Regulatory Focus™ > News Articles > Legislators Move to Close Loophole Affecting Sanofi's New Influenza Vaccine

Legislators Move to Close Loophole Affecting Sanofi's New Influenza Vaccine

Posted 19 June 2013 | By Alexander Gaffney, RAC

When the US Food and Drug Administration (FDA) approved a new four-strain flu vaccine manufactured by French life sciences manufacturer Sanofi in early June 2013, it didn't just mark a momentous occasion for regulatory officials within Sanofi - it also exposed a potential loophole in how US officials accommodate the safety of vaccine products, one legislators are now eager to fix.


The problem uncovered doesn't have to do with the safety of Sanofi's 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.

Rather, the problem has to do with vaccines more generally. As with all medicinal products, vaccines can lead to adverse events in some patients regardless of how safe they are. For example, even if a drug is 99.999% safe, that would statistically leave one person in 10,000 seriously injured. This represents a problem because of the scale at which vaccines are adopted, often due to government requirements.

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; and
  • 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.

Legislators Move a Fix Forward

Which brings us back to Sanofi's quadrivalent vaccine.

Under the 1986 law, the influenza vaccine was only conceived of as having as many as three strains. This means the quadrivalent vaccine wouldn't be considered a taxable vaccine under the law, placing strains on the system if there was ever a problem that required compensation for injuries.

Now legislators are moving to close the loophole. A bill first introduced in February 2013 by Rep. Jim Gerlach (R-PA), H.R. 475, would amend the Internal Revenue Code by adding "any other vaccine against seasonal influenza" to the definition of a taxable vaccine.

The bill passed the House by a unanimous floor vote on 18 June 2013, sending it to the Senate where it is expected to pass without any trouble as well.

"This legislation can help make the upcoming flu season less miserable for millions of Americans and avoid expensive hospital stays for those most susceptible to the flu," Gerlach said. "I am extremely pleased that this bill received broad bipartisan support and hope that it soon becomes law so that vaccine makers can continue working to protect the public against constantly evolving health threats."

Gerlach's Statement

H.R. 475

FDA Approval Notice of Sanofi's FluZone

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