EMA Panel Backs Pandemic Avian Influenza Vaccine

Troy Brown, RN

Disclosures

April 01, 2016

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use recommended granting marketing authorization for the Pandemic Live Attenuated Influenza Vaccine (P/LAIV, AstraZeneca/MedImmune), according to an agency news release.

This development represents the first pandemic live attenuated influenza vaccine for avian influenza (H5N1) to receive approval recommendation in the European Union (EU). The vaccine is a live attenuated, nasal vaccine intended for use in children aged from 12 months to less than 18 years for pandemic preparedness during an officially declared pandemic situation. The nasal vaccine will be easily administered, according to EMA.

Pandemic Preparedness

"This positive recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorized in advance of a pandemic being declared. Once the World Health Organization 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," according to a company news release.

"The vaccine is based on the same biologically-active components currently used to make AstraZeneca/MedImmune's approved seasonal influenza vaccine, Fluenz™ Tetra (AstraZeneca). 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 company news release continues.

The vaccine's active substance is a live, cold-adapted, temperature-sensitive and attenuated reassortant influenza virus of the strain A/Vietnam/1203/2004 (H5N1), produced in Vero cells and then propagated in eggs (ATC code: J07BB03).

The vaccine's virus induces immunity by infecting and replicating in the nasopharyngeal cells of the vaccinated individual. One of the vaccine's benefits is its ability to robustly prime individuals who are naïve to H5N1, which results in an immune memory response that could occur as early as 4 weeks after priming and last for at least 4 to 5 years, as shown by subsequent re-exposure to H5N1 antigens, according to EMA.

Boosted immune responses from the vaccine were reported for up to 6 months and demonstrated broad cross-neutralizing activity against as many as four different clades of H5N1. Researchers found similar results with other potential pandemic strains, including H7N9 and H7N7.

Headaches, URI Symptoms Reported Most Frequently

Headaches and upper respiratory symptoms including nasal congestion and rhinorrhea were the most frequently reported side effects reported by adults in testing.

"The vaccine's safety profile is considered similar to that of Fluenz Tetra (live attenuated influenza seasonal vaccine); hence decreased appetite, headache, nasal congestion/rhinorrhea and malaise are expected to be very common side effects in children, and myalgia and pyrexia are expected to be common," according to the agency news release.

The full indication for the vaccine is: "Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age. Pandemic influenza vaccine H5N1 MedImmune should be used in accordance with official guidance."

A summary of the positive opinion is expected to be published without prejudice to the Commission Decision, usually within 67 days from adoption of the opinion. The product summary will provide detailed recommendations for the use of this product.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official EU languages after the European Commission grants marketing authorization, EMA states.

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