americanpharmaceuticalreviewJuly 17, 2019
Tag: GSK , Seasonal , influenza vaccines
GSK will begin shipping its quadrivalent influenza vaccines to US healthcare providers and pharmacies for the 2019-20 flu season, immediately following licensing and lot-release approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research.
"CDC recommends that everyone 6 months of age and older get a flu shot every season," said Judy Stewart, Senior Vice President, US Vaccines. "To simplify vaccine storage and procurement and to help healthcare professionals realize every appropriate vaccination opportunity, GSK offers two influenza vaccines with the same vaccine dose for all recommended patients."
GSK expects to supply more than 40 million total doses of its influenza vaccines for the US market in the 2019-20 season. FLULAVAL QUADRIVALENT will be available in a 5mL, multidose vial containing 10 doses (0.5mL each) and a 0.5mL, single-dose, prefilled syringe. FLUARIX QUADRIVALENT will be available in a 0.5mL, single-dose, prefilled syringe.
"The 2018-19 flu season was the longest flu season the US has experienced in a decade," said Dr. Leonard Friedland, VP, director of Scientific Affairs and Public Health, Vaccines, North America. "This is an important reminder that the flu is a serious and unpredictable disease and annual vaccination is the best way to help prevent flu illnesses and flu-related hospitalizations and reduce the severity of the disease."
According to the US Centers for Disease Control and Prevention (CDC), annual influenza vaccination is the best available tool to help protect people 6 months and older against the flu. The CDC has estimated that flu vaccination during the 2017-18 flu season prevented approximately 7.1 million illnesses, 3.7 million medical visits and 109,000 hospitalizations associated with flu.
For the 2019-20 flu season, the World Health Organization (WHO) and FDA's Vaccines and Related Biological Products Advisory Committee recommended including the A/Brisbane/02/2018 (H1N1) pdm09-like virus, A/Kansas/14/2017 (H3N2)-like virus, B/Colorado/06/2017-like virus, with the addition of B/Phuket/3073/2013-like (Yamagata lineage) virus for the quadrivalent vaccine.
Seasonal influenza (the "flu") is a contagious respiratory illness, caused by flu viruses. There are two main types of flu viruses, A and B, that spread between people and can cause mild to severe illness. Most flu activity in the US occurs from October through May, and it usually peaks between December and February.
While anyone can get the flu, it can be particularly serious for young children, older people, pregnant women and people with certain health conditions, such as asthma. According to the CDC, the best tool available is to get vaccinated. The more people who are vaccinated, the less chance the virus has to spread. The CDC recommends that all people over the age of 6 months get vaccinated against the flu annually.
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