GSK Ships Seasonal Influenza Vaccines for US Market


GSK today announced it will begin shipping its quadrivalent influenza vaccines to US healthcare providers and pharmacies for the 2018-19 flu season, immediately following licensing and lot-release approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research.

“The 2017-18 flu season was an important reminder that the flu is a serious and unpredictable disease,” said Dr. Leonard Friedland, VP, director of Scientific Affairs and Public Health, Vaccines, North America. “Annual vaccination can help prevent flu illnesses and flu-related hospitalizations and reduce the severity of the disease. The more people of all ages who are immunized, the less chance the virus has to spread and the better we can help protect against the flu this season.”

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The US Centers for Disease Control and Prevention (CDC) estimates that flu vaccination during the 2016-17 flu season prevented an estimated 5.29 million illnesses, 2.64 million medical visits and 84,700 hospitalizations associated with flu, underscoring the benefits of current vaccines. Yet, according to the CDC, approximately 80 percent of flu-related deaths in children during the 2017-18 season occurred in children who were not vaccinated against the flu that season.

“The flu vaccine is the one vaccine that people of almost all ages should receive annually,” said Patrick Desbiens, Senior Vice President, US Vaccines. “GSK is committed to helping healthcare professionals provide flu vaccinations across the lifespan. Beginning with the 2018-19 flu season, we can now offer two vaccines that enable providers to vaccinate all of their recommended patients aged 6 months and older with the same vaccine dose."

GSK expects to supply up to 40 to 45 million total doses across both of its vaccines for the US market in the 2018-19 season, the highest volume of doses planned for distribution by GSK to date. FLULAVAL QUADRIVALENT will be available in a 5mL, multidose vial containing 10 doses (0.5mL each) and a 0.5mL, single-dose, prefilled syringe. FLUARIXQUADRIVALENT will be available in a 0.5mL, single-dose, prefilled syringe.

For the 2018-19 flu season, the World Health Organization (WHO) and FDA’s Vaccines and Related Biological Products Advisory Committee recommended including the A/Michigan/45/2015 (H1N1) pdm09-like virus, A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus and B/Colorado/06/2017-like virus, with the addition of B/Phuket/3073/2013-like virus for the quadrivalent vaccine.

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