Federal advisors hope to build on H1N1 vaccine safety-monitoring lessons

Jul 27, 2010 (CIDRAP News) – Over the next few months, the nation's healthcare providers will shift from giving the pandemic H1N1 vaccine to a seasonal flu vaccine that contains the new virus, which has federal officials grappling with how to transition from a massive vaccine monitoring effort to a likely more routine system for the seasonal version.

Members of the National Vaccine Advisory Committee (NVAC), which advises the Department of Health and Human Services on its immunization programs, discussed the transition today during a public teleconference. In efforts to detect any problems with the new vaccine and assure the public of its safety, federal officials beefed up existing vaccine monitoring systems and added new components, such as collaborations with large managed care organizations, academic institutions, the Department of Defense.

Though the group was not in a position to take any action today, members said lessons learned during safety monitoring of the pandemic H1N1 vaccine will be useful as the nation advances toward a more universal flu vaccination recommendation.  In February a Centers for Disease Control and Prevention (CDC) advisory group recommended seasonal flu immunizations for nearly everyone except babies younger than 6 months old.

Gus Birkhead, MD, MPH, chairman of the group and deputy commissioner of the New York Department of Health, said a lesson learned during pandemic vaccine safety monitoring was the usefulness of coordination among federal agencies on vaccine safety monitoring issues. However, he said NVAC would like to hear more from its members about any efficiency measures for gathering and analyzing vaccine safety data.

Marie McCormick, MD, ScD, a member of NVAC's H1N1 and seasonal flu vaccine safety working groups, said, for example, experts involved with pandemic H1N1 vaccine safety monitoring may have tips about which key pieces of information on medical records were most useful for detecting possible safety signals. In addition, they may be able to offer advice on how to collect the data more efficiently, which could prove useful for upcoming flu seasons, she said.

McCormick, a professor of maternal and child health at Harvard School of Public Health, added that efficiencies could reduce the cost of future flu vaccine monitoring.

Members of NVAC who spoke at today's meeting said they envisioned some sort of standing federal flu vaccine monitoring group that meets less frequently than every other week as they did for the pandemic H1N1 vaccine but more often than at the end of a flu season to issue a safety wrap-up report.

McCormick said an important issue is making sure future flu vaccine safety monitoring systems examine key diverse subgroups, such as ethnic minorities and patients with certain medical conditions.

NVAC members also alluded to a federal survey of agencies that is under way to assess what plans they have to scale down their pandemic response efforts.

In other developments, members discussed a request from the assistant secretary of health for NVAC guidance on a host of other flu issues, including safety monitoring for seasonal flu vaccines, mandates for healthcare worker vaccination, and what impact the new universal flu vaccine recommendation will have had in its first year.

The next NVAC teleconference is scheduled for Aug 25, and the next full face-to-face meeting of the group is slated for Sep 14 and 15.

See also:

NVAC upcoming meetings Web page

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