FDA HAS LOST ITS WAY
The Highwire with Del Bigtree
The Highwire with Del Bigtree
4.9 • 3.4K Ratings
🗓️ 30 May 2022
⏱️ 12 minutes
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Summary
#FDA #PeterMarks #kids #SafetyFirst
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Transcript
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| 0:00.0 | This is the FDA's latest emergency use authorization. |
| 0:04.4 | They're authorizing boosters for kids. |
| 0:07.8 | The first booster, FDA authorizes Pfizer COVID booster dose for kids ages five to 11 years old. |
| 0:14.4 | None of this could happen if it wasn't for Javier Bacera. |
| 0:19.0 | He's the Secretary of HHS and he extended, we reported this about a month ago. |
| 0:24.8 | He extended the COVID public health emergency for another 90 days that was in the headlines. |
| 0:31.0 | And what that did was that allowed these emergency use authorizations for vaccines to stay valid |
| 0:36.6 | and also for them to do what they just did with the FDA is to push more through for these kids. |
| 0:41.5 | So even though there is no emergency for kids, we've covered the numbers. |
| 0:45.1 | There's no hospitalization emergencies. There's no mortality emergencies associated with COVID-19. |
| 0:49.6 | These kids have almost 0% risk on those two factors and a low case correlation to that. |
| 0:56.4 | But let's go right, okay, so let's go right to the FDA press release because we didn't get a |
| 1:01.0 | verpac meeting on this one. We received a press release. Coronavirus update, FDA expands eligibility |
| 1:07.2 | of Pfizer, COVID-19 vaccine booster doses for children five through 11 years old. |
| 1:11.3 | Let's dig into this great press release. It says here, the safety. |
| 1:15.5 | Now, how did they determine the safety? The safety of a single booster dose, the Pfizer-BioNTech COVID-19 |
| 1:21.1 | vaccine in the stage group was assessed in approximately 400 children who received a booster dose. |
| 1:26.4 | So there you go. You're going to send it to about a million plus children throughout the United |
| 1:31.8 | States. Now it says here, the FDA did not hold a meeting of its vaccine-related biological products |
| 1:37.7 | advisory committee on today's action as the agency previously convened the committee for extensive |
| 1:42.6 | discussions regarding the use of booster doses of COVID-19 vaccines. And after review of Pfizer's |
| 1:47.4 | EUA request, the FDA concluded that the request did not raise questions that would benefit from |
... |
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