Vaccines

The US Department of Health and Human Services (HHS, Washington, DC) has awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million does of the vaccine or enough adjuvant for 150 million doses within six months after the onset of an influenza pandemic.

Washington, DC (Dec. 13)-After considerable debate and negotiation, Congress this week passed four bills poised to affect pharmaceutical and biotechnology research, development, and manufacture. All are currently awaiting signature by the President.

Washington, DC (Nov. 20)-The US Department of Health and Human Services awarded contracts totaling $199.45 million to Sanofi Pasteur, Novartis, and GlaxoSmithKline PLC to manufacture 5.3 million 90-?g doses of influenza vaccine designed to protect against the H5N1 influenza virus strain.

Alcan, China Biopharma, US FDA, MedImmune, more

Geneva, Switzerland (Oct. 23)-Aiming to increase capacity for producing influenza pandemic vaccines, the World Health Organization has identified strategies and practical solutions for reducing the anticipated gap in the global vaccine supply.

New York (Oct. 9)-Pfizer has positioned itself to enter the DNA-based vaccine market with its agreement to acquire UK-based PowderMed Ltd., which holds a pipeline of DNA-based influenza vaccines currently in clinical development for treating both seasonal and avian flu.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

GlaxoSmithKline (London, England) has developed a vaccine against the H5N1 bird flu strain that, the company says, shows better immune response than other vaccines in development.

Novartis (Basel, Switzerland) will build a cell culture-derived influenza vaccines manufacturing plant in Holly Springs, North Carolina. Construction is expected to begin in 2007.

Although the number of anti-infective vaccines (as distinct from therapeutic vaccines for cancers and other noninfectious diseases) entering clinical study each year since 2000 has been higher on average than it was in the 1990s, this product area may see little additional growth through the rest of this decade, according to a recentanalysis from the Tufts Center for the Study of Drug Development (Boston, MA).

MedImmune, Inc. (Gaitherburg, MD) reports that US Food and Drug Administration (Rockville, MD) has approved the company's supplemental biologics license application to use reverse genetics technology to construct new vaccine strains to produce seasonal influenza vaccines.

Biopharmaceutical company Lipoxen PLC (London, UK) has developed a Hepatitis E vaccine using its novel vaccine delivery technology "ImuXen," which the company claims to be easy to manufacture. According to the company, the proprietary liposomal formulation method delivers vaccine materials to the immune system in a manner designed to emulate the response of a natural encounter with the infection agent.

GlaxoSmithKline PLC (GSK, London, UK) will invest more than GBP102 million ($188 million) over the next four years in a vaccine manufacturing plant in Singapore.

The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.

Novartis (Basel, Switzerland) has closed on its $5.4-billion acquisition of Chiron Corporation (Emeryville, CA), paving the way for the creation of a new Novartis division focusing on vaccines and diagnostics.

Reverse Genetics Avian Influenza Vaccine Approved in France

GSK Begins Clinical Trials of Two H5N1 Vaccines

Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed.

Progress Continues in Vaccine and Antiviral Development

Chiron Withdraws Measles Vaccine

Development Begins on Mutated H5N1 Virus Vaccine

Novavax, Bharat Biotech Team for Pandemic Influenza Vaccine Development

GSK Gains Approval for Rotavirus Vaccine in Infants; FDA Review Extended for Merck’s Shingles Vaccine

FDA Recommends Changes for 2006-2007 Flu Vaccine

Baxter Wins Contract to Develop Cell-Based H5N1 Vaccine

Cambrex (East Rutherford, NJ) to produce Geron (Menlo Park, CA) telomerase anti-cancer vaccine. Generex (Toronto, ON.) files IND for synthetic vaccine to stimulate cell-mediated immunity to avian influenza. Dow Agrosciences (Indianapolis, IN) wins USDA approval for veterinary vaccine, the first manufactured via plant cell culture. G-8 nations pledge billons for vaccine production.

Merck wins approval for rotavirus vaccine as Sanofi ships investigational H5N1 vaccine to NIH and CDC explores new flue diagnostics and novel vaccine-production technology.

Dow AgroSciences Receives Regulatory Approval for Plant-Made Vaccine

Cell-Grown Vaccine Protects Against Avian Flu Virus

Sanofi Pasteur and BD Team Up to Produce Microneedle Vaccines