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The Power of the Headline

AE56524F-64C9-4C0F-8168-22FCEE83D0F3Yesterday, at about 4:30pm, the headlines from the FDA decision read "FDA denies 3rd shot," in most outlets. When I sat down to write this post, the headline at CNN had changed to FDA advisers first rejected Pfizer's booster application -- but then voted to recommend a third shot for certain Americans.  Maybe the decision was made late in the meeting. If so, why would there have been any news before the meeting was over? I found 473B9A09-84CA-4FCC-93EF-51465282B245screen grabs at Twitter by scrolling back a couple of hours. You can see the AP Tweet. Meanwhile, in Israel,  reports that a booster might last 12 days in the elderly was noted. 12 days.

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(CNN) Advisers to the US Food and Drug Administration on Friday voted unanimously to recommend emergency use authorization of Pfizer's booster shot six months after full vaccination in Americans 65 and older as well as those at high risk of severe Covid-19.

That vote came after the group had first voted and rejected a broader application: to approve the third shot in all Americans 16 and older six months after they were fully vaccinated.

Dr. Steven Pergam, medical director for infection prevention at Seattle Cancer Care Alliance, expressed concern that theStrike reverse recommendation the advisers approved did not cover health care workers, who are at high risk of exposure to the virus, even if they are not necessarily at high risk of severe disease.

Comments

Emmaphiladelphia

Told you so....

Just as I said below, the FDA advisory meeting was a bait and switch to get the booster approved for 16+ through the EUA so Pfizer could maintain its liability protection. The "Trojan horse" was the second group, -individuals at high risk of severe Covid-19 in which ""ACIP will meet to fine tune the recommendations."
I guess the CDC (ACIP) interpreted the high risk to be a two week quarantine from health worker exposure which would further expose their dwindling staff numbers - they refuse the jab and quit. Will the replacements will be Afghans and Haitians?

"CDC chief 'overrules her scientists' to back Biden booster plan:
President says 'fully vaccinated' are safe but need another shot"
https://www.wnd.com/2021/09/4948220/

Emmaphiladelphia

@TOB Fauci confirms my hypothesis....

Fauci appears to flip on FDA's booster-vaccine decision after just a few days
https://www.wnd.com/2021/09/fauci-appears-flip-fdas-booster-vaccine-decision-just-days/

SEE VIDEO
0:40 to end
Interestingly he said ages 18+ rather than 16+. Should be 16+. Big difference.

greyone

I remember an ACIP meeting discussing measles, and vaccine passports vere discussed, with emphasis on Great Britain, Spain and others.
What i fear, is any contagious disease will be an excuse to remove the patient from the home and taken to a facility, and perhaps, permanently separate the person from their family, pending vaccinations. And charge expenses for doing so to continue a nefarious wealth transfer, as they are with covid "facilities" in some lost lands.
Sigh, I remember times when people had a measles sign to put on the front door to warn visitors.

TOB

Nice work, Emma. That interpretation seems reasonable.

I wonder why el presidente didn't go on national TV to tell everyone this little gem:

https://www.whitehouse.gov/briefing-room/presidential-actions/2021/09/17/executive-order-on-adding-measles-to-the-list-of-quarantinable-communicable-diseases/

I mean, I saw forced catch-up for all adults (all 80 or so shots on the kiddie schedule) happening once the national system was rolled out, but I didn't think it would happen before Christmas. Quarantine is a tactic to compel masks and vaccines for everyone forever. For example, the schools are mistreating the kids because state departments of health (even here in FL) have mandatory quarantines for "close contacts" that are policed extremely strictly in schools. If you have a list of 30 diseases with the same hair-trigger quarantine rules as the novel coronavirus, you can get every company to mandate every shot for all adult employees, because they don't want the mass absenteeism of close contacts of people who have tested positive for a normal childhood illness with a crummy test.

I had to chuckle a bit about TB already being on the list. Most TB in the US is in the homeless population. How exactly are they supposed to quarantine?

Angus Files

Trust us were Drs!......`don't larf!!

Pharma For Prison

MMR RIP

Emmaphiladelphia

Here's the lowdown of the FDA votes (there were two):

After watching the meeting live and a second time to take notes, this is my opinion. I believe that it is in Pfizers' financial interest to have their Covid 19 "vaccine" and "booster" to remain classified EUA rather than an FDA licensed product. They would retain their legal liability protection and could sell their products based on a much lower safety and efficacy standard. Because of what CHD's lawsuit calls "bait and switch," the FDA previously licensed their Covid 19 "Comirnaty" (which isn't currently available and has no liability protection) and simultaneously reauthorized the Pfizer BioNTech Covid 19 EUA with an extended product shelf life from 3 to 6 months. At that time, Pfizer did not have an EUA "booster" shot.

At yesterday's meeting, Pfizer submitted their own request for FDA LICENSING of their just licensed Covid 19 shot to be a BOOSTER shot for ages 16 AND UP. It is my opinion that this was a surprisingly poorly worded statement based on their own safety data. All but two of the voting committee members agreed and pointed this out in their commentaries. This justified the comments about the higher risk for heart/blood related adverse events in the younger age group. Israel had data that made the booster appear safer and effective for the 65 and up group, but it was collected for only one month. This set the board up to look good for voting 2-17 against FDA LICENSING, but show a desire to make it available for ages 65 and up.

