Safety and Effectiveness: December 2006 Archives

A persistent criticism from opponents of the Pentagon’s anthrax vaccination program is the charge that defense officials purposely put squalene in some vaccine lots to boost troops’ immune responses and increase the length of time vaccine stocks would remain effective.

The Pentagon and the vaccine’s manufacturer have repeatedly denied those charges, but opponents continue to question whether the fatlike substance may have played a role in illnesses developed by some troops who got anthrax shots during the 1991 Persian Gulf War and in the early stages of the Pentagon’s mandatory anthrax vaccine program in the late 1990s.

BRISBANE, Calif., Dec. 18 /PRNewswire-FirstCall/ -- VaxGen, Inc. (Pink Sheets: VXGN.PK) announced today that the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has informed the company that it is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine. The hold is due to CBER's continued concerns about the vaccine candidate's stability.

The Department of Health and Human Services (HHS), under its contract with VaxGen to purchase 75 million doses of its recombinant anthrax vaccine, rPA102, had imposed a deadline of today, December 18, for the company to initiate its next clinical trial for the vaccine candidate. The Office of Public Health Emergency Preparedness (OPHEP), the office within HHS that administers the contract, has yet to inform VaxGen what direction it intends to take with respect to the contract.

Kozhikode, INDIA - Tetanus vaccination has been temporarily suspended following the death of Rupisha (15), daughter of Rajan of Kuttiyadi. A temporarily ban was put on the vaccine of Mumbai based Afkin Company which is suspected to be the cause of death of the girl. The health department ordered to suspend the vaccine used in the Vattoli sector.

Though the authorities stated that the death was not due to the tetanus vaccine, suspicion arose after temporarily suspending it. The sample of the medicine used for the tetanus injection at the Vattoli High School has been sent for analysis to the National Virology Institute at Hasoli in Himachal Pradesh. The decision to ban the injection temporarily was taken since it takes at least one month to get the report.

source - Keral Online 

CEDAR HILLS — Kara Davis is a staunch believer that you shouldn't give cocktails to babies, especially if a newborn is injected with one in the arm or foot before ever leaving the hospital.

But while Davis and a growing population of like-minded parents share their concerns out loud and on the Internet, others, including a majority of hospital doctors, say those "cocktails" — also known as vaccines — are crucial to saving lives.

Davis, 53, although not an expert, recently persuaded her son not to allow his newborn to receive a hepatitis B vaccine, which is normally administered within the baby's first 48 hours. Davis did allow her six children to be vaccinated when they were young, but that was before she started doing research that generated her ill feelings toward the common shots.

A highly effective live attenuated vaccine, developed more than 60 years ago from the 17D strain of yellow fever (YF) virus, has been a key tool in controlling this disease. The vaccine is given as part of national childhood immunization programs in some endemic areas, and many countries require travelers to provide proof of YF vaccination on entry. Three recent papers report adverse events following YF vaccination.

Researchers in the U.S. report 4 patients (63 and older) with multiple organ-system failure after vaccination with 17D-204 YF. Three died. Researchers found vaccine-related YF virus in the plasma and cerebrospinal fluid of 1 patient and YF antigen in the liver tissue of another. Convalescent sera (available for 2 patients) showed unusually high levels of antibodies.

CHILDREN and pregnant women in Scotland are being given a flu vaccination that has poisonous mercury.

Two years ago, the UK Government announced the withdrawal of mercury-based thiomersal vaccinations after they were linked to autism.

But Scottish Health Minister Andy Kerr last week confirmed it is still being used in flu vaccines north of the Border.

In reply to a question from the SSP's Carolyn Leckie, Kerr said: "In this year's flu programme, there is only one vaccine (Fluarix) which contains thiomersal and could be offered to pregnant women and children."