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In the News

Flu Vaccine Shortage

By Dr. Victor Gong, Medical Director of 75th St. & 126th St. Medical, Ocean Pines Medical & Doctors Weight Control & Wellness centers, Ocean City, MD.

The flu season is about to come upon us. The rainy and cooler summer and unusually chilly fall evenings may be a testament to a cold winter. That means flu and pneumonias. The Centers for Disease Control (CDC) reports that 45,000 Americans die each year from influenza and pneumonia, which together are the sixth leading cause of death in the United States. Flu vaccination typically begins now. However the CDC reports a delay in the manufacture and distribution of the vaccine. There may be a shortage this year. Last season, approximately 80-85 million doses of influenza vaccine were produced for distribution in the United States. The exact number of doses that will be produced this year is uncertain at this time.

The cause of this delay and possible shortage is due to two events. First, some influenza vaccine manufacturers have reported that one of the three influenza virus components (the influenza A (H3N2) strain) used to make this year's vaccine has not grown as well as the corresponding strain used last year.

Secondly, the Food and Drug Administration (FDA) has taken regulatory action against two of the manufacturers licensed to distribute influenza vaccine in the U.S.

The CDC, FDA and other federal health agencies have developed contingency plans in the event of a shortage. The FDA is working closely with both manufacturers to implement corrective actions. The CDC has established a voluntary prioritization schedule for who should receive the vaccine. Top priority will be given to adults age 65 and older, people of any age with chronic medical conditions, and health care workers. Those groups should be vaccinated in October and November as usual. If the vaccine supply is restored in December, then other people who are at low risk but who want to be vaccinated against the flu could receive the vaccine.

The public health impact resulting from a shortage will depend upon several factors. The main factors are the extent of the potential vaccine shortage and the severity of the upcoming influenza season. It is important to realize that the severity of the upcoming winter flu season is unknown and cannot be predicted. The severity of the season largely will be influenced by the number of people infected; the specific influenza viral strain predominating; and the number of people that can be protected to reduce spread of the flu.

While there have been new anti-influenza medications developed, they were not created to prevent the flu. The best way to prevent influenza virus infection is to receive flu vaccine. Antiviral medications are not a substitute for the flu vaccine. Widespread routine use of antiviral drugs for flu prevention is an untested and expensive strategy that could result in a large number of people experiencing side effects.

The best strategy at present is to vaccinate high risk individuals, maintain optimum hygiene practices and optimal health with good nutrition, rest, exercise and vitamins. Local health care providers should cooperate in offering the vaccine to these high risk individuals first and direct persons to providers who do have vaccine. At 75th St. Medical & 126th St. Medical, have abundant vaccines and will continue to provide the vaccine at both offices without appointments, and at our Drive Thru Flu shots in the comfort of your car at our 126 Th St Medical on September 30 and October 7 & 14th. FLu shots will be provided without charge to Medicare patients.

Will there be a delay in the availability or shortage of influenza vaccine this fall?

At this time, delays in the distribution of influenza vaccine are expected for the 2000-2001 influenza season. It is also possible that significantly fewer doses of influenza vaccine might be available for distribution than last year.

How much of an influenza vaccine shortage could there be?

Last season, approximately 80-85 million doses of influenza vaccine were produced for distribution in the United States. The exact number of doses that will be produced this year is uncertain at this time. This situation will be continuously assessed and more precise estimates of the influenza vaccine supply will be available in the future.

What is the cause of the potential delay and potential shortage of influenza vaccine?

First, some influenza vaccine manufacturers have reported that one of the three influenza virus components (the influenza A (H3N2) strain) used to make this year's vaccine has not grown as well as the corresponding strain used last year.

Secondly, the Food and Drug Administration (FDA) has taken regulatory action against two of the manufacturers licensed to distribute influenza vaccine in the U.S.

What is being done to correct the situation?

Both manufacturers are working closely with the FDA, but implementation of corrective actions will require time for both completion and review by the FDA.

What does the CDC recommend at this time in response to the expected delay in the availability of influenza vaccine and a possible vaccine shortage?

The CDC and the Advisory Committee on Immunization Practices (ACIP) recommend that:

  • Implementation of organized influenza vaccination campaigns should be delayed. Health care providers, health organizations, commercial companies, and other organizations planning organized, mass influenza vaccine campaigns for the 2000-2001 season should delay such programs until early to mid-November. The purpose of this recommendation is to minimize cancellations of vaccine campaigns and wastage of vaccine doses resulting from delays in vaccine delivery.
  • Influenza vaccination of individuals at high risk for complications from influenza and their close contacts should proceed routinely during regular health care visits. Routine influenza vaccination activities in clinics, provider offices, hospitals, nursing homes and other health care settings, especially of high risk individuals, health care staff and other persons in close contact with high-risk individuals, should proceed as normal with available vaccine.

Who is at high risk for complications from influenza?

