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

On 28 July 2021, 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 (13 March 2021) as the 1 April 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 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 time “flu season” arrives some months later. If vaccine efficacy wanes over time, the crucial question becomes what level of effectiveness will the vaccine provide when a person is actually exposed to the virus? Unlike covid vaccines, influenza vaccine performance has always been judged over a full season, not a couple months.

And so the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.

Now Israel, which almost exclusively used Pfizer vaccine, has begun administering a third “booster” dose to all adults over 40. And starting 20 September 2021, the US plans to follow suit for all “fully vaccinated” adults eight months past their second dose.

Delta may not be responsible

Enter Pfizer’s preprint. As an RCT reporting “up to six months of follow-up,” it is notable that evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off.  

“From its peak post-dose 2,” the study authors write, “observed VE [vaccine efficacy] declined.” From 96% to 90% (from two months to

But although this additional information was available to Pfizer in April, it was not published until the end of July.

And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off.

Waning efficacy has the potential to be far more than a minor inconvenience; it can dramatically change the risk-benefit calculus. And whatever its cause—intrinsic properties of the vaccine, the circulation of new variants, some combination of the two, or something else—the bottom line is that vaccines need to be effective.

Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.  

The “six month” preprint based on the 7% of trial participants who remained blinded at six months

The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months (see footnote).

This all happened because starting last December, Pfizer allowed all trial participants to be formally unblinded, and placebo recipients to get vaccinated. By 13 March 2021 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded, officially entering “open-label followup.” (Ditto for Moderna: by mid April, 98% of placebo recipients had been vaccinated.)

Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

It is hard to imagine that the <10% of trial participants who remained blinded at six months (which presumably further dwindled after 13 March 2021) could constitute a reliable or valid sample to produce further findings. And the preprint does not report any demographic comparisons to justify future analyses.

Severe disease

With the US awash in news about rising cases of the Delta variant, including among the “fully vaccinated,” the vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message. Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero covid-19 deaths occurred.

In the preprint, high efficacy against “severe covid-19” is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 “severe covid-19” cases were not admitted to hospital; Table S14).

And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).

The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease. Unfortunately, Pfizer’s new preprint does not report the results in a way that allows for evaluating this question.

Approval imminent without data transparency, or even an advisory committee meeting?

Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines without compromising on the science. A “full approval” could remain a high bar.

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.)

It’s not helping matters that FDA now says it won’t convene its advisory committee to discuss the data ahead of approving Pfizer’s vaccine. (Last August, to address vaccine hesitancy, the agency had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.”)

Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.

I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

Peter Doshi, senior editor, The BMJ.

Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.

Provenance: commissioned; externally peer-reviewed.

Footnote: Calculations in this article are as follows. “About 1 month” past month 4 is based on the final row of Fig 2 in the preprint: 1030/12670*12 = 0.98 months (vaccine group) and 895/11802*12 = 0.91 months (placebo group). “53%” is based on Fig 2: (12670+11802)/(23040+23037). “4.4 months” is based on the average of 8412/22505*12 = 4.5 (vaccine) and 8124/22434*12 = 4.3 (placebo) in Fig 2.

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

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https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/?utm_source=salsa&eType=EmailBlastContent&eId=f34e5fbf-195c-4ff7-b4db-8f5b98964da7&fbclid=IwAR2r4Q19x-SoB0DoWz5HNnp9QhQiUjSyPBdLKkNuMn1zRlog2cknJxeNSQo

Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.

Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine.

The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.

But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.

First, the FDA acknowledges that while Pfizer has insufficient stocks of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — available for use.

The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.

Second, the FDA pointed out that both the licensed Pfizer Comirnaty vaccine, and the existing vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

There is a huge real-world difference between products under an EUA compared with those that FDA has fully licensed. EUA products are experimental under U.S. law.

Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.

U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.

EUA-licensed vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.

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https://childrenshealthdefense.org/defender/peter-doshi-fda-data-approval-covid-vaccine/?utm_source=salsa&eType=EmailBlastContent&eId=62651064-d048-4c3f-8cf5-bbe1920c707e

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

The U.S. Food and Drug Administration should have demanded adequate, controlled studies with long-term follow up, and made data publicly available, before granting full approval to COVID-19 vaccines, says BMJ Associate editor Peter Doshi.

