COVID-19

[Aco Popara Zver]

eo malo konspirasija da nas vrne on topik

One Year Later: How the Biden Admin, Big Tech, and Pfizer Fooled Americans into Taking "FDA Approved" COVID Vaccines that Never Actually Existed

https://www.globalresearch.ca/one-year-later-how-biden-admin-big-tech-pfizer-fooled-americans-into-taking-fda-approved-covid-vaccines-never-actually-existed/5790327

tldr
However, everyone in America was being injected with — and continue to take — the legally distinct emergency use authorization (EUA) version of the shot. The FDA approved Comirnaty shot has never become available to the American public in the United States.

dal je ovo uopšte bitno ili tačno...

[Palmer]

Па добро, не знам што сте овде толико осетљиви на "конспираси" и што верујете слепо науци, кад се зна да пара врти где бургија не врти и спенкује науку као своју верну бичарку.... Супер је веровати да ФДА и ЕФСА нису корумпиране, али ја сам некако човек сумње...са контактима. Знам доста Хиндуса који су радили у Фајзеру, једног бившег директора, има данас своју мултинационалку, ради суплементе  АПИ-је, дакле у бизнису је и даље више него успешно и даље у контакту са фајзеровцима итд, и сви ти Хиндуси до једног дословно знају шта је Фајзер и како се крију студије..., зна се и да су ЕФСА па и ФДА корумпирана багра. Смернице неке да, апсолутно поверење никако..

[Aco Popara Zver]

https://pandemijskirealizam.net/blog/viak-smrtnosti-u-hrvatskoj

[tomat]

https://rs.n1info.com/posts/moderna-tuzila-fajzer-zbog-vakcina-protiv-kovida

[Meho Krljic]

Dreaded Side Effect Rears Its Ugly Head in Latest COVID Variant

[Meho Krljic]

COVID raises risk of long-term brain injury, large U.S. study finds

[Palmer]

Poslao mi doktor medicine Amerikanac čije kolege su radile u fajzeru. Film se zove "The real Anthony Fauci". Radi i u brauzeru ne mora da se skida:


https://mega.nz/file/glIHmbCC#H94BgBnHnaBoXvkeE4qmMyQ9YUmRqvDdgqk-DGMhMi4

[Aco Popara Zver]

prilično sam glup za ove dokumentarce. Uopšte ne kontam gdje su dva kraja i sredina, izlažu informacije na meni potpuno nejasan, haotičan način. Ima li đe prepričano...

na 55. minutu opet tvrde da je od vakcina pomrlo dosta ljudi... a nema lilit da komentariše

[Palmer]

Pa dobro na kraju krajeva ostaje ti da odabereš da li ćeš da veruješ fajzeru fakt čekerima i fingiranju studija i ekspertize i prikrivanju i kenslovanju istraživanja za Big Farma neoliberale koje im ne idu u prilog ili zdravom razumu gut feelingu, i insajderskim info iz te raspale kompanije. Ja sam odabrao ovo drugo.. Samo zato što sam radio sa farmaceutima, QMS ovima iz GMP- a i čuo kako Big Pharma inspektovanje izgleda iz prve ruke kao i gde se proizvode, a gde se fotkaju i odlučio sam da im ništa ne verujem. Odeš lepo na CPHI gde se skupi sva farm gamad ovog sveta i vidiš na šta su spali. Sve su to neke prskalice, poklopci high tech kontaktne ambalaže, a niđe prevencija..

[tomat]

Jebiga, meni je oslanjanje za zdrav razum i gut feeling kada pričamo o imunologiji kao kad bi rekao da za razumevanje kvantne fizike treba da se osloniš na intuiciju. Problem je što su ljudi koji pokušavaju da razotkriju big farma zaveru i agendu toliko aljkavi i loši, da je tu velika propuštena prilika da se o tome zaista diskutuje.

Pre neki dan naletim na članak koji kaže da je povećan broj miokarditisa kod vakcinisanih, i sad pazi, kaže incidenca ja do 1 u 27 i više, i čovek mu lepo skrene pažnju da je zapravo rekao da miokarditis dobije od nikog do svih. Još koristi parametar koji nije specifičan samo za miokarditis, i time pokušava da dokaže nešto.

