Adenovirus Vaccine, Live, Oral, Type 4

Status: no longer manufactured; new, replacement vaccines approved

Organizations involved:

Wyeth Pharmaceuticals – Former

U.S. Army Medical Research Acquisition Activity (USAMRAA) – USA mark.

National Institute of Allergy and Infectious Diseases (NIAID), NIH – R&D; Tech.

Walter Reed Army Inst. of Res. (WRAIR) – R&D

Cross ref: See the entry above for Adenovirus Vaccines. See also the entry below for type 7 vaccine.

Description: Adenovirus serotype 4 virus vaccine was a live orally administered vaccine in enteric-coated tablet form containing a viable selected strain of type 4 adenovirus cultured in WI-38 human diploid fibroblast cells. Each tablet contained 4.5 log10 TCID50 (32,000 TCID50) of lyophilized (freeze-dried) live infectious virus in lactose powder. Tablets also contain excipients – monosodium glutamate, lactose sucrose, d-mannose, d-fructose, dextrose, Albumin (Human), potassium phosphate, and plas-done. Tablets contain residual components from the growth and maintenance media for virus and host cells, certain materials used in processing, and cellulose acetate phthalate, alcohol, acetone, castor oil, magnesium stearate, and amberlite. The dating period is 18 months at 2-8˚C. Any existing vaccine is now out-of-date.

Nomenclature: Adenovirus Vaccine, type 4/old [BIO]; Adenovirus Vaccine, Live, Oral, Type 4 [FDA]; NDC 0008-0502 [NDC]

Companies.: Developed and formerly manufactured by Wyeth (now Pfizer).

Manufacture: See Adenovirus Vaccines entry.

FDA class: Biologic PLA

CBER class: Viral And Rickettsial Vaccines

Approvals: Date = 19800701; PLA, ref. no. 67-33

Indications: [full text of the "Indications and Usage” section of product insert, from 1995 FDA label review]:

Live adenovirus immunoprophylaxis is an effective method for the control of specific adenovirus-associated ARD [acute respiratory disease] in populations groups characterized by increases risk of exposure and high susceptibility as measured by low-antibody prevalence.

Adenovirus Vaccine Live Oral Type 4 was indicated for immunization of military populations in which epidemic respiratory disease due to adenovirus, type 4 has been shown likely to occur. Other use of the vaccine is not recommended.

Status: The vaccine is no longer listed by FDA as approved. Wyeth voluntarily withdrew its license.

In 1996, Wyeth ceased manufacture of adenovirus vaccines. Administration of adenovirus vaccines to all military trainees was suspended at basic training centers on March 31, 1997. To conserve the remaining vaccine lots, the military restricted use of adenovirus vaccines to the period of Sept. 1- March 31, the peak season for acute respiratory disease. Supplies were exhausted in 1999.

Medical: A single tablet is taken (swallowed) orally without chewing, preferably 2-4 weeks prior to exposure, and may be taken with the type 7 vaccine.