Food and Drug Administration Grants Emergency Clearance for Pfizer-BioNTech Coronavirus Vaccine in Children.
The US Food and Drug Administration (FDA) has granted an emergency authorization for the Pfizer-BioNTech coronavirus vaccine to be administered to children between the ages of five and 11.
It is the first coronavirus vaccine approved in the United States for young children, following an overwhelming vote by an FDA advisory panel earlier this week.
Friday’s approval is expected to make the vaccine available to 28 million American children, many of whom are back in school to learn in person.
Pfizer and BioNTech said their vaccine was 90.7 percent effective against coronavirus in a clinical trial in children ages 5 to 11.
“Vaccinating younger children against COVID-19 will bring us closer to getting back to normal,” said FDA Acting Commissioner Dr. Janet Woodcock in a statement. “Our thorough and rigorous evaluation of the vaccine safety and efficacy data should help reassure parents and guardians that this vaccine meets our high standards.”
Only a few other countries, including China, Cuba, and the United Arab Emirates, have so far approved COVID-19 vaccines for children of this age group and younger.
An advisory panel from the US Centers for Disease Control and Prevention (CDC) will meet Tuesday to consider how the Pfizer-BioNTech vaccine should be used in that age group. The CDC director will have the final word on approval.
With the FDA’s decision, Pfizer plans to begin shipping millions of vials of the pediatric vaccine, with orange caps to avoid confusion with the purple-capped doses for everyone else, to doctors’ offices, pharmacies and other vaccination sites. Once the CDC makes its ruling, eligible children will receive two vaccinations, three weeks apart.
While children are at a lower risk of serious illness or death from COVID-19 than older people, children ages five to 11 have still been severely affected, including more than 8,300 hospitalizations, about a third requiring intensive care, and almost 100 deaths. since the start of the coronavirus pandemic, according to the FDA.
Nearly 70 percent of children ages five to 11 hospitalized for COVID-19 in the US have other serious medical conditions, such as asthma and obesity, according to federal tracking. Additionally, more than two-thirds of hospitalized youth are black or Hispanic, reflecting long-standing disparities in the effect of the disease.
Pfizer and BioNTech expect data from a clinical trial in children ages two to four by the end of the year.
The United States began vaccinating teens ages 12 to 17 in May. Vaccination coverage among children in that age group is lower than in older groups, according to the CDC.
Pfizer’s vaccine was the first to be licensed for emergency use in the US in December 2020 for people age 16 and older. It was licensed for the 12-15 age group in May and received full approval from the United States in August.
Some American parents are expected to vaccinate their young children before vacation family gatherings and the winter season.
But a recent survey from the Kaiser Family Foundation suggests that most parents won’t rush to get vaccinated. About 25 percent of parents surveyed earlier this month said they would vaccinate their children “immediately.”
But the remaining majority of parents were roughly split between those who said they will wait to see how the vaccine works and those who said they will “definitely” not vaccinate their children against COVID-19.