Pfizer was granted permission by the FDA to extend the COVID-19 vaccine clinical trials to children ages 12-15. Cincinnati Children’s Hospital is the first to report that children are now receiving either a placebo or the real vaccine in these extended trials. Dr. Robert Frenck, director of the National Institutes of Health-funded Vaccine and Treatment Evaluation Unit and Gamble Program for Clinical Studies at Cincinnati Children’s Hospital will be leading the trials and made the announcement that trials on children have begun.
From a Cincinnati The Enquirer article comes the following quotes:
Meanwhile, Pfizer said Friday that it could be ready to apply for emergency-use authorization of its vaccine by late November, the Wall Street Journal reported. It was the first time it or any other leading Western vaccine developer provided such a specific timeline, the Journal said.
The Pfizer vaccine will involve a different process [than previous vaccines], in which molecules known as messenger RNA, or mRNA, are injected into the subject. The mRNA instructs the subject’s own body to create the antigens.
No mRNA vaccines have been approved for human use up to now, but proponents say they are safe and can make vaccine production quicker and less expensive. A selling point is they are not made with fragments of the actual virus, as traditional vaccines are.
Vaccines made with mRNA have been used on human subjects in cancer and influenza research without significant side effects, experts say [the anonymous experts as usual].
Perhaps these are some of the experts as quoted from a Healio article “Time to include children in COVID-19 vaccine trials, experts say.”
There is Paul A. Offit, an Infectious Diseases in Children Editorial Board Member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
“I think what we’re going to see is this de-escalation in age as we move forward,” Offit said. “We’ll study younger and younger people in a sequential manner would be my guess.”
Asked when he felt children should be included in COVID-19 vaccination trials, Offit replied “now.”
“I think we can start to study these vaccines now,” Offit said. “It’s going to be important when we consider strategies to get children universally back into schools, which is critical.”
From Offit’s Wikipedia biography is this quote:
“Offit defines alternative medicine as quackery when it involves unappreciated harm and replacement of conventional therapies that work, with alternative therapies that don’t. His books and articles warn against expense and risk to health for recipients of alternative therapies. In 2013 Offit wrote the book Do you believe in Magic? – The Sense and Nonsense of Alternative Medicine. Offit states that the purpose of the book “is to take a critical look at the field of Alternative Medicine – to separate fact from myth.” and that “There’s only medicine that works and medicine that doesn’t.”(p. 6) One of Offit’s concerns is the scare tactics he says proponents of Alternative Medicine will often use, in a 2010 podcast with the Point of Inquiry Offit stated “it is very difficult to unscare people when you scare them.” [But I guess he doesn’t mind the constant scare tactics that have been used against the public during this “scamdemic.””]
Next is American Academy of Pediatrics President Sara H. Goza, MD, FAAP.
“children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns.”
“It would also be less than desirable to have one or more SARS-CoV-2 vaccines licensed or available under emergency use authorization at a time when no data have been collected on the safety, tolerability, dose, and regimen for children,” Goza wrote. “For these reasons, we urge the inclusion of children in vaccine trials as we move forward in the development of a SARS-CoV-2 vaccine.””
Of course the “best” expert on COVID-19 is National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD.
“…it is important to “strike a balance of making sure you get a vaccine — if it’s safe and effective — to children in a timely manner while you’re also very attentive to the extra potential risk you’d see in a child, given the vulnerability of children.”” What a caring guy.
Will cases of undesirable outcomes to children from these clinical trials be widely reported on and will anyone be held accountable for such outcomes? Don’t hold your breath.