Does the FDA Think These Data Justify the First Full Approval of a COVID-19 Vaccine?

The Defender ^ | 8-24-21 | Peter Doshi

[Meah]

On July 28, Pfizer and BioNTech posted updated results for their ongoing phase 3 COVID-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”

But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (March 13, 2021) as the April 1 press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic COVID-19 through “up to six months of follow-up.”

The 20 page preprint matters because it represents the most detailed public account of the pivotal trial data Pfizer submitted in pursuit of the world’s first “full approval” of a coronavirus vaccine from the U.S. Food and Drug Administration. It deserves careful scrutiny.

The elephant named “waning immunity”

Since late last year, we’ve heard that Pfizer and Moderna’s vaccines are “95% effective” with even greater efficacy against severe disease (“100% effective,” Moderna said).

Whatever one thinks about the “95% effective” claims (my thoughts are here), even the most enthusiastic commentators have acknowledged that measuring vaccine efficacy two months after dosing says little about just how long vaccine-induced immunity will last. “We’re going to be looking very intently at the durability of protection,” Pfizer senior vice president William Gruber, an author on the recent preprint, told the FDA’s advisory committee last December.

The concern, of course, was decreased efficacy over time. “Waning immunity” is a known problem for influenza vaccines, with some studies showing near zero effectiveness after just three months, meaning a vaccine taken early may ultimately provide no protection by the…

[Meah]

Low bar, imho

[bak3r]

Very low bar indeed, but also we are talking about a alphabet agency. Why assume the FDA would be less corrupt that XYZ? Disturbs me personally how the FDA seems to be on a higher pedestal to some.

[Dick Vomer]

do a Google search and enter “FDA” and “revolving door”.

[eastexsteve]

Everyone who has been watching knows they cut the corners on the covid approval.

[griswold3]

They call this science?

[Travis McGee]

“Pfizer Seeking Full Indemnification”
[Dr. Robert Malone on War Room with Steve Bannon. 4 minute video]

Malone says that the new “Comernity” jab that is “FDA approved” is NOT the same as the currently available Pfizer vaxx jab.

“Comernity” is not yet available.

Pfizer and the FDA are playing a “3 card monty” fake switcheroo. They will not make the currently available Pfizer vaxx jab available without the existing extended EUA and full continuing immunity.

The as-yet unavailable “FDA Approved Comernity” at this point is just a fake out to trick the gullible into taking the same old EUA Pfizer vaxx jab.]

https://rumble.com/vlmd4g-pfizer-seeking-full-indemnification.html

[the OlLine Rebel]

It may be more the biggest powers in the gov pushing the FDA to get it done.

[arthurus]

The political data are all the data the FDA needs.

[Robert DeLong]

The FDA has not approved Pfizer vaccine. watch and learn the slight of hand:

Steve Bannon & Dr. Robert Malone: Vaccine FDA Approved? Really? Not.

[Meah]

Yes, am reading this too. As I understand it, Comirnaty (such a creepy name, btw) will not have liability protection from adults who take it and are injured, meaning they can sue Pfizer (?) I will post that article too.

[rolling_stone]

Comparison of Countermeasures Injury Compensation Program (CICP) to the National Vaccine Injury Compensation Program (VICP)

https://www.hrsa.gov/cicp/cicp-vicp

[Kartographer]

If they didn’t approve it do you really thing anyone would ever take a Covid Vax again? It would mean that they would loose all control.

[rolling_stone]

https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html

cdc
Overview, History, and How the Safety Process Works

“To ensure the continued success of vaccines in the United States, it’s crucial to make sure that vaccines are safe.”

FAIL

[datura]

Here is 200+ hundred years of FAIL by the vaccine industry.

https://phoreveryoung.wordpress.com/2015/05/14/the-worst-cover-up-in-the-history-of-the-world-vaccinations-are-monkey-business/

[LegendHasIt]

The only thing the FDA cared about is whether the transfer of money to their individual offshore accounts was completed.