Fall flu immunizations could present health, logistical challenges

Image: Yale School of Public Health

Dealing with H1N1 alongside the normal seasonal flu adds to the challenge of preparing for the coming flu season.

As the Centers for Disease Control and Prevention (CDC) gears up for the fall flu immunizations it shares that this year citizens will be encouraged to get not one shot for seasonal flu virus but two or three shots for the seasonal virus plus H1N1, the swine flu. CDC  officials say children and adults under age 50 may need two doses each of the swine flu virus, although it has yet to be developed and approved.

The CDC has contracted with five flu vaccine manufacturers to produce 120 million seasonal vaccine doses for the coming flu season.

In addition, the Department of Health and Human Services has awarded several multi-million dollar research contracts with numerous pharmaceutical companies to develop a swine flu vaccine. CDC expects to order up to 600 million doses for the 300 million people in the United States. And the Department of Defense has also entered into contracts with pharmaceutical firms for the development of H1N1 flu vaccines.

CDC officials expect complications. According to a June 27 article by an AP health writer reporting from a three-day policy-setting meeting of the Advisory Committee on Immunization Practices:

• CDC said tracking side effects of the new swine flu vaccine will be difficult if vaccines are given at the same time as the seasonal flu shots. If problems do occur with either vaccine, it will be difficult to determine which one is at fault. This happened in 1976 when public health officials vaccinated 40 million Americans to ward off a new strain, also called “swine flu.”  The anticipated swine flu pandemic never occurred but at  least 500 people who got the vaccine developed Guillain-Barre Syndrome, a serious neurological disorder that is sometimes deadly.
• Officials say they haven't figured out how to administer so many doses since local health departments have cut more than 10,000 jobs. They anticipate needing to recruit additional physicians to give flu shots.
• Federal officials need to coordinate with manufactures to make sure the swine flu campaign doesn't compete with production of the seasonal vaccine.

Another complication is the lack of accurate data and testing abilities. Based on the 27,000 lab verified cases of the novel H1N1, the CDC extrapolates a much higher number. “We're saying there have been at least a million cases of this new H1N1 virus in the United States so far this year. That's really not a perfectly accurate estimate.  It's just a number, a ballpark figure, that we think for sure there's been more than a million of these new infections,” said Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory, during a CDC press briefing on June 26. 

Schuchat said there is no test available to hospitals for differentiating H1N1 from other viruses. “Fortunately, we have a new test that can be done in state and public health laboratories that can differentiate this new virus from other viruses but there's really not the sufficient number of those tests or the capacity in terms of the people to do those tests to test every single person who has an influenza-like illness.”

Vaccine manufacturers race to develop H1N1 vaccine

Anticipating the World Health Organization announcement that H1N1 is a world pandemic, many companies have entered a mad dash to produce a vaccine and submit it for approval to the various health agencies. The vaccine must be tested before it can be used.

Baxter International Inc., based in Illinois, said in early June that it has launched production of a vaccine for the H1N1 flu virus that could be ready for use as early as July.

Protein Sciences, a small U.S. company that received a $35 million HHS award to produce an H1N1 vaccine, said it has already produced 100,000 doses.

Novartis of Switzerland received a U.S. award of $289 million to develop an H1N1 flu vaccine. The company recently reported it was ready to begin pre-clinical trials on animals. 

Sanofi-Pasteur based in France also announced it plans to have swine flu vaccine ready for clinical trials within weeks.

GlaxoSmithKline (UK) and Solvay (Belgium) have announced they have received orders for or are ready to begin producing vaccines for swine flu.

AstraZeneca (UK), CSL Ltd. (Australia), and Adimmune Corp. (Taiwan) Novavax (U.S.) , are also working on H1N1 flu vaccines.

In addition, the U.S. Defense Threat Reduction Agency (DTRA), a division of the Department of Defense, has awarded $5.1 million to AVI BioPharma, Inc., for the development of one or more drugs targeting H1N1.

Sources:

UPDATE: Baxter Starts Making Swine Flu Vaccine (WSJ)

Swine Flu Multiple-Shot Vaccine May Overwhelm States (Update3) (Bloomberg)

AVI BioPharma signs agreement with US Defense Threat Reduction Agency for H1N1 Swine Flu therapeutics (Trading Markets)