Thomson Reuters News & Insight
Featured Content from WESTLAW

Legal

  •  
  •  

Injection, file 2009. REUTERS Phil Noble

FDA approves novel type of flu vaccine

1/17/2013 COMMENTS (0)

Jan 16 (Reuters) - The U.S. Food and Drug Administration on Wednesday approved the first influenza vaccine made using recombinant DNA technology, rather than live flu virus.

Flublok, made by Protein Sciences Corp, was approved for the prevention of seasonal influenza in people 18 through 49 years of age, the regulatory agency said. FDA said that unlike current vaccines Flublok does not use the influenza virus or eggs in its production.

Recombinant DNA technology allows the genetic material to be produced artificially by joining different strands of DNA in the laboratory.

"This approval represents a technological advance in the manufacturing of an influenza vaccine," Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "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."

Flublok's manufacturing technology allows for production of large quantities of the influenza virus protein, hemagglutinin - the active ingredient in all inactivated influenza vaccines that is essential for entry of the virus into cells in the bodies.

As it does with all flu vaccines, the FDA said it will evaluate Flublok annually prior to use by the public each flu season.

Flublok was evaluated in a study of about 2,500 people. The most commonly reported adverse events included pain at the site of injection, headache, fatigue and muscle aches, which are also side effects typical for conventional egg-based, inactivated influenza vaccines.

Follow us on Twitter @ReutersLegal | Like us on Facebook   


Register or log in to comment.

© 2013 Thomson Reuters