[Truba]

ne znam ništa
samo znam da su ljudi koji su 2 godine odbijali cepljenje
LEGENDE i SNAŽNI LJUDI
svaka im čast

[Palmer]

Aljkavi su i jedni i drugi. Stvar je senzibiliteta i izbora. Ja nauci u službi kapitalizma verujem koliko i poštanskom sandučetu u Cirihu na osnovu kog se te iste kompanije pozivaju na švajcarski kvalitet za celu porodicu dok Hindus kapsulira u nekoj garaži na nevalidiranoj mašini bez ikakve elementarne validacije čišćenja održavanja belih soba i poštovanja elementarnih QMS procesa i procedura. A reklama i dalje viče kvalitet, kliničke studije. Svaka čast FDA i GMP inspekcijama sveta, ali što bu reko Duci barabe prijatelju moj..

[Aco Popara Zver]

pa ja sam izabrao da vjerujem lilit, da li će mi se to obiti o glavu će vidimo

poenta mi je bila što upalim dokumentarac i ja ne razumijem šta te osobe govore. Drve o svemu i svačemu od neoliberalne deregulacije zdravstva zadnjih 40 godina do toga šta vakcina izaziva, ali ja bukvalno ne kontam, a trebalo bi nakon desetak minuta, šta je pitanje koje se postavlja, šta se želi reći i dokazati, pa i šta je uopšte rečeno

[Truba]

Prijetili otkazima, obitelj ih odbacivala, kolege izbjegavale, mediji pljuvali, prijetili nemogucnoscu putovanja...ljudi odbijali

Ja vidio idu svi reko i ja cu i otisao na cepljenje
Sutra govna da se meze idu svi i ja bi

[mac]

Najvažnije u celoj priči nije zdravlje jednog pojedinca, nego kompletan ekonomski sistem, od koga je zdravstveni sistem samo jedan deo. Da većina populacije nije primila vakcinu na bolest koja se prvi put javila među ljudima broj mrtvih u svetu, a i kod nas, bi bio veći. Onaj ko smatra da je u redu da ljudi umiru, a da ne moraju, nema zvezdicu u mojoj knjizi.

[tomat]

The needs of the many outweigh the needs of the few

[Aco Popara Zver]

bitno je samo da je glavna priča ovih zavjerenika da neko želi depopulaciju Zemlje. To je besmisleno, kapitalizam bi propao sa smanjenjem stanovništva. Samim tim ubijati ih vakcinama ili virusima uopšte nije cilj kapitalizma, nego da budeš zdrav do minimum 65. godine

[tomat]

Manje ljudi manje prodatih vindouza.

Drugar živi u USA pije lekove za pritisak. Kod njih čim pređe 120/80 računaju hipertenzija tip 1 i lekovi, WHO kaže do 140/90 predhipertenzija, lajfstajl čejndžiz. Kontam ja da oni hoće da stvore konzumente lekova, ali i u tom slučaju što više ljudi i što duže žive više korisnika.

[Aco Popara Zver]

moj deda imao pritisak 150, rekli mu u sfrj da batali meso, jeo poparu i krompir i spustio, poslije živio još 40 godina

ovi nas sad sigurno kljukaju nepotrebnim pilulama, treba profite ostvariti

u stvari, bila bi dobra teorija zavjere da se u njihovim lijekovima ništa ni ne nalazi, da su sve placebo, nego da oni troše pare da naprave otrov, pa to je čak skupo potrovati čovječanstvo s milijardama vakcina

[tomat]

Ne mogu mišići od popare


Ja sam na granici već neko vreme, borio sam se da ne postanem ovisnik, vrtim se oko 140/90 ali će morati holter da radi pa možda i neka medecina.

[Aco Popara Zver]

kad može skubi na sočivu i pasulju (i trt-u) možemo i mi!

ja nizak pritisak, 105-10, 120 da igram od sreće

nego 3 kafe i slano da profunkcionišem, dok jednom ne skoči pa će morati popara

najgore kad tako flegma uđem u teretanu, ništa ne mogu dok ne dignem sistem

[Palmer]

Ja sam se šinuo Astrom upravo jer verujem da će makar kratkoročno smanjiti broj mrtvih, a i jer i dalje želim da verujem medicini, ali i pošto smo prestali na srednji rok da planiramo to je postalo nevažno. Očigledno nam je samo i samo ekonomija postala važna i kako pregurati danas.. i juče. Sutra ko jebe.. A beli krst i "švajcarski kvalitet" sa indijske deponije nam  neće nešto pomoći ako otuđimo sve osnovne resurse voda vazduh i hrana..bitno da se ispune "prodajni targeti"

[Aco Popara Zver]

pa normalno, to i jeste dilema, neke korporacije rade i dobre stvari, a i buljuk loših, pa ostaje pitanje kako nastaviti samo dobre i smanjiti loše. Naravno, odgovor je rušenje neoliberalizma.

