Seqirus Wins Approval for Flu Vaccine for Adults 65 and Older

 

Nearly three weeks after the U.S. Food and Drug Administration green-lit Audenz for the protection against influenza A (H5N1) in the event of a pandemic, Seqirus snagged approval for Fluad Quadrivalent, the first-and-only quadrivalent adjuvanted influenza vaccine developed to help protect adults 65 years and older against seasonal influenza.

Influenza impacts adults 65 years and older with higher hospitalization and death rates compared to young, healthy adults. In fact, during the 2017/18 flu season, 70% of flu-related hospitalizations and 90% of flu-related deaths occurred in this age group, Seqirus said in its announcement. The effectiveness of many flu vaccines is also lower in this age population due to age-related immune decline, which reduces the body’s ability to produce a sufficient, protective immune response to the vaccine.

Preliminary estimates from the U.S. Centers for Disease Control report that up to 647,000 people in the United States were hospitalized due to influenza-related complications during the 2018 -2019 influenza season.

Seqirus was established in 2015 after Australia-based CSL Limited acquired Novartis’ influenza vaccines business. The company is now one of the largest providers of flu vaccines in the world. Fluad Quadrivalent and Fluad are the first-and-only adjuvanted seasonal influenza vaccines approved in the U.S. for adults 65 years and older, the company noted.  

Anjana Narain, executive vice president and general manager at Seqirus, said the company is pleased to offer Fluad Quadrivalent as another seasonal vaccine option for influenza. Narain noted that adults over the age of 65 are at a high risk of developing influenza-related complications and it’s important to provide them with a new treatment option.

“The burden of seasonal influenza among adults 65 and older, remains an important public health concern,” Gregg Sylvester, chief medical officer at Seqirus said in a statement. “At Seqirus, we’re committed to developing advanced technologies and vaccines designed to address unmet needs, especially in vulnerable populations, such as adults 65 years and older.” 

Fluad Quadrivalent uses the company’s MF59 adjuvant technology, which is the same technology that its longtime flu-treatment Fluad uses. The MF59 technology is believed to enhance an immune response from the body by inducing antibodies against virus strains that have mutated. The quadrivalent version though includes an additional strain, the company said.

In December, the company released new data that shows Fluad, an adjuvanted trivalent influenza vaccine, was more effective than standard non-adjuvanted trivalent influenza vaccine in reducing the risk of flu- and pneumonia-related hospitalization in patients 65-years-of-age and older.