A vaccine manufacturer’s approach to address medical needs related to seasonal and pandemic influenza viruses

Abstract

Vaccination is considered to be one of the most effective tools to decrease morbidity as well as mortality caused by influenza viruses.For the prevention of seasonal influenza, Fluarix™ and FluLaval™ have been marketed since 1987 and 1992, respectively. Both vaccines have consistently been shown to meet or exceed the regulatory criteria for immunogenicity against the three strains H1N1, H3N2 and B, have a good safety profile, and are recommended for vaccinating children and adults of all ages.For the prevention of pandemic influenza, GlaxoSmithKline (GSK) has obtained licensure of a pre-pandemic vaccine, Prepandrix™. This split-virus H5N1 adjuvanted with AS03, a proprietary oil-in-water emulsion-based adjuvant system, has demonstrated broad immunity against drifted H5N1 strains and has been shown to be effective in preventing mortality and viral shedding in animal studies.The influenza vaccine portfolio of GSK addresses specific medical needs related to seasonal or pandemic influenza viruses, which remain an important public health threat worldwide.

Comparison of adverse events following immunization with pandemic influenza A (H1N1)pdm09 vaccine with or without adjuvant among health professionals in Rio de Janeiro, Brazil

“…After using the vaccine on a larger scale, adverse events surveillance programs in the United States of America and China showed similar results (CDC 2009b, Wu et al 2010, Liang et al 2011. The other vaccine used in the campaign, a split-virus AS03-adjuvanted vaccine, was based on pre-pandemic vaccines against influenza A (H5N1), which had a more restricted clinical use (Baras et al 2008, Girard et al 2010. The studies evaluating the influenza H5N1 vaccine containing the adjuvant AS03 have associated its presence with an increase in vaccine reactogenicity (Leroux-Roels et al 2007, Baras et al 2008, Rümke et al 2008) and trials conducted with the AS03-adjuvanted H1N1 pandemic vaccine also found high rates of adverse events.…”

“…The other vaccine used in the campaign, a split-virus AS03-adjuvanted vaccine, was based on pre-pandemic vaccines against influenza A (H5N1), which had a more restricted clinical use (Baras et al 2008, Girard et al 2010. The studies evaluating the influenza H5N1 vaccine containing the adjuvant AS03 have associated its presence with an increase in vaccine reactogenicity (Leroux-Roels et al 2007, Baras et al 2008, Rümke et al 2008) and trials conducted with the AS03-adjuvanted H1N1 pandemic vaccine also found high rates of adverse events. Local mild to moderate reactions were more common and serious adverse events were rarely reported (Carmona et al 2010, Roman et al 2010a, b, Waddington et al 2010, Nicholson et al 2011.…”

“…The GSK vaccine was the only vaccine that also contained an adjuvant, AS03, which is composed of squalene, DL-α tocopherol and polysorbate 80. Although this adjuvant had been previously used in prepandemic vaccines (Leroux-Roels et al 2007, Baras et al 2008, Rümke et al 2008, it was not present in any of the seasonal influenza vaccines that were used in previous campaigns. As AS03 was a new adjuvant with sparse evidence available on its safety in pregnant women, the WHO initially recommended that the first choice (when available) for this patient group should be non-adjuvanted inactivated preparations (WHO 2009b).…”

Finding a new drug and vaccine for emerging swine flu: What is the concept?

“…95 The current question is how to produce an effective pandemic influenza vaccine. 96,97 Focusing on classical influenza, the problem of the genetic shift highlights the problem of the efficacy of the in-use influenza vaccine. In the case of the novel influenza swine flu, the problem remains.…”

Pricing of new vaccines

“…[51][52][53] GSK's vaccine pricing has accounted for and taken advantage of its broad vaccine portfolio. GSK has offered volume discounts and price bundling (i.e., discounts if different vaccine products are purchased together) to encourage payers to purchase across its portfolio.…”