July 29, 2009
Pregnant women: Among the more unusual aspects of the pandemic A/H1N1 flu is the tendency to cause more illness and death in young adults as compared to the more typical situation with seasonal flu (elderly, very young). The following is of note as it may force authorities to move pregnant women closer to the head of the list for the vaccine when it's available.
The AP (7/29) reports, "Swine flu has been hitting pregnant women unusually hard, so they are likely to be among the first group advised to get a new swine flu shot this fall. Pregnant women account for six percent of US swine flu deaths since the pandemic began in April, even though they make up just one percent of the US population." On Wednesday, a federal advisory panel "is meeting to take up the question of who should be first to get swine flu shots when there aren't enough for everyone," and "at the top of the list are healthcare workers." But "pregnant women may be near the top of the list," even though, so far, the "WHO has not recommended that pregnant women get priority vaccinations." Dr. Denise Jamieson, an epidemiologist with the CDC, "I think the whole concept that this flu only affects pregnant women with underlying medical conditions is incorrect."
Adjuvanted vaccines: It appears likely that the FDA will give approval to an adjuvanted vaccine for the first time as GSK, Sanofi Pasteur and Novartis are all pursuing this approach to spare the amount of antigen needed per dose as well as providing the means to increase the immune response. Of note, adjuvanted vaccines are already approved in Europe.
Bloomberg News (7/29) reports, "Swine flu vaccine makers may rely on a US emergency declaration to use experimental additives made by GlaxoSmithKline Plc and Novartis AG to boost a limited supply of shots that will be available to fight the pandemic." It would mark the first time adjuvants have been added to flu shot in the US. Safety concerns were raised "in 2004 when researchers at the University of Florida in Gainesville reported that mice injected with oils used in the adjuvants developed conditions of the type that occur when the body's immune system produces an excessive protective reaction. Similar reactions haven't been seen in humans." Under the US health emergency, "the FDA may authorize the use of unlicensed vaccines, according to Peper Long, an agency spokeswoman. The FDA convened an advisory committee July 23 to consider what trials are necessary for the vaccines' approval."
Mark M. Blatter, M.D.
Medical Director
Primary Physicians Research