Pfizer has asked the FDA to consider granting authorization for its COVID-19 vaccine to be used in children under 12. The agency’s vaccine advisory committee plans to meet on October 26 to discuss the matter (1).
The company says their vaccine is safe and effective for use in kids between the ages of 5 and 11 years. If the FDA issues the authorization, the Pfizer-BioNTech vaccine would become the first available to children in this age group (2).
What is emergency use authorization and is the COVID-19 vaccine safe for children?
The FDA issues emergency use authorization (EUA) for vaccines and other medical treatments that are urgently needed during a public health crisis. Since the COVID-19 pandemic began, the FDA has issued them for three vaccines. They have also issued them for several drug therapies and medical devices such as testing kits (3).
The FDA granted its first EUA for a COVID-19 vaccine in December 2020. This allowed for the Pfizer-BioNTech vaccine to be used in individuals 16 years of age and older. In May 2021, the agency extended this authorization to also apply to youth between the ages of 12 and 15 years (4).
All three of the COVID-19 vaccines that have received this authorization have gone through rigorous testing. This includes clinical trials in animals and adults (5). Clinical trials could not begin in children until the vaccine was proven to be both safe and effective in adults (6).
Pfizer used a process called age de-escalation testing to determine whether its vaccine was also safe for children under 12. This means the vaccine was tested in children of different age groups using different doses (7). Researchers gradually increased the dosage given to each group to determine whether or not it would make the vaccine more effective. This allowed them to find the optimal vaccine dosage for children (8).
The study found that the COVID-19 vaccine seems to be even more effective in children, youth, and young adults than in older people (9). It also found that while severe side-effects including heart inflammation can occur, especially in boys and young men, they are incredibly rare. Severe side effects were most likely to occur in those over the age of 16 (10).
Why is it needed?
Children under the age of 12 are currently not able to receive a COVID-19 vaccination in the United States (11).
The effect of the pandemic on children and youth has been an ongoing concern for parents and teachers. Many children lost out on academic and social progress when schools closed. Others became food insecure without breakfast and lunch programs available (12).
Data shows that children are less likely than adults to experience severe symptoms as a result of COVID-19. However, COVID-19 can, in rare cases, cause long term health conditions or death in children. It’s especially risky for children who suffer from underlying health conditions (13).
The research is mixed on how easily children can transmit the virus to other people. The CDC currently recommends that children over the age of two years wear a mask when they’re indoors and wash their hands often to help prevent the spread of COVID-19 (14). Even with these protections in place, the rise of the Delta variant could mean there’s an increased risk of community spread in schools this fall and winter.
When the coronavirus spreads through unvaccinated communities it has more opportunities to mutate. The longer this goes on, the greater the chance a variant that’s more contagious or more deadly than Delta will emerge (15). Improving herd immunity by getting more people, including children, vaccinated is the best way to prevent this and end the pandemic (16).