FDA panel to examine 'maternal vaccines' to protect infants
Several manufacturers are already developing vaccines to protect infants via maternal immunization, but the potential of such vaccines has "yet to be fully realized." This Friday, an FDA advisory panel will examine the development and licensing of these "maternal vaccines," MedPage Today reported.
The FDA's Vaccines and Related Biological Products Advisory Committee will decide on recommendations for clinical trial design to assess the safety and efficacy for both experimental and licensed vaccines given to mothers to protect their infants.
Safety will be assessed in both mother and infant, but efficacy will only be measured in the infant, MedPage Today said. FDA staff said that the existing safety standards for infant vaccines could be a starting point for the evaluation of "maternal vaccines," but that the growth and development of the infants should be considered as well.
The main concern with "maternal vaccines" is risk: Previous vaccines have shown that pregnant women experience a higher frequency of adverse events than men and women who are not pregnant, the FDA said, as quoted by MedPage Today. A "theoretical concern" is that vaccination could provoke an immune response in the mother, which could lead to complications such as preterm birth, intrauterine growth or spontaneous abortion.
No specific companies or vaccines will be discussed in the meeting, and advisory committee decisions are not binding. But the FDA usually does follow advisory committee recommendations, so they are likely to affect the work of the companies that are developing such vaccines.
Companies that are developing "maternal vaccines" include Pfizer ($PFE), which is researching a range of conditions that affect humans from birth to old age in an effort to build out its vaccines business. Maryland-based Novavax ($NVAX) is also testing its respiratory syncytial virus (RSV) candidate in multiple age groups, including expectant mothers and older adults. It reported success from its Phase II trial involving infants who had been vaccinated via maternal immunization.
- read the MedPage Today story
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