Back to top

Analyst Blog

Zacks Equity Research

FDA Nod for Novartis' Flucelvax

PFE NVS

 ZacksTrade Now

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

The US Food and Drug Administration (FDA) recently approved Novartis’ (NVS - Snapshot Report) influenza virus vaccine, Flucelvax.  Flucelvax is the first cell-culture-derived vaccine, for patients 18 years of age and older.

The US approval of Flucelvax was based on positive results which showed that Flucelvax was well tolerated compared to placebo.

Cell-culture technology is used to manufacture other vaccines such as polio, rubella and hepatitis A. Flucelvax does not have any preservatives like thimerosal or antibiotics.

We note that Novartis has a partnership agreement with the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA) to develop cell-culture manufacturing technology. The agreement also includes the construction of a state-of-the-art facility in Holly Springs.

HHS awarded more than $1 billion for the development of the technology in the US. Once the Holly Springs facility is ready for commercial production, Flucelvax will be manufactured there.

We remind investors that Novartis’ Vaccines and Diagnostics segment was recently in the news as the Italian Medicines Agency (AIFA) lifted the temporary halt on the company’s seasonal influenza vaccines Agrippal and Fluad. Similar bans were lifted in Canada, Switzerland and Singapore as well.

The Vaccines and Diagnostics segment also received encouraging news as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently gave a positive opinion on Novartis’ meningococcal group B (MenB) vaccine Bexsero. We however note that companies like Pfizer Inc. (PFE - Analyst Report) are looking to enter the MenB vaccine market.

We are encouraged by Novartis’ performance in the Vaccines and Diagnostics segment in the recent past. Currently, we have a Neutral recommendation on Novartis. Novartis carries a Zacks #3 Rank (Hold rating) in the short run.

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
LAKE SHORE G LSG 0.77 +6.05%
QUESTCOR PHA QCOR 80.07 +2.47%
VIPSHOP HOLD VIPS 156.35 +1.82%
ENLINK MIDST ENLC 36.29 +1.60%
BNC BANCORP BNCN 17.33 +1.58%