Medical Inspection – Health Blog

The 2000 and 2001 Vaccine Delays

The magnitude of the 2000 and 2001 vaccine distribution delays is best illustrated by comparing the volume of vaccine delivered by manufacturers by the end of October in those years with the amount of vaccine delivered by the same time point in 1999 (Figure 1). In 1999, four manufacturers distributed a combined total of approximately 75.8 million doses of vaccine (99% of the year’s total) by the end of October. By contrast, in 2000 and 2001, three manufacturers distributed a combined total of approximately 26.6 million (38% of the year’s total) and 43 million (55% of the year’s total) doses of vaccine, respectively, by the end of October. The volume of vaccine delivered by the end of October is an important benchmark because October and early November, traditionally, have been the months of peak influenza vaccine demand in the U.S.The basis for the delays differed somewhat by year. In 2000, some manufacturers experienced difficulties growing and processing the influenza A (H3N2) vaccine strain. Such difficulties are not unusual, especially early in the production and processing of new vaccine strains. Different manufacturers employ different manufacturing techniques, which can affect how well a specific influenza virus strain grows or processes for a particular manufacturer. As a result, some manufacturers might experience difficulties growing or processing a particular strain in a certain year, while other manufacturers do not experience similar difficulties. In any case, manufacturers commonly “tweak” or make minor adjustments (within a range of established and validated parameters) to their vaccine production processes to optimize the yield of vaccine strains.

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INTRODUCTION

During the past decade, substantial increases in the production and distribution of influenza vaccine have been critical for improving vaccination coverage among groups specifically targeted for vaccination, as well as among healthy persons in the U.S. The increases have been critical because annual vaccination is the cornerstone of efforts to reduce the health burden from influenza, a respiratory infection resulting in an average of approximately 20,000 deaths and 114,000 hospitalizations per year in the U.S.

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Because of initial findings of cardiovascular adverse events in the initial generic sumatriptan trials and in the postmarketing surveillance studies, all trip-tans carry a drug-class warning. The use of triptans is contraindicated in patients with ischemic heart disease, Prinzmetal angina, uncontrolled high blood pressure, and prior history of cerebrovascular accident. Moreover, the concomitant use of triptans and ergot-containing products within 24 hours is contraindicated because of additive vasoconstrictive effects. Triptans should also be avoided in patients with risk factors for cardiovascular disease, such as postmenopausal females, males older than 40 years, family history of heart disease, cigarette smokers, and those with hypertension or diabetes mellitus.

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5-HT_1B/1D receptor agonists have been widely used for the treatment of moderate-to-severe migraine attacks. Sumatriptan canadian was the first triptan that was available on the market; it was followed by zolmitriptan (Zomig, As-traZeneca), naratriptan (Amerge, Glaxo Wellcome Inc), rizatriptan (Maxalt drug, Merck), and almotriptan (Axert, Pharmacia), respectively. Eletriptan (Replax, Pfizer) is pending Food and Drug Administration (FDA) approval. Introduction of the 5-HT₁b/₁d agonists has revolutionized our understanding of the pathophysiology and treatment of migraine headache.

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Early Treatment of Migraine Attacks

More recently, evidence indicates that early pharmacologic intervention during a migraine attack could provide higher levels of pain relief than later intervention. Retrospective post-hoc analysis of the Spectrum Study results was performed in patients with disabling headaches who were treated while the pain was mild. Results suggest that 50 mg of sumatrip-tan (Imitrex tablet, Glaxo Wellcome Inc) was more effective than placebo for early treatment of migraine attacks. Moreover, pain-free rates were higher for attacks treated with a 50-mg sumatriptan tablet compared to placebo at two and four hours post-dose when pain was rated mild. Currently, no comparable, randomized, placebo-controlled trials support or refute this finding. This observation was not the primary endpoint of the study and, therefore, merits further investigation. Similar findings were reported by the International 311C90 Long-Term Study Group. Also of interest was the lower incidence of adverse effects reported in patients using 50-mg suma-triptan tablets when pain was mild as compared to patients who medicated when pain was moderate to severe. In part, this might be caused by a heightened sensory sensitivity during a migraine attack when pain is moderate to severe. Patients might have an improved tolerance to medications if they treat the migraine attack early, before the occurrence of heightened sensitivity; however, this needs further investigation.

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Nonpharmacologic treatment modalities, such as relaxation training, thermal biofeedback combined with relaxation training, electromyographic biofeedback, and cognitive-behavioral therapy, should be considered as treatment options. The U.S. Headache Consortium recommended the aforementioned treatment modalities as Grade A. Grade B recommendations, such as behavioral therapy, were also suggested in conjunction with preventive therapy. Evidence-based treatment for migraine with hypnosis, acupuncture, transcutaneous electrical nerve stimulation, chiropractic or osteopathic cervical manipulation, occlusal adjustment, and hyperbaric oxygen are not available and therefore are not recommended until further evidence is available. Nonpharmacologic treatment should always begin with lifestyle changes and avoidance of potential triggers.

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Pain is the most common reason for consultation with primary care physicians, and the most common pain types evaluated are back pain and headaches. Migraine headache is a common complaint, with a higher incidence reported by females. It is estimated that 6% of men and 18% of women currently suffer from this disease. However, the prevalence of migraine headache is probably higher, according to the results of the American Migraine Study. Study results indicated that 71% of men and 59% of women were determined to have migraine headaches from self-reported symptoms but they never received a formal diagnosis.

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