How does the process work for getting approval to expand vaccine rollout to younger age groups?
Now that we have data on the safety of COVID-19 vaccines in millions of adults, pharmaceutical companies have started testing these vaccines in children. Although children tend to have milder COVID-19 symptoms, they can still become sick and sometimes suffer lingering consequences from the virus. Children with underlying health conditions, such as diabetes and heart disease may be more at risk of severe infection. Vaccinating children is also felt to be the key to controlling this pandemic – as otherwise there would be a pool of millions of children at risk of infection to allow continued spread of the virus.
The PfizerBioNTech vaccine was recently authorized for use in children 12-15 years of age after this vaccine was studied in 2,260 children in this age group using the standard dose. Side effects after vaccination such as sore arm, fever, chills, headache, and fatigue were similar to side effects experienced by adults. The vaccine was 100% effective against COVID-19 infection as none of the vaccinated adolescents became infected during the study, while 16 cases of COVID-19 occurred in those who received placebo injections.
Children tend to have brisk immune responses to pathogens and therefore further studies are needed to determine which dose of vaccine is best for children. Currently studies are ongoing in children younger than 12 – starting with those at the older age range. Children in these studies will receive a range of doses of vaccine to determine which dose triggers a strong immune response without too many side effects. Once researchers have determined which dose is optimal for children in each age group they will begin randomized controlled trials to determine the efficacy of these vaccines in children just as they did in adults. These researchers will look at development of immune markers in children, cases of COVID-19 in vaccine and placebo recipients as well as the spread of virus in households to determine how effective these vaccines are in children. Completion of these studies will take several months and we do not know exactly when vaccines will be available for children. Researchers hope that vaccines may be available for older children in the fall, and at the end of 2021 for the youngest children (6 months to 2 years old).
Dr. Virginia Bieluch
Chief of Infectious Diseases, MidState Medical Center