Sanofi-Pasteur will have approximately 5 mil. doses of Menactra (meningococcal quadrivalent conjugate vaccine) available for use in the U.S. during the first 12 months following launch.

The vaccine will be commercially available in March. Menactra received FDA approval on Jan. 14 for use in adolescents and adults 11-55 years of age and a vaccination schedule recommendation from the Centers for Disease Control & Prevention's Advisory Committee for Immunization Practices on Feb. 10.

Sanofi-Pasteur has set a list price of $82/dose. Based on an estimated contract price with CDC of $70, the 5 mil. dose initial supply indicates first-year sales for Sanofi-Pasteur of approximately $400 mil. if all doses are sold (¹ Also see "Sanofi-Aventis Menactra Approved; Launch Awaits ACIP Recommendations" - Pink Sheet, 24 January, 2005., p. 20).

Sanofi-Pasteur is making the first commercial doses of the vaccine at its existing Swiftwater, Pa. vaccine production facility, where the firm also makes Menomune (polysaccharide meningococcal vaccine).

The company has been working on a new production facility for Menactra since 2001. Construction on the new facility was completed in 2003; the facility is now undergoing internal validation. The company anticipates receiving FDA approval by 2007 and having the plant making commercial doses that year.

In the interim, Sanofi-Pasteur will produce 6 mil. doses of Menactra for 2006. The firm has a goal of a minimum of 7 mil. doses for 2007 with the opening of the new facility.

The size of the population in ACIP's initial recommendation is more than twice the number of adolescents that could receive the vaccine given the introductory supply level. The committee attempted to balance the total recommended population against predicted uptake of the vaccination.

During discussion before the ACIP vote, CDC Meningitis Unit Chief Nancy Rosenstein suggested a 40% uptake by the recommended group would be a good result.

Because of the age of the recommended population, vaccine uptake could be accelerated by coverage through the Vaccines For Children program, which picks up the costs for patients under 18 on Medicaid and underinsured individuals who receive the vaccinations at federally qualified clinics. With the addition of meningococcal vaccine to the VFC list, the program will cover 14 diseases.

There are over 12 mil. adolescents and high-risk patients in the initial population. The primary recommended groups for vaccination are 11- and 12-year-olds, 15-year-olds and college freshmen living in dorms.

With each age cohort representing about 4 mil. individuals and freshmen living in dorms estimated at nearly 600,000, the initial population for the vaccine climbs above 12 mil.

ACIP also included several other special high-risk populations for initial vaccination: military recruits, microbiologists exposed to neisseria meningitidis, complement deficient or asplenic patients and travelers to regions with a bacteria epidemic. The at-risk group mirrors existing recommendations for Menomune.

The vaccine has FDA approval for a larger patient population: active immunization of adolescents and adults 11-55 years of age. At the time of FDA approval, the agency said it expected to receive a supplemental BLA from Sanofi-Pasteur during February for use in the 2-10 year-old group.

ACIP expects to consider a recommendation for use of the conjugate vaccine in 2-10 year-olds in about one year. The Meningococcal Working Group will not meet before the cycle of the next ACIP meetings in June and October and expects to consider a recommendation for use in younger patients in 2006.

ACIP selected the 11-12 and 15-year-old target groups to tailor the initial population to initial supply levels. ACIP member Reginald Finger, MD, a medical issues analyst at Focus on the Family, reported that the ACIP Meningococcal Work Group made that balance one of its primary factors in the recommendation.

ACIP also took into consideration the longer duration of protection from the conjugate that permits earlier vaccination. Menactra is expected to provide protection for greater than eight years versus three to five years for the polysaccharide vaccine.

By picking a group that is larger than the initial supply, Finger noted that the working group was attempting to err on the side of having people wait for vaccines instead of leaving extra vaccine on the shelf.

He noted the product is not tied to a short season for vaccination like the flu vaccine. Menactra has a 21-month limit from the date final bulk is manufactured.

