Via libera dell’Agenzia Europea del farmaco ai primi due vaccini contro l’influenza suina: sono stati i sieri Focetria e Pandemrix, prodotti rispettivamente dalla Novartis e dalla GlaxoSmithKline ad aver ricevuto il nulla osta ufficiale dal Comitato Emea per i medicinali destinati a uso umano. Ora per l’immissione in commercio bisogna attendere il visto formale della Commissione europea e poi le autorizzazioni dei singoli Paesi Ue, che sono attese a breve. Per altri due vaccini, Celvapan and Daronrix, è stata autorizzata la procedura cosiddetta ‘mock-up‘, ma non sono ancora stati approvati per l’uso nella corrente pandemia H1N1.
(via Adnkronos/Adnkronos Salute)
Questo dal sito dell’Emea: Vaccines
Influenza vaccines are used to immunise people against an influenza virus that is in circulation among the population. They are one of the most effective means for preventing people from becoming infected and, thus, for controlling the spread of the disease.
In a pandemic situation, it is important to make suitable vaccines available quickly and in large quantities. However, as with all medicines, vaccines still need to be assessed before they can be authorised for use, to ensure that their benefits outweigh any risks associated with their use.
In the European Union, procedures have been put in place to speed up the assessment and authorisation of vaccines that may prove vital in a pandemic situation.
Two vaccines that have benefited from these procedures, and which will thus be available for use in the current H1N1 influenza pandemic, are:
Focetria, which was recommended on 24 September 2009 by the European Medicines Agency for an EU-wide marketing authorisation.
Pandemrix, which was recommended on 24 September 2009 by the European Medicines Agency for an EU-wide marketing authorisation.
For further information on the scientific considerations regarding the licensing of pandemic A(H1N1)v vaccines is available in an Explanatory Note.
Other vaccines, including Celvapan and Daronrix, have been authorised as ‘mock up’ vaccines for potential use during an influenza pandemic, but have not yet been approved for use in the current H1N1 pandemic.
For further information on how pandemic influenza vaccines are assessed, approved for use and monitored in the EU, see Authorisation procedures.
via European Medicines Agencies – A/H1N1 Pandemic Influenza – Vaccine Information.
update: Fazio: influenza A, già pronte 500mila dosi, vaccinazioni al via entro fine ottobre. La Novartis è proprio una delle due aziende a cui è stata affidata la produzione dei vaccini in Italia. Mentre oggi tutti i giornali, prima delle dichiarazioni di Fazio, riportavano in bella vista questa notizia: Niente vaccino fino a Natale.