Medical Inspection – Health Blog

Speaker: Joseph L. Gugliotta, MD, Infectious Disease Specialist, Hunterdon Medical Center, Flemington, New Jersey.

The combination of quinupristin/dalfopristin (Synercid, Aventis) and vancomycin (Vancocin, Lilly) proved to be highly effective in the treatment of bacteremias caused by oxacillin-resistant Staphylococcus aureus (ORSA) strains, demonstrating enhanced bactericidal activity compared with either antibiotic tested alone.

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Short-Duration Antimicrobial Therapy for AECB

Speaker: Marcus J. Zervos, MD, Clinical Professor of Medicine, Wayne State University School of Medicine, Detroit, Michigan, and William Beaumont Hospital, Royal Oak, Michigan.

Five-day therapy with oral telithromycin (Ketek, Aventis), a new ketolide antimicrobial agent, is as effective as standard 10-day treatment with comparators in adult patients with acute exacerbation of chronic bronchitis. When considered along with its convenience of once-daily dosing and tolerabili-ty, this new antibiotic becomes a first-line treatment option for patients with AECB.

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Several points related to the recent influenza vaccine delays and the influenza vaccine process are worth emphasizing. First, the overall process has worked well for decades despite its many complexities and “fragilities.” Although the recent delays highlight the need to take certain actions to strengthen the system, such major disruptions have been exceptional and the potential benefits of any fundamental changes should be considered carefully against the potential drawbacks.

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The public and private sectors both play extensive and critical roles in the influenza vaccine process. Primary responsibilities of the public sector include monitoring changes among circulating influenza viruses, annually updating the vaccine strains, monitoring the vaccine’s effectiveness and coverage rates, and developing recommendations to guide vaccine use. Primary responsibilities of the private sector include the production, distribution, and administration of the vaccine. Both sectors share the responsibility for ensuring the safety and potency of the vaccine. The manufacturers conduct quality-control checks at all stages of the production process while the FDA conducts safety and potency checks on monovalent and trivalent vaccine lots before they are released. In addition, the FDA conducts inspections of plants to ensure that each manufacturer is adhering to current GMP standards. Although complicated, and to a certain extent “fragile,” the current system has worked remarkably well for several decades and has been able to provide increasing doses of vaccine for the U.S. since the 1980s. Some of the key steps of the process are briefly reviewed.

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Among the current manufacturers, Aventis Pasteur and Wyeth Lederle produce influenza vaccine in manufacturing plants located in the U.S. while Evans Vaccines produces influenza vaccine in the United Kingdom, but distributes a percentage of their production in the U.S. In most years, more doses of influenza vaccine are produced by manufacturers, and are released by the FDA, than are distributed. For example, in 1999, 2000, and 2001, respectively, the manufacturers produced combined totals of approximately 77.2 million, 77.9 million, and 87.7 million doses of influenza vaccine while distributing, in those same years, an estimated 76.7 million, 70.4 million, and 77.7 million doses (Figure 2). However, as was previously discussed, the timing of the release of those doses differed significantly by year.

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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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