GSK announces submissions for two influenza vaccines

GlaxoSmithKlineGSK has submitted US and EU regulatory applications seeking approval of a quadrivalent influenza vaccine for the "active immunisation of adults and children from 3 years of age for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine."

A supplemental Biologics License Application has been submitted to the U.S. Food and Drug Administration (FDA) and a new application has been submitted to European regulatory authorities. The quadrivalent influenza vaccine is currently not approved or licensed anywhere in the world for the prevention of influenza.

A regulatory application has also been submitted to the U.S. FDA seeking approval for an H5N1 influenza vaccine.

The Biologics License Application seeks approval for the "active immunisation for the prevention of disease in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine" for use as directed by the U.S. Government.

GSK's H5N1 pandemic influenza vaccine, manufactured in Quebec, is currently approved in Europe under the brand name, Pumarix™. For more information about the currently licensed indication of Pumarix™ in Europe, please visit the EMA website.

The H5N1 influenza vaccine programme was supported by a development contract (HHSO100200700029C) with the Biomedical Advanced Development and Research Authority (BARDA) of the US Department of Health and Human Services.

GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GlaxoSmithKline Biologicals - (GSK Biologicals), GlaxoSmithKline's vaccines business, is one of the world's leading vaccine companies and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development - both in the prophylactic and therapeutic fields. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2010, GSK Biologicals distributed 1.43 billion doses of vaccines to 179 countries in both the developed and the developing world.

Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to the discovery of innovative vaccines that contribute to the health and well-being of people of all generations around the world.

Most Popular Now

SK bioscience and GSK start Phase 3 trial of adjuv…

SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510, in combination wit...

No serious health effects linked to mRNA COVID-19 …

Federal and Kaiser Permanente researchers combing the health records of 6.2 million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 v...

Blood vessels produce growth factor that promotes …

Blood vessels supply tumors with nutrients and, on the other hand, enable cancer cells to spread throughout the body. The settlement of circulating tumor cells in a dista...

First-in-human clinical trial for a vaccine to tre…

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by resear...

Sandoz strengthens pipeline by entering into agree…

Sandoz, a Novartis division, today announced that it has entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for biosimilar bevacizumab (BAT1706). B...

Pfizer and BioNTech submit a variation to EMA with…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Condition...

A drug costing less than €2 a day helps in the tre…

Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19patients. This is the finding of a study by investigators at th...

Rheumatoid arthritis treated with implanted cells …

With a goal of developing rheumatoid arthritis therapies with minimal side effects, researchers at Washington University School of Medicine in St. Louis have genetically ...

NIH scientists build a cellular blueprint of multi…

Chronic lesions with inflamed rims, or "smoldering" plaques, in the brains of people with multiple sclerosis (MS) have been linked to more aggressive and disabling forms ...

Scientific evidence to date on COVID-19 vaccine ef…

An expert review by an international group of scientists, including some at the WHO and FDA, concludes that, even for the delta variant, vaccine efficacy against severe C...

How a plant virus could protect and save your lung…

Using a virus that grows in black-eyed pea plants, nanoengineers at the University of California San Diego developed a new treatment that could keep metastatic cancers at...

COVID-19 nasal vaccine candidate effective at prev…

Breathe in, breathe out. That’s how easy it is for SARS-CoV-2, the virus that causes COVID-19, to enter your nose. And though remarkable progress has been made in develop...