2-dose, child-sized Pfizer vaccine authorized by FDA for 28 million children, 5 to 11. Vaccinations could begin next week.

The CDC will formalize the FDA’s Emergency Use recommendation of the Pfizer vaccine for children ages 5 through 11 this coming week. 28 million children (20% of population) will be eligible to receive the vaccine. The dose would be at a one-third strength and delivered in two shots, three weeks apart. Here is the statement of the FDA issued yesterday, Oct. 29th:

Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent 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.

Key points for parents and caregivers:

• Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In addition, the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11.
• Safety: The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
• The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.

“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,” said Acting 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 Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age 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). 

In the U.S., COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. According to the 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 less than 18 years of age, with 146 deaths in the 5 through 11 years age group.  

“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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

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. 

FDA Evaluation of Available Effectiveness Data

The effectiveness data to support the EUA in children down to 5 years of age is based on an ongoing randomized, placebo-controlled study that has enrolled approximately 4,700 children 5 through 11 years of age.  The study is being conducted in the U.S., 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 dose. The FDA analyzed data that compared the immune response of 264 participants from this study to 253 participants 16 through 25 years of age who had two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune responses of the younger age participants were comparable to the older participants. 

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. 

FDA Evaluation of Available Safety Data

The available safety data to support the EUA include more than 4,600 participants (3,100 vaccine, 1,538 placebo) ages 5 through 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 side effects 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. 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.

The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with Pfizer-BioNTech COVID-19 Vaccine, particularly following the second dose, and with the observed risk highest in males 12 through 17 years of age. Therefore, the FDA conducted its own benefit-risk assessment using modelling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in children 5 through 11 years of age would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause. The FDA’s model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11 years of age.

Ongoing Safety Monitoring

Pfizer Inc. has updated its safety monitoring plan to include evaluation of myocarditis, pericarditis and other events of interest in children 5 through 11 years of age. 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 of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death in vaccinated individuals. It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for 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 Vaccine Formulation to Improve Stability and Storage Conditions

The FDA today also authorized 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 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.

How Children will get their vaccinations:

Ahead of the approvals, the White House has set out its recommended plan for vaccinating 28 million children:

The plan mobilizes a comprehensive effort across the public and private sectors:

Securing vaccine supply for our nation’s children:  There is vaccine to support vaccination for the country’s 28 million children ages 5-11 years old. If authorized by the FDA and recommended by the CDC, the Pfizer-BioNTech vaccine for 5-11 year olds will be a dose and formula specifically for this age group. The vaccine will have packaging available in smaller configurations that will make it easier for physicians’ offices and other smaller, community-based providers to offer the vaccine to kids and their families.

Pending FDA authorization, the packaging configuration will be 10-dose vials in cartons of 10 vials each (100 doses total), delivered in a newly updated product shipper, and the vaccine can be stored for up to 10 weeks at standard refrigeration temperatures and 6 months at ultra-cold temperatures. And, the vaccine will come with all the ancillary supplies that providers need to serve kids, including smaller needles. The U.S. Department of Health and Human Services (HHS) is working hand-in-hand with states to make this vaccine supply available in communities across the country as rapidly as possible.

Standing Up Vaccination Sites in Settings That Kids and Their Parents Know and Trust: Vaccinations will be accessible and conveniently located to families across the country, including vaccination clinics at doctors’ offices, hospitals, pharmacies, community health centers, and school- and community-based sites. Nationwide, more than 25,000 pediatric and primary care provider sites will provide vaccinations for children, in addition to tens of thousands of other provider locations that serve children, including pharmacies, children’s hospitals, and community health centers.

• Over 25,000 Pediatricians’ Offices and Other Primary Care Sites: The Administration, in partnership with states and localities, will make vaccinations available at doctors’ offices across the country — more than 25,000 pediatric offices and other primary care sites in total. Pediatricians, and other doctors, are some of the most trusted sources for families when it comes to COVID-19 vaccines for children. These providers will play a critical role in the nationwide effort to get children vaccinated. To facilitate this, the Administration is working with states to increase the number of pediatric and primary care providers enrolled to administer the vaccine and to provide the training and resources they need — including the vaccine supply in smaller package size and with easier-to-handle storage requirements highlighted above.

