FDA Admits MORE Serious Adverse Effects From Pfizer Vaccine ‘May Become Apparent’ With Widespread Us

[mystery-ak]

FDA Admits MORE Serious Adverse Effects From Pfizer Vaccine ‘May Become Apparent’ With Widespread Use

'Additional adverse reactions, some of which may be serious, may become apparent with more widespread use'

by Patrick Howley   
October 27, 2021

A Fact Sheet for Vaccine Providers published on the Food and Drug Administration (FDA) website admits that “Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.” The Fact Sheet was issued in response to the FDA granting an emergency use authorization for the Pfizer vaccine for people aged 12 and older. The Fact Sheet also notes that the Pfizer vaccine carries risk of the heart conditions myocarditis and pericarditis in addition to numerous other ailments that have been reported in clinical trials, and that “immunocompromised persons…may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.” Recent former FDA commissioner Scott Gottlieb (pictured above) is now on the board of directors of Pfizer. A contingent of recent Pfizer workers who serve on an FDA advisory committee are trying to get the FDA to authorize a Pfizer vaccine for children aged 5 to 11.

The fact sheet for the vaccine for people aged 12 and up is also published on the PFIZER LABELING website and it states: “Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae.”

more
https://nationalfile.com/fda-admits-more-serious-adverse-effects-from-pfizer-vaccine-may-become-apparent-with-widespread-use/

[PeteS in CA]

A Fact Sheet for Vaccine Providers published on the Food and Drug Administration (FDA) website admits that “Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.”

Standard boilerplate type language, not an "admission" (gotta love that tendentious choice of words!), probably used with any newly approved medication.

E.G, re the Shingrix vaccine was approved in 2017, https://www.drugs.com/fda-alerts/3870-18694.html :

New Warning about Risk for GBS following Shingrix

FDA has required a new warning about GBS in the Prescribing Information for Shingrix as a result of new safety data from a postmarketing observational study. In the study, an increased risk of GBS was observed during the 42 days following vaccination with Shingrix.

About Shingrix

Shingrix received FDA approval on October 20, 2017, for prevention of herpes zoster (shingles) in adults aged 50 years and older. Shingrix is administered as a two-dose series, with the second dose given anytime between 2 and 6 months after the first dose. In one clinical trial, compared to placebo, Shingrix reduced the incidence of shingles by 97% in individuals 50 years and older. In another clinical trial, compared to placebo, Shingrix reduced the incidence of shingles by 90% in individuals 70 years of age and older. Prior to approval of Shingrix, FDA evaluated safety data from 17 clinical studies. Approximately 17,000 adults aged 50 years and older enrolled in these studies received at least one dose of Shingrix. Across the two largest studies, the safety of Shingrix was evaluated by comparing approximately 14,600 individuals who received at least one dose of Shingrix to approximately 14,600 individuals who received saline placebo.

After the FDA approves a medication Phase 4 testing ensues, in which recipients are tracked for several years, in addition to reports to the VAERS database. When "news" sources bogeymanize normal processes relying on readers being unaware of what is normal, which the OP article seems to do, the intent is to deceive.

[jmyrlefuller]

That's pretty much standard for any new pharmaceutical. The more widespread the adoption, the more likely that an extremely rare effect will show up somewhere in the population.

[PeteS in CA]

One of the curious things I spotted in the info I posted above about the Shingrix is that the Phase 3 test appears to have had 29,200 participants, half receiving the vaccine, half a placebo. IIRC, the Pfizer vaccine Phase 3 test has ~60,000 participants (IIRC it was 30K initially, but at Pfizer's request the number was bumped up to 60K). And IIRC, 30,000 are participating in Moderna's and J&J's Phase 3 tests. I used present tense because I'm pretty sure the participants who received the vaccines are still being tracked.

[mountaineer]

Pfizer adds ingredient used to stabilize heart attack victims in vax for kids
Posted on October 28, 2021 1:00 pm

Buried on Page 14 in the Pfizer paperwork submitted to the FDA for the Covid vaccine for children is this disturbing nugget.

    Vaccine formulation
    Authorization is being requested for a modified formulation of the Pfizer‑BioNTech COVID-19 Vaccine. Each dose of this formulation contains 10 μg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 that is formulated in lipid particles and supplied as a frozen suspension in multiple dose vials.

    To provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) buffer instead of the phosphatebuffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride. The packaged vials for the new formulation are stored frozen at -90°C to – 60°C. The frozen vials may be thawed and stored at refrigerator at 2°C to 8°C for up to 10 weeks.

Tromethamine (Tris) is a blood acid reducer which is used to stabilize people with heart attacks. ... Rest of story

[Cyber Liberty]

One of the curious things I spotted in the info I posted above about the Shingrix is that the Phase 3 test appears to have had 29,200 participants, half receiving the vaccine, half a placebo. IIRC, the Pfizer vaccine Phase 3 test has ~60,000 participants (IIRC it was 30K initially, but at Pfizer's request the number was bumped up to 60K). And IIRC, 30,000 are participating in Moderna's and J&J's Phase 3 tests. I used present tense because I'm pretty sure the participants who received the vaccines are still being tracked.

Does the article say how many deaths and injuries were sustained with Shingrix?  And what is GBS?

Are we confusing "Vaccine" and whatever this abomination they're pushing is called? 

[LegalAmerican]

Does the article say how many deaths and injuries were sustained with Shingrix?  And what is GBS?

Are we confusing "Vaccine" and whatever this abomination they're pushing is called?

Doctor: Hydras and Parasites in Vaxx, Transfecting Humans Into New Species

Stew Peters Show  Published  October 27, 2021
https://rumble.com/vobn23-doctor-hydras-and-parasites-in-vaxx-transfecting-humans-into-new-species.html

[Hoodat]

If only someone could have warned us about this 18 months ago.  Oh wait  .  .  .

[LegalAmerican]

Actual bioweapon. Take what you want, leave the rest.  Hydrocloraquine  sp? is said to kill HIV virus in jab. No wonder NWO does not want people to use it.

https://www.bitchute.com/video/87Um7fBMJTRi/

[PeteS in CA]

Doctor: Hydras and Parasites in Vaxx, Transfecting Humans Into New Species

Stew Peters Show  Published  October 27, 2021
https://rumble.com/vobn23-doctor-hydras-and-parasites-in-vaxx-transfecting-humans-into-new-species.html

Actual bioweapon. Take what you want, leave the rest.  Hydrocloraquine  sp? is said to kill HIV virus in jab. No wonder NWO does not want people to use it.

https://www.bitchute.com/video/87Um7fBMJTRi/

The claims are ridiculous