Status: withdrawn for the U.S. market

Organizations involved:

BioPort Corp. – Manuf.; R&D; Tech.; Former

Michigan Biologics Products Institute – Former.

Cross ref: See the entries for Pertussis Vaccines (#505); and Diphtheria and Tetanus Toxoids and Pertussis (DTP/DTaP) Vaccine Products entries (#429).

Description: Pertussis Vaccine Adsorbed is an aqueous suspension of formaldehyde inactivated whole Bordetella pertussis bacteria adsorbed on aluminum phosphate adjuvant in solution containing 0.85% sodium chloride and 0.01% thimerosal (mercury derivative; see #939) as preservative. The vaccine contains no more than 2.5 mg of aluminum/mL.

The vaccine is packaged in 5 mL vials, 10 per package. The vaccine should be stored at 2-8˚C (refrigerated) and has a shelf life of 18 months. The B. pertussis dosage is reported as opacity units, with one opacity unit equivalent to one billion B. pertussis cells/ml.

Nomenclature: Pertussis Vaccine Adsorbed [BIO FDA USAN]; Pertussis Vaccine Adsorbed USP [USP]

Companies.: Approval for manufacture was held by BioPort Corp. CBER/FDA est. lic. no. 1260, previously Michigan Biologics Products Institute (before that, Michigan Department of Public Health), CBER/FDA est. lic. no. 0099.

FDA class: Biologic PLA

CBER class: Bacterial Antigens and Vaccines

Approvals: Date = 19671012; first approval, granted to Michigan Department of Public Health

Date = 19981112; approval revoked and granted (reissued) to new owner, BioPort Corp.

Date = 20030422; withdrawn at sponsor’s request

Indications: product insert/labeling not available

Status: The product license was voluntarily revoked. BioPort no longer manufactures this or DTP vaccine.