[tomat]

kad može skubi na sočivu i pasulju (i trt-u) možemo i mi!

Sad ni toliko, eno slika doručkuje karfiol i paradajz

[Palmer]

pa normalno, to i jeste dilema, neke korporacije rade i dobre stvari, a i buljuk loših, pa ostaje pitanje kako nastaviti samo dobre i smanjiti loše. Naravno, odgovor je rušenje neoliberalizma.

Sve je to okej, samo što praksa uvek zakaže kad teorija kaže svoju poslednju reč. Sve manje parova želi da ima decu, što bi rekli ameri: "All sex is rape" Ono činjenice su tvrdoglave stvari ako vidimo da će botovi polako da preuzimaju dosta ljudskih poslova. Pa trenutno imaš na kripto berzi npr. botove koji kupuju i prodaju tokene  u odgovarajućem tajmingu, što čovek na primer ne može da ispuni. Pranje novca se usavršava i čovek postaje suvišan.  U prevodu, uopšte ne sumnjam da postoji algoritam koji pokazuje manju populaciju nego što jeste, kao i nižu prosečnu godinu smrti kako bi doneo veće bogatstvo za korporatokratiju. U prevodu, veća lična potrošaka korpa (bez dece) i manji trošak za državu ako ljudi ne žive preterano dugo -win-win. Naravno elite će i dalje da žive ko kornjače sa galapagosa po 100-120 god.. Neoliberalni pipci se  umnožavaju svakim danom, i postaju sve  veštiji i nevidljiviji u uzimanju života, duha, zajedništva, ali i novca iz džepa uzgredno.

[Palmer]

BTW, nije topic, ali čuo sam da će Kitajci da uvedu Expiry date na pare. 

[mac]

Nisu Ameri rekli nego Andrea Dworkin, a i ona nije baš rekla da je sav seks ravan silovanju, nego onaj seks u kome muškarac misli samo na sebe.

[Palmer]

Nisu Ameri rekli nego Andrea Dworkin, a i ona nije baš rekla da je sav seks ravan silovanju, nego onaj seks u kome muškarac misli samo na sebe.

Pa dobro, feministička je priča,... Šta ćeš...i u drkanju kurca treba da postoji neka empatija prema šaci na kraju krajeva, a kamoli u vođenju ljubavi sa ženom!!!

[mac]

BTW, nije topic, ali čuo sam da će Kitajci da uvedu Expiry date na pare. 

Nije sav juan, nego samo digitalni juan, a u stvari nije ni digitalni juan nego nekakav digitalni vaučer, a čak i tada to nije problem. Kupiš tim digitalnim juanima zlatne pločice i nemaš gubitak. Ili ih staviš u neki fond.

Trenutno države rade istu stvar inflacijom, ali to je po meni nekako pokvarena rabota, jer ne znaš stopu inflacije unapred. Onaj ko je blizu vlasti ima više informacija i može da se obogati saznanjem kada nastupa inflacija. Ovo vreme isticanja mi se čini poštenije. Ako deset godina ne potrošiš novac to je onda mrtav novac, pa i treba da umre.

[mac]

Najpoštenije bi naravno bilo da cela planeta pređe na neku prirodnu valutu, recimo Džul, mera za energiju. Sve može da se svede na energiju. Dobiješ platu u Džulima, plaćaš u Džulima, tvoj Džul je isti svuda u svetu. Naravno, najbitnije je da je to stvaran, konkretan Džul, storniran u nekoj bateriji, i spreman za potrošnju, a ne neki virtuelni Džul koji je energetska-banka izmislila iz malog mozga. Pa ako imaš dovoljno kapaciteta da gomilaš energiju, onda be my guest, gomilaj energiju. Postoje neumitni gubici prilikom čuvanja velikih količina energije. Čak i litijum-jonnska baterija ima 95% efikasnost.

[Palmer]

BTW, nije topic, ali čuo sam da će Kitajci da uvedu Expiry date na pare. 

Nije sav juan, nego samo digitalni juan, a u stvari nije ni digitalni juan nego nekakav digitalni vaučer, a čak i tada to nije problem. Kupiš tim digitalnim juanima zlatne pločice i nemaš gubitak. Ili ih staviš u neki fond.

Trenutno države rade istu stvar inflacijom, ali to je po meni nekako pokvarena rabota, jer ne znaš stopu inflacije unapred. Onaj ko je blizu vlasti ima više informacija i može da se obogati saznanjem kada nastupa inflacija. Ovo vreme isticanja mi se čini poštenije. Ako deset godina ne potrošiš novac to je onda mrtav novac, pa i treba da umre.

