$226 Million Awarded For ‘Pandemic Influenza Production’

Sanofi Pasteur pandemic influenza vaccine will utilize Flublok Quadrivalent technology
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(Precision Vaccinations News)

The U.S. Department of Health and Human Services (HHS) announced a $226 million dollar agreement to increase Sanofi Pasteur’s domestic pandemic influenza vaccine production capabilities in Pennsylvania.

This new HHS contract announced on December 9, 2019, will support the clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine by Sanofi Pasteur to enhance the USA’s and global pandemic preparedness.

This is important news since the risk of influenza-associated morbidity and mortality is potentially higher with pandemic influenza than with seasonal influenza because of the lack of existing immunity to the virus in the general human population, says HHS.

This investigational pandemic vaccine will utilize the same recombinant technology as Sanofi's Flublok® Quadrivalent flu shot.

Flublok Quadrivalent is the only recombinant protein-based influenza vaccine approved by the U.S. Food and Drug Administration (FDA), uniquely providing an exact genetic match of hemagglutinin (HA) from each recommended vaccine virus.

The Flublok Quadrivalent vaccine consists of the 4 influenza strains that have been identified to be the most likely strains for the 2019-2020 flu season. 

In addition, the HHS contract will add both recombinant and adjuvant manufacturing capabilities alongside current egg-based manufacturing.

An influenza pandemic requires rapid production of very large quantities of vaccine.

The contract is supported by federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at HHS.

Moreover, the Executive Order of September 19, 2019, said 'It is the policy of the United States to modernize the domestic influenza vaccine enterprise to be highly responsive, flexible, scalable, and more effective at preventing the spread of influenza viruses.'

"The question is not if, but when the next influenza pandemic will occur, carrying potentially devastating consequences for public health and the U.S. economy," said BARDA Director Rick Bright, Ph.D., in a related press release.

"As the recent presidential executive order on pandemic preparedness emphasized, technology to produce effective vaccines quickly and safely in the United States can improve access, protect more people sooner and, ultimately, strengthen national and global health security.”

The 1918 influenza pandemic was caused by an H1N1 virus with genes of avian origin. It is estimated that about 500 million people in the world became infected with this virus. The number of deaths was estimated to be about 675,000 occurring in the USA.

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Currently, the Flublok Quadrivalent vaccine is indicated for adults 18 years of age and older and proven in a randomized controlled trial to help prevent 30 to 43 percent more cases of laboratory-confirmed influenza in people 50 years of age and older compared to a standard-dose quadrivalent inactivated influenza vaccine.

But, Flublok Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine or after the previous dose of the vaccine.

If Flublok Quadrivalent is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.

Sanofi is a global biopharmaceutical company focused on human health, preventing illness with vaccines, provide innovative treatments to fight pain, and ease suffering.

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