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A new trivalent influenza vaccine approved by the Food and Drug Administration Jan. 16 is the first to be made without eggs.
Instead, Flublok’s manufacturer, Protein Sciences Corp. of Meriden, Conn., uses the expression system of baculovirus (an insect virus) and recombinant DNA.
"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," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The vaccine is indicated for the prevention of seasonal influenza in people aged 18-49 years. It proved 44.6% effective against all circulating influenza strains, not just the three it contains, when tested in about 2,300 people against placebo shots in about the same number.
Side effects were similar to those for egg-based flu vaccines and included injection-site pain, headache, fatigue, and muscle aches. Flublok has a shelf life of 16 weeks, the agency noted, and its manufacturing technique is already in use for other approved vaccines.
Flublok contains full-length, recombinant hemagglutinin proteins against H1N1 and H3N2 influenza A strains and one influenza B strain.
A new trivalent influenza vaccine approved by the Food and Drug Administration Jan. 16 is the first to be made without eggs.
Instead, Flublok’s manufacturer, Protein Sciences Corp. of Meriden, Conn., uses the expression system of baculovirus (an insect virus) and recombinant DNA.
"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," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The vaccine is indicated for the prevention of seasonal influenza in people aged 18-49 years. It proved 44.6% effective against all circulating influenza strains, not just the three it contains, when tested in about 2,300 people against placebo shots in about the same number.
Side effects were similar to those for egg-based flu vaccines and included injection-site pain, headache, fatigue, and muscle aches. Flublok has a shelf life of 16 weeks, the agency noted, and its manufacturing technique is already in use for other approved vaccines.
Flublok contains full-length, recombinant hemagglutinin proteins against H1N1 and H3N2 influenza A strains and one influenza B strain.
A new trivalent influenza vaccine approved by the Food and Drug Administration Jan. 16 is the first to be made without eggs.
Instead, Flublok’s manufacturer, Protein Sciences Corp. of Meriden, Conn., uses the expression system of baculovirus (an insect virus) and recombinant DNA.
"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," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The vaccine is indicated for the prevention of seasonal influenza in people aged 18-49 years. It proved 44.6% effective against all circulating influenza strains, not just the three it contains, when tested in about 2,300 people against placebo shots in about the same number.
Side effects were similar to those for egg-based flu vaccines and included injection-site pain, headache, fatigue, and muscle aches. Flublok has a shelf life of 16 weeks, the agency noted, and its manufacturing technique is already in use for other approved vaccines.
Flublok contains full-length, recombinant hemagglutinin proteins against H1N1 and H3N2 influenza A strains and one influenza B strain.