Tako je na digitalni juan. Pa oni su maltene keš i izbacili, sve ide preko centralizovane dig valute. Dedolarizacija je dug proces ali je def počeo:

https://www.youtube.com/watch?v=W6EAmeO8BF8&t=247s

[Meho Krljic]

Scientists made mini brains and infected them with coronavirus. What they saw could explain Long COVID

[Palmer]

[Aco Popara Zver]

brate Palmere, pa taj Epoch Times je QAnon
https://en.wikipedia.org/wiki/The_Epoch_Times

[mac]

To je neki privremeni efekat, jer telo reaguje na vakcinu. Problem nestane ubrzo nakon što se pojavi, i sperma se vraća na ono što je bila pre vakcine.

[Palmer]

Nadam se da ću nać' studiju da ne bude trust me bro sors. Inače da li je kratki efekat ili dugi prerano je reći i mora još long term studija da se uradi. Inicijalno utiče sve ostalo je domen nagađanja.

[Aco Popara Zver]

Covid-19 vaccination BNT162b2 temporarily impairs semen concentration and total motile count among semen donors

https://onlinelibrary.wiley.com/doi/full/10.1111/andr.13209

[mac]

Pa studija koja je napravljena je merila spermu u nekoliko perioda posle vakcinacije, i ono što su ljudi videli je da je pad privremen.

Reuters je fact-checkovao to, pa vredi pročitati. Evo tl;dr zaključka

The authors of the study (doi.org/10.1111/andr.13209) published on June 17, 2022 emphasize that the drop is short-lived, and while sperm count was temporarily reduced, the sperm the men did produce showed no signs of damage at any point during the study.

A moguće objašnjenje za taj short-lived drop je recimo ovo

The study authors think that fever following vaccination, a widely reported short-term side effect, is the most likely explanation for the changes seen two-to-three months later. Because sperm take about 74 days to develop, it makes sense that the changes were most pronounced at the second time-point, they write in their report.

[Palmer]

https://pubmed.ncbi.nlm.nih.gov/35713410/

Objavljena u časopisu " Andrology".

Zanimljivo bi bilo uraditi istraživanje o padu nataliteta u tom periodu eventualno kod vakcinisanih.

Zajedno sa novim infirmacijama o neredovnim menstrualnim ciklusima kod žena - amenoreje tokom 2-4 meseca nakon vakcinacije pa da se uradi neka korelacija sa stopom nataliteta itd..

[Palmer]

Ali sagita koja u doba najgrđeg neoliberalizma veruje fakt čekerima. 'nači ono. pobedica..

[mac]

Zašto kažeš Sagita, a misliš mac? I, još važnije, kako uopšte funkcionisati u svetu u kome baš nikome ne veruješ? Tako možeš da počneš da veruješ i u ravnu Zemlju, jer zaboga nikome ne možeš verovati, niti jednom naučniku, niti bilo kome ko ti kaže bilo šta što dovodi u pitanje tvoju veru u ravnu Zemlju. To nije dobar put.

[Onaj stari Sendmen]

Nema to veze sa poverenjem, već konzumacijom droga. Naravno da u takvim stanjima ne veruješ ni u šta, sem da je zemlja ravna, pošto popiješ pod na redovnoj bazi.

[ridiculus]

Bio bi to manji problem kada ljudi ne bi prelako verovali u ono što žele da čuju, ili što potvrđuje njihov stav ili ideologiju.

[mac]

To je možda i najveći problem, na žalost. Republikanci su 1994. preuzeli kongres kada je Njut Gingrič promenio taktiku republikanaca sa "napravimo razuman dogovor" na "nema pregovaranja sa teroristima i demokratama". Tada je počela radikalizacija Amerike. Fox News je nastao 1996. godine, dve godine kasnije, da postane udarna pesnica te radikalizacije, i u tome je postao vrlo uspešan. Naplašili su narod najstrašnije raznim gangsterima, muslimanima, imigrantima, i takvo stanje i dalje traje.




EDIT: E čekaj, na pogrešnoj sam temi ovo napisao. Kako lako čovek sklizne u politiku...

