Decreased Antibody Response to Influenza Vaccine Among Nursing-Home Residents Who Received Recalled Vaccine -- New York, 1996

Following a voluntary recall in November 1996 of 11 lots * of Fluogen{Registered} ** trivalent influenza vaccine (Parke-Davis Division, Warner Lambert Company, Morris Plains, New Jersey), the New York State Department of Health and CDC evaluated antibody response to the 1996-97 influenza vaccine among residents (n=86) of three nursing homes who received recalled vaccine and among residents (n=86) of three other nursing homes who received vaccine produced by a different manufacturer. The Fluogen{Registered} lots were recalled because the monitored quantity of A/Nanchang/933/95(H3N2) hemagglutinin antigen in the 1996-97 influenza vaccine had declined since the vaccine initially was released; the reason for this decrease is unknown. The findings of this analysis indicate that, compared with elderly nursing-home residents who received influenza vaccine from a different manufacturer, residents who received Fluogen{Registered} from recalled lots had moderately lower antibody responses to the influenza A/Nanchang/933/95(H3N2) component of the 1996-97 influenza vaccine.

Medical records were reviewed for and blood samples were obtained from the 172 nursing-home residents who received influenza vaccine. Postvaccination serum samples were analyzed for antibody against all three components of the 1996-97 vaccine using the hemagglutination-inhibition test (1).

For the group of residents that received recalled vaccine, both geometric mean antibody titers and the percentage of residents with titers greater than or equal to 1:40 against the A/Nanchang/933/95(H3N2) vaccine component were significantly lower than for the group of residents that received vaccine from a different manufacturer (Table_1). For both groups of residents, antibody titers were similar for the B/Harbin/07/94 and A/Texas/36/91(H1N1) vaccine components. The analysis also assessed demographic characteristics, chronic medical conditions, previous vaccination status, and activity levels; however, none of these factors accounted for the group-specific differences in antibody titers.

Reported by: H Leib, R Gallo, D Ackman, MD, L Pate, P Smith, MD, State Epidemiologist, New York State Dept of Health; R Hodder, MD, Francis Schevier Home and Hospital, Bronx; I Gomolin, MD, Gurwin Jewish Geriatric Center, Commack; FB Olsen, DDS, The Parker Jewish Geriatric Center, New Hyde Park; H Morley, Petite Fleur Nursing Home, Sayville, New York. Office of the Director, and Influenza Br and WHO Collaborating Center for Surveillance, Epidemiology, and Control of Influenza, Div of Viral and Rickettsial Diseases, National Center for Infectious Diseases; Div of Applied Public Health Training (proposed), Epidemiology Program Office, CDC.

Editorial Note

Editorial Note: Based on the finding in New York that antibody response among nursing-home residents who received recalled Fluogen{Registered} was moderately lower than that among residents who received influenza vaccine from a different manufacturer, health-care providers might consider revaccinating persons who received recalled Fluogen{Registered}. Several factors have been considered for determining whether persons who received recalled Fluogen{Registered} should receive an additional dose of the 1996-97 influenza vaccine. First, although higher postvaccination antibody levels generally are associated with greater protection from influenza-like illness and its complications (2-4), there is no absolute antibody titer that ensures protection. Second, because revaccination does not ensure development of higher antibody titers, it is difficult to estimate the potential clinical and public health benefits associated with revaccination. Finally, a recent study of young adults indicated that antibody titers did not differ among groups randomized to receive either recalled or nonrecalled Fluogen{Registered} manufactured for the 1996-97 influenza season (P.A. Gross, S. Sperber, Hackensack University Medical Center, personal communication, 1996). Although the total number of persons who received vaccine from recalled lots of Fluogen{Registered} represent only 5%-7% of all persons nationwide who received a 1996-97 influenza vaccination, most doses of vaccine have been administered before the influenza season (October-mid-November), and all remaining supplies of 1996-97 vaccine are limited.

Based on these factors, CDC and the Food and Drug Administration recommend that physicians consider vaccinating the following persons with the remaining supplies of influenza vaccine, in order of priority: 1) all high-risk persons (5) who have not received any doses of the 1996-97 influenza vaccine, especially those with chronic medical conditions; and 2) high-risk persons, especially those with chronic, debilitating medical conditions, who received Fluogen{Registered} from recalled lots. Revaccinaton is not recommended for other persons, including healthy persons who received Fluogen{Registered} from a recalled lot.

An alternative strategy for controlling influenza type A among high-risk patients is the use of the antiviral agents amantadine or rimantadine, especially for chronically ill, institutionalized, or severely debilitated persons who have been or may be exposed to influenza type A during an outbreak. Amantadine and rimantadine are equally effective for prevention and treatment of influenza type A infection. Additional information about the indications, dosage, side effects, and contraindications for these drugs is available in the recommendations of the Advisory Committee on Immunization Practices (5) and the drug package inserts.

References

1. Rota PA, Regnery HL, Kendal AP. Influenza virus. In: Rose NR, de Macario EC, Fahey JL, Friedman H, Penn GM, eds. Manual of clinical laboratory immunology. 4th ed. Washington, DC: American Society for Microbiology, 1992:576-81.

2. Morris JA, Kasel JA, Saglam M, Knight V, Loda FA. Immunity to influenza as related to antibody levels. N Engl J Med 1966;274:527-35.

3. Arden NH, Patriarca PA, Fasano MB, et al. The roles of vaccination and amantadine prophylaxis in controlling an outbreak of influenza A(H3N2) in a nursing home. Arch Intern Med 1988;148:865-8.

4. Dowdle WR, Coleman MT, Mostow SR, Kaye HS, Schoenbaum SC. Inactivated influenza vaccines. 2. Laboratory indices of protection. Postgraduate Medical Journal 1973;49:159-62.

5. ACIP. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices. MMWR 1996;45(no. RR-5).

* Lot numbers are 00176P, 00276P, 00576P, 00586P, 00676P, 00686P, 00786P, 00886P, 00966P, 00986P, and 01066P. 

** Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services or the Public Health Service.

TABLE 1. Geometric mean antibody titer and percentage of antibody >=1:40 in nursing-home residents who
received either recalled Fluogen * or influenza vaccine from a different manufacturer, by vaccine component
-- New York, 1996
===========================================================================================================
                                                    Received
                                    Received        vaccine
                                    recalled      a different
Category/                          Fluogen(R)     manufacturer
 Vaccine component                   (n=86)          (n=86)        p value +
-----------------------------------------------------------------------------------------------------------
Geometric mean titers
  A/Nanchang/933/95(H3N2)             33.2            54.8           0.01
  A/Texas/36/91(H1N1)                 73.8            54.8           0.12
  B/Harbin/07/94                      66.5            77.5           0.33

% Residents with titers >=1:40
  A/Nanchang/933/95(H3N2)             52.3%           67.4%          0.04
  A/Texas/36/91(H1N1)                 80.2%           75.6%          0.54
  B/Harbin/07/94                      77.9%           81.4%          0.57
-----------------------------------------------------------------------------------------------------------
* Use of trade names and commercial sources is for identification only and does not imply
  endorsement by the U.S. Department of Health and Human Services or the Public Health Service.
+ P values for geometric mean titers were calculated using the Wilcoxon-rank sum two-sample
  test; for the percentage of residents with titers >=1:40, the Mantel-Haenszel chi-square test was
  used.
===========================================================================================================

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