Ja i moji? Ko su "ja i moji"?tranquil wrote: ↑08/07/2021 14:39Kad pričaš o FDA, evo direktnog linka FDA o "emergency approval", pa da provjerimo tvoje navode:Naslovnica wrote: ↑08/07/2021 13:23
Odavno nismo čuli ovu "pametnom dosta".
Svima nam je poznato da su vakcine odobrene kao "emergency approval". Postoje razlike između tog odobrenja i regularne procedure.
How does a full approval from the FDA differ from an emergency use authorization?
An emergency use authorization is used by the FDA to provide quick access to medical products, such as vaccines, that can be used when there are no other adequate, approved or available options during a public health emergency.
The FDA will make a product available based upon the best available evidence, without waiting for all of the data to be processed, if the product's benefits outweigh the risks.
An emergency use authorization remains in effect until the end of the public health emergency. Only FDA-approved vaccines would be allowed to remain on the market once the public health emergency concludes.
The FDA expects vaccine manufacturers who receive an emergency use authorization to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval.
When a manufacturer seeks full approval from the FDA, it must submit a comprehensive Biological License Application. A BLA consists of preclinical and clinical data and information, as well as details of the manufacturing process and facilities.
Full approval from the FDA requires all late-stage clinical trial data to be reviewed after all three phases are complete. The agency must determine whether the data and other information show that the drug is safe and effective for its intended use, and that the product can be made according to federal quality standards.
Pa smo tako saznali da AZ u rijetkim slučajevima može izazvati ta famozna zgrušavanja, a to nije bilo na listi nuspojava. Pa smo onda naknadno saznali da mRNA vakcine izazivaju miokarditis i perikarditis kod mlađe populacije, isto nije bilo na listi nuspojava. Neko je rekao da se to desilo zato što su faze testiranja vršene na relativno malom uzorku da bi se te nuspojave i mogle detektovati, ali sada mogu nakon što je vakcinisana veća populacija. Vrlo vjerovatno moguće. Pa su onda skontali da je bolje poslije AZ roknuti se s mRNA nego ponovo AZ, pa baba Merkelica nakon AZ primi Modernu. Zašto pobogu?
U decembru prošle godine je data prva mRNA vakcina u široj populaciji, van testiranja. Znači, prošlo je otprilike 8 mjeseci od početka upotrebe vakcina u široj populaciji, van testne grupe.
btw, pametnom nikada nije dosta.
https://www.fda.gov/vaccines-blood-biol ... -explained
Da li je "emergency approval" u pravilima? Jeste, eto ga tamo. Da li je dakle time prekršeno neko pravilo? Nije. Da li su svi testovi obavljeni? Pa pogledajmo:
Are the COVID-19 vaccines rigorously tested?
Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA.
Tvoj izvor pominje tri faze, evo i njih:
Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people. In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine. In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on effectiveness and additional important safety data. This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo.
Nisu se čekali rezultati sve tri faze, kažeš, pa da i to provjerimo:
From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.
Dakle, prije odobrenja su prikupljeni podaci iz sve tri faze, s tim da je treća ograničena na podatke iz dva mjeseca, jedina razlika. I to, da napomenem, nije protiv pravila, nego pravila upravo regulišu ovu proceduru.
Dakle ponovo pitam tebe i Dozera koje je pravilo prekršeno?
Dalje, na istom linku imaš i informacije koje ti i tvoji stalno fulate ili ignorišete, između ostalog i kako je vakcina brzo razvijena.
Što se tiče "pametnom dosta", frazu "pametnom dosta" (sa smajlijem koji namiguje) mrzim svom svojom dušum. Čudo je nisi prepoznao, to je česta uzrečica sveznalica koji znaju sve tajne i sve zavjere svijeta, zato sam je i upotrijebio
Ja imam alibi, jučer se revakcinisao Pfizerom, za sada živ i zdrav.
Sve po zakonu, što bi Branković rekao, nikalvo pravilo nije prekršeno.
Jesam li ja negdje rekao da je neko pravilo prekršeno?
Da li sam šta slagao u ovome iznad što sam napisao?
Znači jedina razlika je što je treća faza ograničena ma podatke iz 2 mjeseca? Pa nuspojave kao zgrušavanja krvi, miokarditis i perikarditis nisu uvršteni u listu nuspojava. Pa se Merkelica nakon AZ ubila mRNA vakcinom. A moja mati sutra ode na drugu dozu AZ, isto godište kao ova baba. Niko je ništa i ne pita, ona sva sretna.