[Aco Popara Zver]

a bre mače, a kao nisu ih plašili komunistima prije toga? Snimili ljudi The Thing kao antisovjetsku propagandu, taman kao što je korona danas kineski virus

Ali sagita koja u doba najgrđeg neoliberalizma veruje fakt čekerima. 'nači ono. pobedica..

a bre Palmere ne pratiš na času
mi se cijepili fajzerom jer nam lilit rekla a ne fektčekeri

[Palmer]

Zašto kažeš Sagita, a misliš mac? I, još važnije, kako uopšte funkcionisati u svetu u kome baš nikome ne veruješ? Tako možeš da počneš da veruješ i u ravnu Zemlju, jer zaboga nikome ne možeš verovati, niti jednom naučniku, niti bilo kome ko ti kaže bilo šta što dovodi u pitanje tvoju veru u ravnu Zemlju. To nije dobar put.

Pa dobro neko veruje u Boga a neko u vlasnike privatnog kapitala...Svakom svoje!

[Palmer]

Novo objavljeno što sam vid'o, kao i svakom poštenom Srbinu, crveno slovo za mene je Zakon!

.https://www.bmj.com/content/379/bmj.o2527.long


BMJ2022 Oct 25;379:o2527.doi: 10.1136/bmj.o2527.FDA urged to publish follow-up studies on covid-19 vaccine safety signals
Maryanne Demasi1
Affiliations

   
• ¹ Sydney, Australia.

   
• PMID: 36283706

   
• DOI: 10.1136/bmj.o2527

Erratum (switched references) in

   
• FDA urged to publish follow-up studies on covid-19 vaccine safety signals.
  [No authors listed] BMJ. 2022 Oct 28;379:o2593. doi: 10.1136/bmj.o2593. PMID: 36307119 No abstract available.

The FDA has been criticised for taking more than a year to follow up a potential increase in serious adverse events in elderly people receiving Pfizer's covid-19 vaccine, Maryanne Demasi reportsIn

July 2021 the US Food and Drug Administration (FDA) quietly disclosed findings of a potential increase in four types of serious adverse events in elderly people who had had Pfizer's covid-19 vaccine: acute myocardial infarction, disseminated intravascular coagulation, immune thrombocytopenia, and pulmonary embolism.


1 Little detail was provided, such as the magnitude of the increased potential risk, and no press release or other alert was sent to doctors or the public. The FDA promised it would "share further updates and information with the public as they become available."
Eighteen days later, the FDA published a study planning document (or protocol) outlining a follow-up epidemiological study intended to investigate the matter more thoroughly.2 This recondite technical document disclosed the unadjusted relative risk ratio estimates originally found for the four serious adverse events, which ranged from 42% to 91% increased risk. (Neither absolute risk increases nor confidence intervals were provided.) More than a year later, however, the status and results of the follow-up study are unknown. The agency has not published a press release, or notified doctors, or published the findings by preprint or the scientific literature or updated the vaccine's product label.

The BMJ has also learnt that the FDA has not publicly warned of similar signals detected in a separate observational cohort study it conducted of the third dose (first booster dose) in the elderly3; nor has the agency publicly acknowledged other published observational studies or clinical trial reanalyses reporting compatible results. Experts spoke to The BMJ about their concerns about the data and have called on the FDA to notify the public immediately.

"To keep this information from the scientific community and prevent us from analysing it ourselves, is irresponsible. It presumes that these organisations are perfect and cannot benefit from independent scrutiny," says Joseph Fraiman, an emergency medicine physician in New Orleans, who recently carried out a reanalysis of serious adverse events in Pfizer's and Moderna's randomised trials.4
Unearthing safety dataThe FDA's July 2021 findings came from a "near real time surveillance" system called Rapid Cycle Analysis (RCA) that the agency has in place to monitor a list of 14 adverse events of special interest. The RCA study is not capable of establishing a causal relation but rather is intended to detect potential safety signals rapidly. The agency said the associations were not identified for the other two covid-19 vaccines authorised in the US made by Moderna and Janssen (Johnson & Johnson). The July 2021 follow-up study protocol states that there is a "manuscript in preparation" for the original RCA study, but to date nothing has been published for either study.2
"The fact that the FDA found these four safety signals means they should have followed up on the results and I don't understand why we haven't had more information since then. It has been over a year," says Tracy Høeg, epidemiologist and physician currently conducting covid-19 vaccine research with the Florida Department of Health and California's Marin County Department of Health and Human Services.
In 2022 details regarding the results of a separate (third) safety study were disclosed inside another study protocol for evaluating boosters. Buried within that protocol the FDA stated, "In a cohort study of the third dose safety in the Medicare population where historical controls were used, we detected a statistically significant risk for immune thrombocytopenia (incidence rate ratio 1.66, confidence interval 1.17 to 2.29) and acute myocardial infarction (IRR 1.15, CI 1.02 to 1.29) among people with prior covid-19 diagnosis as well as an increased risk of Bell's palsy (IRR 1.11, CI 1.03 to 1.19) and pulmonary embolism (IRR 1.05, CI 1.0001 to 1.100) in general."3Again, the FDA has made no public statement regarding these results. "It's disturbing that they have not released any of these data. If the FDA is stating publicly that they're collecting it, then they should be publicly reporting it. They shouldn't be burying the results in protocols as they've done. It's sneaky," said Fraiman.