• Over 100 Children’s Hospitals and Health Systems Across the Country: The Administration is launching a partnership with the Children’s Hospital Association to work with over 100 children’s hospital systems across the country to set up vaccination sites in November and through the end of the calendar year. Parents know and trust children’s hospitals to be there for their children’s medical needs, and these vaccination efforts will be no different. Pediatricians, pediatric specialists, nurses and team members will administer the vaccine to kids in trusted, family-friendly settings that serve kids every day. Participating hospitals will work to partner with community- and faith-based organizations, school districts, and other partners to conduct outreach to their local communities, and offer vaccinations at convenient hours that work for kids and their parents – such as after school, evenings, and on weekends. And, pediatric clinicians will be available to parents for questions about vaccine safety and effectiveness. Children’s hospitals and health systems will be a critical part of our efforts to advance equity and ensure access for our nation’s highest-risk kids, including those with obesity, diabetes, asthma, or immunosuppression.

• Tens of Thousands of Pharmacies: As part of the federal government’s pharmacy program, tens of thousands of pharmacies across the country will offer the vaccine to their local communities. Pharmacists are a trusted source of information for parents, and local pharmacies will be a convenient, accessible option for many families. Pharmacies will offer family-friendly in-store clinics to best meet the needs of local communities. And, pharmacies will offer vaccinations at convenient hours for kids and their parents – allowing for advanced appointment scheduling and walk-ins wherever available. Pharmacy partners will launch comprehensive campaigns to reach parents and families, including texts, calls and outreach to meet local communities where they are.

• Hundreds of School and Community-Based Clinics: The Administration will work with states and local partners to make vaccination sites available at schools and other trusted community-based sites across the country. The Administration, through the Federal Emergency Management Agency (FEMA), is providing full funding to states to support vaccination operations and outreach – including setting up sites, procuring equipment and supplies to store and administer the vaccine, providing transportation to and from vaccination sites, and communicating with the public, such as through in-person community engagement, call center support, public service announcements, and translation services. And, for those schools who need extra help, the Administration will launch a new effort to match school districts with vaccine providers who will provide on-site vaccination clinics for their students and local communities.

• Hundreds of Community Health Centers and Rural Health Clinics: The Administration will work with community health centers and rural health clinics across the country to provide vaccinations to the children and families they serve. Health centers and rural health clinics play a critical role in providing care for kids and their families well. Nationwide, over 3 million 5-11 year olds get their primary health care from community health centers. The Administration – working through states, the federal Health Center COVID-19 Vaccine Program, and the Rural Health Clinic COVID-19 Vaccine Program –will make vaccine supply available to health centers and rural health clinics across the country, and work hand-in-hand with providers to ensure they have the resources and support they need to serve kids and their families.

Supporting Education and Engagement Efforts to Build Public Trust: To ensure that parents have the information they need to make informed choices for their families, HHS will conduct a national public education campaign to reach parents and guardians with accurate and culturally-responsive information about the vaccine and the risks that COVID-19 poses to children. To achieve this, the campaign will invest heavily in trusted messengers; work with schools, state and local health departments, faith leaders, and national and community organizations to increase vaccine confidence; create forums for parents to ask questions to pediatricians; and reach out to parents directly through press and social media across channels and in multiple languages. Central to this work will be close collaboration with the major national organizations, and their local affiliates, that reach families across the country – including provider and parent organizations and other key partners from across the public and private sectors. And, the over 14,000 members of the COVID-19 Community Corps will play a critical role in mobilizing grassroots efforts to keep kids and their families safe. Additionally, while many parents will go to their own pediatrician to get their questions answered, we know some children do not have a consistent medical provider and their parents may have questions. To ensure that every parent can get answers from trusted sources, the Surgeon General will enlist pediatricians and community leaders to talk to Americans directly via popular media and social media channels and through visits to hard-hit and high-risk communities.