Capljina74 wrote: ↑26/01/2021 15:44
Mogy87 wrote: ↑26/01/2021 15:38
Capljina74 wrote: ↑26/01/2021 15:37
1. odsustvo odobrenja za neke proizvodne pogone,
2. nedostatak podataka o komercijalnim partijama vakcine,
3. i najvažnije, činjenica da su otkrivene značajne razlike između komercijalnih partija i onih koje su se primenjivale tokom kliničkih testiranja.
Mond o mRNK.
Naravno ocekujem dokaze.
https://www.lemonde.fr/planete/article/ ... _3244.html
Hvala. S odmakom da komentarisemo clanak koji se oslanja na ukradene dokumente (vrlo pouzdano) evo zakljucka:
When requested, the EMA confirmed that this quality issue was subsequently resolved: “
The company was able to resolve these issues and provide the information and data necessary to enable the EMA to progress towards a recommendation. positive for this vaccine ”. The agency also ensures that the current specifications on the level of RNA "are considered scientifically justified and acceptable ". For example, it is unlikely, the agency stresses, that these truncated RNA molecules can be translated into protein or peptide, and thus cause undesirable effects.. “Despite the urgency, there has always been a consensus across the EU not to compromise high quality standards and to base any recommendations on the strength of scientific evidence, safety, quality and efficacy of 'a vaccine, and nothing else ,' insists the EMA.
Upravo je to poenta rolling review procesa. Proizvodjaci vuku na svoju stranu, regulator postavi granicu ispod koje nece ici, proizvodjaci se povinuju i svi sretni.
Regardless of the reading of these documents, the facts are as follows: Pfizer-BioNTech's vaccine will finally be approved on December 21, 2020 by the EMA, three weeks after the UK and two weeks after the US,
which shows that the European Agency has nevertheless taken some time to resolve this quality problem before giving the green light.
Znaci nisu pustili dok nisu ispravili nedostatke. Meni je ovo odlican primjer kako stvari ispravno funkcionisu u praksi.
Jer, pazi, niko nije dijete. Farmaceuti bi vrlo rado preskocili koju fazu i ustedili gomilu para. Regulatori su tu da to sprijece. Sto je EMA i ucinila.
