Status: approved; marketed

Organizations involved:

Merck & Co., Inc. – Manuf.; R&D; Tech.; World mark.

University of Pennsylvania – R&D; Tech.

Chiron Corp. – Manuf. other

Novartis AG – Parent

Evans Vaccines Ltd. – Former

PowderJect Pharmaceuticals plc – Former

Cross ref: See the Pneumococcal Vaccine entry (#512), and the entry above for a similar 23-valent unconjugated vaccine, PNU-Imune, from Wyeth/Lederle Labs.

Description: Pneumococcal Vaccine, Polyvalent or Pneu-mo-vax is an aqueous mixture of partially hydrolyzed, purified capsular poly-saccharide antigens from 23 types of Streptococcus pneu-moniae bacteria. Each 0.5 mL dose of vaccine contains 25 µg of each type of capsular polysaccharide (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F and 14, using U.S. nomenclature; and 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F, using Danish nomenclature) dissolved in an isotonic saline solution containing 0.25% phenol as preservative. manufacture involves independent culture and preparation of 23 different type-specific antigens (vaccines) for blending into the final formulation.

The 23 types (serotypes or strains) of Streptococcus pneu-moniae represent the most prevalent and invasive pneumococcal types, including the six most frequently causing invasive drug-resistant pneumococcal infections among children and adults in the U.S. The 23-valent vaccine accounts for at least 90% of pneumococcal blood isolates and at least 85% of all pneumococcal isolates. A major difference between Pneumo-vax 23 and a comparable vaccine, PNU-Imune 23, from Wyeth is that this vaccine contains type 12F, while PNU-Imune 23 contains type 12. Otherwise the same S. pneumoniae types are included in each.

Pneumovax 23 is packaged in single-dose and 5-dose vials and in pre-filled single-dose glass syringes with a 1 inch needle for intramuscular or subcutaneous injection. Each 0.5 mL dose of vaccine contains 25 µg of each of the 23 polysaccharide types dissolved in isotonic saline solution containing 0.25% phenol as a preservative. Thimerosal (mercury derivative; entry #939) was formerly added as a preservative.

Nomenclature: Pneumococcal Vaccine/Merck [BIO]; Pneumovax 23 [TR]; Pneumococcal Vaccine Polyvalent [FDA]; Pneumococcal Vaccine, Polyvalent [FDA former]; Streptococcus pneumoniae capsular polysaccharide vaccine [SY]; Pneumovax II [TR foreign]; Pulmovax [TR foreign]; NDC 0006-4739-00; NDC 0006-4894-00; NDC 0006-4943-00 [NDC]

History: See the History section of the Pneumococcal Vaccines entry (#512).

FDA class: Biologic PLA

CBER class: Bacterial Antigens and Vaccines

Approvals: Date = 19771121; PLA ref. no. 75-49; granted to Merck Sharp & Dohme for Pneumovax 14, containing 14 Pneumococcal types, 50 µg each

Date = 19830630; PLA supplement ref. no. 83-25; approval of current vaccine with Pneumococcal polysaccharides from 23 types, with amount of each reduced to 25 µg

Date = 19860106; product license revoked under old proper name and granted (reissued) under new FDA proper name

Indications: [portion of the "INDICATIONS AND USAGE” section of product insert/labeling]:

PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine. Effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteremia has been demonstrated in controlled trials in South Africa, France and in case-control studies.

Status: A shortage of Pneumovax 23 developed in 2003 (about the same time as a shortage of Prevnar). The FDA formally designated a shortage on Oct. 29, 2003, and ruled this resolved on Nov. 10, 2003 (although disruptions in market availability probably lasted longer than this period).

Prevnar (see entry above) is largely replacing this older, unconjugated vaccine.

Tech. transfer: U.S. 5,847,112, “Process for making capsular polysaccharides from Streptococcus pneumo-niae,”, assigned to Merck & Co., Dec. 8, 1998, discloses methods for preparation of type-specific capsular polysaccharide preparations from S. pneumoniae, having on average less than about 1,000 oligosaccharide repeat units per molecule, and less than 3% contamination of type-specific polysaccharide by group-specific C-polysaccharide.

Medical: The 23 purified pneumococcal capsular poly-saccharides each induce type-specific antibody production at titers effective in preventing pneumococcal disease against these and cross-reactive types of S. pneumoniae. Clinical studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in polyvalent vaccines.

Market: First-half 2013 sales were $213 million. Total sales are estimated at $430 in 2012; were $498 million in 2011; $376 million in 2010; and $346 million in 2009.

The 2007 Average Wholesale Price (AWP) is $351.24 for 10 single-dose vials, with a Direct Price (Manufacturer’s discount price) of $292.70; $156.47/5-dose vial, with Direct Price of $130.99; and $1,596.51/ten 5-dose vials, with Direct Price of $1,330.45 (Red Book, 2007).

As reported by the National Immunization Program (NIP), Centers for Disease Control and Prevention (CDC; 7/2007), the Private Sector Cost/Dose (average cost) per adult dose is $26.08 for 10-packs of 5-dose vials and $29.28 for 10-packs of 0.5 mL single-dose vials. The CDC Cost/Dose, the cost negotiated by NIP, CDC, for bulk contract purchase for public-sector state and local immunization programs,is $14.86 for 10-packs of 5-dose vials and $16.91for 10-packs of 0.5 mL single-dose vials. These prices include the $3.00/dose ($.75/covered component vaccine) Federal Excise Tax charged by the manufacturer for the federal vaccine injury compensation program. Merck’s contract with NIP, CDC, expires on March 31, 2008.

In its March, 2006 price list, FFF Enterprises, a major biologics distributor, reported $119.60/five-dose 2.5 mL vial (same in 2005; $108.86 in March 2004) and $268.10/package of 10 single-dose vials (same in 2005; $244.34 in March 2004).

In late 2011, it was reported that Pneumovax 23 sells for about $50 a shot on average, while Prevnar 13 costs $114 on average. For adults, one or two shots of Pneumovax 23 are needed and then a booster after age 65.