The FDA advisory committee gave a green light for the vaccination of children ages 5 to 11 years old with the Pfizer-BioNTech vaccine.
The rate of children infected with the COVID-19 virus is lower than adults, and the symptoms are also less severe. However, children can still get sick and can spread the virus to others.
Parents worry about their children’s safety as the delta variant spreads among children, especially since schools have long been open. In the previous months, parents have been anxiously waiting for a vaccine to be administered to their children.
Pfizer-BioNTech Trial Results
Pfizer-BioNTech has been studying the COVID-19 vaccine for children earlier this year. In March 2021, the company started its trial on children to learn if the vaccine could produce an immune response against the virus.
Last week, Pfizer-BioNTech announced the positive result of their pivotal trial of the COVID-19 vaccine for children. The results showed that the vaccine was safe and caused significant neutralizing antibody responses in children aged 5 to 11.
Pfizer-BioNTech forwarded the result to the FDA for initial review. The company also submitted a formal request for Emergency Use Authorization (EUA) of the Pfizer-BioNTech Covid-19 vaccine in children aged 5 to 11 years. Additionally, the company also presented the results to the European Medicines Agency (EMA).
FDA Advisory Committee Recommends The Vaccine
On Tuesday, the FDA’s advisory committee held an open discussion on the request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) to administer their vaccine to children between 5 to 11. Several members stated that the shot would be critical for children to continue in-person learning.
Others expressed concern about the risks to the Children. Some also voiced concern that approving the vaccine for this age group could result in vaccination mandates for the schools. However, the majority of the committee decided that the vaccine’s benefits outweighed the risks for the age group.
The vaccine advisory committee of the Centers for Disease Control and Prevention is scheduled to meet next week to consider the results. The vaccination for children below 12 years old can begin if the CDC director accepts the recommendations.