FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Children Ages 5-11

The FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine Oct. 29 for the prevention of COVID-19 in children 5 to 11 years of age. This was based on a safety review of more than 3,000 patients receiving the vaccine ages 5-11. #COVID19 #COVIDvaccine #COVID #SARSCoV2. Getty Images

The FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine Oct. 29 for the prevention of COVID-19 in children 5 to 11 years of age. This was based on a safety review of more than 3,000 patients receiving the vaccine ages 5-11.

November 5, 2021 — The U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTechCOVID-19vaccine Oct. 29 for the prevention ofCOVID-19in children 5 to 11 years of age.

The emergency use authorization (EUA) was based on the FDA’s evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.

支持EUA的现有安全数据包括正在进行的研究中的4600多名5至11岁的参与者(3100支疫苗，1538支安慰剂)。在这项试验中，共有1444名疫苗接种者在第二次接种后接受了至少两个月的安全随访。

Key points for parents and caregivers in the emergency use authorization announcement included the following subsections:

Effectiveness in Young Children Comparable to Ages 16-25

The immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In that study, the vaccine was 90.7% effective in preventing COVID-19 in children 5 through 11.

FDA表示，支持EUA对5岁以下儿童的有效性数据是基于一项正在进行的随机、安慰剂对照研究，该研究已招募了约4700名5至11岁儿童。这项研究正在美国、芬兰、波兰和西班牙进行。疫苗组的儿童接种了两剂辉瑞- biontech COVID-19疫苗，每剂疫苗含有10微克信使RNA。FDA分析了该研究中264名参与者的免疫反应，以及此前一项确定该疫苗可以有效预防COVID-19的研究中，年龄在16至25岁之间的253名参与者的免疫反应。年龄较小的参与者的免疫反应与年龄较大的参与者相当。

The FDA also conducted a preliminary analysis of cases of COVID-19 occurring seven days after the second dose. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, 3 cases of COVID-19 occurred among 1,305 vaccine recipients and 16 cases of COVID-19 occurred among 663 placebo recipients; the vaccine was 90.7% effective in preventing COVID-19.

Safety of the COVID Vaccine in Children Ages 5-11

The vaccine’s safety was studied in approximately 3,100 children age 5-11 who received the vaccine. There were no serious side effects detected in the ongoing study.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” saidActing FDA Commissioner Janet Woodcock, M.D.“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

The FDA has determined this Pfizer vaccine has met the criteria for emergency use authorization. Based on the totality of scientific evidence available, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals down to 5 years of age outweigh the known and potential risks.

“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust. We are confident in the safety, effectiveness and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated,” saidPeter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Dosing for of the COVID Vaccine For Children

The Pfizer-BioNTech COVID-19 Vaccine for children ages 5-11 is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

The vaccine vials for children ages 5-11 come with an orange cap and must be diluted.Read the instructions for use on the FDA website.

COVID Infection Statistics for Children

In the U.S., COVID-19 cases in children ages 5-11 make up 39% of cases in individuals younger than 18 years of age. According to the Centers for Disease Control and Prevention (CDC), approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization.

As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals younger than 18 years, with 146 deaths in the 5 through 11 years age group.

Side Effects of the COVID Vaccine in Children

Commonly reported side effects in the clinical trial include:
• Injection site pain (sore arm)
• Redness and swelling
• Fatigue
• Headache
• Muscle and/or joint pain
• Chills
• Fever
• Swollen lymph nodes
• Nausea
• Decreased appetite

More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days.

Concerns About Myocarditis in Younger Patients Receiving the COVID Vaccine

The FDA and CDC safety surveillance systems have previouslyidentified increased risks of myocarditis(心肌炎症)和心包炎(心脏周围组织炎症)接种辉瑞- biontech COVID-19疫苗后。这种情况在第二次服用后最为明显，观察到的风险在12至17岁的男性中最高。因此，FDA进行了自己的受益-风险评估，利用建模来预测疫苗在5至11岁的儿童中可以预防多少有症状的COVID-19病例、住院、重症监护病房(ICU)入院和COVID-19死亡，以及疫苗可能导致的潜在心肌炎病例、住院、ICU入院和死亡的数量。

The FDA said its model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11 years of age.

Pfizer has updated its safety monitoring plan to include evaluation of myocarditis, pericarditis and other events of interest in children ages 5-11. In addition, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety problems.

It is mandatory for Pfizer Inc. and vaccination providers to report to any serious adverse events, cases ofMultisystem Inflammatory Syndrome in Children (MIS-C)以及导致接种疫苗者住院或死亡的COVID-19病例。It is also mandatory for vaccination providers toreport all vaccine administration errors to VAERSfor which they become aware and for Pfizer Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports to the FDA.

Data Supports New COVID Vaccine Formulation to Improve Stability and Storage Conditions

The FDA Oct. 29 also authorized a manufacturing change for the vaccine to include a formulation that uses a different buffer. Buffers help maintain a vaccine’s pH level and stability. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers.

The new formulation of the vaccine developed by Pfizer Inc. contains Tris buffer, a commonly used buffer in a variety of other FDA-approved vaccines and other biologics, including products for use in children. The FDA evaluated manufacturing data to support the use of Pfizer-BioNTech COVID-19 Vaccine containing Tris buffer and concluded it does not present safety or effectiveness concerns.