The European Commission generally follows the recommendations of the CHMP and delivers its final decision within two to three months. The EU submission for Focetria was considered a "mock-up" since it lays the groundwork for a more rapid approval and availability of a specific vaccine once a pandemic has been declared. Focetria would be manufactured to contain the pandemic influenza strain declared at the time of a pandemic along with the proprietary adjuvant MF59 developed by Novartis. Studies have shown that MF59 could boost the body's immune response to the vaccine's active constituent and extend vaccine supplies by allowing for smaller amounts of viral antigens to be used in each dose compared to vaccines without this additive. This positive recommendation for our proprietary MFadjuvanted pandemic vaccine brings us one step closer to achieving public health and pandemic preparedness goals," said Dr.
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Vaccine , 16 Apr , 29 26 : DOI: Read article at publisher's site DOI : Vaccine , 35 15 , 09 Mar Cited by 5 articles PMID: Vaccine , 33 51 , 09 Aug Cited by 1 article PMID: Hum Vaccin Immunother , 10 10 , 21 Nov Vaccine , 33 1 , 06 Nov Cited by 4 articles PMID: Pharmacol Res , , 10 Nov To arrive at the top five similar articles we use a word-weighted algorithm to compare words from the Title and Abstract of each citation.
Cited by 28 articles PMID: Vaccine , 29 6 , 18 Dec Cited by 10 articles PMID: BMJ , d, 25 Jan Cited by 13 articles PMID: Pediatrics , Suppl 1:S, 18 Apr Cited by 22 articles PMID: Vaccine , 29 43 , 05 Aug Cited by 11 articles PMID: Coronavirus: Find the latest articles and preprints.
Szmigiel A ,. Hidalgo-Simon A. Affiliations All authors 1. Share this article Share with email Share with twitter Share with linkedin Share with facebook. The number of vaccinees on 30 April was estimated to be at least 37,, with a reporting rate of per million vaccinees. Areas to be reinforced in order to improve the response to a future pandemic and to strengthen vaccine pharmacovigilance systems in general are highlighted. Observed-to-expected analyses were affected by uncertainties regarding the numbers of vaccinated individuals and age-specific background incidence rates.
Imbalance analysis used by the Agency may overcome some of these limitations but needs further development. A multinational vaccine health outcome resource is needed to assess the burden of vaccine preventable diseases and the epidemiology of potential adverse outcomes, and to quickly evaluate safety signals, estimate the utilization, benefits and risks of vaccines and evaluate the effectiveness of public health measures.
Pandemic Influenza A H1N1 v vaccines authorised via the core dossier procedure. Explanatory note on scientific considerations regarding the licensing of pandemic A H1N1 v vaccines. European Medicines Agency. CHMP recommendations for the pharmacovigilance plan as part of the risk management plan to be submitted with the marketing authorisation application for a pandemic influenza vaccine.
Revision 1. Committee for Human Medicinal Products CHMP Guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases. Twenty-second pandemic pharmacovigilance update. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. Show 10 more references 10 of Smart citations by scite.
The number of the statements may be higher than the number of citations provided by EuropePMC if one paper cites another multiple times or lower if scite has not yet processed some of the citing articles. Explore citation contexts and check if this article has been supported or contradicted. The incidence of childhood and adolescent seizures in the UK from to A retrospective cohort study using the Clinical Practice Research Datalink. Safety of ASadjuvanted inactivated split virion A H1N1 pdm09 and H5N1 influenza virus vaccines administered to adults: pooled analysis of 28 clinical trials.
Events supposedly attributable to vaccination or immunization during pandemic influenza A H1N1 vaccination campaigns in Latin America and the Caribbean. Ongoing pharmacovigilance on vaccines. Spontaneous reporting of adverse events following immunisation against pandemic influenza in Denmark November March Immunization-safety monitoring systems for the H1N1 monovalent influenza vaccination program.
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FOCETRIA EMEA PDF
Washington, D. FORM 6-K. Report on Form 6-K dated May 21, Commission File No. Novartis AG.
Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance.
Focetria® pandemic influenza vaccine receives positive European Union regulatory agency op