"The protocols say that they're looking into these data further, but I'd like to know the results now, it's been long enough. They need to view this from a public health perspective, they need to consider a person's right to informed consent. As physicians, we recommend medical therapies and we need to explain the full risks and benefits to the patient. This is not happening," adds Fraiman.

Dick Bijl, physician epidemiologist in the Netherlands, says, "The FDA managed to determine the efficacy of the vaccines in a short period of time, but they have not analysed the pharmacovigilance data with the same speed. If they found signals in July 2021, they should have been analysed and published within months."

As president of the International Society of Drug Bulletins, Bijl has campaigned for years to have drug safety data communicated to doctors in a timely manner. He credits his organisation for prompting the World Health Organization to begin publishing regular updates about drug safety signals. These are possible safety problems that circulated only in pharmacovigilance centres and have been incorporated in the WHO Pharmaceuticals Newsletter since 2012, so that all doctors can take note of them.
"The FDA should have informed doctors about any early safety signals from the vaccines," says Bijl. "Most doctors are not trained to, nor are they focused on, recognising side effects, especially because vaccines are generally regarded as quite safe. It's important that doctors are told what to look out for."

Other studiesOther research groups, including Fraiman's, have produced results that are compatible with the FDA's surveillance data.4

An observational study from three Nordic countries—Denmark, Finland, and Norway—found statistically significant increases in thromboembolic and thrombocytopenic outcomes following both Pfizer and Moderna mRNA vaccines.
5
"Nordic countries have very good, nationalised health systems so they have good medical records of these events," said Høeg, who was not involved in the study.

"What stood out to me with the mRNA vaccines was the risk ratios of intracranial haemorrhage for Pfizer and for Moderna. It was 2.2 for Moderna, and it's statistically significant. I've heard that people have seen it clinically but a robust analysis like this is much more convincing than anecdote."
Christine Stabell Benn, a vaccinologist and professor in global health at the University of Southern Denmark, highlights two studies that analysed the data from the phase 3 randomised controlled trials of covid-19 vaccines—one by Fraiman and colleagues4 and the other a preprint6 by her own research group. "The safety signal seems to be gathering around cardiovascular and cerebral vascular events, things to do with circulation and our larger organs, and these are the same signals that appear to be popping up in the FDA surveillance data as well," says Stabell Benn.

According to Stabell Benn,

the underlying problem with documenting adverse events is that the covid-19 vaccines "were not tested properly." She says, "The phase 3 trials offered vaccines to the control groups just a few months after the randomisation, so it doesn't allow for assessment of the long term adverse events—but it's the best evidence we have so far, since no phase 4 trials were carried out. Now, we largely have to rely on poorer quality data and studies."



Adding to the difficulty is the type of adverse events being documented. "Myocardial infarction and thrombosis are events that occur often in the elderly and so doctors are less likely to report them as potentially linked to the vaccine, unlike vaccine induced immune thrombotic thrombocytopenia which is so dramatic and rare and also affected younger age groups, so it was easier to pick up," says Stabell Benn.
To disclose or not to disclose?Tom Frieden, former US Centres for Disease Control and Prevention (CDC) director, says it's a challenge for public health agencies to balance the release of contentious information. "There's a valid concern that reports of adverse events will be misinterpreted as causal when they're not causal to the treatment or vaccine given, and another concern is if you don't present the information, you may be seen as hiding something, which is also problematic. So, this is not an easy area," says Frieden.
He believes that the FDA and CDC have done a good job at publicly communicating the safety signals of covid-19 vaccines, pointing to the decision to pause the Johnson & Johnson vaccine after six reported cases of cerebral venous sinus thrombosis.7 "That was exactly the right decision at the time, it was just kind of 'stop, look, and listen,' and then come to a conclusion. Frankly, it was a judgment call whether to reintroduce the Johnson & Johnson vaccine at all. I think they were shared promptly. They were shared openly. I don't see a lot to criticise in how they were shared. The reality is that it's a very difficult thing to do—to share information well, in a way that will lead to people making the right conclusions."

