For Immediate Release: Jan. 16, 2013
Media Inquiries: Rita Chappelle, 301-796-4672,
rita.chappelle@fda.hhs.govConsumer Inquiries: 888-INFO-FDA,
OCOD@fda.hhs.gov
FDA approves new seasonal influenza vaccine made using novel technology
The
U.S. Food and Drug Administration today announced that it has approved
Flublok, the first trivalent influenza vaccine made using an insect
virus (baculovirus) expression system and recombinant DNA technology.
Flublok is approved for the prevention of seasonal influenza in people
18 through 49 years of age.
Unlike current flu vaccines, Flublok
does not use the influenza virus or eggs in its production. Flublok’s
novel manufacturing technology allows for production of large quantities
of the influenza virus protein, hemagglutinin (HA) – the active
ingredient in all inactivated influenza vaccines that is essential for
entry of the virus into cells in the body. The majority of antibodies
that prevent influenza virus infection are directed against HA. While
the technology is new to flu vaccine production, it is used to make
vaccines that have been approved by the FDA to prevent other infectious
diseases.
“This approval represents a technological advance in the
manufacturing of an influenza vaccine,” said Karen Midthun, M.D.,
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.”
Each
year, the FDA, World Health Organization, the Centers for Disease
Control and Prevention and other public health experts collaborate on
the review of influenza disease surveillance and laboratory data
collected from around the world in an effort to identify strains that
may cause the most illness in the upcoming season. Based on that
information and on the recommendations of the FDA’s Vaccines and Related
Biological Products Advisory Committee, the FDA selects the different
influenza strains each year that manufacturers should include in their
vaccines for the U.S. population for the upcoming influenza season. The
closer the match between the circulating strains causing disease and the
strains in the vaccine, the better the protection against influenza.
Flublok
contains three, full-length, recombinant HA proteins to help protect
against two influenza virus A strains, H1N1 and H3N2, and one influenza
virus B strain.
As it does with all influenza vaccines, the FDA
will evaluate Flublok annually prior to use by the public each flu
season. The recombinant HA proteins produced in the baculovirus
expression system and included in Flublok will be assessed by the FDA.
The
effectiveness of Flublok was evaluated in a study conducted at various
sites in the United States that compared the use of Flublok in about
2,300 people to a placebo that was given to a control group of similar
size. Flublok was about 44.6 percent effective against all circulating
influenza strains, not just the strains that matched the strains
included in the vaccine.
Flublok’s safety evaluation was conducted
in a study of about 2,500 people who were vaccinated with Flublok. The
most commonly reported adverse events included pain at the site of
injection, headache, fatigue and muscle aches, events also typical for
conventional egg-based, inactivated influenza vaccines.
Flublok
has a shelf life of 16 weeks from the date of manufacture. Health care
providers should check the expiration date before administering Flublok.
Flublok is manufactured by Protein Sciences Corp, of Meriden, Conn.
For more information:
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm335891.htm