Adenovirus type 4 and type 7 vaccine (military use)

The disease and why it matters

Adenoviruses can cause illness that is usually mild but can be serious in some cases; people with weakened immune systems, or existing lung or heart disease, are at higher risk of developing severe illness. Adenovirus infection can cause common cold or flu-like symptoms, fever, sore throat, acute bronchitis, pneumonia, diarrhea and conjunctivitis, and rarely more serious problems such as severe pneumonia or neurologic disease and even death. ^[1]

Adenoviruses usually spread through close personal contact, through the air by coughing and sneezing, or through handling objects an infected person has touched; some spread through stool, and certain types (including Type 4 and Type 7) have caused severe outbreaks of respiratory illness among military recruits. ^[1]

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Products available

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is an enteric-coated tablet vaccine (initial U.S. approval 2011) listed by FDA under STN BL 125296 with Barr Labs, Inc. as manufacturer on the FDA page; the label is distributed by Teva Pharmaceuticals USA, Inc. and was revised 10/2019. ^{[2] [3]}

The vaccine is a live vaccine containing viable, selected strains of human adenovirus Type 4 and Type 7 prepared in human-diploid fibroblast cell cultures (strain WI-38); the virus strains have not been attenuated. A single dose is two tablets, one Type 4 tablet and one Type 7 tablet, each enteric coated to pass intact through the stomach and release the live virus in the intestine, with a potency of no fewer than 32,000 tissue-culture infective doses (4.5 log10 TCID50) per tablet. ^[3]

The Type 4 tablet is a white to off-white round coated tablet (NDC 51285-174-02) and the Type 7 tablet is a light peach round coated tablet (NDC 51285-175-02); the single carton (NDC 51285-138-50) holds 100 tablets of each component. The Type 7 tablet also contains FD&C Yellow #6 aluminum lake dye, and the inner core contains anhydrous lactose; the dried virus material includes human serum albumin (<0.3 mg/tablet). ^[3]

Who should get it

The label describes the vaccine as given to individuals undergoing intensive military training who have limited contact with pregnant women, children under age seven and persons with compromised immune systems. ^[3]

Dosing and schedule, including catch-up

A single vaccine dose is administered orally as two tablets: one tablet of Adenovirus Type 4 and one tablet of Adenovirus Type 7. ^[3]

Administration

• The tablets should be swallowed whole, without chewing, to avoid releasing the virus in the upper respiratory tract; the tablets should not be chewed or crushed. ^[3]
• Postpone administration to individuals with vomiting and/or diarrhea because the effectiveness of the vaccine depends upon the multiplication of orally administered live adenovirus within the intestinal tract. ^[3]
• The vaccine may be given at the same time as other vaccines; in the trial it was given concurrently with other vaccines, but data were not available to assess whether it interferes with the immune response to the other vaccines. ^{[1] [3]}
• There are no data regarding use with immunosuppressive therapies such as irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids used in greater than physiologic doses. ^[3]

Storage and handling

Store refrigerated between 2° and 8° C (35° and 46° F); do not freeze; keep the bottle tightly closed and protect from moisture; do not remove the desiccant canister from the bottle. ^[3]

Contraindications and precautions

Safety and adverse events

Safety was evaluated in a multicenter, double-blind, randomized, placebo-controlled study of 3031 vaccine and 1009 placebo (lactose tablet) recipients, healthy active duty U.S. Army and Navy military recruits in basic training (mean age 21 years, range 17 to 42), who were given other vaccines concomitantly. No deaths were reported; at least one serious adverse event was experienced by thirty-five vaccine recipients (1.2%) and 12 placebo recipients (1.2%); and at least one adverse event during the 56-day period by 91.2% of the vaccine group and 93.9% of the placebo group, with no subject discontinuing because of an adverse event. ^[3]

Pyrexia (temperature of 100.5 °F or higher) within 7 days was reported in 1.4% (42/3030) of vaccine recipients and 0.5% (5/961) of placebo recipients who were not diagnosed with ARD. ^[3]

Postmarketing reports identified hypersensitivity reactions (including anaphylaxis) and Guillain-Barré syndrome; because these are voluntary reports from a population of uncertain size, frequency and causal relationship cannot always be established. The CDC VIS states that more serious problems including blood in the urine or stool, pneumonia, or inflammation of the stomach or intestines occur rarely after vaccination. ^{[3] [1]}

The vaccine contains live viruses that are shed in the stool and can cause disease if transmitted; in a study of 58 subjects (30 vaccine recipients), vaccine strains were shed in stool as early as day 7, 8 of 30 (27%) tested positive for Type 4 and 18 of 30 (60%) for Type 7 at least once, no shedding was detectable by 28 days, and vaccine strain virus was not detected in the throat of any subject. ^[3]

In the efficacy trial a placebo recipient developed febrile acute respiratory disease from which adenovirus Type 4 vaccine strain was detected in posterior pharyngeal and tonsillar swabbing. ^[3]

Special populations

• Pregnancy: do not administer to pregnant females; females of reproductive potential should have a pregnancy test before vaccination and use effective contraception during treatment and for 6 weeks following receipt of vaccine; fecal shedding during delivery may result in vaccine virus transmission to the newborn infant. ^[3]
• Lactation: there are no data on the presence of the vaccine in human milk, effects on milk production, or on the breastfed infant; the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the vaccine. ^[3]
• Children and older adults: safety and effectiveness have not been evaluated from birth through age 16, and the clinical studies did not include subjects aged 65 and over. ^[3]
• Close contacts: vaccinees should exercise caution during the 28-day shedding period when in close contact with children less than 7 years of age, immunocompromised individuals (such as those with HIV infection and cancer, or receiving immunosuppressive therapy) and pregnant women, because fetal harm may result if pregnant women are exposed to adenovirus. ^[3]

Counseling pearls for the pharmacy counter

• Inform women to avoid becoming pregnant following vaccination for at least 6 weeks to prevent the fetus from being exposed to adenovirus; instruct patients to swallow each tablet whole without chewing. ^[3]
• The vaccine contains live virus that is shed in the stool for up to 28 days after vaccination and can cause disease if transmitted; instruct patients to observe proper personal hygiene, such as frequent hand washing, especially following bowel movements, during the 28 days. ^[3]
• Tell the vaccine provider about allergic reactions after a previous dose or severe allergies, a weakened immune system, age under 17 or over 50, pregnancy or nursing or planning pregnancy, inability to swallow the tablets whole, and current vomiting or diarrhea. ^[1]

Common patient questions

References

1. Centers for Disease Control and Prevention. Adenovirus Vaccine VIS: Adenovirus Vaccine: What You Need to Know (current edition January 8, 2020). Accessed October 12, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/adenovirus.html. Accessed October 12, 2026.
2. U.S. Food and Drug Administration. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral product page (content current as of 10/15/2019). Accessed October 12, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/adenovirus-type-4-and-type-7-vaccine-live-oral. Accessed October 12, 2026.
3. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, enteric coated tablets for oral administration: prescribing information (revised 10/2019). Teva Pharmaceuticals USA, Inc. U.S. Food and Drug Administration. Accessed October 12, 2026. https://www.fda.gov/media/80211/download?attachment. Accessed October 12, 2026.