6 Things to Know about COVID-19 Vaccines for Children

According to the Centers for Disease Control and Prevention, weekly COVID-19–associated hospitalizations among children and adolescents rose nearly five-fold from late-June to mid-August 2021, due in large part to the highly transmissible Delta variant. Those hospitalization rates were 10 times higher among unvaccinated kids than among those who were fully vaccinated.

Vaccination remains the most effective protection against COVID-19, and Pfizer is currently the only FDA-approved vaccine for everyone 12 years of age and older. Clinical trials are underway for children under 12 and the results and vaccines may be available soon. For now, though, here are six things you need to know about COVID vaccination and children:

• When will vaccines be available for children under the age of 12?
  
  
  The FDA expects vaccines will be available for children before the end of 2021. Pfizer Bio-N-Tech is the furthest along in pediatric clinical trials and expects to submit data to the FDA in late September 2021.
  
  
  
  
• Why are separate vaccine clinical trials and testing done for children?
  
  
  Children are still growing and developing and are not just small adults. Pediatric vaccine trials can include different doses or strengths of vaccines already in use in adults. It is important clinical trials are completed to evaluate the safety and immune response to a COVID-19 vaccine in children.
  
  
  
  
• How will the FDA ensure the safety and efficacy of COVID-19 vaccines in children?
• Completed clinical trials with children including a follow-up period of at least two months
• Manufacturers analyze clinical trial data to evaluate the safety and effectiveness of the vaccine. The FDA works closely with manufacturers to ensure data analysis meets regulatory standards.
• After a full evaluation, manufacturers request an emergency use authorization (EUA) or submit for permanent approval through a biologics license application (BLA).
• The FDA evaluates the data in an independent review evaluating the benefits and risks.
• The FDA approves or denies the EUA or BLA request based on its findings.
  
  
  
  
• How can the FDA review data so quickly?
  
  
  Data from the full clinical trials are reviewed by multi-disciplinary experts following submission by vaccine manufacturers. The FDA expects this review will take place in weeks instead of months due to added funding to dedicate time and additional resources to a quick, but thorough review.
  
  
  
  
• Can I ask my pediatrician to vaccinate my kids now?
  
  
  Children are still developing. Vaccine doses being studied in younger children are different than those for adults and children ages 12 and older. Clinical trials are important before vaccinating young kids to ensure the vaccine is likely to prevent COVID-19 and doesn’t cause unexpected safety issues.
  
  
  
  
• How can I protect my children until they are eligible for vaccination?
  
  
  The best way is for all adults around them to get vaccinated. Children should also wear masks as recommended and follow other precautions until they can receive vaccination.