FDA Approves H5N1 Influenza Vaccine

The US Food and Drug Administration (FDA) has approved an adjuvanted influenza A H5N1 monovalent vaccine (Audenz). The approval was granted to Seqirus.

The vaccine is approved for individuals 6 months of age or older to protect against influenza A H5N1. The vaccine is the first adjuvanted, cell-based vaccine designed to be used against H5N1 in a potential pandemic scenario.

According to a press release issued by Seqirus, pandemic influenza carries the additional risk of morbidity and mortality because of limited pre-existing immunity to the virus. The new vaccine can be stockpiled for use and is designed to be able to be rapidly deployed.

“If the A (H5N1) virus were to change and become easily transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be very serious, with an approximate 60% mortality rate,” the company wrote in the statement.

The FDA granted fast track designation for the vaccine in December 2015. Fast track allows the FDA to expedite review of drugs that fulfill an unmet medical need.

Seqiris has a public-private partnership with the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) which would allow the company to manufacture the vaccine on a pandemic scale.

The inactivated vaccine is approved for use in people 6 months of age and older who are at increased risk of exposure to H5N1 influenza.

Use in children aged 6 months through 17 years was approved under accelerated approval based on the immune response elicited. Continued approval for use in this age group may be dependent on further verification with a confirmatory trial.

In children aged 6 through 17 years, the most common adverse reactions reported in clinical trials were injection site pain (68%), myalgia (30%), fatigue (27%), malaise (25%), headache (22%), decreased appetite (14%), nausea (13%), and arthralgia (13%).

In adults 18 to 64 years of age, the most common adverse reactions reported in clinical trials were injection site pain (64%), fatigue (25%), headache (25%), malaise (22%), myalgia (14%), arthralgia (10%), and nausea.

In adults 65 years of age and older, the most common adverse reactions reported in clinical trials were injection site pain (36%), fatigue (20%), malaise (16%), headache (16%), and arthralgia (10%).

"Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives," said BARDA Director Rick Bright, PhD in the press release. "Ultimately, this latest licensure means we can protect more people in an influenza pandemic."