- For immediate release:
Today, the U.S. Food and Drug Administration approved emergency use of the Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19 to include children ages 5 to 11 years. The approval was based on the FDA’s thorough and transparent evaluation of the data, which included input from independent advisory committee experts who predominantly voted to make the vaccine available to children in this age group.
Key points for parents and relatives:
- Efficacy: Immune responses in children aged 5 to 11 years were comparable to those in persons aged 16 to 25 years. In addition, the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 to 11 years of age.
- Safety: The safety of the vaccine was examined in approx. 3,100 children aged 5 to 11 who received the vaccine and no serious side effects have been identified in the current study.
- Centers for Disease Control and Prevention (CDC) Advisory Committee on Vaccination Practices meet next week to discuss further clinical recommendations.
“As a mother and doctor, I know that parents, caregivers, school staff and children have been waiting for today’s authorization. Vaccination of younger children against COVID-19 will bring us closer to returning to a sense of normalcy, “said Acting FDA Commissioner Janet Woodcock, MD.” Our comprehensive and rigorous evaluation of vaccine safety and efficacy data should help ensure parents and guardians. that this vaccine meets our high standards. “
The Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11 years is administered as a two-dose primary series at 3-week intervals, but is a lower dose (10 micrograms) than that used in people 12 years of age and older (30 micrograms).
In the United States, COVID-19 cases in children aged 5 to 11 years account for 39% of cases in people under 18 years of age. According to the CDC, approximately 8,300 COVID-19 cases in children aged 5 to 11 years resulted in hospitalization. Pr. On October 17, 691 deaths from COVID-19 have been reported in the United States in people under the age of 18, with 146 deaths in the age group of 5 to 11 years.
“The FDA is committed to making decisions that are governed by science that the public and the health care system can rely on. We are confident in the safety, efficacy, 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 released documents today that support our decision, and more information about our evaluation of the data will be published soon.We hope this information helps build trust in parents who make decisions for whether their children should be vaccinated, ”says Peter Marks, MD, Ph.D., director of the FDA’s Center for Biological Evaluation and Research.
The FDA has determined that this Pfizer vaccine meets the criteria for emergency use. Based on the available scientific evidence available, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals up to 5 years of age outweigh the known and potential risks.
FDA evaluation of available efficacy data
The efficacy data to support EUA in children up to 5 years of age are based on an ongoing randomized, placebo-controlled study that has included approx. 4,700 children aged 5 to 11 years. The survey is conducted in the United States, Finland, Poland and Spain. Children in the vaccine group received two doses of the Pfizer-BioNTech COVID-19 vaccine containing 10 micrograms of messenger RNA per day. dosage. The FDA analyzed data comparing the immune response of 264 participants from this study with 253 participants aged 16 to 25 years who had two higher doses of the vaccine in a previous study, which determined that the vaccine was effective in preventing COVID-19. The immune responses of the younger participants were comparable to those of the older participants.
The FDA also conducted a preliminary analysis of cases of COVID-19 that occurred seven days after the second dose. In this analysis, 3 cases of COVID-19 occurred among participants without evidence of previous infection with SARS-CoV-2 among 1,305 vaccine recipients and 16 cases of COVID-19 among 663 placebo recipients; The vaccine was 90.7% effective in preventing COVID-19.
FDA evaluation of available safety data
The available safety data in support of EUA include more than 4,600 participants (3,100 vaccines, 1,538 placebo) aged 5 to 11 years enrolled in the ongoing study. In this trial, a total of 1,444 vaccine recipients were followed for safety for at least 2 months after the second dose.
Commonly reported adverse reactions in the clinical trial included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and / or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. More children reported side effects after the second dose than after the first dose. The side effects were generally mild to moderate in severity and occurred within two days of vaccination, and most disappeared within one to two days.
FDA and CDC safety monitoring systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissues surrounding the heart) after vaccination with Pfizer-BioNTech COVID-19 Vaccine, especially after the second dose, and with the observed risk highest in men aged 12 to 17 years. Therefore, the FDA conducted its own benefit-risk assessment using modeling to predict the number of symptomatic COVID-19 cases, admissions, intensive care unit (ICU) admissions, and deaths from COVID-19, the vaccine in children aged 5 to 11 years. would prevent versus the number of potential myocardial infarctions, hospitalizations, intensive care units, and deaths that the vaccine may cause. The FDA’s model predicts that the benefits of the vaccine as a whole will outweigh its risks in children aged 5 to 11 years.
Ongoing security monitoring
Pfizer Inc. has updated its safety monitoring plan to include evaluation of myocarditis, pericarditis and other events of interest in children aged 5 to 11 years. In addition, the FDA and CDC have several systems in place to continuously monitor COVID-19 vaccine safety and enable rapid detection and investigation of potential safety issues.
It is mandatory for Pfizer Inc. and vaccination providers to report all serious adverse reactions, cases of multisystem inflammatory syndrome and cases of COVID-19 resulting in hospitalization or death of vaccinated persons. It is also mandatory for vaccination providers to report any vaccine administration errors to VAERS that they become aware of and to Pfizer Inc. to include an overview and analysis of all identified vaccine administration errors in monthly safety reports to the FDA.
Data support new vaccine formulation to improve stability and storage conditions
The FDA today also approved a manufacturing change for the vaccine to include a formulation that uses a different buffer; buffers help maintain a vaccine’s pH (a measure of how acidic or alkaline a solution is) and stability. This new formulation is more stable at refrigerated temperatures for longer periods, allowing 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 biological drugs, including products for use in children. The FDA evaluated production data to support the use of Pfizer-BioNTech COVID-19 vaccine containing Tris buffer and concluded that it does not raise safety or efficacy concerns.
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The Agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.