Date: 2012-03-07
Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Vepacel®
Compound: pre-pandemic influenza vaccine composed of purified, inactivated whole influenza virion
Therapeutic area: Infectious diseases
Action mechanism: Vepacel® is a pre-pandemic influenza vaccine manufactured using Baxters proprietary advanced Vero cell technology.
Vepacel® is composed of purified, inactivated whole influenza virion, licensed as a suspension for injection containing 7.5 µg haemagglutinin (HA) antigen per 0.5 ml dose.
Vepacel® has the potential to generate a broader immune response than conventional egg-derived vaccines due to its use of Vero cell technology, which allows for use of the natural influenza virus (identical in protein composition to the virus circulating in nature) in vaccine production.
Company: Baxter (USA)
Disease: active immunization in adults 18 years and older (including immunocompromised and chronically ill patients) against the H5N1 subtype of influenza A (A/Vietnam1203/2004), commonly known as bird or avian flu
Latest news: * On October 24, 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positiveopinion recommending a variation to the terms of the marketing authorisation for Vepacel®. The CHMP adopted a new indication as follows: active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains.
* On March 2, 2012, Baxter International has announced that the European Commission has granted marketing authorization for Vepacel® in all European Union Member States, as well as Iceland , Liechtenstein and Norway.
* On 15 December 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vepacel, 7.5 ?g Haemagglutinin (HA) antigen per 0.5 ml dose, suspension for injection intended for the prophylaxis of H5N1 subtype of influenza A in either a pre-pandemic or pandemic situation in adults aged 18 years and older. The benefits with Vepacel® are its ability to mount an appropriate immune response in individuals from the age of 18 years onwards that are immunologically naïve against the vaccine strain, including immunocompromised and chronically ill subjects. The most common side effects are injection site reactions, headache and fatigue.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2012-03-02
Favourable opinion UE: 2011-12-15
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
