Swine Flu Vaccines Likely to Be Shielded From Tort Claims

Vaccine manufacturers are ready to begin producing swine flu vaccines once the government gives them the nod to go forward. As they do so, they may be free from one worry: the risk of being sued for vaccine-related injuries.

Under the 2006 Public Readiness and Emergency Preparedness Act, HHS provides immunity from tort liability for products used to treat diseases and conditions constituting a public health emergency. HHS has invoked the law several times and is likely to apply it to swine flu, or influenza A H1N1, vaccines.

An HHS spokesperson could not say whether tort immunity would apply in the case of H1N1 vaccines since the government has not yet awarded contracts for their development.

In October HHS announced that Roche's Tamiflu (oseltamivir) and GlaxoSmithKline's Relenza (zanamivir) were countermeasures to avian H5N1 influenza A viruses. HHS explained that tort immunity would apply to federal contracts, cooperative agreements, grants and interagency agreements of memoranda of understanding involving the countermeasures except in the case of willful misconduct.

HHS also has declared that tort immunity applies to countermeasures against botulism, smallpox, anthrax, H2, H6, H7 and H9 influenza and acute radiation syndrome.

The 2006 law, part of a defense supplemental appropriations measure, provides compensation to individuals injured by the covered countermeasures.

The law appears to provide greater protection from tort claims than that provided in the National Childhood Vaccine Injury Compensation Act of 1986. That law shields manufacturers from liability if the injury or death from vaccine side effects was unavoidable. An appeals court in one state has ruled that the Vaccine Act does not pre-empt tort claims and manufacturers are seeking Supreme Court review of the case (see ¹ (Also see "Vaccine Makers Ask Supreme Court To Assess Their Liability In Tort Claims" - Pink Sheet, 11 May, 2009.)).

Caryn Silverman, a partner at Sedgwick, Detert, Moran & Arnold, said that under the Emergency Preparedness Act, as long as there is a declaration from the Secretary that products are covered as countermeasures, manufacturers should be protected from liability. She noted that the law has an express pre-emption provision, similar to that included in the Medical Device Amendments.

"It appears they tried to cover all bases so manufacturers wouldn't fear personal injury suits" in responding to a national health crisis, she said.

Silverman noted that the law has two potential exceptions to tort immunity: if there is evidence of willful misconduct by a manufacturer and if the covered countermeasure was used to treat some other condition.

Sanofi, Novartis Set To Develop Vaccine

While government agencies have not yet decided whether to authorize production of an H1N1 vaccine, manufacturers are ready to take action (² 'The Pink Sheet,' May 4, 2009, p. 3). Sanofi Pasteur has been in daily discussions with HHS, the World Health Organization and the Centers for Disease Control and Prevention about the possibility of producing an H1N1 vaccine.

"We are prepared to do that if asked," said Sanofi Pasteur spokesperson Donna Cary. "The ball is in the court of HHS and CDC."

Influenza vaccines generally contain a dead or weakened form of a circulating virus. Cary said government agencies do not yet have a seed virus of H1N1 to give manufacturers. Once Sanofi Pasteur gets the seed virus - a purified and attenuated strain of H1N1 - she said the company would begin development of a vaccine and run pilot scale lots and then go into full scale production.

On May 6, FDA licensed Sanofi's new influenza manufacturing facility in Swiftwater, Penn. While the license is for production of the company's Fluzone seasonal flu vaccine, the company said it would help Sanofi respond to requests for an H1N1 vaccine.

Novartis also has been in discussions with CDC and WHO about different possibilities for developing a vaccine. Novartis spokesperson Eric Althoff said the company is evaluating whether to develop the vaccine in a cell culture or for use as an adjuvant. Growing the vaccine virus in cells rather than in chicken eggs would get around the need for a supply of eggs.

The company also is considering whether adjuvant MF59 could be used against H1N1. Earlier this month the company announced results of a Phase II trial showing that its avian influenza vaccine Aflunov , formulated with the adjuvant MF59, can produce an immune response against all known H5N1 antigenic variants. Althoff said that hopefully the same reaction would be seen in H1N1. The company's next step will be to develop a seed virus to begin developing a vaccine.

Testing Needed To Determine Proper Dosage

At a May 5 press briefing, HHS Secretary Kathleen Sebelius said the government has begun developing a vaccine.

"You can't begin to develop a vaccine until you know what the virus strain looks like," Sebelius said. She said the strain has been identified and testing will get under way "to get to the right dosage and to make sure that we are administering this in the safest possible fashion and to be ready should the decision be made to go into the production phase."

At a press briefing the following day, CDC Acting Director Richard Besser said the agency has been in discussion with manufacturers about the virus and the studies they will need to do under the direction of the National Institutes of Health.

"They need to do studies to determine how much stuff needs to be in the vaccine, how much of an antigen needs to be in the vaccine to stimulate protection and immunity," Besser said. They will also have to determine if one dose provides sufficient immunity.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told a Senate committee last month that six hundred million doses would probably be needed to immunize everyone in the country.

The World Health Organization said CDC has identified and prepared candidate vaccine strains and that WHO Collaborating Centers have begun preparing vaccine candidate viruses. Once the strains are developed they will be distributed to manufacturers upon request. WHO said it expected the strains to be available in mid-May and that the first doses of H1N1 vaccine could be available in five to six months. There are more than a dozen manufacturers with licenses to produce influenza vaccine.

- Brenda Sandburg ([email protected])