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On Tuesday, Dr. Robert Malone, the inventor of mRNA vaccine technology, appeared on Bannon’s War Room to explain the Covid vaccine’s FDA “approval status.”

According to Dr. Malone, the Pfizer vaccine looks to be incompletely approved, and they were only granted an extension under the Emergency Use Authorization (EUA), which provides them with full liability protection.

Join The True Defender Telegram Chanel Here: https://t.me/TheTrueDefender

The FDA has approved a Biologics License Application (BLA) for the Comirnaty vaccine, which is “substantially similar but not necessarily identical” and has not yet been developed.

“It’s [Comirnaty] not available at all. So, the little trick they’ve pulled here is that they’ve sent out two separate letters.

On Tuesday, Dr. Robert Malone, the inventor of mRNA vaccine technology, appeared on Bannon’s War Room to explain the Covid vaccine’s FDA “approval status.”

According to Dr. Malone, the Pfizer vaccine looks to be incompletely approved, and they were only granted an extension under the Emergency Use Authorization (EUA), which provides them with full liability protection.

The FDA has approved a Biologics License Application (BLA) for the Comirnaty vaccine, which is “substantially similar but not necessarily identical” and has not yet been developed.

“It’s [Comirnaty] not available at all. So, the little trick they’ve pulled here is that they’ve sent out two separate letters.

The FDA put out two letters about the two vaccines, confusing the public and participating in the manipulation of the fake-news media.

Rather than awarding full approval to both, Pfizer is extending the EUA so that Pfizer’s vaccine can be administered when Comirnaty vaccine supply is “restricted or non-existent.”

https://thetruedefender.com/fully-approved-you-might-wonder-the-fda-approval-letter-for-a-pfizer-vaccine-raises-questions-is-it-just-an-extension-of-the-eua-dr-malone-appearance-in-bannons-war-r/

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Two important facts about EUA drugs and vaccines   

We know there are some important differences between EUA drugs and vaccines, and fully licensed drugs or vaccines.

We also know these two facts about EUA products:

1. EUA vaccines are designated as experimental or investigational products under U.S. law. As such, they cannot be mandated. You have the right to refuse, without suffering consequences.
2. EUA vaccines have a huge liability shield that protects everyone involved with the product from being sued. If you are injured by an EUA vaccine, the only way to obtain compensation for damages is to apply to the Countermeasures Injury Compensation Program (CICP), which might cover unpaid medical expenses and lost wages only. However, only 3% of claims made have been compensated, and so far the program has approved no claims for COVID vaccine injuries.

Some say the CICP, which is run through the U.S. Department of Health and Human Service and does not give petitioners the right to a judge or jury, withholds due process from injured Americans.

Yet this is the only pathway by which an injured party can seek help after receiving an EUA vaccine or drug.

It’s right there in the fact sheet — FDA says it’s ‘your choice’

Legally, in order to mandate a vaccine, the vaccine must be fully approved. However, once a vaccine for use in adults moves from an EUA product to a licensed everyday product, it loses its liability shield.

We believe it is likely the FDA was instructed to find a way to both license the Pfizer vaccine — so mandates would be legally supported — while also retaining the vaccine’s liability shield.

The FDA could not find a way to do this under existing law. So instead, as we reported Aug. 24 in The Defender, the agency chose to create confusion regarding the legal status of the two Pfizer-BioNTech vaccines. In a document we discuss here for the first time — the fact sheet required to be given to recipients of either the Comirnaty or Pfizer-BioNTech COVID vaccine — the FDA acknowledges the facts we have just presented.

But the FDA also has added something new — the final sentence of the fact sheet states:

“This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.”

According to this fact sheet, the FDA also has designated the licensed Comirnaty vaccine as an EUA product. By doing so, the FDA has guaranteed the Comirnaty vaccine the same liability shield as the EUA Pfizer-BioNTech vaccine.

However, that means the Comirnaty vaccine cannot be mandated. The FDA admits this in the fact sheet, where it states:

“WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE?

“Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.”

The fact sheet is FDA’s admission, buried in the fine print, that no one can currently be mandated to receive any COVID vaccine in the U.S., as all remain under the EUA.

