This article is only available in the PDF format. Download the PDF to view the article, as well as its associated figures and tables.
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
Marwick C. Third Vaccine for Haemophilus influenzae? JAMA. 1991;266(15):2050–2052. doi:10.1001/jama.1991.03470150018005
Coronavirus Resource Center
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: