The Food and Drug Administration (FDA) announced the approval of six vaccines on July 18, 2011. These approved trivalent vaccines for the seasonal flu will all contain vaccine for the H1N1/09 "Swine Flu" and two other viruses suggested by CDC for this season (see more below). These approved vaccines are:

1. Afluria (CSL Limited)

2. Fluarix (Glaxo Smith Kline Biologicals)

3. FluLaval (ID Biomedical Corporation)

4. FluMist (MedImmune Vaccines, Inc.)

5. Fluvirin (Novartis Vaccines and Diagnostics Limited)

6. Fluzone, Fluzone High-Dose, Fluzone Intradermal (Sanofi Pasteur, Inc.)

The Fluzone Intradermal made fy Sanofi Pasteur, Inc. is a new inactivated formulation for administration in the layers of the skin (intradermal injection) instead of the intramuscular (IM) injection. Fluzone Intradermal administration uses a microinjection system with a very fine needle. Approved for those aged 18 through 64. It is marketed under the brand names Intanza and IDflu.

The CDC-approved trivalent vaccines for this flu season will protect against the following three virus strains:

1. A/California/7/09 (H1N1)-like virus (Pandemic (H1N1) 2009 influenza virus)

2. A/Perth/16/2009/ (H3N2)-like virus [A/Victoria/210/2009 X-187]

3. B/Brisbane/60/2008-like virus

In Europe:

Re: Pandemrix made by GlaxoSmithKline (GSK) July 21, 2011 according to Reuters:

LONDON (Reuters Health) Jul 21 2011 - European regulators have recommended restricting the use of GlaxoSmithKline's pandemic flu vaccine Pandemrix because of a potential risk of narcolepsy in children or adolescents.

The European Medicines Agency said on Thursday that Pandemrix should only be used in people under 20 years in the absence of seasonal trivalent influenza vaccines, following its link to very rare cases of narcolepsy in young people.

Overall, the vaccine's benefit-risk balance remains positive, the watchdog added.

More than 31 million doses of Pandemrix have been given to people in 47 countries, and GSK said it had been notified of 335 cases of narcolepsy in those vaccinated as of July 6. Two-thirds of the narcolepsy cases were in Finland and Sweden.

Britain's biggest drugmaker said in a statement it had committed to conduct further research into any potential association between Pandemrix and narcolepsy.

Pandemrix was widely used during the 2009-10 outbreak of H1N1 swine flu, although it was not administered in the United States.

Several other drugmakers, including Novartis , Sanofi , CSL and Baxter also made vaccines against H1N1 flu during the pandemic, which was declared over in August last year.

Finnish and Swedish researchers were the first to raise concerns over a possible narcolepsy link to Pandemrix last August after noting cases in children recently given the GSK shot.

One research team earlier this year suggested children given Pandemrix were nine times more likely to suffer from the condition.

Researchers at Finland's National Institute for Health and Welfare said the increase they found in narcolepsy was "most likely" a joint effect of Pandemrix and some other factor or factors.

For the prior flu seasons:

There were four manufacturers' products approved by The Food and Drug Administration (FDA) for the 2009 A-H1N1 Influenza. The drug companies are: CSL, Novartis, Sanofi Pasteur, and MedImmune.GlaxoSmithKline has not yet had approval for their vaccine in the US but it was approved in Europe.

CSL, Novartis and Sanofi Pasteur have produced the vaccines for injection that are made with inactivated viruses, and MedImmune has produced the nasal spray. None of the vaccines approved in the US by FDA contain adjuvants [A substance added to a vaccine to improve the immune response so that less vaccine is needed.]

CSLMelbourne-based CSL Ltd. NovartisNovartis AG, based in Basel, Switzerland Sanofi PasteurSanofi-Aventis SA, based in Paris MedImmuneMedImmune, LLC, the Maryland US- based Subsidiary of London's AstraZeneca

Note of Interest:

The U.S. is in "very active discussions" about donating some of its supply to countries that need it. CSL plans to donate vaccine to developing nations in Asia and the South Pacific. They are working on this with the World Health Organization to start by providing as many as 100,000 doses. According to the WHO, an initial distribution of the more than 300 million doses, which were donated by other countries to over 90 countries in need, will begin sometime in November.

Vaccine for H1N1/09 is being made for the US by Melbourne-based CSL Ltd., Sanofi-Aventis SA, based in Paris (aka Sanofi-Pasteur), London-based AstraZeneca Plc (MedImmune subsidiary), and Novartis AG based in Basel, Switzerland. GlaxoSmithKline Plc also is in the process of review by the FDA for their vaccine but it is not approved yet. They have gotten approval for one version of vaccine from the European EMEA, however, and is producing it for use in Europe.

Glaxo initially concentrated on development of its vaccine that contained an adjuvant, which is the version approved by the EMEA. Adjuvants are ingredients used in vaccines to boost the effectiveness. The Department of Health and Human Services in the US had decided to only use vaccines without adjuvants. Glaxo is also now doing clinical tests on vaccines without adjuvants for review by the FDA at a later date.

Besides Glaxo's vaccine, EMEA has also approved manufacture of vaccine for European use by Novartis which also contains an adjuvant.

Other countries have contracted with additional manufacturers.

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