This fact sheet for vaccine recipients is key to avoid being forced to accept an experimental vaccine.

We suggest you print it out, highlight the relevant passages and present it to anyone who tries to force vaccinations on employees.

https://childrenshealthdefense.org/defender/no-one-can-force-you-pfizers-comirnaty-vaccine/?utm_source=salsa&eType=EmailBlastContent&eId=4050fe4d-20c9-40cb-bba6-a999ea641ee3&fbclid=IwAR1Iiiua2h6y9yz3DoJdYpYCARYSou2grMUw2nacQ2wnOR1iP7KbufAngjo

https://www.fda.gov/media/144414/download

Prevod: Meryl Nass, dr. med.: Dve pomembni dejstvi o zdravilih in cepivih z dovoljenjem za uporabo v sili (EUA)

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Prevara FDA pri odobritvi Pfizer cepiva: https://principia-scientific.com/major-law-firm-confirms-fda-deceived-america-with-its-approval-of-pfizer-vax

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Odvetnik Domen Gorenc: V kolikor je bilo  namreč res, da je bilo s cepivom Janssen cepljenih več kot dvesto mladoletnih otrok, smo bili v Republiki Sloveniji s pravnega vidika, po mojem mnenju, v 21. stoletju priča izvajanju poskusov na človeku. Navedeno je seveda izrecno prepovedano tako z 18. členom Ustave RS, Kazenskim zakonikom (KZ-1), Zakonom o pacientovih pravicah, Zakonom o zdravniški službi, Zakonom o zdravilih, Zakonom o zdravstveni dejavnosti, kot seveda tudi s Kodeksom zdravniške etike. Med mednarodnopravnimi akti velja, poleg že večkrat citirane Evropske konvencije o človekovih pravicah in Nürnberškega kodeksa, ki določa absolutno nujnost privolitve v medicinski poskus, na tem mestu izpostaviti predvsem Helsinško deklaracijo in s strani Sveta Evrope izdano Oviedsko konvencijo s protokoli o človekovih pravicah v zvezi z biomedicino.

https://domengorenseklaw.law.blog/2021/10/03/pogoj-cpt-za-vsako-ceno/amp/?__twitter_impression=true&s=03

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Znanstveniki tožijo FDA za podatke, na osnovi katerih so odobrili Pfizer cepivo: 

Dovolj neverjetno je, da je zvezna vlada za milijone Američanov predpisala Pfizerjevo cepivo Covid-19, ko je podjetju Pfizer zagotovila popolno finančno imuniteto za škodo, ki jo je povzročil ta izdelek. Tako ne morete reči ne, ne morete tožiti zaradi škode in ne morete videti podatkov, na katerih temelji trditev vlade, da je izdelek varen in učinkovit. Nekateri bi takšno ravnanje lahko opisali kot avtoritarno. Seveda bi bila takšna trditev verjetno cenzurirana. In cenzura bo seveda vsakomur, ki bo trdil, da je takšno pooblastilo avtoritarno, pomagala razumeti, da se moti.

https://aaronsiri.substack.com/p/scientists-sue-the-fda-for-data-it?fbclid=IwAR01TgBfddTjHWWOSX4YIqFxrnA7CxHC4COSdIbA1uyAQU-qlhbSF6sQLHs

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https://maryannedemasi.com/blog/f/a-credibility-blow-to-pfizer’s-covid-19-vaccine?fbclid=IwAR1S7uB3ZrWkxIdRUISjs1Jff_W5kxZqflcKMBtAVPwg83dfY3ZbV2_ui50

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Uprava za zdravila in hrano (FDA) prosi zveznega sodnika, naj ji odobri popolno objavo Pfizerjevih podatkov o cepivu COVID-19 DO LETA 2076.

Ameriška zvezna vlada ščiti podjetje Pfizer pred odgovornostjo. Podarila mu je milijarde dolarjev. Prisilila je Američane, da jemljejo njihov izdelek. Vendar vam ne dovoli vpogleda v podatke, ki potrjujejo varnost/učinkovitost Pfizer cepiva. Za koga dela vlada?

