Kas ražo un maksā, tas pasūta mūziku jeb kā “Pfizer” vakcīna pārstāja būt eksperimentāla

FDA apstiprina Pfizer “Comirnaty”. Cik objektīvi?

Visi pasaules un Latvijas mediji steidz paziņot, ka FDA beidzot ir izdevis pilnu autorizāciju “Comirnaty” preparātam.

Svarīgi pieminēt: FDA norāda, ka “Pfizer” preparāts ir apstiprināts lietošanai tikai no 16 gadiem!

Šim preparātam joprojām ir piemērojama ārkārtas lietošanas atļauja bērniem no 12-15 gadiem.

Avots: twitter.com/udumpis

Bet vai pieņemtais lēmums ir objektīvs? Kādēļ FDA nenorāda visus konkrētos klīniskos pētījumus, uz kuri pamata tikai apstiprināts šis preparāts? Vai tas ir tas pats klīniskais pētījums, kuru sponsorē pats ražotājs “BioNTech SE”? Vai tādā gadījumā klīniskā pētījuma iznākums var būt objektīvs, ja informāciju FDA nodrošina pats preparāta ražotājs “BioNTech SE”?

Avots: clinicaltrials.gov

Turpat tālāk klīniskā pētījuma tekstā norādīts, ka placebo grupa varēs saņemt  “Pfizer” injekciju kādā noteiktā klīniskā pētījuma fāzē! Vai to sauc par objektīvu pētījumu? Vai šādā veidā tiek izlīdzināta blakusparādību līkne starp injekciju saņēmušajiem un placebo grupu?

Avots: clinicaltrials.gov

Turpat zemāk: Placebo saņēmēju vakcinācija ar BNT162b2 – 1. posms.

Dalībniekiem vecumā no 16 gadiem, kuri sākotnēji saņēma placebo un ir tiesīgi vakcinēties pret Covid-19, ievērojot visus vietējos vai valstiskos ieteikumus, pētījuma ietvaros tiks piedāvāta iespēja saņemt BNT162b2.

Avots: clinicaltrials.gov

FDA ziņojumā rakstīts: ““Mūsu zinātnieki un medicīnas eksperti veica neticami rūpīgu un pārdomātu šīs vakcīnas novērtējumu. Mēs izvērtējām zinātniskos datus un informāciju, kas ietverta simtiem tūkstošu lappušu garumā, paši veicām “Comirnaty” drošības un efektivitātes analīzi, kā arī detalizēti novērtējām ražošanas procesus, ieskaitot ražošanas iekārtu pārbaudes,” sacīja Pīters Marks, MD, Ph. D., FDA Bioloģijas novērtēšanas un pētījumu centra direktors.”

Rodas vairāki jautājumi:

Kādēļ nav norādīts šo klīnisko pētījumu un zinātnisko datu saraksts?

Kādēļ sabiedrībai nav pieejami viņu veiktās “Comirnaty” drošības un efektivitātes analīzes rezultāti? Vai sabiedrībai ir jātic uz “vārda”?

Kur paliek iespēja veikt “fact check” minētajai informācijai?

Avots: www.fda.gov

Šeit ir pieejams FDA dokuments “Regulatīvās darbības kopsavilkums – “Comirnaty””, kurā paveras daudz neparastu lietu. Pirmkārt, liels informācijas daudzums ir “aizkrāsots” ar pelēkas krāsas blokiem.

Avots: www.fda.gov

Otrkārt, norādīti daži klīniskie pētījumi, kuri ņemti par pamatu šī preparāta apstiprināšanai. Pirmajā klīniskajā pētījumā Placebo grupa saņēma fizioloģisko šķīdumu vai “Comirnaty” preparātu! Otrajā klīniskajā pētījumā vispār nebija Placebo grupas, lai varētu salīdzināt preparāta drošumu un efektivitāti.

Avots: www.fda.gov

Turpat tālāk tiek norādīts, ka joprojām turpinās C4591001 klīniskais pētījums!

Avots: www.fda.gov

Skatīt “Pfizer” klīniskā pētījuma protokolu šeit. Arī šī pētījuma sponsors ir pats ražotājs jeb “BioNTech”.