ACIP also set the schedule to take advantage of preventive care visits by young adolescents. The 11- to 12-year-old group is currently scheduled for Td boosters.

The 15-year-old recommendation is set to coincide with entry into high school. The committee discussed using high school departure as a vaccination point but felt it would produce low vaccination rates.

The addition of the meningococcal vaccination at age 11 could help affirm the visit at that age as an adolescent preventive care platform, which could have a positive impact on several other adolescent vaccines approaching the U.S. market.

Merck and GlaxoSmithKline gave presentations to ACIP on Feb. 10 on their upcoming human papilloma vaccines, and GSK and Sanofi-Pasteur gave presentations on new boosters for Tdap (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis).

The Tdap boosters are designed to replace Td boosters and address a developing re-emergence of pertussis among adolescents.

A BLA for GSK's Boostrix in 10- to 18-year-olds was submitted in early July 2004 and a BLA for Sanofi-Pasteur's Adacel was submitted for the 11-64 age range in mid-August 2004. Both products are scheduled for FDA advisory committee review on March 15. [Editor's note: To ² watch a webcast of the advisory committee meeting on the Tdap boosters, visit FDAAdvisoryCommittee.com.]

At ACIP, GSK reported that the FDA action date for the Boostrix application is May. The company hopes to have the Tdap vaccine available this summer in time for back-to-school doctor visits. The initial licensing for the product outside the U.S. occurred in 1999. GSK said that it is licensed in 42 countries, with more than 1.9 mil. doses distributed.

The Feb. 11 discussion at ACIP about pertussis prevalence and vaccination strategies sets the stage for a vote by ACIP at its June 29-30 meeting to coincide with FDA action on the pending applications.

GSK's U.S. and international Boostrix formulations will differ in two ways: the U.S. vaccine will contain 0.3 mg aluminum (vs. 0.5 mg) and will be preservative free (compared to use of 2-phenoxyethanol).

Sanofi-Pasteur has seven North American studies on Adacel (four in the U.S. and three in Canada) with 7,000 individuals receiving the booster. Canadian follow-up to eight years will be available in 2006. From the existing data the booster appears to maintain effectiveness up to 10 years, the company said.

A review of pertussis epidemiology presented by CDC National Immunization Program's Trudy Murphy showed a sharp upswing in reported pertussis cases in 2002-2004. From a steady annual level of about 8,000 cases per year from 1996-2000, the number of cases jumped to 10,000 in 2002, approached 12,000 in 2003 and exceeded 18,000 in 2004.

ACIP will face competing strategies and target populations for upcoming human papilloma virus vaccines, but both leading candidates are looking at adolescents as part of the appropriate populations.

Merck considers the early adolescent years to be the prime period for use of its quadrivalent HPV vaccine candidate, Gardisil. An initial BLA filing is projected for the second half of this year.

Three clinical trials (over 25,000 patients) focused on women only in the 16-23 age range. The company also has a Phase III study in ages 9-15 of both genders.

Merck's Protocol 016 study enrolled 506 females age 10-15, 508 males age 10-15 and 511 females age 15-23 (as controls). The rationale for the two-gender, adolescent study, Merck explained, is that "mass vaccination programs should target boys and girls prior to sexual debut." Merck is continuing work on mid-adult women (24-45) because women remain at risk while they are sexually active.

Merck included HPV 6 and 11 to extend the vaccine to prevent genital warts as well as to prevent precancerous conditions. By offering protection against genital warts, Merck hopes the vaccine will have a "self-esteem" appeal to adolescents to support the long-term health effects against cervical cancer.

GSK's two-component vaccine against HPV 16-18 also has a target population starting with adolescents but is aimed specifically at women.

GSK maintains that "the most efficient strategy or cervical cancer prevention is to ensure high coverage levels in women." Modeling studies on male use of HPV vaccines, GSK told ACIP, show limited incremental benefit and less cost efficacy.

Menactra Launches For 11, 12, 15 Year Olds; First In Wave Of Teen Vaccines?

More from Archive

More from Pink Sheet