October 2007 NVAC Meeting Minutes
Dr. Schuchat concluded her update by mentioning that the second international conference on congenital cytomegalovirus, “Public Health Action toward Awareness, Prevention, and Treatment,” will be held next year from November 5 through 7 in Atlanta. She thought the conference may be of interest to NVAC, especially due to the recent progress in vaccine development.
Dr. Riley asked if NCIRD had thought about looking at the Tdap recommendations for pregnant women. She wanted to know why pregnant women cannot be vaccinated during the third trimester so that the baby would develop passive immunity. Dr. Schuchat explained that NCIRD is trying to promote use of Tdap among adults but that they are not doing well with adult immunizations. However, she went on to explain that ACIP has a new Working Group that is focusing on vaccines in pregnancy. This Working Group is reviewing all current ACIP recommendations that mention pregnancy.
Advisory Commission on Childhood Vaccines (ACCV)/National Vaccine Injury Compensation Program (VICP)—Dr. Geoffrey Evans
Dr. Evans began his update by explaining that the number of claims received by the VICP has been fairly steady over time; however, this year there was an increase as the 2-year deadline ended for the filing of retroactive claims whenever a new vaccine is added to the VICP. To date, the program has received 184 claims for the flu vaccine, which is manageable.
Dr. Evans also reported that VICP received an increased number of autism claims since the June autism hearing. Of the now 4,900 active claims, most do not have medical records. Recently, the court decided that the United States Department of Justice should being conducting legal reviews of these claims to confirm they fall within the VICP’s statute of limitations. During the next fiscal year, Dr. Evans believes the court may also begin requiring medical reviews; however, this remains uncertain.
Dr. Evans then discussed the status of the Omnibus Autism Proceeding. There are three test cases for each of the three autism theories. The first two theories allege that either the MMR vaccine alone, or thimerosal can cause autism. The third “combined” theory alleges that both MMR and thimerosal, in combination, can cause autism. The decision on the first of the hearings is expected sometime in the spring of 2008, and the decision on the second set of hearings could be sometime in mid-2009. However, appeals are expected to follow which could take several years. It is believed the final outcome may not be known until 2010 or 2011.
Dr. Gellin asked whether countries other than the United States were reporting autism cases as well. Dr. Evans stated that the Legal Aid Foundation Office in the United Kingdom tried to put together a case; however, their funding was discontinued. He was unaware of any other cases in the United Kingdom or Canada.
Dr. Almquist wondered if after the first three theories have been tested, a fourth theory could be tested. He explained that Autism Speaks has been expressing concern regarding the total number of antigens introduced into children as a possible cause of autism. Dr. Evans stated that the court has gone out of its way to allow people to bring theories forward. Therefore, he would not rule it out. However, based on the deadlines set by the court, he thought it might be difficult to bring a fourth theory forward at this time.
Vaccines and Related Biological Products Advisory Committee (VRBPAC)/United States Food and Drug Administration (FDA)—Dr. Norman Baylor