Kāda objektivitāte ir iespējama, ja pētījuma sponsors ir ražotājs un Placebo grupā tiek izmantots arī eksperimentālais preparāts?

Avots: cdn.pfizer.com/

Tālāk FDA dokumentā “Regulatīvās darbības kopsavilkums – “Comirnaty””, norādīts: “No 1. devas līdz 2021. gada 13. marta datu pārtraukšanas datumam kopumā bija 38 nāves gadījumi, 21 “Comirnaty” grupā un 17 placebo grupā. Neviens no nāves gadījumiem netika saistīts ar vakcināciju.

Avots: www.fda.gov

FDA piešķīra šim pieteikumam prioritātes pārskatu. Apstiprinājums tika piešķirts uzņēmumam BioNTech Manufacturing GmbH.”

Prioritārās pārskatīšanas apzīmējums nozīmē, ka FDA mērķis ir rīkoties saistībā ar pieteikumu 6 mēnešu laikā (salīdzinot ar 10 mēnešiem standarta pārskatīšanas laikā).

Ievērojamu uzlabojumu var pierādīt ar šādiem piemēriem:

  • pierādījumi par paaugstinātu efektivitāti ārstēšanā, profilaksē vai stāvokļa diagnostikā;
  • ārstēšanu ierobežojošas zāļu reakcijas likvidēšana vai būtiska samazināšana;
  • dokumentēta pacientu atbilstības uzlabošana, kas, domājams, uzlabos nopietnus rezultātus; vai
  • pierādījumi par drošumu un efektivitāti jaunā apakšpopulācijā.
Avots: www.fda.gov

Tā ir teorija, bet kāda ir realitāte?

Kā norādīts EudraVigilance (Eiropas datubāze par iespējamajām zāļu blakusparādībām), Eiropā kopā saņemti 370 390 ziņojumi par blaknēm (dati līdz 21.08.2021) pēc “Pfizer” Covid preparāta injicēšanas.

Avots: www.adrreports.eu
(COVID-19 MRNA VACCINE PFIZER-BIONTECH (TOZINAMERAN))

Savukārt, VAERS (ASV blakņu ziņošanas sistēma, kurā parādās tikai 1-10% ziņojumu), norādīts, ka jau ir iesniegti 13 068 ziņojumi par nāvi pēc Covid injekcijas (dati līdz 13.08.2021.).

Avots: ​​www.medalerts.org

Citā VAERS tabulā norādīts, ka ir iesniegti 4698 ziņojumi par nāvi pēc Covid injekcijas 0 – 2 dienu laikā pēc tās saņemšanas!

Uzmanības vērta informācija: šie eksperimentālie preparāti tiek injicēti arī bērniem zem 3 gadu vecuma!

VecumsSkaitsProcentuāli
<3 gadi30.06%
12 – 17 gadi20.04%
17 – 44 gadi1543.28%
44 – 65 gadi58412.43%
65 – 75 gadi67214.3%
75+185439.46%
Nezināms vecums142930.42%
KOPĀ4698100%
Avots: www.medalerts.org

Vai visi minētie ziņojumi par blakusparādībām pēc šī preparāta netika ņemti vērā? Vai tie neskaitās kā pierādījumi, ka šis preparāts nav līdz galam pārbaudīts un drošs?

Kopumā VAERS iesniegti (dati līdz 13.08.2021.) 595 622 ziņojumi par blakusparādībām pēc Covid injekcijām!

Avots: www.medalerts.org

Par ziņotajām blakusparādībām pēc Covid injekcijām lasiet šeit: 3. Covid mīts “Saņemot Covid-19 preparātu, būtiskas blakusparādības novērojamas ārkartīgi retos gadījumos”

Avots: www.vakcinrealitate.org

Ja preparāta sākotnējais mērķis bija pārtraukt vīrusa izplatību un pasargāt vakcinētos no saslimšanas, tad tagad pieejama informācija, ka šie Covid-19 preparāti neiedarbojas tā, kā tas ticis iecerēts.

