1. The FDA’s recent approval of a trivalent seasonal influenza vaccine made using novel manufacturing technology marks a significant milestone in the ongoing battle against this life-threatening illness. According to a Jan. 16 FDA release, Flublok, which is approved for use in adults ages 18-49, does not rely on the traditional method of growing the targeted influenza virus strains in chicken eggs and, thus, can be produced more rapidly than current vaccines.
The vaccine is the first such antitoxin that does not require the use of chicken eggs or live viruses during the production process. Instead, the company uses an insect virus (baculovirus) expression system and recombinant DNA technology to generate purified hemagglutinin antigens specific to each flu virus strain included in the annual vaccine.
the new vaccine does not use the whole influenza virus or eggs in its production, so it is safe for people with egg-related allergies. Moreover, the preservative-free vaccine is formulated to contain three times the active ingredients found in other available flu vaccines and may confer greater immunogenicity in elderly and immunocompromised patients.
In its release, the FDA noted that the vaccine’s effectiveness was evaluated in a study comparing about 2,300 people vaccinated with Flublok to a control group of similar size that was given a placebo.
“Flublok was about 44.6 percent effective against all circulating influenza strains, not just the strains that matched the strains included in the vaccine,” the release said. “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.”
The company will distribute approximately 100,000 doses in 2013, primarily to pre-identified customers and practices that have special needs. At the same time, Dunkle said, the company is expanding to a new manufacturing facility, which it expects will allow it to offer 3-5 million doses during the 2013-14 season.
Typical flu vaccines are 60-70 percent effective against the circulating strains.
2. Medicago USA, a subsidiary of the Canada-based company, was previously awarded a $21 million agreement with the Defense Advanced Research Projects Agency for a proof-of-concept demonstration to produce 10 million doses of a vaccine candidate in 30 days. The company said the project was successfully completed in July
Medicago is developing vaccine candidates that use “virus-like particles” that mimic the structure of a virus, allowing them to be recognized by the body’s immune system. However, they do not contain the virus’ genetic material, so they’re not infectious.