News of the Day ... In Perspective10/31/2006
Israel suspends, restarts flu shots; U.S. researchers find them safe for children; efficacy questioned
When four patients, aged 52-76, died unexpectedly after receiving influenza vaccine, the Israeli Health Ministry instructed health facilities to suspend vaccinations immediately. All the injections were from the same vaccine pool. It was unclear whether there was any connection between the injections and the deaths (Haaretz.com 10/22/06).
Shots were resumed the next day. Health Minister Yaakov Ben-Yizri had a flu shot on live television at the end of a news conference.
"All of the experts, all of the doctors, all of the pathologists,...ruled out completely the possibility of a connection between the unfortunate incidents...and the vaccination," he told reporters (News-Leader, Springfield, MO, 10/23/06).
Sanofi-Aventis sent experts from France to study the deaths. An autopsy showed that at least one death was caused by a heart attack.
Meanwhile, a CDC-funded study concluded that influenza vaccine is safe for babies and toddlers, according to an Associated Press story. Based on chart reviews, researchers found that "45,000 children showed almost no side effects." Thus, "we can move ahead with great, great confidence," stated Dr. William Schaffner of Vanderbilt University, who was not involved in the study. While nine of the study's 19 coauthors reported financial ties to vaccine manufacturers, industry had no direct role in the study (Ariz Daily Star 10/25/06).
Although the Advisory Committee on Immunization Practices (ACIP) has recommended influenza vaccines for all children between 6 and 23 months old since the winter season 2004-2005, this is the first large safety study conducted in young children. It sought "medically attended events" within 6 weeks after vaccination. Of 14 ICD-9 codes that showed significant differences from control periods, all but one occurred less frequently after vaccination.
The authors also note in their conclusions that "there is scant data on the efficacy and effectiveness of influenza vaccine in young children." (See Hambidge SJ et al. JAMA 2006;296:1990-1997).
In fact, there is only poor and contradictory evidence of the effectiveness of the inactivated influenza vaccine in any age group, according to an Oct. 28 BMJ article entitled "Influenza Vaccination: Policy Versus Evidence" by Tom Jefferson, coordinator of the vaccines field at the Cochrane Collaboration. Along with other methodologic defects, there is heavy reliance on non-randomized studies.
Despite a dataset of several million observations in a general population of elderly persons, safety was reported in only five randomized controlled trials with 2963 total observations, which concerned local and systemic adverse reactions occurring within one week of the injection.
"Although there appears to be no evidence that annual revaccination is harmful, such a lack of knowledge is surprising," Jefferson stated (Jefferson T. BMJ 2006;333:912-915).
Jefferson's call for an urgent reevaluation of the UK’s vaccination campaign, which costs more than 150 million pounds annually, was widely covered in the British and Canadian press, but not the American.