The H1N1 vaccination will be available sooner than expected, according to presenters at a teleconference sponsored by the Centers for Medicare and Medicaid Services (CMS), and the vaccine will be free.

In a CMS Hospitals Open Door Forum, 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," said 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, since the seasonal flu is available, get that now and then get the H1N1 vaccine when it's available."

Kathleen Sebelius, secretary of Health and Human Services, said the earliest doses will be used for health care workers and high-priority groups, which the CDC lists as: pregnant women, health care 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," said Nicole Lurie, MD, assistant secretary for Preparedness and Response, Department of Health and Human Services, at the forum.

Safety Questions

"H1N1 vaccine is manufactured and tested using the same process as the seasonal flu vaccine," said Philip R. Krause, MD, FDA Center for Biologics Evaluation and Research. 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 says, 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."

Perennial Concern

Another safety concern has been the issue of thimerosal as a preservative in vaccines. According to the FAQs section at www.flu.gov, since 2001 no new pediatric vaccine licensed by the FDA has used thimerosal, "except for multidose formulations of influenza vaccine." The 2009 H1N1 influenza vaccines that FDA is approving will be manufactured in several formulations. Some will come in multidose vials and will contain thimerosal as a preservative. Multidose vials of seasonal influenza vaccine also contain thimerosal to prevent potential contamination after the vial is opened. Some vaccine manufacturers will be producing 2009 H1N1 influenza vaccine in single-dose units, which will not require the use of thimerosal as a preservative. In addition, the live-attenuated version of the vaccine, which is administered intranasally (through the nose) is produced in single units and will not contain thimerosal, according to www.flu.gov.

The Web site states removing thimerosal as a preservative in pediatric vaccines "was done as a precautionary step and not because there was evidence confirming that thimerosal-containing vaccines were causing health problems. The most recent and rigorous scientific research does not support the hypothesis that thimerosal-containing vaccines are harmful."

Ensuring Continued Operation

Roslyne Schulman, senior associate director for Policy Development at the American Hospital Association, addressed surge issues. "We have done a lot of planning coordinating state and local health departments but the real factor is the health of our staffs. Hospitals are encouraging seasonal flu shots for employees. . We have heard members' concerns about inadequate supplies of N95 respirators and other PPEs."

Schulman said N95 respirators must be fit-tested and that should be done now. However, there is concern that there aren't enough of these respirators to go around; the CDC says these respirators should be used once and then thrown out.

Protection of health care professionals and others in a facility should include engineering and administrative controls, as well as the use of PPE, said John A. Jernigan, MD, MS, Division of Healthcare Quality Promotion at the CDC. "The CDC issued guidance on infection control for healthcare facilities this spring and since then learned a lot and has revised the document. We are in the process of making those revisions."

Jernigan said early identification of H1N1 patients is important so "appropriate infection control precautions can be put in place." Placing masks on patients in transport, vaccinating staff, installing partitions in triage areas, having procedures to identify ill employees and encouraging them to stay home are all engineering or administration controls that can make a difference, Jernigan said.

Gail O. Guterl is editor at ADVANCE.