FDA advisers recommend Pfizer-BioNTech coronavirus vaccine, with agency action expected soon

[BumRushDaShow]

Source: Washington Post

Federal advisers endorsed the Pfizer-BioNTech coronavirus vaccine on Thursday, making it all but certain the Food and Drug Administration will authorize the vaccine on an emergency basis within hours or days, kicking off an unprecedented effort to inoculate enough Americans to stop a rampaging pandemic.

The thumbs’ up from the FDA’s vaccine advisory committee was the culmination of an all-day meeting during which the panel heard presentations on the safety and effectiveness of the vaccine, including plans to monitor its longer-term safety.

The key moment came at the end of the meeting when the agency asked its independent advisers: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?” The committee voted yes.

If as expected, the FDA follows quickly with an emergency authorization, the shots will start being moved to the states within 24 hours, according to officials at Operation Warp Speed, the Trump administration’s effort to accelerate the development and delivery of vaccines. Inoculations could begin early next week, officials say.

Read more: https://www.washingtonpost.com/health/2020/12/10/fda-advisory-panel-recommends-covid-vaccine/

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I have had the stream of this on since 9 am EST this morning and watched the vote. This is just the members of the advisory committee (various physicians and researchers) and the agency's final decision should come shortly.

[riversedge]

1. Breaking: The FDA advisory panel approves the use of Pfizer's #covid vaccine for emergency use.

@B52Malmet
Breaking: The FDA advisory panel approves the use of Pfizer’s #covid vaccine for emergency use. Because if ever there was a public health emergency it is now. The full FDA is expected to to grant the authorization as early as Friday.

Link to tweet

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Link to tweet

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[rickyhall]

2. But can we trust anything from the Trump Regime?

[BumRushDaShow]

3. The advisory committee is made up of "outsiders" and are not affiliated with the government

The main concerns brought up by some members were -

1.) the inclusion of ages under 18 (they felt there was not enough data for the 16 & 17 year olds although the vote question was to allow for use for age 16 and older),

2.) the issue of possible adverse reactions by people with allergies (particular those with peanut/egg allergies who carry epipens and those who often opt-out of vaccines like the flu one due to that)

3.) not a large enough sampling of the black population in the trials (only about 9% of the 43K)

4.) the brief time span from the start of this latest phase in July, with submitted results only covering about 4 months (through to November 18).

5.) the novel nature of the vaccine itself - i.e., most vaccines are either live viruses, weakened viruses, or dead viruses and this is none of that... it is injecting cells with genetic material that tunnel inside certain types of your own cells, release their RNA for replication, to trigger your cells to morph into something that will sortof "mimic' the actual virus with its spikes, which would in turn trigger the body to produce antibodies to the now-manufactured "fake" virus look-alike, which would then be effective enough to fool and neutralize the real virus

[ProfessorGAC]

4. Pfizer Cares Not A Whit About Him

They declined to be part of Warp Speed. They didn't want to be involved with that gang.
So, they were totally independent, and so was this advisory panel.
This has nothing to do with PINO.