Turklāt FDA pēc “Pfizer-BioNTech” COVID-19 vakcīnas ievadīšanas veica stingru pēcreģistrācijas drošības uzraudzības datu novērtējumu, kas attiecas uz miokardītu un perikardītu, un ir noteikusi, ka dati liecina par paaugstinātu risku, īpaši septiņu dienu laikā pēc otrās devas. Novērotais risks ir augstāks vīriešiem līdz 40 gadu vecumam, salīdzinot ar sievietēm un vecākiem vīriešiem. Novērotais risks ir visaugstākais vīriešiem vecumā no 12 līdz 17 gadiem. Pieejamie dati no īslaicīgās novērošanas liecina, ka lielākajai daļai cilvēku simptomi ir izzuduši. Tomēr dažiem cilvēkiem bija nepieciešams intensīvās terapijas atbalsts. Vēl nav pieejama informācija par iespējamiem ilgtermiņa veselības rezultātiem. Uzņēmuma izrakstīšanas informācija ietver brīdinājumu par šiem riskiem.”

FDA dokumentā “Regulatīvās darbības kopsavilkums – “Comirnaty”” minēts, ka miokardīts un perikardīts ir oficiāli atzīta blaknes pēc “Comirnaty”, un šī informācija tika iekļauta lietošanas instrukcijā.

Avots: www.fda.gov

Neskatoties uz šādiem riskiem, FDA tik un tā apstiprinājis šo preparātu? Kāda ir tā preparāta iedarbība ilgtermiņā pēc pārdzīvotā miokardīta jauniešiem vecumā no 12 – 17 gadiem?

Avots: www.fda.gov/

Vai ziņojumi par vismaz dažiem nāves gadījumiem jauniešu vidū nav jāizskata kā nopietns brīdinājums par šī preparāta bīstamību konkrētai vecuma grupai?

VAERS ziņojums 124573: 15 gadus vecs puisis mirst pēc sirdstriekas divas dienas pēc “Pfizer” preparāta saņemšanas.

Avots: www.medalerts.org

VAERS ziņojums 1225942: 16 gadus veca jauniete mirst no sirdstriekas 10 dienas vēlāk pēc “Pfizer” injekcijas saņemšanas.

Avots: www.medalerts.org

Covid preparātus injicē ne tikai jauniešiem, bet arī grūtniecēm un barojošām māmiņām. VAERS ir pieejama statistika, cik procentuāli problēmas ar grūtniecību rodas pēc Covid injekcijām un citām tā dēvētajām klasiskajām vakcīnām.

Kā norādīts tabulāpēc Covid injekcijas iesniegti 4832 ziņojumi t.i. 105,46% (Tā kā dažos gadījumos ir vairākas vakcinācijas un simptomi, viens gadījums var ietvert vairākus ierakstus šajā tabulā. Šī iemesla dēļ kopējais skaits ir lielāks par 4582 (konstatēto gadījumu skaits) un kopējais procents ir lielāks par 100, salīdzinot ar citām vakcīnām, kur rādītāji ir no 0,02 – 0,04%.

Avots: www.medalerts.org

Viens no pamatojumiem šī preparāta autorizācijai ir tāds, ka nav pieejamas citas alternatīvas un apstiprinātas Covid ārstēšanas metodes.

Avots: www.fda.gov

Šo pašu norāda arī Latvijas Zinātņu akadēmija. “Vakcīnrealitāte” komanda ir izpētījusi šo jautājumu, secinot, ka informācija ir nepatiesa. Pieejamas daudz un dažādas ārstēšanas metodes, kas veiksmīgi ārstē Covid-19. Par to lasiet šeit.

Avots: www.vakcinrealitate.org

Runājot par vakcīnas efektivitāti

CDC mājaslapā norādīts, ka pat pilnībā vakcinēts cilvēks, saslimstot ar Delta paveidu, var inficēt citus.

Cilvēki ar novājinātu imūnsistēmu var nebūt pasargāti no saslimšanas pat, ja ir pilnībā vakcinēti.

Vakcinētiem cilvēkiem joprojām ir jānēsā maskas iekštelpās.

Ieceļojot no citām valstīm ir jāveic tests, lai iekļūtu ASV.

