Citat:
Ursprungligen postat av
korrektamund0
"Jag vill att du...", "jag vill att du...", "jag vill att du..."... Värre patetiskt exempel på entitled bortskämd snorunge och okunnig tramspajas har jag aldrig sett. Jag föreslår att om du vill argumentera för att testerna inte klarade de kraven är det DU som får kila iväg och begära testrapporterna från EMA.
Du förklarar saker som jag redan vet som om jag inte visste det. Det finns inga publicerade resultat och det finns ingen komplett innehållsförteckning då man hävdar att dessa ämnen/sammansättningar är företagshemligheter. Återigen har du inte lyckats göra annat än att skriva massor av bullshit som jag inte har efterfrågat och som inte är relevant.
Du får det att låta som om myndigheter och dessa clown-företag vet vad de pysslar med hela tiden.
https://apnews.com/article/business-...a7ca4a9feb818e aj då...
Eftersom du lusläst dokumentet så vet du också att EMA hävdar följande "Comirnaty is intended for active immunisation against SARS-CoV-2, thereby preventing COVID-19." Sida 130 punkt 3.1.1. I nästa punkt skriver man följande "There is currently no approved vaccine in the EU available to prevent COVID-19"
Är det läkemedelsbolagen eller EMA som är förvirrade här? Avsikten är att immunisera folk mot SARS-COV-2, för att förhindra covid19. I nästa andetag snackar man om ett vaccine som ska förhindra covid19. Men läser man vidare så har det aldrig varit frågan om något annat än att förhindra SARS-CoV-2.
Citat:
The pivotal study was not designed to assess the effect of the vaccine against transmission of SARSCoV-2 from subjects who would be infected after vaccination. The efficacy of the vaccine in preventing
SARS-CoV-2 shedding and transmission, in particular from individuals with asymptomatic infection, can
only be evaluated post-authorisation in epidemiological or specific clinical studies.
Duration of protection has currently been followed up for approximately 100 days after dose 1. Data on
longer term protection are anticipated to the extent that the ongoing phase 3 study can continue as
planned with a placebo group. The assessment of efficacy over a period of at least 6 months is expected
to determine the need and the appropriate time of a booster dose.
There seems to be at least a partial onset of protection after the first dose, but this remains
unconfirmed at this stage.
There are very limited or no data in immunocompromised subjects and in pregnant women. Efficacy in
subjects aged 16-17 years is extrapolated from young adults as no cases of disease were reported in
this small group at this stage.
Available data do not suffice to establish efficacy in subjects seropositive for SARS-CoV-2 at baseline,
and subjects with a known history of COVID-19. However, efficacy is anticipated in this group, to the
extent that they are not naturally protected against re-infection, which is presently incompletely
characterised.
Citat:
In view of the declared Public Health Emergency of International Concern and in order to ensure early
supply this medicinal product is subject to a time-limited exemption allowing reliance on batch control
testing conducted in the registered site(s) that are located in a third country. This exemption ceases to
be valid on 31 August 2021. Implementation of EU based batch control arrangements, including the
necessary variations to the terms of the marketing authorisation, has to be completed by 31 August
2021 at the latest, in line with the agreed plan for this transfer of testing. Progress reports have to be
submitted on 31 March 2021 and included in the annual renewal application[/spoiler]
Du förklarar saker som jag redan vet som om jag inte visste det. Det finns inga publicerade resultat och det finns ingen komplett innehållsförteckning då man hävdar att dessa ämnen/sammansättningar är företagshemligheter. Återigen har du inte lyckats göra annat än att skriva massor av bullshit som jag inte har efterfrågat och som inte är relevant.
Du får det att låta som om myndigheter och dessa clown-företag vet vad de pysslar med hela tiden.
https://apnews.com/article/business-...a7ca4a9feb818e aj då...
Eftersom du lusläst dokumentet så vet du också att EMA hävdar följande "Comirnaty is intended for active immunisation against SARS-CoV-2, thereby preventing COVID-19." Sida 130 punkt 3.1.1. I nästa punkt skriver man följande "There is currently no approved vaccine in the EU available to prevent COVID-19"
Är det läkemedelsbolagen eller EMA som är förvirrade här? Avsikten är att immunisera folk mot SARS-COV-2, för att förhindra covid19. I nästa andetag snackar man om ett vaccine som ska förhindra covid19. Men läser man vidare så har det aldrig varit frågan om något annat än att förhindra SARS-CoV-2.
