HHS preparing to handle claims of harm from H1N1 vaccine

Mar 12, 2010 (CIDRAP News) – While the pandemic H1N1 influenza vaccine seems to be just as safe as seasonal flu vaccines, the federal government has been getting some letters from people saying they plan to seek compensation for injuries caused by the injection, according to the Department of Health and Human Services (HHS).

As of yesterday, HHS had received letters from 106 people saying they plan to submit claims for compensation benefits because of problems related to the vaccine, according to David Bowman, a spokesman for HHS's Health Resources and Services Administration (HRSA).

At this point HRSA is accepting only letters of intent to file claims, rather than actual claims, because the administrative policies and procedures for handling them have not yet been approved, Bowman reported. He said the agency has no information yet on what kinds of injuries people are claiming.

People who believe they were injured by the H1N1 vaccine, or by certain other pandemic-related medical items such as flu antiviral drugs, must write to HHS about it within a year from when they were vaccinated or treated, according to the agency. That preserves their right to file a claim later, after the regulations for claim processing have been approved.

Injury claims related to the pandemic vaccine are covered by the Countermeasures Injury Compensation Program (CICP), which was set up to deal with claims related to countermeasures for pandemic flu, bioterrorist attacks, and other public health emergencies. The CICP is separate from the much older Vaccine Injury Compensation Program (VICP), which handles claims pertaining to seasonal flu vaccines and routine childhood vaccines.

The CICP was established under the Public Readiness and Emergency Preparedness (PREP) Act, passed in 2005, which shields pharmaceutical companies and medical providers from most lawsuits claiming harm from medical countermeasures for pandemic flu and other public health threats, with the aim of helping to ensure a supply of countermeasures. The law set up the CICP in lieu of the right to pursue damages in court, with few exceptions. The HHS secretary determines which countermeasures are needed to respond to declared threats.

Though it was part of legislation enacted several years ago, the CICP received funding to begin operations just last September, according to Bowman.

Claims related to the H1N1 vaccine are not covered at this point by the VICP, established in the 1980s, because it is "not currently a vaccine recommended by the CDC [Centers for Disease Control and Prevention] for routine administration to children," Bowman said, adding that seasonal flu vaccine is covered by the older program because it is routinely recommended.

"If the H1N1 pandemic vaccine becomes a component of the trivalent seasonal vaccine (as is currently planned for next year's flu season), then it would be covered by the VICP and not the CICP at that time," Bowman said.

The compensation program is intended to cover reasonable medical expenses, lost employment income, and death benefits for injuries caused by the vaccine, according to a presentation given by Vito Caserta, director of the program, at a recent meeting of the National Vaccine Advisory Committee. Those benefits will be paid only after any payments from other parties, such as insurance companies.

Processing of damage claims must wait until the administrative policies and procedures are completed, according to HHS. The regulations are currently under review at HHS, and once that is finished, they will be sent to the Office of Management and Budget (OMB), Bowman reported. Following OMB approval, they will be published and HHS will take public comments.

Bowman said he couldn't predict how long it will take for the regulations to be approved and implemented.

Although the regulations are still in the works, claims under the CICP will be handled somewhat differently from claims under the VICP, according to an HHS online comparison of the two programs. In the CICP, HHS will make the decisions about entitlement and benefits. The VICP involves more of a judicial process, in which VICP physicians review claims and write reports, but special masters or judges of the US Court of Claims make the decisions on entitlement and benefits.

Although the CICP covers antiviral drugs and other H1N1-related countermeasures, such as respiratory protection equipment, HRSA has not received letters of intent about anything except the vaccine, Bowman reported.

Besides the H1N1 vaccine, countermeasures currently covered by the CICP program include vaccines and drugs for anthrax and smallpox, under HHS declarations made in 2008, according to Bowman.

Many members of the US military receive anthrax and smallpox vaccinations, depending on where they are deployed. Bowman said the CICP covers claims from military members related to those immunizations, but so far the program hasn't received any claims from military personnel, he reported.

He said the program is planning to make a presentation to the Department of Defense's vaccine agency to inform officials about the program and to request that they provide vaccine recipients with information about it.

In an update last week, the CDC said the volume and types of reports to the Vaccine Adverse Events Reporting System indicates that the H1N1 vaccine has a safety profile very similar to that of seasonal flu vaccines, which are regarded as very safe.

See also:

CICP home page

Comparison of CICP and VICP

CICP frequently asked questions

CDC's H1N1 vaccine information statement

Mar 5 CIDRAP News story "CDC: Pandemic vaccine safety record still matches seasonal vaccine"

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