Meer data over veiligheid H1N1 Vaccin

Health officials told the National Vaccine Advisory Committee during a Nov. 6 teleconference that they plan to increase availability of safety data on influenza A(H1N1) vaccine in the upcoming weeks.

Dr. Marie McCormick, chairman of a new vaccine safety working group convened by the Department of Health and Human Services, said that almost 10 million people are under some kind of surveillance for adverse events related to the 2009 H1N1 vaccine. But most of the systems for monitoring those events are not reporting data just yet, said Dr. McCormick, a professor of child and maternal health at the Harvard School of Public Health in Boston and also an NVAC member.

NVAC advises HHS on vaccine policy.

Since early October, the rate of adverse events reported for the H1N1 vaccine has been similar to that seen for the seasonal flu vaccine, said Dr. McCormick, citing data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System. As of Oct. 30, there had been 605 reports filed to VAERS. There were 3 deaths, 1 case of Guillain-Barré Syndrome, and 17 other serious events.

All of the reports are being reviewed by the Food and Drug Administration, the CDC, and state health departments, Dr. McCormick said.

It’s not clear yet whether any of the reports are directly associated with vaccination, she said. Her working group will be examining the VAERS data and other reports every 2 weeks and reporting back to NVAC.

VAERS data is available to the public and is updated every Tuesday. But there’s not a lot of context or clarity to that data, Dr. Abbigail Tumpey, a CDC official, told the NVAC members. But the CDC has determined that the public is interested in the VAERS data and is discussing it, regardless of whether it’s understood, said Dr. Tumpey.

The CDC now plans on adding a summary to the data each week, delineating serious vs. nonserious events, how the federal government is investigating, and the limitations of the data.

Tawny Buck, an NVAC member and director of government relations for the National Vaccine Information Center, said that the government should better publicize how people can report side effects, especially as more vaccine becomes available.

Several state and local health officials who participated in the teleconference said that vaccine doses have started to flow more readily. Dr. Anne Bailowitz, a Baltimore health official, said that the city ordered 20,000 doses at the end of September and has now received about 63% of that order. But she said half of that had come in the past few days and that she expected to have a full complement of doses by the week of Nov. 9.

Michiel

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