Compensation and safety essential to immunization

By Rep. Dave Weldon (R-Fla.)
The Hill

The year: 1976. The last time our nation faced the serious threat of a nationwide flu epidemic.

The administration mobilized the vaccine industry, Congress provided liability protection, and more than 150 million doses of swine-flu vaccine were produced to inoculate all Americans.

Only three weeks into that vaccination campaign, the city of Pittsburgh suspended all vaccinations because of public fears that the deaths of three elderly vaccine recipients were linked to the vaccine. As nationwide reports of other adverse reactions surfaced, the nation’s vaccination campaign came to a screeching halt after only a fraction of Americans had been immunized.

Fortunately, the deadly swine-flu epidemic in 1976 never materialized. Though most Americans did not receive a swine-flu vaccination, only one death was attributed to swine flu.

For today, the question is: What lessons have we learned from history should an avian flu pandemic hit our nation in the next few years? Will we escape as easily?

The administration’s influenza-pandemic preparedness plan involves expanding vaccine manufacturing capacity and stockpiling essential medical supplies, including anti-viral drugs. As was the case in 1976, an essential component of this preparedness plan involves liability protection for vaccine manufacturers.

However, we in Congress must recognize that by indemnifying manufacturers we are assuming responsibility for problems that will undoubtedly emerge in the course of seeking to protect Americans under such extraordinary circumstances. We must accept this responsibility with integrity by (1) ensuring that the safety of pandemic countermeasures is independently researched and reviewed and (2) by providing fair compensation for individuals who experience adverse reactions to the vaccines or drugs they receive.

Liability protection for industry must be accompanied by an independent, robust vaccine-safety research program and a fair compensation program prior to an outbreak of pandemic influenza. This will help give both the manufacturers and the public the confidence they need to participate fully in our nation’s preparedness plans. Had all of these elements been in place before undertaking the swine-flu vaccination program in 1976, that program might not have been terminated.

Research later demonstrated that the 1976 deaths of the three elderly vaccine recipients from Pittsburgh were unrelated to the vaccine, but the data emerged far too late to salvage the vaccine campaign. Investing now in a robust and independent vaccine-safety infrastructure, like that contained in H.R. 4245, will provide the tools necessary for answering future public concerns more thoroughly and efficiently.

The swine-flu vaccination campaign was also undermined by nationwide reports of a rare neurological condition known as Gullian-Barré syndrome (GBS) in vaccine recipients. A scientifically credible research enterprise dedicated to understanding the varied responses to vaccines and other countermeasures may allow us to better discern genuine adverse reactions. Developing screening tools to identify those most at risk for adverse reactions will further assure the public that the federal government is taking these safety issues seriously.

Furthermore, considering the growing concerns that some Americans have about routine vaccinations, we must recognize that building public confidence requires that the countermeasure-safety research program be completely independent of those recommending and administering the countermeasures and free from conflicts of interest.

With these components in place — liability protection, fair compensation and a robust, independent safety research program — we will be appropriately recognizing the risk both industry and individuals will be taking to protect our nation from the threat of a deadly pandemic.

It would be a mistake to implement plans to combat pandemic influenza without also building public confidence. One hundred million doses of swine-flu vaccine went to waste in 1976 because public confidence disappeared. In a true pandemic, we cannot afford to have our carefully planned and coordinated response similarly stopped dead in its tracks because we took public confidence for granted.

Weldon, a doctor, is a member of the Labor, Health and Human Services and the Science, State, Justice and Commerce subcommittees on Appropriations.

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