FDA Approves First Seasonal Flu Vaccine with Adjuvant, and More

Fluad – Seasonal Influenza

The FDA has approved Fluad, the first seasonal flu vaccine containing an adjuvant. Fluad contains 3 virus strains, and is approved for prevention of seasonal influenza in individuals 65 years and older.¹
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The vaccine is formulated with the adjuvant MF59, an oil-in0water emulsion of squalene oil. Adjuvants are used in some vaccines to enhance or direct immune response.

Fluad’s effectiveness were evaluated in a multicenter clinical trial in which 7082 participants were randomized between Fluad and an unadjuvanted trivalent influenza vaccine. Antibody levels induced in patients given Fluad were comparable to those in the unadjuvanted vaccine.

The vaccine’s safety was evaluated in nearly 27,000 individuals. No safety concerns were identified.

Fluad was first approved in Italy in 1997 and is currently approved in 28 countries.

Portrazza – Squamous Non-Small Cell Lung Cancer

The FDA has approved Portrazza (necitumumab) in combination with 2 forms of chemotherapy for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC).²

Portrazza is a monoclonal antibody that blocks activity of EGFR, a protein found on squamous NSCLC tumors.

The safety and efficacy of Portrazza was evaluated in a multicenter, randomized, open-label clinical study of 1093 participants with advanced squamous NSCLC who received chemotherapy with or without Portrazza. Those taking Portrazza lived longer on average (11.5 months) than those only taking chemotherapy (9.9 months)

The most common side effects are skin rash and magnesium deficiency.

BioThrax – Anthrax Disease

The FDA has approved a new indication for BioThrax to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacteria that causes anthrax. It is approved in conjunction with recommended antibiotic treatment.³

The safety of BioThrax was evaluated in a study of 200 healthy adults given subcutaneous injections in 3 doses at 0, 2, and 4 weeks. Most participants generated antibody responses that correlated to a 70% probability of survival if exposed to the disease.

—Michael Potts

References:

1 FDA. FDA approves first seasonal influenza vaccine containing an adjuvant [press release]. November 24, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474295.htm.

2. FDA. FDA approves Portrazza to treat advanced squamous non-small cell lung cancer [press release]. November 24, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474131.htm.

3. FDA. FDA approves vaccine for use after known or suspected anthrax exposure [press release]. November 23, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474027.htm.