AnonymousSource: FDA
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.
Related Information
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Moving in the right direction. Hopefully this will be fully approved before the next school year vaccines can be mandated for this age group as well. Homeschooling, or going to a private school that doesn’t mandate vaccines will be the alternative option.
Sure Babycakes, are you anti-vaxx on all vaccines or just the ones for Covid?
And are you against all mandates for vaccinating children like the ones that have been in place for decades for schools? You a big fan of measles? Whooping Cough? Polio?
A school that does not mandate vaccination is not providing a proper education.
Unless my child had a pre-existing condition, I would not vaccinate him for COVID until more is known and it has been de-politicized.
No one in their right mind will have their children pumped with this vaccine. If the government thought they had problems mandating the vaccine with adults, just wait until they attempt to mandate for children! This is already backfiring on the pols who are pushing for this stuff.
None of the public schools are providing a proper education.
OOPS – how is the vaccine “politicized?” You know, other than covid being a “liberal hoax” and all…..
“It’s a very, sort of, personal choice. If I had a child who was a transplant recipient, I would really want to be able to use a vaccine. And there are certainly kids who probably should be vaccinated. The question of how broadly to use it, though, I think is a substantial one. And I know it’s not our question, and I know we’re kind of punting that to ACIP (the CDC’s Advisory Committee on Immunization Practices, which meets Nov. 2). But I do think that it’s a relatively close call … it really is going to be a question of what the prevailing conditions are. But we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes. That’s how we found out about rare complications of other vaccines like the rotavirus vaccine.” – Dr. Eric Rubin, FDA committee member who voted to approved the use of the vaccine for young children after a study of only 3,100 children for mere months. I’ll repeat, they approved this based on a study of only 3,100 children over several months.
SBTownie, how about a long-term study that last more than a few months and involves more than 3,100 kids?
VOR – I have no problem with them doing the science and giving it emergency approval. There certainly are going to be cases and kids where it makes sense to get the vaccine. There hasn’t been any science or logic though that we should then mandate all kids to get it. It’s a big difference that a lot of people don’t seemingly grasp. Considering how few kids COVID effects (and how vaccinated people are spreading it in similar levels to unvaccinated) this approval means that a few 5 to 11 year olds should probably get it…but it’s a very small and select few.
100% agree Duke. What this doctor (on the FDA advisory panel) said makes it truly shocking that people still think Newsom is “following the science” by mandating this for all children.
It took the BS folks a while to unclog their snorkels, but here they are with their antivax nonsense.
I quoted this article and a member of the FDA advisory panel who voted to approve it but sure, just wipe those facts away as B.S. from an antivaxer who, very oddly for an antivaxer, has as all their vaccinations.
3:03 – Then you’re continuing your reign as the ultimate hypocrite, casting shade on public health mandates every chance you get.
It will be interesting to hear the logic for the 5-11 year old mandate (if it comes)… because there doesn’t appear to be any (logic) at this point. It’s good it got emergency approval as there are a select few small kids that need this…. But it’s (by all science and logic) a VERY select few…
Mandated vaccination of school-age children benefits everybody. That’s why it’s happening, despite all the butt snorkeling by people opposed to public health measures.