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EMA Confidential report: Risk Management Plan Comirnaty (vaccin Pfizer) 20.12.2020

Aangezien bepaalde experten ( en fact-checkers ๐Ÿค“) de rapporten van EMA blijkbaar niet lezen (zelfs niet de vertrouwelijke rapporten zoals deze ), gaan we het ze even wat gemakkelijker maken en relevante materie voorkauwen.

https://www.ema.europa.eu/.../comirnaty-epar-risk...


Pagina 57-58-59:


Module SIV. Populations Not Studied in Clinical Trials ๐Ÿ‘ˆ๐Ÿ‘ˆ๐Ÿ‘ˆ

SIV.1. Exclusion Criteria in Pivotal Clinical Studies Within the Development

Programme

Detailed descriptions of all inclusion and exclusion criteria for clinical studies are provided in the individual CSRs which were filed in Module 5.3.5.1.


Inclusion criteria

  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

  • Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included. In order for the overall Phase 3 study population to be as representative and diverse as possible, the inclusion of participants with known chronic stable infection with HIV, HCV, or HBV was permitted as the study progressed. Specific criteria for these Phase 3 participants can be found in the C4591001 protocol, Section 10.8 (please refer to Module 5.3.5.1).

  • Phase 2/3 only: Participants who, in the judgment of the investigator, are at higher risk for acquiring COVID-19 (including, but not limited to, use of mass transportation, relevant demographics, front-line essential workers and others).


Exclusion criteria ๐Ÿ‘ˆ๐Ÿ‘ˆ๐Ÿ‘ˆ

The participants enrolled were 12 years of age and older; with the 12- to โ‰ค16-year-old cohort most recently being included in the protocol.


Phase 1 exclusion criteria were stricter than criteria in Phases 2 and 3 of the study. Participants were excluded from the studies according to the general criteria listed below:

  • Previous vaccination with any coronavirus vaccine Reason for exclusion: To avoid confounding the assessment of serological or clinical immune response in the study population.

  • Previous clinical or microbiological diagnosis of COVID-19 Reason for exclusion: Phase 1 excluded participants with a previous clinical or microbiological diagnosis of COVID-19 because these participants may have some degree of protection from subsequent infection by SARS-CoV-2 and therefore would confound the pivotal efficacy endpoint. During Phase 2/3, participants with prior undiagnosed infection were allowed to be enrolled. Screening for SAR-CoV-2 with BNT162b2 nucleic acid amplification test by nasal swab or antibodies to non-vaccine SARS-CoV-2 antigen by serology was not conducted before vaccine administration in Phase 2/3, but samples were taken to run these assays after vaccination, thus identifying participants with unidentified prior infection. This group will be assessed to identify whether prior infection affects safety.

  • immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory /physical examination Reason for exclusion: Immunocompromised participants may have impaired immune responses to vaccines and would therefore limit the ability to demonstrate efficacy, which is the primary pivotal endpoint.

Is it considered to be included as missing information? Yes.

Rationale: Participants with potential immunodeficient status were not specifically included in the study population. However, since the study population is intended to be as representative as possible of the vulnerable population to COVID-19 illness, sub-analyses of immunogenicity data in future studies may provide further understanding of immune responses in this population.

  • Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study Reason for exclusion: To avoid confounding the assessment of serological or clinical immune response in the study population.

  • Women who are pregnant or breastfeeding Reason for exclusion: To avoid use in a vulnerable population.

Is it considered to be included as missing information? Yes.

Rationale: It is not known if maternal vaccination with COVID-19 mRNA vaccine would have unexpected negative consequences to the embryo or foetus.


Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigatorโ€™s judgment, make the participant inappropriate for the study

Reason for exclusion: To avoid misleading results deriving from non-compliance to study procedures.


SIV.2. Limitations to Detect Adverse Reactions in Clinical Trial Development Programmes The clinical studies are limited in size and, therefore, unlikely to detect very rare adverse reactions, or adverse reactions with a long latency.


SIV.3. Limitations in Respect to Populations Typically Under-Represented in Clinical Trial Development Programmes

There has been limited exposure to COVID-19 mRNA vaccine in some special populations and no epidemiologic studies have been conducted in pregnant/breastfeeding women, paediatric participants (<16 years of age), and specific subpopulations that were excluded from the data.

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Wat zei Pierre Van Damme ook al weer ?

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