FDA approves Flublok, a trivalent influenza vaccine not made with eggs
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday approved Protein Sciences’ Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology.
“This approval represents a technological advance in the manufacturing of an influenza vaccine,” stated Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “The new technology offers the potential for faster startup 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.”
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 — 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.
According to a post on Protein Sciences’ website, Flublok supply is limited for the 2012-2013 influenza season. The company expects to have full production available during the 2013-2014 influenza season. The makeup of that vaccine will be determined in the spring by health officials.
For the 10-page package insert on Flublok, click here.
The shot, which contains three times the active ingredient as compared with many other flu vaccines, is administered to a patient’s upper arm. Subsequent side effects are similar to that of flu shots currently on the market. In an effectiveness study of about 4,500 people, Flublok was about 44.6% effective versus placebo against all circulating influenza strains, not just the strains that matched the strains included in the vaccine.
Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age. 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. Protein Sciences is also working on a pandemic vaccine Panblok, which is designed to protect against pandemic influenza in partnership with the Biomedical Advanced Research and Development Authority, a division of the U.S. Department of Health and Human Services.
Flublok has a shelf life of 16 weeks from the date of manufacture. Healthcare providers should check the expiration date before administering Flublok.
In anticipation of the approval, in November Protein Sciences leased a production facility from Pfizer at the Pearl River Campus in Rockland County, N.Y.
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Coalition for Pulmonary Fibrosis, CDC partner to promote flu shots
CULVER CITY, Calif. — An advocacy group focused on a rare lung disorder is working with government authorities to educate patients about the need to get flu shots.
The Coalition for Pulmonary Fibrosis said it would partner with the Centers for Disease Control and Prevention to inform patients about the need for immunizations. PF is a disorder with no known cause or cure that causes scarring and deterioration of the lungs, affecting about 128,000 Americans.
"We value the CDC’s recommendations for flu shots for our patients," coalition CEO Mishka Michon said. "PF patients have lungs that are already fragile and many of them can’t afford to be exposed to additional risk."
According to the CDC, patients with chronic lung diseases such as PF are 2.5 times more likely to be hospitalized due to the flu.
Giffen releases STD-prevention app
NEW YORK — A new app allows people to share their STD statuses with potential partners.
Giffen Solutions announced the launch of MedXSafe, a new feature to its MedXCom Patient platform. The app allows people to bump phones with a potential partner and exchange contact information as well as their STD status. Giffen emphasized that users choose to share their information and that the app doesn’t violate medical confidentiality laws, and only licensed healthcare providers can register to use the MedXCom system.
"In our view, anything that helps the war against STDs is a good idea," MedXCom creator and Giffen chief technical officer Michael Nusbaum said. "There has been a relaxed attitude towards STDs lately as many people think medicine can cure all — it can’t."