Leslie Carol Botha: How is is that world health organizations, governments and health agencies can turn their heads when it is well known and documented – even by the NIH that thimerosal (ethylmercury) leads to a five-fold increase in the levels of oxidant damaged mitochondrial DNA base. Read the Journal of Toxicology Study on thimerosal as a mitochondrial toxin published June 28, 2012.
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.
Vical Incorporated (Nasdaq:VICL) announced today that the company’s DNA vaccine against A/H1N1 pandemic influenza (swine flu) has demonstrated robust immune responses in 100% of vaccinated animals against virus strains isolated from recent outbreaks in three distinct geographic locations — California, Texas and Mexico.
With two new swine flu vaccines approved for use and five million doses scheduled for delivery this month, China is set to become the first country to begin a mass vaccination campaign against the H1N1 pandemic. But officials with the World Health Organization say that there are some concerns about potential side effects.
The Australian Infection Control Association this week warned the government against proceeding with the programme, saying that the planned use of multidose vials (used to vaccinate several people) posed a “significant potential risk to patient safety.” The association’s president, Claire Boardman, said that use of multidose vials would contravene national infection control guidelines (www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/02A94EEE98D72244CA25740F00251B98/$File/NationalInfectionControlGuidelines.pdf) and that numerous adverse events related to their use had been well documented.
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.
MedImmune is putting its FluMist nasal spray technology to the test against swine flu. FluMist, which got off to a shaky start in the U.S., brought in only $104 million last year, a fraction of what the big global manufacturers have been able to earn with their flu shots. But all those naysayers who scorned the terms of the MedImmune buyout in the face of such weak performance could well be silenced by the rewards available when a pandemic hits. AstraZeneca plans to make 200 million doses of swine flu vaccine by next spring.
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.