Anyone who still thinks that AstraZeneca paid too much when it offered a hefty premium for MedImmune’s shares should check out a new report from Jefferies International, which estimates that the global swine flu windfall will be worth around $2.3 billion in new sales for the Maryland manufacturer in 2009 and 2010 reports FierceVaccines.

MedImmune is putting its FluMist nasal spray technology to the test against swine flu. FluMist, which got off to a shaky start in the U.S., brought in only $104 million last year, a fraction of what the big global manufacturers have been able to earn with their flu shots. But all those naysayers who scorned the terms of the MedImmune buyout in the face of such weak performance could well be silenced by the rewards available when a pandemic hits. AstraZeneca plans to make 200 million doses of swine flu vaccine by next spring.

“This puts MedImmune in a better light and helps pay back some of that $15 billion,” Jefferies analyst Jeffrey Holford told Bloomberg in an interview. “This is the first positive surprise that’s tangible.”

MedImmune has already started recruiting for human trials, saying it will test the vaccine in children aged 3 to 17 and adults aged 18 to 49. Preliminary data may be available in a matter of weeks.

- Read  more about MedImmune in this  Bloomberg feature

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Fears about swine flu have spurred more than 3,000 people so far to volunteer to take part in upcoming clinical trials of a new vaccine. That’s already more than the number scientists will need at eight different sites around the U.S.

“We don’t generally ever get a response like this,” Dr. Lisa Jackson, the principal researcher in charge of the clinical trials being readied at Seattle-based Group Health Cooperative, which fielded more than a thousand calls from people in two days.
U.S. government officials, meanwhile, say they plan to start vaccinating people in October, after researchers have a chance to review the data from trials that should wrap in September. And the Advisory Committee on Immunization Practices is reviewing how a new vaccine for A/H1N1 should be provided to people just as the fall seasonal flu vax campaign gets underway. The U.S. has placed orders for 200 million doses with MedImmune, CSL, GlaxoSmithKline, Novartis and Sanofi-Aventis. But health officials haven’t ruled out a national vaccination campaign that would require up to 600 million doses.

Altogether more than 50 governments have placed orders for a huge supply of swine flu vaccine, providing a bonanza for the big manufacturers in the field. And smaller biotech companies are benefiting as well. Early this week shares of Vical, Novavax and BioCryst Pharmaceuticals all shot up as investors scouted the industry for companies likely to get a boost from the pandemic.

New research has highlighted the need to provide vaccinations to pregnant women first, who are among the most vulnerable to the swine flu. Pregnant women are also being advised to take an antiviral like Tamiflu now if they come down with the flu. A new study in the Lancet concludes that while it’s still unknown just how the drugs could affect the fetus, the likely benefits outweigh the risks.

- check out the report from MSNBC
- read the story from the Guardian
- read the story from Reuters

©2012 An Inconvenient Woman. All Rights Reserved.

The newly emergent 2009 H1N1 influenza virus is a novel virus with pandemic potential. Consistent with the National Strategy for Pandemic Influenza, HHS is committing funds for the production of pilot lots for clinical studies, as well as a bulk supply of antigen and adjuvant for use in a potential vaccine for the 2009 H1N1 which will become a part of the national stockpile of pre-pandemic influenza vaccines.

A vaccine is made from a virus or bacteria (referred to as an antigen), which causes the human body’s immune system to develop antibodies against a specific virus or bacteria so the body can recognize and fight the virus or bacteria. Adjuvants may be added to a vaccine to help generate a stronger immune response so less vaccine is needed for the body to recognize and fight a virus or bacteria.

Vaccine Development

When the 2009 H1N1 strain was isolated and identified as a novel influenza virus, work began to prepare a virus reference strain. This is a standard practice when new influenza strains are discovered, where a clinical sample of the virus is mixed with another influenza virus that grows in eggs to develop a new virus that has some of the properties of the novel virus and the ability to grow in eggs. This work is necessary in order to create an influenza vaccine using conventional methods.

Once a virus reference strain is ready, it will be made available to influenza vaccine manufacturers in order to create a master virus seed, which prepares a virus to be used in making the vaccine.

Health and Human Services (HHS)Contracting Activities

Since 2004, HHS has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS issued new orders on these contracts to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most will be stored in bulk, and a small amount will be prepared as vaccine for use in clinical studies to evaluate vaccine safety and the dosage required for a protective effect. This research will include studies with adjuvant to determine its safety and the effect it would have on the immune system’s response.

Orders for Bulk Supply of 2009 H1N1 Influenza Vaccine Antigen and Adjuvant

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