GSK today announced it started shipping its quadrivalent influenza vaccines to U.S. healthcare providers and pharmacies for the 2021-22 flu season. This immediately follows a licensing and lot-release approval from the Food and Drug Administration's Center for Biologics Evaluation and Research.
GSK expects to distribute more doses than it has in any previous flu season with a record supply of more than 50 million doses of its influenza vaccine for the 2021-2022 season to the U.S. market.
The Centers for Disease Control and Prevention recommends that everyone 6 months of age and older who do not have contraindications get a flu vaccine every season. In recent weeks, the CDC has repeatedly emphasized the importance of influenza vaccination this flu season to help reduce the burden of disease and the impact of influenza on the healthcare system and other critical infrastructures during the COVID-19 pandemic.
"Many people have fallen behind on their routine immunizations during the pandemic, causing immunization rates to decline across the lifespan; from children to adults, including influenza vaccination during the 2020-2021 season," said Dr. Leonard Friedland, vice president, director of Scientific Affairs and Public Health, GSK Vaccines.
"The flu remains a serious and unpredictable disease that can result in mild to severe illness. As more people are vaccinated against COVID-19 and we return to more normal, social activities, it is important that anyone over the age of 6 months is vaccinated against the flu."
A recent claims analysis commissioned by GSK and conducted by Avalere Health showed a significant and sustained drop in immunization rates for recommended vaccines among adolescents and adults throughout the pandemic in 2020, including influenza immunization. The report indicated rates were lower in 2020 than in 2019, with total influenza vaccinations dropping 14-35% in 2020 compared to 2019.
"The Avalere Health study showed us that the need for people to make up for missed healthcare visits and receive their recommended immunizations is stronger than ever," said Judy Stewart, senior vice president and head of U.S. Vaccines at GSK. "GSK's focus continues to be increasing vaccination rates during the COVID-19 pandemic and flu vaccination is an integral part of that public health effort."
The CDC's updated recommendation on COVID-19 vaccines and coadministration with other vaccines now notes that they can be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccine and other vaccines on the same day, as well as coadministration within 14 days.
Both Flulaval Quadrivalent and Fluarix Quadrivalent will be available in a 0.5mL, single-dose, pre-filled syringe, and indicated for patients 6 months and older in line with CDC recommendations.
According to the CDC, annual influenza vaccination is the best way to help protect people 6 months and older against the flu. The CDC has estimated that flu vaccination during the 2019-20 flu season prevented approximately 7.5 million illnesses, 105,000 associated hospitalizations, and 6,300 deaths.
For the 2021-22 flu season, the World Health Organization and FDA's Vaccines and Related Biological Products Advisory Committee recommended including A/Victoria/2570/2019 (H1N1) pdm09-like virus, A/Cambodia/e0826360/2020 (H3N2)-like virus, B/Washington/02/2019 (B/Victoria lineage)-like virus and B/Phuket/3073/2013 (B/Yamagata lineage)-like virus for egg-based vaccines.