Sep 15, 2010 (CIDRAP News) – The number of people who intend to submit claims that they were harmed by the 2009 H1N1 influenza vaccine has grown to 275 in recent months, but the procedures for processing the claims have not yet been fully worked out, according to the US Department of Health and Human Services (HHS).

The Countermeasures Injury Compensation Program (CICP) had received 275 letters of intent to file claims about injuries related to the pandemic flu vaccine as of Sep 13, up from 106 in mid-March, reported Vito Caserta, MD, MPH, director of the CICP in the Health Resources and Services Administration (HRSA).

However, the administrative regulations for handling the injury claims remain under review, Caserta said. HRSA officials said they couldn't predict when the regulations would be completed and published in the Federal Register.

Reports have generally indicated that the monovalent 2009 H1N1 vaccine is just as safe as seasonal flu vaccines. But people who believe they were harmed by the vaccine can file claims under the CICP, which was set up under the Public Readiness and Emergency Preparedness (PREP) Act, passed in 2005.

The program is designed to give claimants an avenue for pursuing damages without going to court, while shielding drug companies and medical providers from most lawsuits claiming harm from medical countermeasures for pandemic flu and other public health emergencies, such as bioterrorist attacks. Although the PREP Act was passed in 2005, the CICP was not funded until September 2009.

People who believe they were injured by the H1N1 vaccine, or by certain other pandemic-related medical items such as antiviral drugs, must submit a letter of intent to HHS within a year from when they were vaccinated or treated. That preserves their right to file a formal claim later, after the regulations for claim processing have taken effect.

HRSA spokesman David Bowman said he couldn't give much information yet about the kinds of injuries described in the letters the agency has received, because they are not very detailed and are not backed by medical records. He added, "The letters are generally written by non-medical people, so the complaints in the letters are usually vague chronic pain and fatigue complaints such as arm pain, migraines, joint pains, fibromyalgia, weakness. Of course these will all be correctly categorized once we receive and review the medical records."

The CICP covers the 2009 H1N1 vaccine only in its monovalent form. The 2009 H1N1 virus is included in this year's seasonal flu vaccine, along with two other flu strains. Injury claims related to seasonal flu vaccines and other vaccines are covered by the long-standing Vaccine Injury Compensation Program (VICP), Caserta noted.

Besides pandemic flu vaccines, the CICP covers vaccines for anthrax and smallpox, which are administered to many US military personnel, and countermeasures for botulism and radiation. Caserta said a few letters of intent to file claims over anthrax and smallpox vaccines have trickled in.

"As of 13 September 2010, the CICP has received three letters of intent for smallpox vaccine, and one letter of intent for smallpox, anthrax, and seasonal influenza vaccines given simultaneously," he reported by e-mail.

"One letter of intent also alleges an adverse reaction in an individual who received Tamiflu [oseltamivir], Relenza [zanamivir], and the 2009 H1N1 influenza vaccine," he added.

The 275 letters regarding H1N1 vaccine-related injuries so far are roughly comparable with the numbers of claims filed in the VICP in recent years for problems related to all vaccines, excluding autism claims, HRSA figures show. For example, in fiscal year 2010 there have been 387 non-autism injury claims, according to a HRSA chart. The numbers for the past few fiscal years included 288 claims in 2009, 163 in 2008, 238 in 2007, and 155 in 2006.

The HRSA figures show that 505 VICP injury claims have been filed over seasonal flu vaccine since the program began in 1989, including 29 involving deaths. So far, 170 of those have resulted in compensation and 45 have been dismissed.

See also:

Mar 12 CIDRAP News story "HHS prepares to handle claims of harm from H1N1 vaccine"

CICP homepage

http://www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/