Pandemic influenza vaccine receives positive CHMP opinion

AstraZenecaAstraZeneca and its global biologics research and development arm, MedImmune, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the conditional approval of Pandemic Live Attenuated Influenza Vaccine (P/LAIV). P/LAIV is indicated for the prevention of influenza in an officially declared pandemic in children and adolescents from 12 months to less than 18 years of age.

This positive recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorised in advance of a pandemic being declared. Once the World Health Organisation has declared an actual pandemic, a variation dossier specific for the pandemic strain can be submitted to the EMA for an accelerated assessment and approval. This provides an additional public health tool to protect European children when the next pandemic emerges.

P/LAIV is an intranasally administered vaccine that contains a live attenuated H5N1 strain of influenza virus. The vaccine is based on the same biologically-active components currently used to make AstraZeneca/MedImmune’s approved seasonal influenza vaccine, Fluenz™ Tetra. P/LAIV differs from Fluenz Tetra, because it protects against a single influenza A pandemic strain as opposed to four seasonal strains in Fluenz Tetra.

The positive CHMP opinion was based on a review of safety and immunogenicity studies of the H5N1 vaccine conducted in collaboration with the US National Institutes of Health as well as by the comprehensive clinical data that demonstrate the safety and efficacy for Fluenz Tetra in children.

The CHMP’s opinion will now be advanced to the European Commission for adoption of a decision on EU-wide marketing authorisation of the vaccine as a pandemic preparedness vaccine. The final decision will be applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.

About Influenza Pandemics
Influenza pandemics are defined as world-wide flu epidemics with high levels of morbidity and mortality. An influenza pandemic can occur when a non-human (novel) influenza virus for which individuals have limited or no immunity gains the ability to be transmitted easily between humans and then spreads globally. The last pandemic occurred in 2009 and the global mortality rate has been estimated between 18,000 and 186,300 deaths.

About FluMist®/Fluenz™
FluMist® Quadrivalent (US brand name) / Fluenz™ Tetra (EU brand name) is the only widely available quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray and contains four protective strains for the prevention of influenza.

FluMist was originally approved in the US in 2003 and since the original approval, more than 100 million doses have been distributed around the world. Since 2013 it has become the vaccine of choice in the UK’s largest pediatric vaccine programme and preferential recommendations have also been adopted by vaccine advisory groups in Canada, Finland, Sweden (high-risk individuals) and Germany (high-risk individuals). A general recommendation for quadrivalent LAIV in people aged two to 49 has been adopted in the US.

About MedImmune
MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology - as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Most Popular Now

Regorafenib to be tested in brain cancer patients …

Bayer announced that the regorafenib arm of the platform trial "GBM AGILE" (Glioblastoma Adaptive Global Innovative Learning Environment) opened for enrollment in the US ...

Sanofi and Google to develop new healthcare Innova…

Sanofi and Google will establish a new virtual Innovation Lab with the ambition to radically transform how future medicines and health services are delivered by tapping i...

Bristol-Myers Squibb provides update on pending me…

Bristol-Myers Squibb Company (NYSE: BMY) today provided an update on the approval process and timeline for the Company’s pending merger with Celgene Corporation (NASDAQ: ...

Artificial DNA can control release of active ingre…

A drug with three active ingredients that are released in sequence at specific times: Thanks to the work of a team at the Technical University of Munich (TUM), what was o...

LEO Pharma completes the acquisition of Bayer’s pr…

LEO Pharma and Bayer announced today the achievement of the relevant closing conditions to allow the transfer of Bayer’s global prescription dermatology business to LEO P...

Pathogen engineered to self-destruct underlies can…

A team of investigators has developed a cancer vaccine technology using live, attenuated pathogens as vectors. A feature of the vaccine causes these bacteria to self-dest...

Novartis successfully completes acquisition of Xii…

Novartis today announced that it has completed its acquisition of Xiidra® (lifitegrast ophthalmic solution) 5%, the first and only prescription treatment approved to trea...

How gastric stem cells fight bacteria

Stem cells are not only key players in tissue regeneration, they are also capable of taking direct action against bacteria. This is the finding of a study conducted by re...

New study showing drug prolongs life for patients …

Women with ovarian cancer who have undergone four or more rounds of chemotherapy typically haven't had much hope that another treatment option will lengthen their lives i...

Pfizer completes acquisition of Therachon

Pfizer Inc. (NYSE: PFE) announced the successful completion of its acquisition of the privately held clinical-stage biotechnology company Therachon Holding AG. Under the ...

Sports playbook helps doctors predict cancer patie…

In this season of global soccer competitions and hotly contested political primaries, bookies and pundits are scouring every evolving scrap of information and sifting thr...

FDA seeks public feedback on new drug approval tra…

Today the U.S. Food and Drug Administration issued a Federal Register notice, New Drugs Regulatory Program Modernization: Improving Approval Package Documentation, to ope...