FDA Commissioner Addresses H1N1 Vaccine Safety Concerns
Emma Hitt, PhD
Posted: 11/11/2009
November 11, 2009 — In a letter yesterday, the commissioner of the US Food and Drug Administration (FDA), Margaret A. Hamburg, MD, reassured healthcare professionals about vaccine safety and thanked them for their “extraordinary efforts” during the 2009 H1N1 influenza outbreak.
MedWatch, the FDA’s safety information and adverse event reporting program, announced the letter in a posting yesterday.
“Delays in vaccine delivery and the persistence of myths about vaccination have not made your job any easier,” she stated. “Thank you for rising to this public health challenge.”
Reassuring Patients About Vaccine Safety
Dr. Hamburg, who was confirmed on May 18, 2009 as the FDA’s new commissioner, described information about H1N1 that can be used to allay patient fears about vaccine safety.
She noted that some patients might think that the safety of the H1N1 vaccine is unconfirmed because the vaccine became available only 6 months after the 2009 H1N1 virus appeared. However, this fear is misguided because the H1N1 vaccine is produced in exactly the same way as the seasonal influenza vaccine.
“Companies began manufacturing the 2009 H1N1 vaccines in the same factories where they are licensed to manufacture seasonal influenza vaccines — using the same equipment and the same testing procedures,” she pointed out.
According to Dr. Hamburg, if the H1N1 virus had emerged a few months earlier, “it could have been included as 1 of the 3 strains in the 2009 seasonal vaccine. In this key respect, although the strain of the 2009 H1N1 virus is new, the 2009 H1N1 influenza vaccines are not.”
In addition, in National Institutes of Health–sponsored clinical trials of more than 3600 people, no serious adverse events have been attributed to the vaccine.
Dosing of the 2009 H1N1 influenza
Until recently, it was unclear how many doses of the vaccine would be needed. According to the letter, only a single dose of H1N1 vaccine is needed for healthy adults, the elderly, and older children. “For children ages 9 and younger, two doses of the H1N1 vaccine will likely be optimal, also similar to seasonal vaccine,” Dr. Hamburg said.
The letter is available on the FDA Web site. More information on H1N1 influenza is available here.
Adverse effects linked to any vaccine, including the 2009 H1N1 influenza vaccine, should be reported to the Vaccine Adverse Event Reporting System (http://vaers.hhs.gov/index).
Adverse events can also be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
[CLOSE WINDOW]Authors and Disclosures
Journalist
Emma Hitt, PhD
Emma Hitt is a freelance editor and writer for Medscape.