Concerns raised about H1N1 vaccine

October 25, 2009 by admin  
Filed under Berita

Concerns raised about H1N1 vaccine. The message that the vaccine appears safe for almost everyone may not be getting across — even as the vaccine arrives in states and cities and mass vaccination programs are set to begin.

A study released Oct. 2 by Harvard School of Public Health researchers found that only 40% of adults were “absolutely certain” they would get the H1N1 vaccine for themselves and 51% of parents were “absolutely certain” they would get the vaccine for their children. Children are among the designated priority groups to receive the vaccine.

But if the flu outbreak is severe in their own communities, those queried told researchers they might be more inclined to get the vaccine for themselves and their children. The survey was conducted Sept. 14-20 by telephone with a sample of 1,042 adults.

Those who were not “absolutely certain” they would get the H1N1 vaccine said they were concerned about possible side effects, did not think they were at risk of getting seriously ill from the virus or thought they could get medication to treat H1N1 if they got sick.

By late September, widespread H1N1 activity had been reported in 27 states, and the virus’ spread showed no signs of slowing, according to the CDC. If the increasing reach of the illness prompts more people to get the vaccine, tracking systems will help determine if anything unusual occurs.

VAERS, which is jointly managed by the CDC and the Food and Drug Administration, is ready to receive reports of events from physicians and others, said Claudia Vellozzi, MD, MPH, deputy director of the CDC’s Immunization Safety Office. Staff is being increased for the upcoming flu season to process reports more rapidly, she said.

But there are limitations to VAERS, Dr. Vellozzi said. The quality of the data varies, and there is no unvaccinated comparison group. There also is a great deal of underreporting, she said.

Some other tracking efforts include the Vaccine Safety Datalink project, a joint effort involving the CDC’s Immunization Safety Office and eight large managed care organizations.

A new tracking system, the Real Time Immunization Monitoring System, will use a Web-based system developed at Johns Hopkins Bloomberg School of Public Health to follow people for up to six weeks postvaccination.

The CDC and six academic medical centers with vaccine safety experts will provide clinical expertise in the evaluation of serious adverse events. The Dept. of Defense is monitoring 1.5 million active duty personnel. Another tracking component is Post-Licensure Rapid Immunization Safety Monitoring, a collaboration involving the National Vaccine Program Office, the FDA and the CDC.

About 600,000 doses of the nasal-spray H1N1 vaccine have been shipped and scheduled to arrive in early October in 25 states and cities, Dr. Schuchat said. Injectable vaccine was expected to be shipped soon after that.