Novartis announces positive clinical trial results for novel H7N9 vaccine

NovartisNovartis announced today interim results from a Phase 1 clinical trial with its proprietary cell culture vaccine for the H7N9 avian influenza virus involving 400 healthy volunteers (18-64 years of age). The data shows 85% of subjects achieved a protective immune response after two doses of the 15 ug MF59 adjuvanted vaccine. Only 6% of subjects achieved a protective response when given two doses of the 15ug un-adjuvanted vaccine. The full data set from the trial will be submitted to a peer-reviewed journal for publication in the near future.

The vaccine was produced utilizing full-scale cell-culture manufacturing technology, an alternative technology that can significantly accelerate vaccine production versus traditional egg-based methods.[1] Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.[2]

"This rapid response underscores our leadership position in pandemic preparedness" said Andrin Oswald, Division Head, Novartis Vaccines. "Thanks to our investments into innovative production technologies and adjuvants, we are now able to offer a protective solution for a potentially deadly pandemic virus within a few months after the emergence of the H7N9 virus."

Reports of H7N9 infection first emerged in China in March 2013. Novartis, along with its partners at the Craig Venter Institute, first synthesized the viral strain several days after it was shared with global researchers by the Chinese Centers for Disease Control. Novartis then produced clinical trial lots, began clinical trials in August, and initiated large-scale production in its Holly Springs (NC), USA and Marburg, Germany facilities in October.

This project has been funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO1002012000141

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 133,000 full-time equivalent associates and operate in more than 140 countries around the world.

1. U.S. Department of Health and Human Services. "HHS Awards Contracts Totaling More Than $1 Billion to Develop Cell-Based Influenza Vaccine." 2006 Available at: http://archive.hhs.gov/news/press/2006pres/20060504.html.
2. Ambrozaitis, Arvydas et al. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. Vol 27. Issue 43. October 9, 2009: 6022-6029. Available at: http://www.sciencedirect.com/science/article/pii/S0264410X09011177. Accessed on October 3, 2012.

Most Popular Now

Top 20 breaking World Pharma News of 2017

We are proud to announce the top 20 most popular breaking World Pharma News from 2017. Have a wonderful 2018 new(s) year filled with health, happiness, and spectacular su...

Novartis advances head-to-head superiority trials …

Novartis announced today the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab** in ankylosing spondyl...

Diabetes drug 'significantly reverses memory loss…

A drug developed for diabetes could be used to treat Alzheimer's after scientists found it "significantly reversed memory loss" in mice through a triple method of action...

Sandoz regulatory submission for proposed biosimil…

Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics Licen...

Zika remains a research and public health challeng…

Since 2016, when Zika was declared by the World Health Organization as a public health emergency of international concern, the virus has become established in more than 8...

Try exercise to improve memory, thinking

For patients with mild cognitive impairment, don't be surprised if your health care provider prescribes exercise rather than medication. A new guideline for medical pract...

Dirt-dwelling microbe produces potential anti-mela…

A type of soil-dwelling bacterium produces molecules that induce death in melanoma cells, research at Oregon State University shows. The molecule is a secondary metabolit...

Novartis Kisqali® received FDA Breakthrough Therap…

Novartis today announced Kisqali® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pr...

FDA approves first treatment for breast cancer wit…

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast can...

New research paper shows that AstraZeneca has achi…

In a research paper published today by Nature Reviews Drug Discovery(1), AstraZeneca's IMED Biotech Unit documents a more than four-fold improvement in R&D productivity f...

Berry gives boost to cervical cancer therapy

According to the Centers for Disease Control and Prevention, approximately 12,000 women in the United States are diagnosed with cervical cancer each year. One of the most...

Novartis appoints Elizabeth Barrett as Oncology He…

Novartis announced today that Elizabeth (Liz) Barrett, currently Global President Oncology at Pfizer, Inc., has been appointed CEO Novartis Oncology and a member of the E...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]