Friday, August 13, 2021

Some getting booster shot without FDA approval

From TMJ4:

The FDA and CDC expected to authorize an emergency use third dose COVID-19 vaccine for some people



Posted at 5:56 PM, Aug 12, 2021
 
and last updated 5:56 PM, Aug 12, 2021

MILWAUKEE — Local experts believe clearance for a COVID-19 booster vaccine could be on the horizon for those who are immunocompromised, yet some who are not among the most vulnerable have gone ahead and received their own third dose anyway.

Dr. Hashim Zaiback oversees Hayat Pharmacies. He has had to turn away many people here in Milwaukee from requesting third-dose shots.

"People are very honest, they come to you and say, 'you know, I've already gotten my two doses of Pfizer, I want the third one,' and we very respectfully say you just have to wait for the approval," said Dr. Zaiback.

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Thursday afternoon during the Department of Health Services briefing, Dr. Ryan Westergaard, Chief Medical Officer of the DHS, shared that some people may have already gone through extreme lengths to obtain the third booster, despite medical recommendations.

"Some people may have gone out and gotten a third dose on their own. There aren't robust systems to prevent others from doing it if they crossed state lines," said Dr. Westergaard.

According to the CDC internal briefing documents, an estimated more than 1.1 million people have already received the third dose of the vaccine.

Dr. William Hartman has been a principal COVID-19 Trial Investigator working with the CDC to study the potential of the shot. He believes the booster will be recommended for those who are immunocompromised with both doses of the Moderna or Pfizer shots. However, the FDA has yet to authorize this.

"We know that these individuals haven't had as effective of a response to the vaccines as people who have normal [immune systems]. It'll be a third dose of the typical vaccine that they've already received, and so there is no difference in the formulation versus the ones that went out in the first round," Dr. Hartmman.

Resident Darnelle Dowles falls into the immunocompromised pool and is eager to get her third booster when it comes available.

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"I carry quite a few diagnoses, so if they do 4, 5, 6, 7, 8 or 9 booster shots, I'm taking all 9 of them because this is serious," said Dowles.

From: https://www.tmj4.com/news/coronavirus/some-getting-booster-shot-without-fda-approval

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