After the first vote, suddenly the meeting became about a vote on a question that the COMMITTEE wrote for Pfizer, to create an EUA Pfizer booster. Here is the wording:

"Voting Question #2" (EUA)

Based on the totality of scientific evidence available, including the safety and effectiveness data from clinical trial C4591001, do the known and potential risks of a Pfizer-BioNTech Covid 19 vaccine booster dose administered at least 6 months after completion of the primary series for use in:
- individuals 65 years of age and older, and
-individuals at high risk of severe Covid-19"

During discussion, high risk individuals were defined as immunocompromised, nursing home residents, the obese, and one committee member wanted to make sure that it included health care workers because they couldn't afford to have them get sick and be out of work for 2 weeks because of the staff shortages (many have quit their jobs rather than take the jab). Others stated it would be at their doctor's discretion. This made it clear that the booster could still include ages 16+. At the end, the moderator stated that "ACIP will meet to fine tune the recommendations."

This is a disturbing outcome. Now that pharma jabs can get lower safety/efficacy standard EUA status and still get liability protection, they have no financial incentive to get their product FDA licensed. The HHS Secretary has huge Federal powers created by the Emergency Declaration and the EUA's. They will not want to give those up. An EUA "booster" could help perpetuate the "emergency" into a continual one. The mRNA platform could become pharma's platform for ALL "treatments/vaccines." Just change out the mRNA code for the latest outbreak and you quickly have a new "booster."

We must continue to just say "NO!"

Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement

REFERENCES
6:19:27 - 6:22:07, 6:32:40 , 6:36:48, 6:40:50, 6:41:20, 6:45:53, 6:48:19-6:49:29, 7:03:40, 7:13:30, 7:21:50, 7:24:15, 7:42:06, 7:47:50, 7:50:10, 7:52:15, 7:53:15, 7:53:49 "ACIP will meet to fine tune the recommendations."

TOB

Maurine, I was watching the livestream. It was very strange. The basic consensus among VRBPAC members seemed to be that the 300-person trial from Pfizer didn't make a strong case for a third dose, that the Israeli data was in direct conflict with published CDC data on hospitalization risk among people who had two shots, and that CDC didn't provide nearly enough data on big questions for VRBPAC to greenlight a third dose.

It was clear, though, that some people (Walensky, Marks, Biden) were going to be embarrassed if a third shot wasn't OK'd for somebody, so Monto asked the committee to say out loud what voting question would get a "yes" from them, as an EUA expansion (rather than a supplemental BLA). VRBPAC members suggested ages, Marks wrote up a new question, and they voted again. It was very interesting.

Nice moment from Dr. Hayley Gans (pediatrics professor at Stanford) on the absolute crapitude of the data:

“I am struck by FDA asking us to look at the totality of evidence, when there’s several key points that we’re lacking right now. One of them is the very strong safety data that we could have, actually, with one million third doses that have been given [to immunocompromised Americans under the existing EUA…] That’s a really missed opportunity and something that should be considered when FDA considers that these 300 people [that Pfizer submitted for the supplemental BLA] is not a large enough study.

"Along with Dr. Hildreth, [I believe] another missed opportunity that I think FDA could have asked for is looking at both humoral and T-cell immunity We really could […] have the answers, and to be told that ‘they’re complicated assays’ or ‘it’s up and coming’ is … feels that we’re making decisions when there’s data out there that we’re not [being given].”

She was not the only one to voice that kind of frustration. She's tired of getting pushed around and told to yes/no a complicated question with absolute garbage data. It was kind of cool to hear her say it out loud. Too bad NYT didn't decide to report it. (Maybe their reporter didn't watch the whole meeting?)

drymeadow

excellent point, something changed. somehow the main population was spared from the 3rd jab while the elderly were, once again, thrown under the bus. Perhaps too many teenagers are presenting at the Vanderbilt ER with serious heart conditions and Dolly is ticked.

Maurine Meleck

Wonder who arrived with the ammunition to change the vote.
Maurine

Bob Moffit

Speaking of the "Power of the Headline" .. a recent headline quoted Biden saying we are in a "PANDEMIC OF UNVACCINATED" .. which was immediately parroted by the pathetic main-stream media outlets.

Recent revelation of people vaccinated with two doses are counted as UNVACCINATED if they are hospitalized with covid prior to six months following second dose. Would think MEDIA would ascertain if fully VACCINATED are being deliberately classified as UNVACCINATED .. no?

Interview with a "whistleblower" who was fired for diligently REPORTING ADVERSE EVENTS FOLLOWING VACCINATION … after serving as a hospital administrator for 17 years .. this courageous woman refused to "dis-continue sending reports of vaccine injuries to VAERS" when the administering doctors refused complete extensive VAERS information necessary for receiving VAERS verification. Apparently this failure to report to VAERS is happening because it is so complicated and time consuming UNREPORTING is country wide in hospitals and doctor offices.

"Meanwhile, in Israel, reports that a booster might last 12 days in the elderly was noted."

Now THAT DESERVES POWER OF THE HEADLINE news.

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