Avots: www.cdc.gov

5. Covid mītā “Covid-19 injekciju aizsardzības ilgums ir izpētīts” uzsvērts, ka pat Eiropas Medicīnas aģentūras mājaslapā tiek teikts, ka nav zināms šo preparātu sniegtais aizsardzības ilgums.

Avots: www.ema.europa.eu

Nav zinātniski apstiprināts, ka šis preparāts novērš vīrusa transmisiju!

Avots: www.ema.europa.eu

Jaunākais britu pētījums – ir cilvēki, kuriem pēc vakcinācijas antivielu nav vispār! Līdz ar to viņi var gan saslimt, gan pārnēsāt vīrusu un inficēt citus.

Avots: papers.ssrn.com

Pētījuma autori uzsver: “No tā izriet, ka aptuveni 11% pacientu visās slimību grupās nerada antivielas, kas reaģē uz SARS-CoV-2 smailes proteīnu 4 nedēļas pēc divu vakcīnu devu saņemšanas.”

Pētījuma vadītājs, Glāzgovas Universitātes profesors Ians Makkinns bilst: “Lai gan pēc dubultās vakcīnas devas tika konstatēts, ka 40% cilvēku no šīs riska grupas ir zema vai nenosakāma imūnā atbilde, mēs esam pārliecināti, ka šis skaitlis nav lielāks. Ir iespējams, ka arī daļēja aizsardzība var būt ieguvums, un to mēs rūpīgi turpināsim uzraudzīt.”

Tāpat pētījuma autori uzsver, ka cilvēkiem ar pazeminātu imūnsistēmu ir ieteicams saņemt vismaz vēl vienu t.i. trešo devu!

Aizvien biežāk medijos parādās informācija, ka Covid uzliesmojumus visvairāk inficēto ir tieši vakcinēto vidū, piemēram, bēdīgi slavenais Masačūsetsas gadījums. Izraēlā preparāta efektivitāte pret Deltas paveidu ir zem 40%: lasīt šeit.

Svarīga informācija: FDA ir organizācija, kas piedāvā pakalpojumu par attiecīgu samaksu.

Kā secina Džona Hopkinsa Blumberga Sabiedrības veselības skolas: “Saskaņā ar jauno pētījumu, ko veica komanda, kurā piedalījās pētnieki no Džona Hopkinsa Blumberga Sabiedrības veselības skolas, klīniskie pētījumi, kas atbalsta FDA apstiprinājumus jaunām zālēm, vidēji izmaksā 19 miljonus ASV dolāru.”

Avots: publichealth.jhu.edu

FDA mājaslapā norādīta sekojoša informācija:

2021. un 2022. fiskālā gada lietotāju maksa:

Lietotāja maksājuma veids20212022
Maksa par pieteikšanos – nepieciešami klīniskie dati$2,875,842$3,117,218
Maksa par pieteikšanos – nav nepieciešami klīniskie dati$1,437,921$1,558,609
Programmas maksa$336,432$369,413
Avots: www.fda.gov

Informācijai:

FDA paziņojums par preparāta autorizāciju: šeit.

FDA vēstule par preparāta autorizāciju: šeit.

FDA lapa par “Comirnaty” preparātu: šeit.

FDA: jautājumi un atbildes par “Pfizer” preparātu: šeit.

FDA dokumentā “Regulatīvās darbības kopsavilkums – “Comirnaty””: šeit.

“Comirnaty” lietošanas instrukcija angļu valodā: šeit

Faktu lapa par “Comirnaty” veselības aprūpes speciālistiem: šeit.

ES klīnisko pētījumu reģistrs: C4591001 klīniskais pētījums: šeit.

ClinicalTrials.gov: NCT04368728 klīniskais pētījums: šeit.

VAERS tabula par blaknēm pēc Covid injekcijas: šeit.

VAERS tabula ar nāves gadījumiem pēc Covid injekcijas: šeit.

VAERS tabula ar blaknēm grūtniecēm pēc Covid injekcijas: šeit.

VAERS tabula ar nopietnām blaknēm pēc Covid injekcijas un sadalījums pēc vecuma: šeit.

Kas ražo un maksā, tas pasūta mūziku jeb kā “Pfizer” vakcīna pārstāja būt eksperimentāla

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