The head of the Food and Drug Administration is urging healthcare professionals to report any adverse effects they believe might be linked to the H1N1 influenza vaccine to the agency's
Vaccine Event Reporting System.
“We are not cutting any corners,” FDA Commissioner Margaret Hamburg wrote in a
nearly four-page letter to U.S. physicians about the manufacturing and distribution process for the vaccine.
“Just as for seasonal influenza vaccine, no lot of the 2009 H1N1 vaccine can be used until it has been carefully evaluated and released as sterile and potent by both the manufacturer and the FDA. In addition, the FDA and other agencies are looking for any unexpected, rare, serious adverse events and are quickly investigating concerns,” she continued. “We are also collaborating with our global counterparts to share information and experience. Should any safety concerns arise, we will evaluate them thoroughly and bring them to the nation's public attention quickly.”
Both the National Institutes of Health and vaccine manufacturers conducted clinical trials in the summer and no serious adverse events emerged from those trials, which have so far included about 3,600 patients just at NIH-supported institutions, according to Hamburg, who also said there are about 41 million doses of the vaccine available, with more available each day.
Meanwhile, the New Jersey Hospital Association issued voluntary visitation guidelines for the state's hospitals to protect patients, staff and visitors from contracting the virus. Those recommendations include prohibiting visitors who are under the age of 18, unless they are patients or have been approved by the facility, as well as prohibiting those visitors who are sick.
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