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FDA approves egg-free influenza vaccine
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The FDA approved this week the first trivalent influenza vaccine made using an insect virus expression system and recombinant DNA technology. The vaccine is indicated for prevention of seasonal influenza in patients aged 18 to 49 years, according to a press release from the FDA.
Flublok (Protein Sciences Corp.), unlike current influenza vaccines, does not use the influenza virus or eggs in its production. This manufacturing technology allows production of large quantities of hemagglutinin. Although this technology is new to influenza vaccine production, it is used to produce other FDA-approved vaccines.
Karen Midthun
“This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic because it is not dependent on an egg supply or on availability of the influenza virus.”
The vaccine includes an influenza A/H1N1 and influenza A/H3N2 strain, and one influenza virus B strain. The vaccine’s effectiveness was evaluated in a US study conducted at various sites that compared Flublok vs. placebo in approximately 2,300 patients in each group. The vaccine proved about 45% effective against all circulating influenza strains, not just the strains that matched the strains included in the vaccine.
The most commonly reported adverse events included pain at the site of injection, headache, fatigue and muscle aches.
Flublok has a shelf life of 16 weeks from the date of manufacture. Health care providers should check the expiration date before administering the vaccine, according to the FDA.