Posted by: Salvatore J. Zambri, founding partner
A massive recall of swine flu vaccine doses drew national attention recently when it was announced by the Center for Disease Control. ABC World News (12/15, story 6, 0:20, Gibson) reports that federal health officials “are recalling 800,000 children doses of swine flu vaccine…made by Sanofi Pasteur.” NBC Nightly News (12/15, story 2, 0:35, Williams) reported that the doses “are less potent than they should have been.”
The Los Angeles Times (12/16, Maugh) reports that Centers for Disease Control and Prevention director Dr. Anne Schuchat said the recall was “non-safety-related,” and was “part of a routine quality assurance program.” Schuchat emphasized that “children who received the vaccine do not need to be re-immunized,” but the agency “wanted to make sure that doses that weren’t already given won’t be.” The Washington Post (12/16, Stein, Laris) reports that “most of the vaccine, which was distributed nationwide in November, has probably already been used.”
Bloomberg News (12/16, Randall) reports that Sanofi “began delivering swine flu vaccine in the US in September, with the bulk of deliveries expected in the fourth quarter.” The United States “has ordered 75 million doses from the Paris- based company.” CQ HealthBeat (12/16, Norman) reports that the problem was identified during “ongoing quality assessments” made by the drugmaker. The New York Times (12/16, A28, Mcneil) reports that Dr. Schuchat “said the vaccine was fully potent at release but dropped by about 12 percent in follow-up tests.” In a story appearing in some form on over 320 news websites, the AP (12/16, Stobbe) reports that Jesse Goodman, the FDA’s deputy commissioner for science and public health, said the problem may be related to the antigen sticking to the walls of children’s pre-filled syringes.
USA Today (12/16, Sternberg) reports that the affected vaccine, “packaged in half-dose amounts meant for children 6 months to nearly 3 years old, represents about 1% of the nation’s H1N1 vaccine supply.” Sanofi spokesman Len Lavenda said the doses comprise roughly “18% of the 4.5 million doses in prefilled syringes made by Sanofi for children in that age group.” Lavenda commented that officials were “baffled” by the weakened vaccine, adding “we can’t remember a time when flu vaccine lost potency.” The Wall Street Journal (12/16, Dooren) reports that Sanofi will be notifying providers to return any unused doses.
Reuters (12/16, Fox) also reported on this story, while Time (12/16, O’Callaghan) mentioned the recall in their “Wellness” blog.
Please be careful when taking a vaccine or allowing a loved one to be injected. We urge you to speak with your doctor about all pros and cons of any drug before ingesting it.
About the author:
Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all lawyers in the Washington metropolitan area. The magazine also describes him as “one of Washington’s best–most honest and effective lawyers” who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims. Mr. Zambri has also been named a “Super Lawyer” by Super Lawyer magazine (March/April 2009)–a national publication that honors the top lawyers in America.
Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books – a company that is touted as “the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world’s most respected companies and law firms.” To read Mr. Zambri’s publication, entitled “Constantly Preparing To Win”, please click here.