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Same-Day Analysis

Swine Flu Vaccine Supply Concerns Heightened as Number of Infected Reaches 22 mil.

Published: 11/13/2009

U.S. health authorities have issued the first specific estimates of the scale of the swine flu epidemic, noting close to 4,000 fatalities in six months; the issue of availability of swine flu vaccine is now foremost on the list of concerns.

IHS Global Insight Perspective

 

Significance

The Centers for Disease Control and Prevention (CDC) has indicated that 22 million people have been affected by the Influenza A (H1N1) virus—swine flu—in the United States since April 2009 and is spreading at an "unprecedented rate".

Implications

The supply of swine flu vaccines from five manufacturers have fallen short of official estimates, primarily because of the complexity of the manufacturing process and distribution problems.

Outlook

The initial teething problems in terms of supply are expected to ease as the second and third phase of immunisation kicks off towards the end of the year. CDC is also expected to step up surveillance and work on a new statistical model to ensure correct data estimates.

Swine Flu Incidence

The first official specific estimate from the Centers for Disease Control and Prevention (CDC) on the spread of the Influenza A (H1N1) virus—swine flu—has revealed a wide spectrum of the U.S. population has been infected by the disease. Since April 2009, when the outbreak of the disease was exclusively tracked, the CDC has noted that 22 million people have been infected by the virus, with 3,900 recorded fatalities. Bloomberg quoted Anne Schuchat, director at CDC's Center for Immunisation and Respiratory Diseases, as stating that the level of incidence being reported is "unprecedented for this time of year". The majority of the deaths have been people in high-risk groups—namely, population under 64 years of age, including those with pre-conditions such as asthma, diabetes, as well as pregnant women and children. The CDC suggests that 540 children and adolescents are part of the fatality list. 98,000 people have so far been hospitalised.

Vaccine Supply Woes

As the national picture on the spread of swine flu begins to emerge, U.S. residents have voiced new concerns over the lack of swine flu vaccine availability. Such concerns mark the start of the first phase of immunisation in the United States. Since October 2009, close to 43 million doses of swine flu vaccine have been supplied to different state health bodies, the Wall Street Journal reports. However, the figures fall short of the estimates. By the end of October 2009, more than half of the estimated 30-million vaccine doses were delivered. In fact, the source notes that the CDC and the U.S. FDA are not certain how many of the 8 million doses expected to be delivered next week will indeed arrive from vaccine makers. The U.S. government has five authorised vaccine manufacturers—Novartis (Switzerland), CSL (Australia), GlaxoSmithKline (U.K.), Sanofi-Aventis (France), and MedImmune (a part of U.K.-based AstraZeneca)—to supply swine flu vaccines.

Outlook and Implications

The new figures depict the CDC's attempt at providing a larger picture of the extent of the disease spread by extrapolating numbers from ten states. Although the numbers still represent only an estimate, the CDC is expected to work on a statistical model to provide a more accurate indication of incidence in the country. Concerns are rising, as ground-level reports are indicating that the rate of incidence is increasing. The onset of the winter season has brought on a seasonal flu outbreak, further increasing the vulnerability of the population. U.S. President Barack Obama declared a national emergency over swine flu last month.

The problem in terms of vaccine supply is primarily due to over-estimation of vaccine supply numbers. But the over-estimation stems from not anticipating potential manufacturing process problems, primarily in terms of production time needed. The complexity of the production process, and the time needed to conduct limited clinical trials to test the vaccines, were found to have been the main hurdles. Still, the FDA has noted that the vaccine-supply problems should ease in the coming months. They will have to, as the next phase of immunisation—targeting a far larger population than just the risk groups of children, elderly, and pregnant women—will begin towards the end of 2009. The supply shortage also reveals the difference between U.S. health authorities and their European counterparts in terms of the vaccines that they have ordered. European health authorities are known to be purchasing a supply of adjuvanted vaccines, which boost the immune-system response (source: Reuters).

Looking ahead, however, the FDA is expected to persist with the unadjuvanted egg-based vaccine technology for its swine flu vaccines, and will employ a streamlined system to increase availability of the vaccines. The lessons learnt during the first few weeks of the vaccination drive, when only 60% of the medicines needed were available, will be fresh on the minds of the U.S. authorities. Distribution channels will also be a key focus area in efforts to maintain vaccine accessibility over the next few weeks.
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