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October 16, 1991

Third Vaccine for Haemophilus influenzae?

JAMA. 1991;266(15):2050-2052. doi:10.1001/jama.1991.03470150018005

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THE WAY has been opened to license a third vaccine against Haemophilus influenzae for use in 2-month-old infants.

Pasteur Merieux, Swiftwater, Pa, the manufacturer of the third vaccine, was in the midst of two double-blind, placebo-controlled studies a year ago when the Food and Drug Administration (FDA) licensed a vaccine against H influenzae to Lederle-Praxis Biologics, Wayne, NJ. A second license was issued to Merck & Co Inc, West Point, Pa, for a similar vaccine 2 months later (JAMA. 1990;264:1375).

With vaccines on the market that are effective in 2-month-old infants, the Merieux study could not ethically be continued. The trial was stopped.

To deal with this situation, the FDA asked an advisory committee to decide on surrogate methods that could be used to measure efficacy in lieu of placebo-controlled studies. The committee now says that it has no objection to measuring serum antibody response to see if that is