Earlier this year, the CDC admitted to withholding deliberately critical data on boosters and hospital admissions. Kristen Nordlund, CDC spokesperson, told the New York Times that the agency had been slow to release data to the public on breakthrough infections "because they might be misinterpreted as the vaccines being ineffective."8

In addition, CDC director Rochelle Walensky acknowledged that the agency had not conducted a disproportionality analysis that the agency had indicated it would conduct in 2021 to analyse spontaneous adverse event reports.9 When asked about his thoughts on Walensky's admission, Frieden said, "I don't know what the reality is. I can't comment."
Cody Meissner, a paediatrician and member of the FDA's Vaccines and Related Biological Products Advisory Committee, said he did not think that the FDA was "deliberately" withholding data from the public but did agree that sharing data is key to establishing trust. "I fully concur that transparency is key, and veryone should know all the information that is available. One of the great tragedies of this pandemic is likely to be the loss of confidence in public health authorities.

One of the great problems was the suppression of opposing voices to various recommendations and that's going to cause extraordinary harm," says Meissner. "Everyone is aware that there are going to be side effects from any vaccine and as time goes by, we're going to find out[size=78%] more and more about those side effects. Whether it's an association with myocarditis or association with a pulmonary embolus, it's going to take time," he adds.[/size]

The Pfizer and Moderna clinical trial reanalysis by Fraiman and colleagues indicated the mRNA vaccines were associated

with an additional serious adverse event for every 800 people vaccinated,4 far more than the 1-2 for each million reported for vaccines in general.10 Fraiman says he and his colleagues asked the FDA to warn the public based on their reanalysis, and replicate their study, but this has not happened.
"It seems to me that doctors have a much higher tolerance for covid vaccine side effects because there's been this sense that if you don't take the vaccine, you die. Obviously, that is completely the wrong way to think about it," says Stabell Benn."We don't want to create a lot of unnecessary anxiety and we can't say there is now proof that the vaccines cause these events because the data are of poor quality, but we can say there is a danger signal, and the medical profession needs to be alerted to this," she adds.


The BMJ has learnt that the FDA's medical record review and statistical analyses have recently been completed, and the overall study results are currently under internal review. "The findings to date from the fully adjusted epidemiologic study on the primary series vaccinations do not provide strong support for an association between the vaccine and any of the four outcomes described in the posting to the FDA website. Additional analyses, including evaluation of booster doses, are still being conducted. Release of the study findings is expected later this fall," said the FDA.
Footnotes

   
• Peter Doshi, a senior editor at The BMJ, is co-author with Fraiman of a recent reanalysis of serious adverse events in Pfizer's and Moderna's randomised trials, published in Vaccine.

   
• Competing interests: None declared.

   
• Commissioned; not externally peer reviewed.

   
• This feature has been funded by the BMJ Investigations Unit. For details see www.bmj.com/investigations

This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.https://bmj.com/coronavirus/usageReferences

   
• Food and Drug Administration. Initial results of near real-time safety monitoring covid-19 vaccines. 2021. www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/initial-results-near-real-time-safety-monitoring-covid-19-vaccines-persons-aged-65-years-and-older.
• Wong HL, Zhou CK, Tworkoski E, et al. Assessment of acute myocardial infarction, pulmonary embolism, disseminated intravascular coagulation and immune thrombocytopenia following covid-19 vaccination. FDA, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology. 2021. https://bestinitiative.org/wp-content/uploads/2021/09/C-19-Vaccine-Safety-AMI-PE-DIC-ITP-Protocol-2021.pdf
• Food and Drug Administration. Safety assessment of 3rd dose/booster of covid-19 mRNA vaccines (master protocol). 2022. https://bestinitiative.org/wp-content/uploads/2022/09/C19-Post-Booster-Dose-AESI-Risk-Protocol-2022.pdf.

   
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  • Fraiman J,
  
        
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. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine2022;40:5798-805. doi:10.1016/j.vaccine.2022.08.036 pmid:36055877
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  • Dag Berild J,
  
        
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  • Myrup Thiesson E,
  
        
  • et al

. Analysis of thromboembolic and thrombocytopenic events after the AZD1222, BNT162b2, and MRNA-1273 covid-19 vaccines in 3 Nordic countries. JAMA Netw Open2022;5:e2217375. doi:10.1001/jamanetworkopen.2022.17375 pmid:35699955
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• Benn CS, Schaltz-Buchholzer F, Nielsen S, Netea MG, Aaby P. Randomised clinical trials of covid-19 vaccines: do adenovirus-vector vaccines have beneficial non-specific effects? 2022. https://papers.ssrn.com/abstract=4072489.

