GlaxoSmithKline expects the Advisory Committee on Immunization Practices to make a coverage recommendation for the Pediarix combination vaccine during its Feb. 25-26 meeting.

The combination diphtheria, tetanus & acellular pertussis/hepatitis B/inactivated polio virus vaccine will be available in pediatricians' offices in early January following FDA approval Dec. 13 (see ¹ Also see "Pediarix Simplifies Vaccine Schedule; Prevnar Labeling Update Due In 2003" - Pink Sheet, 23 December, 2002.).

The February review by ACIP is the precursor to breaking into the public market administered by the Centers for Disease Control & Prevention.

The approval fell within GSK's expected time frame; the company predicted during a recent investor meeting that it would receive approval before the end of the year (² Also see "GSK’s X-Factor: Augmentin XR, Other Line Extensions Key To Growth" - Pink Sheet, 28 October, 2002., p. 11). GSK has already begun taking orders for the vaccine.

GSK already markets four of the vaccine components in the U.S. The company is the leading supplier of DTaP vaccine ( Infanrix ) and markets a recombinant hepatitis B vaccine ( Engerix-B ). GSK does not market a polio vaccine in the U.S., but does in other countries.

GSK is pricing Pediarix at a slight premium to the separate vaccine components. According to Red Book, Pediarix will be sold in 10-vial packages for an average wholesale price of $825.42, or $82.54 per dose.

According to Red Book pricing data, a dose of GSK's DTaP vaccine Infanrix costs $23.59 AWP and the company's hepatitis B vaccine Engerix-B costs $25.64. The AWP for the only licensed inactivated polio vaccine (Aventis' IPOL ) is $28.95, for a combined cost of $78.18 for all three. Pediarix is indicated for administration at 2, 4 and 6 months. The difference in cost at list prices for the full series would be $13.08 ($247.62 versus $234.54).

The public sector prices of the individual vaccine components are significantly lower. CDC pays $11.75 per dose for Infanrix, $9 per dose for Engerix-B and $8.80 per dose for IPOL, for a combined cost of about $30 per dose, or $90 for the three-dose series.

One complication in calculating the overall cost implications of Pediarix is the potential for children to receive an extra hepatitis B dose as part of the series.

Pediarix' indication is for use "as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age."

Many hospitals, however, encourage routine hep B immunization immediately after birth; the vaccine is indicated for use during the first 12 hours of life for children born of hepatitis B surface antigen-positive mothers, or mothers whose HBsAg status is unknown.

Pediarix labeling allows for use of the vaccine in children who receive monovalent hep B immunization at birth. "Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered three doses of Pediarix according to the recommended schedule."

Pediarix offers an obvious dosing advantage over separate administration of DTaP, hepatitis B and polio, allowing a total of six fewer injections. A fourth and fifth booster shot for DTaP and a fourth booster for polio will still need to be administered after the three-dose Pediarix series.

Pediarix could take away a large share of the market for IPOL - particularly if GSK discounts the product aggressively.

The launch of Pediarix will also pose a challenge for Merck, which markets a hepatitis B/haemophilus influenza b combination vaccine ( Comvax ). Pediatricians will essentially be choosing between using two vaccines (Pediarix plus Hib) or three (Comvax plus DTaP plus Hib) for the primary immunization series.

Aventis is developing its own multi-component combination vaccines, but GSK appears to have a significant head-start in the U.S. Aventis markets a DTaP/hepatitis B/IPV/Hib combo ( Hexavac ) in Europe, but the company has said it does not expect to file for approval in the U.S. until after 2005. Aventis sells a five component DtaP/IPV/Hib vaccine ( Pentacel ) in Canada; it is in Phase III.

GSK also markets a six component combination that includes the Hib component in Europe as Infanrix HeXa . GSK said it has an active U.S. IND for Infanrix HeXa, but is not currently conducting any trials.

GSK Pediarix Price Is $82.54 Per Dose; Coverage Meeting Set For February

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