Color Coded Vaccines

On October 29, the FDA removed the combined COMIRNATY/Pfizer-BioNTech Fact Sheet for Healthcare Providers.  In its place, the FDA issued three new Fact Sheets for Healthcare Providers Administering Pfizer-BioNTech vaccines, one for each of the now three versions of the product which are distinguished by vial cap colors.  Vaccine vials with purple caps are authorized for individuals 12 years of age and older and must be diluted before injection.  Vaccine vials with orange caps are authorized for children 5-11 years of age and must be diluted before injected.  Vaccine vials with gray caps are authorized for undiluted administration to individuals 12 years of age and older but are not available in the United States.   

Sound complicated?  It is.  And it raises disturbing questions.  But first, here’s an updated (and complicated) vaccine chart:

Now the questions.

Is there an FDA approved vaccine for children under 16 years of age?

No.  COMIRNATY is FDA approved for individuals 16 years of age and older.  Quoting from the Pfizer-BioNTech Orange Fact Sheet, “The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 5 years of age and older.”

Why did the FDA approve COMIRNATY if it’s not available in the United States?

I don’t know for sure, but I can speculate.  The FDA News Release on August 23 makes it seem as if Pfizer-BioNTech is an approved vaccine.  This may be the reason for COMIRNATY’s approval—to provide a veneer of legitimacy to the authorizations for boosters and child vaccines that followed.  The Fact Sheets are clear: Pfizer-BioNTech vaccines are not approved.  Not for anyone.

Why is COMIRNATY not yet available?

In the emergency use authorization letter for Pfizer-BioNTech reissued on August 23, the FDA acknowledged that, “There remains, however, a significant amount of Pfizer-BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses.”  In other words, FDA will allow Pfizer’s inventory to be consumed under EUA before requiring production and distribution of COMIRNATY. By the way, you’ll have to go to web.archive.org to find this letter. I can no longer find it on FDA’s active website.

If COMIRNATY is not yet available because of Pfizer’s vaccine inventory, how does Pfizer manufacture two new versions (Gray and Orange) of its vaccine so quickly?

Good question.  Is Pfizer just consuming inventory or is Pfizer producing new vaccine?  I don’t know for sure, but it seems to me Pfizer is producing new vaccine.

Why did the FDA authorize Pfizer-BioNTech Gray if it’s not available in the United States?

I’m puzzled by this question.  How can the FDA authorize use of an unapproved product for an emergency when that product is not available?  If you have an idea, please tell me.

Are all COVID Vaccines experimental?

Yes.  There is not an approved, licensed COVID vaccine available in the United States.  All available vaccines are unapproved products permitted for emergency use only.  It’s a big experiment.  Vaccinated individuals are part of the experimental group.  Unvaccinated individuals are part of the control group.  We will analyze the results in a few years.

Can I or my child be forced to accept a COVID Vaccine?

No and Yes.  Fact Sheets for Healthcare Workers Administering Vaccines say that the person administering the vaccine must disclose that “the recipient or their caregiver has the option to accept or refuse” the COVID-19 Vaccine.  Fair enough, but this hasn’t prohibited vaccination by coercion.  There are many people who have been forced to accept a COVID vaccine to keep their jobs, and people who refused vaccination have lost freedoms and employment.  Coerced consent is and always will be unethical.

Are we sure Pfizer-BioNTech Orange COVID vaccines are safe for children?

No, and this is the most disturbing part of the October 29 actions.  The CDC insists the vaccines are safe for children.  But many prominent physicians have disputed this claim, saying that long term effects of vaccines on children are unknown.  I agree.  Without a time-machine, it’s impossible to know the future effects of vaccines given to children today.  But I’m not the only one who thinks this way.  At the 170^th meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, Dr. Eric Ruben, Editor-in-Chief of the New England Journal of Medicine and temporary voting member of the committee, said, “We’re never going to learn about how safe this vaccine is unless we start giving it.  That’s just the way it goes.”  Dr. Ruben voted for authorization of experimental vaccines in children.  Whatever you think of his judgement, at least he’s honest about the safety data.  We don’t have any yet.