An observation by my journalist friend on the risks of final approval for COVID vaccinations

[brooklynite]

One a medical treatment is "approved for use", the determination on HOW it's used shifts to individual doctors who can change dosages, frequency of administering, etc. May explain why final approvals are taking so long.

[LisaL]

1. We need that ASAP, so we can get boosters.

Per Pfizer, vaccine efficacy wanes, so we need boosters at 6 months. Right now there is no way to get boosters, since FDA/CDC didn't approve them.
Once it's fully approved, I am assuming our doctors can prescribe it.

[Igel]

4. Let's wait for the evidence for this.

Pfizer wants to sell booster shots. "VE doesn't wane" is not a good sales pitch.

I wonder what reinfection does to an already-vaccinate person's immune response to SARS-CoV-2.

[LisaL]

6. Israel is already giving out boosters while we are waiting for something.

NT

[Hoyt]

2. If trump is reinstated on Aug 13, we bash him for developing a short-lived vaccine.

[hlthe2b]

3. Off label drug treatments are one thing--physicians assume the risk & liabiity...

But vaccines come under the standards of CDC's ACIP (Advisory Committee on Immunization Practices) as well as pharmaceutical company and FDA-approved guidelines. Administering in a manner inconsistent with this (especially vaccine-handling or using a reduced dose for someone they 'perceive' to be at more risk of an adverse reaction) would open them up to tremendous liability.

Off-label use of medications are typically supported by 1. there being few or no alternatives; 2. fully informed consent; 3. advice from other leading specialty groups.

No one is going to support a physician who elects to ignore such specific vaccine guidelines and I see few willing to do so. Physicians have lost licenses from improper vaccine handling that has lead to disease break-through clusters. Such investigations are not uncommon nor hard to pinpoint the culprit.

Despite public impatience, approvals are actually NOT taking so long. I do foresee immediacy, however, given how much data has been provided by Pfizer. (Moderna, on the other hand, has NOT provided all they are required to do thus far)

So, no. On this I disagree with Laurie Garrett strongly.

[LisaL]

5. Moderna applied later for full approval than Pfizer.

NT

[hlthe2b]

7. That is correct, but Moderna has not yet provided all the data that has been requested & completed.

It is not a simple process, believe me. But, Pfizer has been prepping for this all along, armed with vast experience in prior drug and vaccine applications. Moderna is new to the game.