The H1N1 vaccination will be available the first full week of October, sooner than expected, according to presenters at a teleconference sponsored by the Centers for Medicare and Medicaid Services, Sept. 14. And the vaccine will be free.

In a CMS Hospitals Open Door Forum, basically an update on all things connected to H1N1, presenters addressed H1N1 vaccine safety, immunization, surge capacity, documentation of vaccine administration, fees, personal protective equipment, liability issues and infection control.

The vaccine "will be distributed pro rata to states and territories," according to Capt. Clare Helminiak, MD, co-chair of the CMS Hospitals Open Door Forum (for a list of the order in which the vaccine will be distributed go to www.cdc.gov). Be aware physicians' offices or facilities that give shots may charge for administration costs.

Getting the H1N1 vaccine as well as the seasonal flu vaccine is voluntary and can be done at the same time, Helminiak continued. "But," she suggested, "since the seasonal flu is available, get that now and then get the H1N1 vaccine when it's available."

Sept. 13, Kathleen Sebelius, secretary of Health and Human Services, said the earliest doses will be used for healthcare workers and high-priority groups, which the CDC lists as: pregnant women, healthcare workers and emergency medical responders, people caring for infants under 6 months of age, children and young adults from 6 months to 24 years, and those aged 25 to 64 years with underlying medical conditions, such as diabetes and asthma.  

Presenters at the Hospitals Open Door Forum stressed adults need only one shot to be sufficiently immunized, with immunization kicking in about 10 days after vaccination. Previously it was thought two doses were necessary for adults. "Whether [very young] children and the elderly will need two doses won't be known until the end of the month," reported Nicole Lurie, MD, assistant secretary for Preparedness and Response, Department of Health and Human Services, at the forum.

Safety Questions
Whether one needs one dose or two, Philip R. Krause, MD, FDA Center for Biologics Evaluation and Research, said the vaccine is safe.

"H1N1 vaccine is manufactured and tested using the same process as the seasonal flu vaccine," Krause said. The only difference is H1N1 uses a different seed virus. "There have been no safety signals in testing [the H1N1 vaccine] so far; no curious adverse events," Krause said, adding that "safety of the vaccine will be closely monitored" throughout trials and administration to the general population. "Side effects to date are mild fever, body aches," he noted. The vaccine began testing in mid-July.

Krause did caution that since all flu vaccines are produced using eggs, "those allergic to eggs shouldn't get this vaccine."