in five- to 11- year-olds, and they plan to ask for authorisation to use the vaccine in children in that age range in the United States, Europe and elsewhere as soon as possible.
"These trial results provide a strong foundation for seeking authorisation of our vaccine for children five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency." A rapid authorisation could help mitigate a potential surge of cases in the fall, especially with schools already open nationwide.
The companies expect data on how well the vaccine works in children two to five years of age and children six months to two years of age as soon as the fourth quarter of this year.Unlike the larger clinical trial the drugmakers previously conducted in adults, the 2,268-participant pediatric trial was not primarily designed to measure the vaccine's efficacy by comparing the number of COVID-19 cases in vaccine recipients to those who received a placebo.
CONCLUSION Applying strict scrutiny, the Court should find Respondent’s vaccine mandate fails to advance a compelling government interest that is narrowly tailored to protect public health. Dated: August 10, 2021 Respectfully submitted
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