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October 2007 NVAC Meeting Minutes - page 12 / 40





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October 2007 NVAC Meeting Minutes

and efficacy and ACIP evaluating vaccines for their safety, cost-effectiveness, efficacy, and the target population to select. Dr. Feinberg stated that it was not clear whether there was going to be an additional level of review that would happen at the State level. He was concerned that there would be significant delays, complexity, and variations from State to State.

Dr. Gordon said that the White Paper specifically addresses mandates or State laws that require immunization as a prerequisite for school admission. He went on to explain that it is in the purview of the individual States to make the decisions regarding the passage of laws. He explained that this is a separate matter from NVAC recommendations and that the White Paper does make clear the importance of the ACIP recommendations.

Dr. Feinberg continued to express concern about the States’ ability to evaluate vaccine safety issues, especially when the FDA, ACIP, and CDC are all actively engaged in monitoring and evaluating vaccine safety. Dr. Humiston asked if Dr. Feinberg was suggesting striking the words “safety profile” from the last line on page 11 of the White Paper. Dr. Feinberg agreed with the change suggested by Dr. Humiston. He also brought the Committee’s attention to table 2 on page 21, which also contained language about safety and target population.

Dr. Gordon said that although experts from the FDA, the NIH, and sometimes the CDC were involved in developing and licensing a vaccine, the vaccine is tested only on a representative population. Therefore, safety was a concern for the States. Dr. Birkhead asked that the document be amended to make clear that the recommendation is not that States undertake their own safety assessment. He explained that States have to assume that if a vaccine is on the market and recommended for use, safety issues have been addressed.

Dr. Birkhead noted that States do not immediately create mandates upon ACIP approval; the barriers relate to vaccine supply, financing issues, and getting the vaccine accepted into practice. Dr. Gordon said that they tried to make the recommendations very general as they will vary by product.

Dr. Pavia agreed with Dr. Birkhead’s comments and said that safety would become an added benefit of the need to wait to establish the supply, financing, and logistical issues of the vaccine. He proposed adding a sentence to the end of the document showing that an additional benefit to establishing these criteria before mandates are considered would be that more safety data would have accumulated.

Dr. Schuchat asked whom the recommendations are for. She also asked if the Committee discussed the legality of the recommendations from NVAC being aimed more broadly than to States—to advocacy groups or pharmaceutical companies, for instance, that often drive State activities. Ms. Levine stated that part of the advantage of the Assistant Secretary of Health making the recommendations directly to the State legislatures is that there are antilobbying restrictions on grassroots lobbying.

Dr. Clover commented on the fact that issues around transmissibility of vaccine-preventable diseases were discussed in the body of the text of the White Paper but not in the recommendations. Dr. Gordon explained that the Working Group considered whether mandates were intended to address only diseases that are casually transmitted in a school setting or whether they were a capture point used to encourage vaccination. He explained that the initial focus was on school transmission but that the report includes more examples on the capture aspect. Because there are different circumstances for different diseases, the Working Group decided to identify the issues but not make a recommendation either that mandates be restricted to diseases casually transmitted in a school environment or that mandates encourage the use of the school as a capture point.

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