Does the FDA think these data justify the first full approval of a covid-19 vaccine? – The BMJ Opinion

August 23, 2021

The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi.

But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data. (The preprint reports “decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports,” but provides no data tables showing the frequency of these, or other, adverse events.)

Iraeli Ministry has Pfizer at 17% efficacy and is already reporting booster failures.  Mayo Clinic has Pfizer at 42% protection among Rochester MN patients.  Should be NO approval based on failed efficacy and clearly off the market for poor safety.

https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/

Truckers Closing Down Australia?

The truck drivers of Australia are planning to shut down the country over covid mandates… They are telling you to stock up on food for a couple of weeks . Interesting. Let’s see how this plays out.

https://twitter.com/gillianmckeith/status/1429456942569857026?s=10

https://healthimpactnews.com/2021/australian-truckers-warn-citizens-to-stock-up-on-food-as-they-prepare-to-take-over-the-country-by-shutting-down-the-supply-chain/

Warnings of FDA COVID-19 vaccine approval shortcuts

In the letter, Mr. Johnson outlined some of the data from VAERS, which tallies adverse effects in people who get shots, though the shots have not been shown as the cause of the adverse effects:

• As of Aug. 20, 12,791 worldwide deaths over an eight-month period have been associated with the three COVID-19 vaccines.

• Of the deaths, 4,632, or 36.2%, occurred within two days of the vaccination.

• A total of 571,831 adverse effects were reported, including 51,242 hospitalizations and 16,044 permanent disabilities.

Mr. Johnson noted that the 12,791 deaths eclipse the 8,966 deaths related to all other vaccines reported on VAERS since its creation 31 years ago.

[…] He said the lack of transparency in the approval process was a disservice to Americans who have already suffered through the pandemic.

https://m.washingtontimes.com/news/2021/aug/22/ron-johnson-warns-fda-covid-19-vaccine-approval-sh/

This issue increasingly defines the times – LeoHohmann.com

Look at the sampling of warnings below that indicated the world’s first-ever coronavirus “vaccine” would end in failure:

  • “Intriguingly, recent data from England and Wales (February 2021) show the accumulation of E484K in the B.1.1.7 background, suggesting a selection of this mutation in the response to the vaccination program.”— Viruses, May 2021
  • “More recently starting in March 2021, B.1.1.7 has become the predominant lineage in the United States, with an extremely rapid increase across the country, coinciding with a major vaccination effort.” “These 2 lineages [B.1.351 and P.1] also had a worrisome mutation, E484K, that has been shown to enhance the escape of neutralizing antibodies in vitro and may be linked to lower efficacy for vaccines.”— JPIDS, August 2021
  • “These results show that SARS-CoV-2 can mutate its spike proteins to evade antibodies, and that these mutations are already present in some virus mutants circulating in the human population. This suggests that any vaccines that are deployed on a large scale should be designed to activate the strongest possible immune response against more than one target region on the spike protein.” â€” eLifeJuly 2020 (pre-vaccine rollout)
  • “Mutationally, this virus is going in a direction that could ultimately lead to escape from our current therapeutic and prophylactic interventions that are directed against the viral spike protein. If the rampant spread of the virus continues and more critical mutations accumulate, then we may be condemned to chasing after the evolving SARS-CoV-2 continually, …”— Nature, May 2021
  • “E484K, K417N, and N501Y cause widespread escape from monoclonal antibodies”— Cell, April 2021
  • “Cross-neutralization of strains with receptor-binding domain (RBD) mutations is poor” “Both RBD and non-RBD mutations mediate escape from vaccine-induced humoral immunity” …”We find that although neutralization is largely preserved against many variants, those containing the K417N/T, E484K, and N501Y RBD mutations, namely, P.1 and B.1.351 variants, have significantly decreased neutralization even in fully vaccinated individuals.”— Cell, April 2021
  • “Our data suggest that vaccine escape by the virus of current spike-directed vaccines designed against the Wuhan-1 strain will be inevitable, particularly given that E484K is emerging independently and recurrently on a B.1.1.7 (501Y.V1) background, and given the rapid global spread of B.1.1.7. Other major variants with E484K such as 501Y.V2 and V3 are also spreading regionally.”— Nature, May 2021

Even the CDC admitted these vaccines have failed to stop people from getting sick when its director, Rochelle Walensky, told NBC News Today that a booster shot will be needed this fall. In less than six months after people received the first two shots, they will need another. The goal posts will continue to be moved and they will need another, then another, then another.

For millions of Americans, the definition of “fully vaccinated” is about to change and they will once again be on the outside looking in, going from clean to unclean as declared by a corrupt medical bureaucracy in the pockets of Big Pharma.

https://leohohmann.com/2021/08/22/trump-the-populist-is-losing-his-base-over-this-one-issue-that-increasingly-defines-the-times/

Scientists Don’t Have Answers – Bloomberg

Anecdotes tell us what the data can’t: Vaccinated people appear to be getting the coronavirus at a surprisingly high rate. But exactly how often isn’t clear, nor is it certain how likely they are to spread the virus to others. 

https://www.bloomberg.com/news/articles/2021-08-21/science-can-t-keep-up-with-virus-creating-worry-for-vaccinated

What is everyone dying from?
What is the Delta variant?
What about Covid antibodies?

Before we view Dr. Sam’s presentation on her new book, here is an informative video on Germ Theory VS Terrain Theory. https://seed163.bitchute.com/dfphN1OrEQzj/3DepkMD0v20N.mp4

New Zealand’s Dr. Sam offers answers with references (Scroll to bottom)

Please listen to this 3 times- just to be certain you really heard what you thought you heard. Then study her reference at the bottom of this post.

New Book, Virus Mania Paperback:

Day 141 of Year 7 Low-SOS Vegan Plan

EXERCISE:
* Stood perfectly still 2.5 hours (yes, that’s exercise!)

WATER:
(3) × (25) = 75 oz

EATS:
* oatmeal w/ berries, almonds & oatmilk
* bbq chik’n nuggets (soy & wheat)
* Trader Joe’s veggie (cabbage & carrots) wrap w/ hummus
* gorilla salad w/ avocado toast

*** SUN HAS SET ***

Cmmt: XL indicates uncommon extravagantly luscious food