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The Highwire with Del Bigtree

FDA & MANUFACTURERS TO TERMINATE VACCINE SAFETY MONITORING

The Highwire with Del Bigtree

The Highwire with Del Bigtree

News, Society & Culture, Health & Fitness

4.93.4K Ratings

🗓️ 16 December 2020

⏱️ 4 minutes

🧾️ Download transcript

Summary

The FDA has revealed Pfizer, and other Covid vaccine makers, plan to unblind their Phase 2/3 placebo groups and vaccinate them after just six months. With the #Covid19 vaccines already rushed to market faster than any vaccine before it, this potentially dangerous move makes it all but impossible to evaluate the long-term effects of this brand new vaccine platform.

Transcript

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0:00.0

There is a saline placebo being used for the first time really in vaccine safety

0:06.9

trials in the pre-licensure phase, which is where we've been because the

0:12.2

informed consent action network, our nonprofit petitioned the FDA. They were

0:16.9

going to be using meningococcal vaccines and things that were being used

0:20.5

around the world and we said the informed consent action network will not allow

0:25.4

you to call this a safety trial. If you do not have a true you know safety

0:29.9

baselines set by a saline placebo and within days we saw them stop down based

0:34.6

retrials and add a saline placebo. So now what are they you know what is it you

0:39.5

want to share about that placebo? Yeah this is in Pfizer's own documents. Now

0:43.8

they're talking about this is the heading called sponsors plans for

0:46.6

continued blinded placebo control follow-up. It says the sponsor Pfizer plans to

0:52.7

offer vaccination to participants equal to or over 16 years of age who

0:57.8

originally received placebo and who become eligible for recipient of BNT 162B2

1:04.4

that's Pfizer shot according to local or national recommendations. The sponsor

1:08.6

also proposes that all placebo recipients equal a greater to 16 years of age

1:13.0

will be offered the shot after completing six months of follow-up after dose

1:17.6

two if they did not request and receive vaccine previously. So they're

1:24.7

unblinded so we're going to basically what this is saying in a lot of words is

1:30.0

after six months we are going to destroy our placebo group we're essentially

1:34.8

going to offer everyone in the placebo group. First of all let them know you

1:39.2

were in the placebo group and start injecting with a vaccine if you want it

1:43.2

therefore I mean here's the news flash right for for the last several years we

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