The U.S. Food and Drug Administration (FDA) has approved four vaccines for use against the 2009 H1N1 influenza virus. The vaccines—made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc.—will be distributed nationally after the initial lots become available. This is expected to occur within the next four weeks.
As manufacturers work furiously to make a vaccine to protect against 2009 influenza A (H1N1) virus, a Rice University bioengineer is trying to improve the process for future flu seasons. The goal is to shorten the time it takes to identify targeted flu strains and manufacture the vaccines for them.
The BioSante presentation, “BioVant Calcium Phosphate (CaP) Nanoparticles: An Effective & Safe Adjuvant for Influenza Vaccines including H1N1 and H5N1,” showed that BioVant-adjuvant effectively enhanced the natural immune response to the swine flu, using a BioVant-adjuvanted matrix protein M1 vaccine, and to H5N1 (bird flu), using a BioVant-adjuvanted H5N1 vaccine delivered via intranasal administration.
WHO is aware of some media reports that have expressed concern about the safety of vaccines for pandemic influenza. The public needs to be reassured that regulatory procedures in place for the licensing of pandemic vaccines, including procedures for expediting regulatory approval, are rigorous and do not compromise safety or quality controls.
Fears about swine flu have spurred more than 3,000 people so far to volunteer to take part in upcoming clinical trials of a new vaccine. That’s already more than the number scientists will need at eight different sites around the U.S. “We don’t generally ever get a response like this,” Dr. Lisa Jackson, the principal researcher in charge of the clinical trials being readied at Seattle-based Group Health Cooperative, which fielded more than a thousand calls from people in two days.
Health and Human Services Secretary Kathleen Sebelius said she is urging school superintendents around the country to spend the summer preparing for the possibility of turning schools into swine flu vaccine clinics this fall. “If you think about vaccinating kids, schools are the logical place,”
Analysts note that the pandemic couldn’t have come at a better time for Glaxo, one of the world’s largest vaccine makers. Generics have been steadily eating into the company’s margins, leaving Glaxo looking for new products to make up the shortfall.
Faced with the first World Health Organization (WHO) declared pandemic in four decades, health officials arou world are rushing to order huge stock-piles of the H1N1 (Swine) Fl vaccine in what is shaping up as a multibillion-dollar windfall for the world’s biggest manufacturers.
Novartis is one of five big manufacturers preparing swine flu vaccines for the U.S. market, a CDC official says. Dr. Pascale Wortley, the CDC’s pandemic-vaccine coordinator, says that by October the U.S. expects to have between 40 million and 160 million doses of vaccine ready for use. That could mean that this fall, U.S. school children may be expected to get a seasonal flu shot as well as a double dose of swine flu vaccine.