Why did it take so long for the FDA to make a decision about vaccines for children under 5?

All the COVID-19 vaccines have undergone a rigorous review process before being authorized for a given age group. The FDA’s evaluation of vaccines for young kids has been part of this overall thorough review process. Clinical trials were not started in children until after the trials in adults showed safety and efficacy of the vaccines. 

Additionally, part of what made the review process longer for young kids is that experts were determining what dosage and series would be safe and effective for children under five. After reviewing initial data on the effectiveness of the vaccine in young kids, the FDA waited to receive additional findings from clinical trials to ensure that its recommendation was based on a substantial amount of clinical data.  

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1. Are the available COVID-19 vaccines safe and effective?
2. Is it safe to get my child vaccinated?
3. Why did it take so long for the FDA to make a decision about vaccines for children under 5?
4. Is it safe to get vaccinated if I am pregnant or breastfeeding?
5. How was the vaccine developed so quickly?
6. What ingredients are used in the vaccines?
7. What are the possible side effects of a COVID-19 vaccine?
8. Who is NOT recommended for each vaccine?
9. Can I get COVID-19 from the vaccine?
10. Is Johnson & Johnson’s Janssen COVID-19 vaccine safe?
11. Does the Johnson & Johnson/Janssen vaccine require special precautions?