Citat:
The pivotal study was not designed to assess the effect of the vaccine against transmission of SARSCoV-2 from subjects who would be infected after vaccination. The efficacy of the vaccine in preventing
SARS-CoV-2 shedding and transmission, in particular from individuals with asymptomatic infection, can
only be evaluated post-authorisation in epidemiological or specific clinical studies.
Duration of protection has currently been followed up for approximately 100 days after dose 1. Data on
longer term protection are anticipated to the extent that the ongoing phase 3 study can continue as
planned with a placebo group. The assessment of efficacy over a period of at least 6 months is expected
to determine the need and the appropriate time of a booster dose.
There seems to be at least a partial onset of protection after the first dose, but this remains
unconfirmed at this stage.
There are very limited or no data in immunocompromised subjects and in pregnant women. Efficacy in
subjects aged 16-17 years is extrapolated from young adults as no cases of disease were reported in
this small group at this stage.
Available data do not suffice to establish efficacy in subjects seropositive for SARS-CoV-2 at baseline,
and subjects with a known history of COVID-19. However, efficacy is anticipated in this group, to the
extent that they are not naturally protected against re-infection, which is presently incompletely
characterised.
Citat:
In view of the declared Public Health Emergency of International Concern and in order to ensure early
supply this medicinal product is subject to a time-limited exemption allowing reliance on batch control
testing conducted in the registered site(s) that are located in a third country. This exemption ceases to
be valid on 31 August 2021. Implementation of EU based batch control arrangements, including the
necessary variations to the terms of the marketing authorisation, has to be completed by 31 August
2021 at the latest, in line with the agreed plan for this transfer of testing. Progress reports have to be
submitted on 31 March 2021 and included in the annual renewal application
Hur var det nu med dina fantasier om riktlinjer och annan onödig varmluft som inte gäller i detta fall? Gjordes dessa kontroller? Ibland då USA(som "third country" i praktiken innebär i det här fallet) har hittat ett antal enorma brister. Men på så här kort tid går det helt enkelt inte att utföra inspektioner i gigantiska fabriker. Resultatet från japan blev att 500 000 människor blev injicerade med en kontaminerad batch.
Citat:
In order to complete the characterisation of the active substance and
finished product, the MAH should provide additional data.
July 2021. Interim reports:
31 March 2021
In order to ensure consistent product quality, the MAH should
provide additional information to enhance the control strategy,
including the active substance and finished product specifications.
July 2021. Interim reports:
March 2021
In order to confirm the consistency of the finished product
manufacturing process, the MAH should provide additional validation
data.
March 2021
In order to confirm the purity profile and ensure comprehensive
quality control and batch-to-batch consistency throughout the
lifecycle of the finished product, the MAH should provide additional
information about the synthetic process and control strategy for the
excipient ALC-0315.
July 2021. Interim reports:
January 2021, April 2021.
In order to confirm the purity profile and ensure comprehensive
quality control and batch-to-batch consistency throughout the
lifecycle of the finished product, the MAH should provide additional
information about the synthetic process and control strategy for the
excipient ALC-0159.
July 2021. Interim reports:
January 2021, April 2021.
In order to confirm the efficacy and safety of Comirnaty, the MAH
should submit the final Clinical Study Report for the randomized,
placebo-controlled, observer-blind study C4591001.
December 2023
Sista punkten... hur gick det med den nu igen? När alla i Sverige redan blivit injicerade ska MAH ha rättat till alla problem. När alla redan har pressats och lurats till att ta produkten som innehåller två nya syntetiska delar(ALC-0159) och (ALC-0315)
Passande nog avslutar man med;
Citat:
New Active Substance Status
Based on the CHMP review of the available data, the CHMP considers that single-stranded, 5’-capped
messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA
templates, encoding the viral spike (S) protein of SARS-CoV-2 is a new active substance as it is not a
constituent of a medicinal product previously authorised within the European Union
God jul Mundo.