In the U.S., 70 to 76 million people (approximately 35 million people aged 65 and under; 33 to 39 million people over 65 years with high risk conditions, and 2 million pregnant women) are estimated to be at high risk for serious complications from influenza infections, including hospitalization or death. Persons at high risk for complications from influenza should receive annual vaccination and include the following:

  • Persons aged 65 and older
  • Residents of nursing homes and other chronic-care facilities with residents of any age who have chronic medical conditions
  • Adults and children aged 6 months and older who have chronic pulmonary and cardiovascular diseases, including asthma
  • Adults and children aged 6 months and older who have required regular medical follow-up or hospitalization during the past year because of chronic metabolic diseases (including diabetes mellitus), kidney dysfunction, blood disorders (hemoglobinopathies), or immune system problems (immunocompromised e.g. HIV infection, immunosuppressed by medication, chemotherapy, or radiation therapy)
  • Children and teenagers (aged 6 months to 18 years) who are receiving long-term aspirin therapy and therefore might be at risk for Reye Syndrome after influenza infection
  • Women who will be in the second or third trimester of pregnancy during the influenza season.

Who else should receive influenza vaccine each year?

Other persons who should be vaccinated each year include:

  • Health-care workers, employees of hospitals, clinics, offices, and chronic care institutions who directly care for and have close contact with persons at high risk from complications of influenza.
  • Household members (including children aged 6 months and older) of persons in high-risk groups (individuals who are most likely to transmit influenza to high-risk persons).

When will influenza vaccine for the upcoming season be available?

Typically, influenza is usually first available for distribution in July. Most vaccine is usually available for administration by September or October. Limited quantities of influenza vaccine for the 2000-2001 influenza season will be released for distribution beginning in July. However, it is likely that less influenza vaccine than usual will be available at an early time this year that there will be delays in availability.

How are the virus strains for influenza selected?

Influenza vaccine contains three different inactivated (killed) influenza virus strains. Since influenza viruses are continuously changing, the vaccine virus strains must be updated each year. The World Health organization (WHO) makes recommendations for the composition of the influenza vaccines for the upcoming influenza seasons for the Northern and southern Hemispheres.

Two new influenza type A virus strains (A/Panama/2007/99-like (H3N2) and A/New Caledonia/20/99-like (H1N1) were recommended for inclusion in the 2000-2001 influenza vaccine. The third strain, B/Yarnanashi/166/98-like virus, is unchanged from last year's influenza vaccine. The introduction of new vaccine strains has bad effects on vaccine production in the past. Different manufacturers may be affected differently, since manufacturing processes differ.

When should influenza vaccine be offered?

The optimal time for influenza vaccination is October through mid-November. To avoid missed opportunities for vaccination, persons at high risk for complications who are seen for routine care or are hospitalized should be offered influenza vaccine beginning in September.

What can hospitals, public health clinics, nursing homes, and other groups do now to prepare for the 2000-2001 season?

Institutions and organizations can develop contingency plans to maximize influenza vaccination of high-risk persons and health-care workers if a shortage develops. These groups can also begin to work together with health departments to develop local networks to help re-distribute unused influenza vaccine or direct persons desiring vaccination to providers with available vaccine.

What impact could a potential shortage have on public health?

The public health impact will depend upon several factors. The main factors are the extent of the potential vaccine shortage and the severity of the upcoming influenza season. It is important to realize that the severity of the upcoming winter flu season is unknown and cannot be predicted. The severity of the season largely will be influenced by:

  • How many people become infected
  • The specific influenza virus strains that predominates during the 2000-2001 season
  • How many people are protected from infection and complications of influenza, especially high risk persons.

What about the new antiviral drugs for influenza? Will they help prevent me from getting the flu next winter?

The best way to prevent influenza virus infection is to receive influenza vaccine. Antiviral medications are not a substitute for influenza vaccination.

Four antiviral drugs (amantadine, rimantadine, zanamivir, and oseltamivir) are approved by the FDA for treatment of acute, uncomplicated influenza.

  • Amantadine and rimantadine are active against influenza A viruses.
  • Zanamivir and oseltamivir are active against influenza A and influenza B viruses.

When used for treatment, these drugs are only effective if treatment is started within two days of the beginning of symptoms. All four antiviral agents can reduce the duration of influenza symptoms by about one day if treatment is started within 48 hours of symptom onset.

Two antiviral drugs (amantadine and rimantadine) are approved by the FDA for use as chemoprophylaxis (prevention) against influenza A. The use of these drugs has been associated with adverse reactions that affect the central nervous system and other side effects. Amantadine and rimantadine are not generally recommended for widespread use in healthy persons. The new antiviral drugs for influenza (zanamivir and oseltamivir) are not approved for prophylaxis of influenza.

Use of antiviral medications for the prevention of influenza can be highly effective in specific individuals of in certain situations such as for the control of influenza outbreaks in nursing homes.

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