One of three manufacturing sites commissioned by the Department of Health and Human Services to quickly develop and produce flu vaccines in the case of a pandemic is expected to be fully operational by 2017, officials say.
The highly anticipated vaccine and potential blockbuster is being manufactured at a plant in Neuville-sur-Saone, France. Fill and pack will be done at another Sanofi Pasteur plant.
Another vaccine has shown promise in early-stage studies against the virulent H7N9 avian influenza strain, which has so far infected more than 130 people and caused 39 deaths.
A universal flu vaccine is the holy grail of influenza immunizations. The yearly process of making educated guesses about the upcoming flu season would end, replaced by a vaccine for many of the strains. It is a massive challenge, but one that Sanofi and others have taken up.
In pandemic flu preparation, a lot of focus is placed on protecting against the specific viral strain. Yet analysis of the 1918 pandemic shows secondary bacterial pneumonia directly caused many of the deaths. This brings Pfizer's Prevnar 13 into play, and the Big Pharma is talking up its role.
The Department of Health and Human Services last year anted up $400 million as part of an ambitious plan to expand vaccine manufacturing in the U.S. which it could tap in case of a pandemic. One leg of a three-legged stool on which that plan sits is about to be built.
In response to concerns about biodefense, the Department of Health and Human Services is helping GlaxoSmithKline and Texas A&M build a $91 million vaccine production plant.
Just as news channels use computer models to forecast weather, data on weather conditions might also be helpful in predicting disease outbreaks.
CSL will manufacture and store antigens that can be used against influenza strains with pandemic potential.
Australia-based vaccine maker CSL Biotherapies, which has had to deal with some quality issues raised by the FDA, has been selected by the U.S. government to further strengthen the country's supply of pre-pandemic and pandemic vaccine antigens in case of an influenza outbreak.