Agencija FDA je zveznega sodnika zaprosila, naj ji dovoli, da do leta 2076 razkrije vse podatke in informacije, na podlagi katerih je izdala dovoljenje za Pfizerjevo cepivo COVID-19. To ni tiskarska napaka. Želi 55 let, da bi te informacije predložila javnosti.

Kot je bilo pojasnjeno v prejšnjem članku, je FDA večkrat obljubila "popolno preglednost" v zvezi s cepivi COVID-19, vključno s ponovno potrditvijo "zavezanosti FDA k preglednosti" pri izdaji licence za Pfizerjevo cepivo COVID-19.

S to obljubo je avgusta in takoj po odobritvi cepiva več kot 30 akademikov, profesorjev in znanstvenikov z najprestižnejših univerz v tej državi zahtevalo podatke in informacije, ki jih je družba Pfizer predložila agenciji FDA za pridobitev licence za cepivo COVID-19.

Odgovor FDA? Ničesar ni pripravila. Zato je moje podjetje septembra v imenu te skupine vložilo tožbo proti FDA in zahtevalo te informacije. Do danes, skoraj tri mesece po izdaji licence za Pfizerjevo cepivo, FDA še vedno ni izdala niti ene strani. Niti ene.

Namesto tega je FDA pred dvema dnevoma zaprosila zveznega sodnika, naj ji do leta 2076 omogoči, da v celoti predloži te informacije. FDA je sodnika prosila, naj ji dovoli, da več kot 329 000 strani dokumentov, ki jih je Pfizer predložil FDA za pridobitev licence za cepivo, pripravi po 500 strani na mesec, kar pomeni, da jih ne bo pripravila prej kot leta 2076. Obljuba agencije FDA o preglednosti je, milo rečeno, kup iluzij.

Od trenutka, ko je družba Pfizer začela pripravljati dokumentacijo za izdajo dovoljenja (7. maja 2021), do trenutka, ko je agencija FDA izdala dovoljenje za Pfizerjevo cepivo (23. avgusta 2021), je minilo natanko 108 dni. Če je agencija FDA verjela svojim besedam, je opravila intenziven, temeljit, temeljit in popoln pregled in analizo teh dokumentov, da bi zagotovila, da je cepivo Pfizer varno in učinkovito za izdajo licence. Medtem ko lahko ta intenzivni pregled Pfizerjevih dokumentov opravi v 108 dneh, zdaj zahteva več kot 20.000 dni, da te dokumente da na voljo javnosti.

Torej, razjasnimo si to. Zvezna vlada ščiti podjetje Pfizer pred odgovornostjo. Daje mu milijarde dolarjev. Prisili Američane, da jemljejo njegov izdelek. Vendar vam ne dovoli vpogleda v podatke, ki potrjujejo varnost in učinkovitost njenega izdelka. Za koga dela vlada?

Ponovno se je treba naučiti, da državljanske in individualne pravice nikoli ne smejo biti odvisne od medicinskega postopka. Vsakdo, ki se želi cepiti in cepiti, mora imeti pravico, da to stori. Vendar pa vlada ne sme nikogar prisiliti, da se udeleži kakršnegakoli medicinskega postopka. Nikakor pa ne takega, pri katerem želi vlada do leta 2076 skriti vse informacije, ki so podlaga za izdajo dovoljenja!

https://aaronsiri.substack.com/p/fda-asks-federal-judge-to-grant-it?s=09

Združenje strokovnjakov za javno zdravje, zdravstvenih delavcev, znanstvenikov in novinarjev, PHMPT, je štiri dni po tem, ko je bilo cepivo Pfizer odobreno za starost 16+, FDA-ju oddalo zahtevo na podlagi njihovega Zakona o svobodi obveščanja za vse podatke v Pfizerjevi datoteki bioloških izdelkov za cepivo proti COVID-19. Zdaj tožijo FDA, ker podatkov ni posredovala PHMPT-ju po hitrem postopku. S tempom, s katerim bi pridobivali podatke, bi za vse trajalo 55 let. Več o tem tu: https://zvezdanestaze.com/fda-trazi-od-suda-55-godina-da-u-potpunosti-objavi-podatke-o-bockiprotiv-c-19-kompanije-pfizer?fbclid=IwAR1-Dz5Ga1NrFeWdPhk1xap6uIoGiAgv0xKC7DfmupzWb7D7dgDlNDoq638