   
• Marks P, Schuchat A. Joint CDC and FDA statement on Johnson & Johnson covid-19 vaccine. FDA Med Bull. 2021. www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine

   
• Mandavilli A. The CDC isn't publishing large portions of the covid data it collects. New York Times. 2022. www.nytimes.com/2022/02/20/health/covid-cdc-data.html.
  

   
• Stieber Z. CDC director admits agency gave false information on covid-19 vaccine safety monitoring. Epoch Times. 2022. www.theepochtimes.com/cdc-director-admits-agency-gave-false-information-on-covid-19-vaccine-safety-monitoring_4726981.html.
  

   
• Office of Infectious Disease. HIV/AIDS Policy. Vaccine side effects. 2021. www.hhs.gov/immunization/basics/safety/side-effects/index.html.

[Palmer]

Zemlja nije ravna, ali su ljudi postali ravnodušni na to što vide. Dokle god postoji VEnture Capitalist koji ima interes, i moje poverenje u gadamerski rečeno: uposlenu nauku u ruho ekspertize zarad vlasnika privatnog kapitala, i moje poverenje u nauku biće ne tako snažno. Naravno da pijem i suplemente i lekove i primam vakcine jer nije kao da imam drugi izbor osim da verujem u trenutnu postavku i da se nadam najboljem, ali verujem i svojim očima i gledam apsurd svakog dana kao i svi mi izgubljeni u moru kompromisa.


Kada te iste naučnike pitam zašto kancerogeni titanijum dioksid može u lek a ne u suplement, svi me gledaju belo i na kraju skrušeno priznaju jer je BIG PHARMA tako rešila.


Kada pitam zašto je beli švajcarski krst na lekovima/suplementima kad svi znaju da se to pravi u indiji u "neuslovnim uslovima" bez belih soba, bez validacija čišćenja, procedura SOP-va, a ne u poštanskom sanduetu u Ženevi, ostaju bez odgovora.


Kada pitam zašto kriju afere oko API-a i ekscipijenasa i zašto produžavaju rokove sirovinama u dilu sa "kredibilnim" laboratorijama, opet sležu ramenima. Moj pod, moje su oči, i moja svest samo je moja, da znam de ću da padnem ja bih seo, ali barem na jeftine trikove neoliberala ne padam, sedim mirno posmastram i zaključujem pa makar 1000 puta neko bio PhD ili ekspert.

[Aco Popara Zver]

Palmer, niko ne konta šta oćeš da kažeš. Misim, džaba pejst ako ne konta. Možda ne kontaju ni šta ja hoću reći, ali problem je isti sa koje god strane pogledaš.

Npr, šta ja znam šta gore piše, nešto tipa da 1 u 800 ljudi ima neke posljedice od vakcine. Super, a koliko ljudi ima posljedice od bilo koje vakcine? Vidiš, kad to poređenje nedostaje onda prosto meni ništa ne govori.

I ovaj se pita zašto se to krije od ljudi, pa ok, ali onda se krije ta informacija za svaku vakcinu. Zašto, možda zato što se mi petljamo na Sagiti i dalje oko toga, a kao nešto smo u prosjeku više obrazovani nego drugi. Šta tek raditi sa Miroljubom Petrovićem i takvima kad čuju da mogu biti 1 u 800.

[Palmer]

Fasovo sam COVID, neko bi rekao karma, izgoreh 3 dana 39.5, ali sad je ok, izbegavao sam i antipiretike i brufen jer izaziva krvarenje želuca ko ne zna eto sad zna... Izbacujem studije koje mi dolaze, svako nek tumači za sebe, svako je pismen za toliko valjda, naravno uvek će razlog da se nađe da se nešto opravda ili ne, to što ima od podataka ima, mislim da je ok da se pejstuje pa koga ne mrzi nek čita...Naprosto je nemoguće uraditi sve te studije za tako kratko vreme kad privatne kompanije kriju podatke, ali verujem da će biti i tih koje pominješ. Evo ti poredbena studija koja se bavi  odnosom rizika od mRna vakcine/ismanjenja hospitalizacije. Pogled na tabele daje odnos rizika na 10.000 ispitanika.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9428332/




Results: Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33. , respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

We found excess risk of serious AESIs to exceed the reduction in COVID-19 hospitalizations in both Pfizer and Moderna trials.
Full transparency of the COVID-19 vaccine clinical trial data is needed to properly evaluate these questions. Unfortunately, as we approach 2 years after release of COVID-19 vaccines, participant level data remain inaccessible.