Regulatory Focus™ > News Articles > HRSA Closes Loophole for Quadrivalent Vaccines

HRSA Closes Loophole for Quadrivalent Vaccines

Posted 11 November 2013 | By Alexander Gaffney, RAC

Regulators at the Health Resources and Services Administration (HRSA) have finally closed a loophole in the National Vaccine Injury Compensation Program that had left legislators scrambling to pass a fix over the summer.


To incentivize research and development in vaccine products, the US government has set up a special fund, known as the National Vaccine Injury Compensation Program (NVICP), as well as a specific vaccine claims court system. The two are intended to serve two purposes:

  • make sure those injured by vaccines are given fair compensation for their injuries, especially when they were compelled into participating in a vaccination program
  • make sure that claims are heard by a panel of experts, which serves to decrease the costs of litigation for companies engaged in the manufacture of vaccines by protecting them against potentially frivolous lawsuits

The NVCIP is funded by a tax assessed on vaccines as defined by the Internal Revenue Service (IRS) by the Internal Revenue Code of 1986.

Under the 1986 law, the influenza vaccine was only conceived of as having as many as three strains, a reality that remained unchanged for decades.

But within the last year, French biopharmaceutical manufacturer Sanofi won approval for and sought to market a quadrivalent vaccine known as Fluzone. By all accounts the vaccine is extremely safe, and regulators have only called for Sanofi to conduct postmarketing studies typically required of all vaccine products.

A Definitional Problem

But despite its similar safety profile and added efficacy, Sanofi was running into a problem: Because of the old definition under the law, its product was technically not eligible for coverage under the NVICP, opening it up to direct liabilities under the law.

Legislators, recognizing this, swiftly moved to remedy the situation by unanimously voting in favor of H.R. 475,To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines.

Signed into law by President Barack Obama in June 2013, the bill changes the IRS definition of a flu vaccine from a trivalent formulation to add "any other vaccine against seasonal influenza."


Now the HRSA has issued updated compensation program tables to include the vaccine, providing an interim fix before it issues final regulations.

In the 12 November 2013 announcement, HRSA said the vaccine tables will henceforth split influenza vaccines into two separate categories: Category XIV will continue to reflect trivalent vaccines, while Category XVII ("new vaccines") will cover all other influenza vaccines, such as Sanofi's Fluzone.

"This notice ensures that petitioners may file petitions relating to all vaccines against seasonal influenza (not already covered under the VICP) with the VICP even before such vaccines are added as a separate and distinct category to the Table through rulemaking," HRSA wrote.

The change will be in effect as of 12 November 2013.

HRSA Notice

Tags: Vaccine, HRSA

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