Content about H5N1 clinical trials

December 28, 2012
Emergent BioSolutions secures manufacture and sales rights to pandemic influenza vaccine in U.S.

Emergent BioSolutions announced that it has signed a license agreement with VaxInnate Corporation under which Emergent acquired the exclusive right to manufacture and sell VaxInnate’s pandemic influenza vaccine candidate in the United States.

ROCKVILLE, Md. — Emergent BioSolutions on Friday announced that it has signed a license agreement with VaxInnate Corporation under which Emergent acquired the exclusive right to manufacture and sell VaxInnate’s pandemic influenza vaccine candidate in the United States. 

December 18, 2012
FDA approves GSK four-strain flu vaccine

The Food and Drug Administration has approved a new four-strain flu vaccine made by GlaxoSmithKline, the drug maker said.

LONDON — The Food and Drug Administration has approved a new four-strain flu vaccine made by GlaxoSmithKline, the drug maker said.

GSK announced the approval of its Fluarix Quadrivalent (influenza virus vaccine) for children and adults against seasonal influenza subtypes A and B. The company said the vaccine was the first for intramuscular injection that protects against four strains of the virus.

November 21, 2012
FDA approves first flu vaccine manufactured by Novartis using cell culture technology

The Food and Drug Administration on Wednesday announced the approval of Novartis' Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced the approval of Novartis' Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older.

October 22, 2012
Sanofi Pasteur presents influenza vaccine trial data

Sanofi Pasteur announced Monday the presentation of three clinical trials of an experimental influenza vaccine.

SWIFTWATER, Pa. — Sanofi Pasteur announced Monday the presentation of three clinical trials of an experimental influenza vaccine.

August 14, 2012
FDA approves formulation for 2012-2013 flu vaccines

The Food and Drug Administration has approved the formulation for the 2012-2013 flu vaccine, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved the formulation for the 2012-2013 flu vaccine, the agency said Monday.

The agency's approval is for all six licensed flu vaccines for the 2012-2013 season: Afluria, made by CSL; Fluarix, made by GlaxoSmithKline; FluLaval, made by ID Biomedical; FluMist, made by MedImmune Vaccines; Fluvirin, made by Novartis; and Fluzone, made by Sanofi.

August 3, 2012
MedImmune ships flu vaccine

AstraZeneca's biologics division has begun shipping doses of influenza vaccine to distributors for the 2012-2013 flu season, the company said.

GAITHERSBURG, Md. — AstraZeneca's biologics division has begun shipping doses of influenza vaccine to distributors for the 2012-2013 flu season, the company said.

October 21, 2011
Study: Fluzone High-Dose works well in senior population

Sanofi Pasteur, the vaccines division of Sanofi, released data from a new study examining the ability of its Fluzone High-Dose vaccine to provoke an immune response in elderly and younger adults, compared with a standard dose of Fluzone vaccine.

SWIFTWATER, Pa. — Sanofi Pasteur, the vaccines division of Sanofi, released data from a new study examining the ability of its Fluzone High-Dose vaccine to provoke an immune response in elderly and younger adults, compared with a standard dose of Fluzone vaccine.

"The results further support the immunogenicity advantages of Fluzone High-Dose vaccine as compared to Fluzone vaccine, the standard dose comparator, in seniors 65 years of age and older," stated Peter Tsang, director clinical development, Sanofi Pasteur.

May 10, 2011
FDA OKs Sanofi Pasteur's Fluzone Intradermal

Sanofi’s vaccines division has won Food and Drug Administration approval for a vaccine designed for injection into the skin, the company said Tuesday.

SWIFTWATER, Pa. — Sanofi’s vaccines division has won Food and Drug Administration approval for a vaccine designed for injection into the skin, the company said Tuesday.

Sanofi Pasteur announced the FDA approval of Fluzone Intradermal (influenza virus vaccine), which injects the vaccine into the skin via a short, fine needle, also known as a microinjection.

February 16, 2011
Baxter on verge of revolutionizing flu shot life cycle

Baxter International on Tuesday announced results of a study published in this week's issue of The Lancet that demonstrated effectiveness and tolerability of the company’s Preflucel in protecting against seasonal influenza.

DEERFIELD, Ill. — Baxter International on Tuesday announced results of a study published in this week's issue of The Lancet that demonstrated effectiveness and tolerability of the company’s Preflucel in protecting against seasonal influenza.

August 30, 2010
Salmonella not a threat to flu vaccine production

Despite concerns that this year's flu vaccine production will be affected by the recent salmonella...

NEW YORK Despite concerns that this year's flu vaccine production will be affected by the recent salmonella outbreak, a Food and Drug Administration official and a drug maker advised that is not the case, according to published reports.

Although chicken eggs, which were said to be the source of this summer's salmonella outbreak, are used to make the flu vaccine, an FDA spokeswoman said that chicken eggs used in creating the flu vaccine are fertilized, unlike those used for consumption.

February 18, 2010
Investigational flu vaccine boosts immune response, clinical trial shows

Patients who received a dose of between 5 and 45 micrograms of an investigational flu...

February 10, 2010
Flu vaccine trial yields positive results, Novavax says

A clinical trial of a seasonal influenza vaccine that began in May 2009 has produced...

January 11, 2010
FDA approves Fluzone

The Food and Drug Administration has approved a flu vaccine from Sanofi Pasteur for use...

October 15, 2009
NIH announces government-sponsored clinical trial of H1N1 vaccine

There still is widespread concern over the safety and efficacy of the new H1N1 influenza...

NEW YORK There still is widespread concern over the safety and efficacy of the new H1N1 influenza vaccine, despite public assurances from executives at the highest levels of the Centers for Disease Control and Prevention — the point agency around the H1N1 pandemic — that the H1N1 vaccines have been subject to the same safety and efficacy protocols as seasonal vaccine, which generally is considered both safe and effective.