Dokumenti se bodo pa sproti objavljali na

https://phmpt.org/

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https://www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18/?utm_campaign=trueAnthem%3A%20Trending%20Content&utm_medium=trueAnthem&utm_source=facebook&fbclid=IwAR2ILILGhYGgfTAdsBeXVJQt0VQHVSah6kirvTl9Nqa4FAumqRq1K0bNwn0

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Novozelandski epidemiolog Simon Thornley je analiziral 6-mesečne podatke o varnosti in učinkovitosti iz Pfizerjeve študije o cepivu za Covid-19. 

Povzetek:

- Študijska skupina s cepivom: 21 smrtnih primerov 

- Študijska skupina s placebom: 15 smrtnih primerov 

https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full

https://maryannedemasi.com/publications/f/are-adverse-events-in-covid-19-vaccine-trials-under-reported?fbclid=IwAR0Ih_JMwbQZ9PXJShBFmVBcyFprIGNuzJM38Hw0gNBDjb3KnZY4bbb44-4

https://www.nakedcapitalism.com/2021/08/sloppy-pfizer-booster-clinical-trial-consent-form-provides-way-to-exclude-reactions-that-require-emergency-care.html

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https://zadardanas.com/2021/11/markotic-priznala-pokuse-na-djeci-pupic-trazi-uhicenje/?fbclid=IwAR3HzZGDp3RFiFV-g2oY2PrJXjyvDIRpAQmz9pJuCXHr2FWwI5gHYGtwttc

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Odvetnik Mirnez Ajanovič: c-19 cepiva v Bosni nimajo dovoljenja za promet- niso registrirana: https://www.facebook.com/BOSSBiH/videos/307482267935419/?extid=NS-UNK-UNK-UNK-AN_GK0T-GK1C

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Dvom v Pfizer podatke o testiranju: https://maryannedemasi.com/publications/f/experts-weigh-in-after-suing-fda-for-access-to-pfizer-trial-data?fbclid=IwAR1bGFbkVg5_YliyURo8O7HTml6VV_zayjn4bS_8s0LWAtD_Xk87YjH8nIQ

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Dvom v podatke testiranja: https://worldcouncilforhealth.org/multimedia/deanna-mcleod-evidence-analysis-pfizer/

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Podaljšali klinično spremljanje do 2024

https://www.ema.europa.eu/en?fbclid=IwAR3sk-qeUNz68-JVu05iraPT_b7Stg5aRLWMAWaTrAQuC2tZQx7hg2YmeOY

Comirnaty, INN-COVID-19 mRNA Vaccine (nucleoside-modified) 

https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_sl.pdf?fbclid=IwAR0MO0m-bh_IaZumR_U4UhGH_rY2WpikCIHqGKx2i1tI2OSsyGnYigwYKRw

Comirnaty, da zaključijo primarno serijo cepljenja, cepivo Comirnaty pa naj ... Za navodila glede odtaljevanja, rokovanja in odstranjevanja cepiva glejte ...

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že v uradnem listu iz 30.12.2020 (lani!) so objavili, da ukrepi cepljenja veljajo do decembra 2023 ‼️Kako so 2020 vedeli, da bo korona trajala do konca 2023? In to z eksperiumentalnim cepivom!!

(5) Zagotavljanje podatkov o izvedenem cepljenju in morebitnih neželenih učinkih cepljenja in evidentiranje v skladu z metodološkimi navodili NIJZ, objavljenimi na spletni strani NIJZ, je za izvajalce cepljenja obvezno. Do povračila stroškov so upravičeni le izvajalci zdravstvene dejavnosti, ki podatke evidentirajo v skladu z navedenimi navodili NIJZ ter sproti posredujejo zapise o cepljenju in morebitnih neželenih učinkih cepljenja v CRPP in zbirko Register obveznikov za cepljenje in izvajanja cepljenja iz zakona, ki ureja zbirke podatkov s področja zdravstvenega varstva.

(6) Ukrep cepljenja proti COVID-19 velja do 31. decembra 2023