Advisory Committee for Immunization Practices
From the Executive Director: The CDC’s Advisory Committee for Immunization Practices considers using “evidence -based” guidelines for vaccine recommendations.
Over the past decade, I have attended several meetings of the Advisory Committee for Immunization Practices (ACIP) held at the Centers for Disease Control and Prevention (CDC) in Atlanta. The committee is charged with making recommendations on the use and administration of vaccines approved by the FDA. ACIP recommendations are then adopted by individual states and become state law. The committee came under fire by Congress in 2000 when it was revealed that six of the eleven voting members of the committee, at that time, had financial interests in the pharmaceutical companies that manufacture vaccines and that, for the prior 10 years, every one of the recommendations by the ACIP had been accepted by the CDC and translated into public law. This is also the committee who has flatly refused to state a preference for thimerosal free vaccines for pregnant women, infants and children despite recommendations from the Institute of Medicine to do so and the urgent plea by SafeMinds and fourteen other organizations.
What was different at the most recent ACIP meeting, held June 23-24, 2010, is that the first session opened with a discussion surrounding the utilization of “evidence- based” guidelines for deciding vaccine recommendations. It may be surprising to many of you that the committee had not been using such guidelines in the past. According to a presentation by the American College of Physicians (ACP), the U.S.’s largest medical specialty organization, the development of an ACIP evidence-based work group was largely due to pressure from ACP and other professional societies.
The ACIP evidence-based work group then presented their findings. Key elements for consideration of a vaccine recommendation using an evidence- based approach would include safety, efficacy and burden of illness. Vaccine recommendations would be scored using grades of A, B, C or D based on the strength of the science supporting the recommendation. Click here for the presentation. Although the utilization of evidence- based guidelines was supported by the American Academy of Pediatrics, the American Academy of Family Physicians and the ACP, one organization, the Infectious Disease Society of America (IDSA) spoke in opposition. Dr. Samuel Katz, representing IDSA, felt the recommendations would result in an erosion of public confidence in vaccine recommendations and that the anti-vaccine groups would exploit the rating system to cast doubt on ACIP recommendations that received a low score for being based on scientific evidence. SafeMinds views this initiative as a scientific step forward for the ACIP and looks forward to seeing the work group recommendations translated into committee policy.
Update on Rotavirus Vaccine Contamination with Pig Viruses
The ACIP also received updates from both Merck and GlaxoSmithKline regarding the contamination of their rotavirus vaccines with porcine circoviruses. There was also a presentation from the FDA Center for Biologics Evaluation and Research (CBER) on the meeting in May where the recommendation for suspension of the contaminated vaccines was discussed. The presentation indicated that risks from vaccine contamination with adventitious agents like viruses may be difficult to assess. SafeMinds spoke during the public comment period acknowledging that while the technology to detect genetic contamination of vaccines was not available until relatively recently, the dangers of generating new viruses and bacteria that can cause disease were foreseen by the pioneers of genetic engineering. Horizontal gene transfer (HGT) refers to the direct uptake and incorporation of genetic material from unrelated species, in this instance from adventitious viral contaminants in live viral vaccines, into a human host’s DNA. Unlike chemical pollutants which break down and become diluted, these nucleic acid contaminants are infectious; they can invade cells and genomes, multiply, mutate and recombine indefinitely. Potential hazards of HGT include the generation of new viruses and bacteria that can cause disease, spreading drug and antibiotic resistance genes making infections untreatable, random insertion into genomes of cells resulting in harmful effects including cancer and reactivation of dormant viruses which may cause disease. Click here for SafeMinds public statement.