Organisaties zoals het EMA en peer review onder wetenschappers bestaat juist om ervoor te zorgen dat alles zo objectief mogelijk gebeurt en er geen belangenverstrengeling kan zijn.

Afgaan enkel op beweringen van bedrijven die het product ontwikkeld hebben, is precies het tegenovergestelde. Dat is onverstandig, maar is ook precies wat er nu gebeurt.

Zakenbelangen en politiek staan voorop, wetenschap en transparantie zijn naar de achtergrond verdwenen. Prima, maar dan moeten ze niet gek opkijken als veel mensen nee gaan zeggen tegen dat vaccin. Je kunt net zo goed naar een handelaar in tweedehands auto's gaan.

@21
In antwoord op de EU ombudsman, reageert de EMA o.a.:

Will EMA ensure transparency of its COVID-19 related activities, including the possibility
of rapidly publishing clinical data for the products in question.
Transparency and the provision of timely information about medicines, including clinical data, is
more relevant than ever in the present circumstances. In addition to meeting an unprecedented
public demand for information, transparency in relation to COVID-19 medicines will support global research and allow for public scrutiny.
EMA is therefore implementing exceptional measures with regard to medicines for COVID-19,
speeding up standard publication timelines and providing more information than is usually the
case. These measures include:
a) Publication of the product information with details of the conditions of use at the time of the
CHMP’s positive opinion on the marketing authorisation application.
b) Expedited publication of the full EPAR, within 3 days of authorisation by the European
Commission.
c) Publication of clinical data submitted to EMA in support of the applications for COVID-19
medicines after the authorisation of a medicine and once personal data have been anonymised
and any commercially confidential information redacted. The first set of clinical data that EMA
will publish for a COVID-19 medicine will be those of remdesivir. We expect to publish the data
in the coming weeks. (EMA suspended publication of trial data in August 2018 in the context of
EMA’s Brexit Preparedness Business Continuity Plan but announced in June 2020 that it will
restart this activity for COVID-19 medicines as a priority.)
d) Publication of the full risk management plan (excluding annexes) for authorised COVID-19
medicines. (EMA usually only publishes a summary.)
e) Publication of news announcements within 1 day of the start of initial rolling reviews or the
evaluation of new or extension of indication applications for COVID-19.

@22,

Dat is leuk, maar allemaal achteraf.

Ik zal maar kopiëren uit de bron. O.a.:

"In the United States, all eyes are on Pfizer and Moderna. The topline efficacy results from their experimental covid-19 vaccine trials are astounding at first glance. Pfizer says it recorded 170 covid-19 cases (in 44,000 volunteers), with a remarkable split: 162 in the placebo group versus 8 in the vaccine group. Meanwhile Moderna says 95 of 30,000 volunteers in its ongoing trial got covid-19: 90 on placebo versus 5 receiving the vaccine, leading both companies to claim around 95% efficacy.

Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown. Third, these results reflect a time point relatively soon after vaccination, and we know nothing about vaccine performance at 3, 6, or 12 months, so cannot compare these efficacy numbers against other vaccines like influenza vaccines (which are judged over a season). Fourth, children, adolescents, and immunocompromised individuals were largely excluded from the trials, so we still lack any data on these important populations.

I previously argued that the trials are studying the wrong endpoint, and for an urgent need to correct course and study more important endpoints like prevention of severe disease and transmission in high risk people. Yet, despite the existence of regulatory mechanisms for ensuring vaccine access while keeping the authorization bar high (which would allow placebo-controlled trials to continue long enough to answer the important question), it’s hard to avoid the impression that sponsors are claiming victory and wrapping up their trials (Pfizer has already sent trial participants a letter discussing “crossing over” from placebo to vaccine), and the FDA will now be under enormous pressure to rapidly authorize the vaccines."

Dat het EMA belooft met allerlei productinformatie te komen, nieuwe reviews en een risk management plan enzovoorts, is prima.

Maar dat doet niks af aan het feit dat men nu wil beginnen met vaccineren terwijl de trials gewoon niet degelijk waren en veel te weinig informatie geven over o.a. bijwerkingen, bescherming in bepaalde groepen zoals ouderen, effect op de lange termijn, enzovoorts.

@23
Je kan van alles kiezen als eindpunt in een klinische studie, maar Pfizer kiest een heel gebruikelijk eindpunt voor vaccins. De degelijkheid van de vaccins is onderdeel van de EMA beoordeling.

@24
cor,: de degelijkheid van het gekozen traject in de trials en de trials opzet is onderdeel van de EMA beoordeling.

En de niet risicogroepen vanaf augustus. Als het al niet uitloopt zijn sommige van die vaccinbedelaars op NK pas lente 2022 aan de beurt. Hahahahaha
En die blafkappen? zoals ik al verwachtte zullen die in ieder geval nog heel 2021 verplicht zijn, gezien het feit dat in augustus pas de helft is gevaccineerd.
Eerlijk gezegd denk ik dat augustus wat optimistisch is omdat Hugo faalhaas het moet regelen.

@23
Over klinische studies en eindpunten van vaccins. Hier een document wat beoordelaars dienen te gebruiken.
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-vaccines-revision-1_en.pdf

Leeghoofd De Jonge.