Companies Update Activities for Pandemic and Seasonal Flu Vaccines

Baxter International (Deerfield, IL), sanofi aventis (Paris), and Novartis (Basel, Switzerland) provided updates last week of their production and regulatory activities relating to preparedness in supplying the A(H1N1) pandemic influenza vaccine. Novartis also outlined its activities for providing seasonal flu vaccines.

Baxter completes commercial production
Baxter announced last week that it completed production of its first commercial batches of its Celvapan A(H1N1) pandemic influenza vaccine in late July and is discussing plans for distribution with national health authorities, subject to obtaining appropriate authorizations. Celvapan is made using the company’s proprietary Vero cell-culture technology. The product was developed and commercially produced using this process within 12 weeks of receiving the A(H1N1) virus strain, according to the company.
 
Baxter plans to deliver initial quantities of Celvapan to national public health authorities that have pandemic agreements with the company. These health authorities placed orders for the vaccine following the World Health Organization's (WHO) elevation of the pandemic alert level to Phase 6 and declaration of a pandemic.
 
Baxter is collaborating with regulatory authorities to ensure the company is in accordance with all requirements needed to support approval and use of Celvapan. The company said that it applied the same development, qualification, and manufacturing processes used in gaining European Medicines Agency (EMEA) licensure of a mock-up pandemic vaccine. The mock-up vaccine, made with a different pandemic strain, was tested in five clinical trials worldwide in more than 1300 people. In addition, more than 3500 people have been vaccinated during an ongoing Phase III study, said the company in its announcement. Confirmatory trials are scheduled to begin in August.
 
Baxter has initiated its license application for Celvapan based on the EMEA published guidelines for pandemic vaccine marketing authorization and will supplement its application postapproval with the appropriate safety and immunogenicity data from the confirmatory clinical trials. Once national vaccination programs are initiated, Baxter will also conduct a large-scale observational study. In all countries, decisions to administer the vaccine will be determined by local public health authorities.
 
Baxter received the A(H1N1) strain for testing and evaluation from the US Centers for Disease Control and Prevention (CDC) in early May. The company then undertook preproduction testing and evaluation of the virus strain to assess its growth characteristics and ability to work in the company's proprietary Vero cell culture. Based on the virus' ability to grow in the Vero cell culture, Baxter initiated commercial production on June 3, 2009. The bulk Celvapan vaccine is produced at Baxter’s large-scale commercial facility in Bohumil, Czech Republic, and is sent to its facilities in Vienna, Austria, for the final formulation and fill–finish before distribution.
 
Sanofi Pasteur submits supplemental license application
Sanofi Pasteur (Lyon, France and Swiftwater, PA), the vaccines division of sanofi aventis, announced last week that it has submitted to the US Food and Drug Administration a supplemental application for licensure of its influenza A(H1N1) 2009 monovalent vaccine. The supplemental application requests FDA’s evaluation of the influenza A(H1N1) 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.

The supplemental application follows recent recommendations by FDA to evaluate the influenza A(H1N1) 2009 monovalent vaccines using the same regulatory process by which it approves new viral strains contained in the annual seasonal influenza vaccines, according to the company. Sanofi Pasteur’s influenza A(H1N1) 2009 monovalent vaccine supplemental application specifies the evaluation of a nonadjuvanted vaccine.

Although these strain-change supplements are not required to be supported by new clinical data, immunogenicity and safety data will be made available through clinical studies. Sanofi Pasteur will test the immunogenicity and safety of its influenza A(H1N1) 2009 monovalent vaccine through US clinical trials, which began August 6. The planned clinical trials will consist of approximately 2000 subjects and will also evaluate the safety and potential benefits of adding an adjuvant to the pandemic vaccine.

Novartis meets early deadline for seasonal flu
Novartis reported last week that it has started shipping seasonal influenza vaccine to US healthcare facilities for the 2009-2010 season. The company delivered its Fluvirin influenza virus vaccine, which has been approved by FDA, to the US weeks ahead of schedule in anticipation of the increased demand for seasonal influenza vaccine created by the current global (A)H1N1 influenza pandemic.

"Novartis Vaccines committed early on that we would not let production of a pandemic vaccine get in the way of our ongoing commitment to provide seasonal influenza vaccine for the U.S. market," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, in a company press release "We have been able to meet that promise with the early delivery of Fluvirin to the US Our next goal will be to bring an (A)H1N1 influenza vaccine for public health use as soon as possible."

Novartis will provide the US market with approximately 30 million doses of Fluvirin vaccine, indicated for patients four years and older. Fluvirin vaccine contains antigens to the three influenza virus strains for this year's vaccine recommended by WHO: A/Brisbane/59/2007, IVR-148 (H1N1); A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus); and B/Brisbane/60/2008.

US government says flu vaccine production on track
Last week the CDC issued updated federal guidelines for state and local public health and school officials for responding to 2009 H1N1 influenza in schools, depending on how severe the flu may be in their communities. In a joint news conference by Health and Human Services (HHS) Secretary Kathleen Sebelius, Education Secretary Arne Duncan, Homeland Security Secretary Janet Napolitano, and CDC Director Thomas R. Frieden, Sebelius said that “a seasonal flu vaccine is ready to go, and we should have one for the 2009 H1N1 flu by mid-October,” in a HHS press release.