GSK presents child efficacy data supporting Fluarix Quadrivalent
GSK presented today at the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices meeting that its Fluarix Quadrivalent vaccine demonstrated 63.2% efficacy against moderate to severe influenza and 49.8% efficacy against influenza of any severity in children 6 months through 35 months of age.
These results are based on a randomized, observer-blind, non-influenza vaccine-controlled trial that enrolled 12,018 children in five independent cohorts in 13 countries in Asia, Europe, and Central America from 2011 through the end of 2014.
“Children 6 months through 35 months of age are particularly vulnerable to the flu, and the efficacy results from this trial are promising,” Leonard Friedland, vice president, scientific affairs and public health, GSK Vaccines, said. “Fluarix Quadrivalent can help ensure health care provider and parents have the ability to help protect young children against the flu.”
Fluarix Quadrivalent was immunogenic against all four vaccine strains (i.e., A/H1N1, A/H3N2, B/Victoria and B/Yamagata).
The safety and reactogenicity profile was similar to vaccines used in the same age group. No safety signal was observed.
Additionally, the study found that Fluarix Quadrivalent reduced healthcare utilization (i.e., antibiotic use, general practitioner visits and emergency department visits) related to confirmed influenza illness.
Fluarix Quadrivalent was first approved in 2012 in the U.S. for the prevention of influenza disease in people 3 years of age and older. In 2018, the indication was expanded to children 6 months and older. It is also approved in more than 30 other countries worldwide.
Fluarix Quadrivalent is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluarix Quadrivalent is approved for use in persons aged 6 months and older.
There are two main types of seasonal flu viruses, A and B, that spread between people and can cause mild to severe illness. Most flu activity in the U.S. occurs from October through May, and it usually peaks between December and February.
MainPointe Pharma acquires several Mission Pharmacal OTCs
Mission Pharmacal on Wednesday divested several consumer products to MainPointe Pharmaceuticals along with the marketing rights of additional consumer products that have been licensed by Mission to MainPointe. As part of these transactions, the companies have also entered into a renewable contract manufacturing agreement to continue manufacturing all of the included products that are currently made in Mission’s manufacturing facility.
“These are exciting agreements that will provide consumers greater access to the products involved due to MainPointe’s existing relationships within more diverse distribution channels,” Neill Walsdorf, Jr., Mission president, said. “Mission remains passionate about the products involved, and more importantly, we are steadfast in our support of the end users who rely on these products every day.”
As part of the agreements, the Thera-Gesic, Thera-Gesic Plus, Dr. Smith’s Diaper Rash Ointment, Dr. Smith’s Diaper Rash Spray, Dr. Smith’s Adult Barrier Spray and Dr. Smith’s Adult Ointment have been divested.
In addition, marketing rights have been licensed by Mission to MainPointe for the following Calcet, Fosfree, Heat Guard, Maxilube and Lycelle Head Lice Removal Kit.
“We look at these agreements as the beginning of an exciting strategic partnership between Mission and MainPointe,” Walsdorf said. “Our industry is continually evolving and we hold strong to the belief that partnering for success is more essential today than ever before.”
The new portfolio of products joins Nexafed and Nexafed Sinus as core MainPointe Pharmaceuticals OTC products being supplied by the manufacturer. This past fall, MainPointe acquired the rights to these popular diversion-resistant cough/cold products from Acura Pharmaceuticals.
As part of that deal, MainPointe brought Nexafed 2.0 to market late last year.
“Conversion of pseudoephedrine products into methamphetamine remains an acute problem in many communities,” John Schutte, MainPointe chairman and CEO, said when MainPoint first acquired the rights to market Nexafed. “The Nexafed products have proven to be a success in curbing this costly problem and we look forward to driving this business forward.”
Walgreens: As West recovers, flu incidence gains in Northeast
While flu incidence appears to recede in the West, influenza-like illnesses are trending in the East, and particularly in the Northeast, according to the latest Walgreens Flu Index released Wednesday.
Week to week, there was little change in the flu incidence heat map issued by Walgreens, though Tennessee moved from red, indicating a high level of flu activity, to orange. Meanwhile, Maine moved from a “green” status, suggesting fewer incidents of flu, to orange.
For the week ending Feb. 17, the top 10 designated market areas experiencing flu activity gains were:
- Lincoln & Hastings-Kearney, Neb.;
- Memphis, Tenn.;
- Salisbury, Md.;
- Nashville, Tenn.;
- Paducah, Ky.-Cape Girardeau, Mo.-Harrisburg, Ill.;
- Youngstown, Ohio;
- Lexington, Ky.; and
- Traverse City-Cadillac, Mich.
Overall, the top 10 DMAs with flu incidence for that week were:
- Oklahoma City;
- Dallas-Ft. Worth, Texas;
- Little Rock-Pine Bluff, Ark.;
- El Paso, Texas (Las Cruces, N.M.);
- Nashville, Tenn.;
- Waco-Temple-Bryan, Texas;
- Greensboro-High Point-Winston Salem, N.C.;
- Shreveport, La.;
- Lincoln & Hastings-Kearney, Neb.; and
- Tyler-Longview (Lufkin & Nacogdoches), Texas.
The Walgreens Flu Index is a weekly report developed to provide state- and market-specific information regarding flu activity, and ranks those states and markets experiencing the highest incidences of influenza across the country. The Flu Index provides insight by showing which cities or metropolitan areas are experiencing the most incidences of influenza each week based on Index methodology. The data does not measure actual levels or severity of flu activity.
The Walgreens Flu Index is compiled using weekly retail prescription data for antiviral medications used to treat influenza across Walgreens and Duane Reade locations nationwide, including Walgreens locations in Puerto Rico. The data is analyzed at state and geographic market levels to measure absolute impact and incremental change of antiviral medications on a per store average basis, and does not include markets in which Walgreens has fewer than 10 retail locations.