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As more and more children are receiving the covid-19 genetic injections, more and more pediatricians and pediatric subspecialists are voicing concerns as they observe side effects. Pediatricians, as a group, are incredibly pro-vaccine and most desparately want to avoid the stigma of ever being labeled “anti-vax,” so this is a noteworthy change.

Use of the traditional term “vaccine” for these products implied traditional mechanisms of action, safety profiles, and development and regulatory processes. The mechanism of action of these genetic technologies is far different than a traditional vaccine, reports to the Vaccine Adverse Event Reporting System since their introduction are greater than the previous 30 years for all vaccines combined, and nothing about the development and regulatory processes has been usual.

The usual vaccine development timeline takes about 5-10 years and consists of:

  1. Preclinical trials, typically in animal models
  2. Phase 1 clinical trials in small groups of healthy human volunteers to assess dosing, short-term safety, and immune response
  3. Phase 2 clinical trials in larger groups of more diverse human volunteers to further assess safety and immune response
  4. Phase 3 clinical trials in tens of thousands of volunteers to assess longer-term safety and vaccine efficacy
  5. Regulatory approval by the Food and Drug Administration (FDA)
  6. Scaling up vaccine manufacturing
  7. Post-licensure vaccine safety monitoring

Phase 2 trials for the covid-19 genetic injections can be summarized as follows:

  • Pfizer: 45 participants, ages 19-54 (mean 35)
  • Moderna: 300 participants, ages 19-54 (mean 37); 50 participants, ages 55-87 (mean 64)
  • J&J: 796 participants, ages 18-55 (mean 34); 394 participants, ages 65-88 (mean 69)
  • The following populations were excluded:
    • Previous confirmed COVID-19 disease
    • Pregnant and lactating women (Pfizer, Moderna)
    • Children
    • Immune compromised
  • They were only designed to assess whether vaccines elicited expected antibody response with low short-term side effect profile.

Technically, all of these products are still under Phase 3 trial. None of the products available in the U.S. have been approved (Comirnaty was approved for ages 16+ but it is unavailable in the U.S.) All of the available products are still under Emergency Use Authorization (EUA).

It’s helpful to review the EUA timeline for these products:

December 2020

· Initial EUA for limited populations for Pfizer-BioNTech and Moderna

February 2021

· Initial EUA for limited populations for J&J

April 15, 2021

· Pfizer-BioNTech authorized for all, ages 16+

· Moderna and J&J authorized for all, ages 18+

May 12, 2021

· Pfizer/BioNTech authorized for 12-17 years old

November 3, 2021

· Pfizer/BioNTech authorized for 5+

November 20, 2021

· Boosters authorized for all 18+ (eligible 6 months after completing Pfizer or Moderna, or 2 months after receiving J&J)

December 17, 2021

· CDC/DOH recommendation that individuals 18+ receive mRNA product (Pfizer-BioNTech or Moderna) instead of J&J

January 6, 2022

· Boosters authorized for all ages 12-17 (eligible 5 months after completing initial series)

May 17, 2022

· Boosters authorized for ages 5-11 (eligible 5 months after completing initial series)

June 15, 2022

· Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss EUA for Pfizer and Moderna for children aged 6 months to 5 years old

As the FDA’s process has not inspired trust (they failed to convene the VRBPAC, an independent advisory panel, when they authorized boosters in children ages 5 to 11, for example), there is an increasing urgency among physicians and physician groups to raise alarms so that parents have full informed consent if they are considering boosters or initial injections in their younger children. One group to do so recently is the North Carolina Physicians for Freedom. Expect more.

Meanwhile, all concerned parties can take action by submitting written concerns to the FDA before their June 15 meeting.