages of 12 and 18, and immediately after to newborns and adolescents, then to pregnant women and immunocompromised individuals.
Levy noted vaccinating children will help the country reach herd immunity, echoing comments made by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, during Sunday’s Meet the Press:
“Vaccinating young people will be necessary to approach herd immunity and significantly slow the spread of COVID-19 in the United States. While they typically have fewer symptoms than adults with COVID-19, children can still spread the disease.”
Children’s Health Defense President and General Counsel Mary Holland disagreed, stating that decades of intensive effort “have not attained herd immunity for any childhood disease.” Holland has conducted extensive research on the history of vaccine policies.
Immunologist Tetyana Obukhanych, Ph.D., and others agree that officials use the concept of herd immunity as a “trump card to justify any measures, often at odds with personal freedom of choice, aiming to increase vaccination compliance,” The Defender reported.
Most of the world’s vaccine market is pediatric vaccines, according to the Times, so it’s not surprising that J&J would be looking to capitalize on a relatively untapped market for its coronavirus vaccine.As The Defender reported in February, Bill Gates set the stage for a pediatric push last year, declaring his desire to make COVID-19 vaccines “part of the routine newborn immunization schedule” despite the fact that 99.997% of young people ages 0-19 survive COVID-19 with most experiencing either mild or no symptoms at all.
A study published in the European Journal of Pediatrics showed only a rare subset of children — mostly children with serious underlying medical conditions — experienced hospitalization or worse from COVID.