@bubu12
 

bubu12 1er mai 

Vous affirmez que les vaccins commercialisés en France sont toujours en phase 3, que ce n’est pas normal. Or à qui sont destinés ces vaccins ? aux adultes. L’essai de phase 3 de Pfizer sur les adultes est terminé et publié.

 

 19 February 2021 EMA/707383/2020 Corr.1*1 Committee for Medicinal Products for Human Use (CHMP) Assessment report Comirnaty Common name : COVID-19 mRNA vaccine (nucleoside-modified) Procedure No. EMEA/H/C/005735/0000

 

Missing information

Since pregnant and breast-feeding women were excluded from the study, no information is available for those populations. It is agreed to include use during pregnancy and while breastfeeding as missing information in the RMP.

At the data cut-off of 14 Nov-20, 10-14 weeks safety data are available. Thus, long-term safety is included as missing information and will be characterised as part of the continuation of the pivotal clinical trial and the PASS.

Interaction with other vaccines, has not been evaluated in clinical trials and may be of interest to prescribers. As elderly individuals will be one target group for vaccination, and they often may need vaccination with other vaccines such as influenza and pneumococcus vaccines, further data is requested. The Applicant commits to conduct a study of the co-administration of Comirnaty with inactivated quadrivalent influenza vaccine.

Data from use in frail patients with co-morbidities (e.g. chronic obstructive pulmonary disease (COPD), diabetes, chronic neurological disease, cardiovascular disorders), is limited, and it is desirable to gather further data in these groups. Therefore, use in frail patients with co-morbidities (e.g. chronic obstructive pulmonary disease (COPD), diabetes, chronic neurological disease, cardiovascular disorders) has been included as missing information in the RMP. Furthermore, information is limited on the use in patients with autoimmune or inflammatory disorders, as well as in immunocompromised patients. Thus, these groups are also included as missing information. Such missing information will be collected in the post-authorisation safety studies.

 

The Applicant proposes 6 interventional studies, of which 2 are ongoing and 4 are planned.