The US Food and Drug Administration (FDA) recently approved
) influenza virus vaccine, Flucelvax. Flucelvax is the
first cell-culture-derived vaccine, for patients 18 years of age
The US approval of Flucelvax was based on positive results
which showed that Flucelvax was well tolerated compared to
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
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
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
) 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.
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