COVID-19 Vaccines For Kids: Don’t Forget The Rotavirus Experience
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An ex-member of the strategic advisory group to WHO's Global Vaccine Safety Initiative and infectious diseases expert shares his views on COVID-19 vaccines, shaping pediatric trials and areas that may need attention.
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Could Serum Institute or Bharat Biotech be the first company to have a COVID-19 vaccine for children under 12 years of age? While Pfizer and Moderna have begun pediatric trials for children 12 years and above, Serum plans to begin testing its indigenous vaccine and Bharat Biotech its Covaxin in children under 12
Although UK labeling for the Pfizer/BioNTech vaccine recommends against use in women who are pregnant or breastfeeding, the US FDA’s labeling under an emergency use authorization is not expected to follow suit; agency says developmental and reproductive toxicity studies for some early candidates are nearing completion, but data will not available for EUA decision-making.
Sponsors are moving to younger populations as the adult clinical trials near enrollment goals; Moderna’s CEO says data in children younger than 12 will be slow to emerge.