FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 to 11 Years of Age
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On October 29, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech (Pfizer) 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.
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The authorization for this age group is only for the Pfizer vaccine. The Moderna and Johnson & Johnson vaccines are available to people age 18 and older.
What you need to know:
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Dosing: The Pfizer vaccine for children 5-11 is administered as a two-dose primary series, 3 weeks apart. It is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).
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Safety: The vaccine’s safety was studied in approximately 3,100 children age 5-11 who received the vaccine. No serious side effects have been detected in the ongoing study.
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Efficacy: 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 ages 5 through 11.
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In addition, more than 5,200 children and teens have developed MIS-C, or multisystem inflammatory syndrome in children, a condition linked to COVID-19 that often leads to ICU admission. The median age of kids getting MIS-C is 9 years old.
At least 791 children have died from COVID-19, including 172 children ages 5 to 11. Learn more about why you shouldn't wait to vaccinate your children:
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In It for the Long Haul:
What to Know About Long-Haul COVID in Children and Teens
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Most kids and teens who test positive for COVID-19 have mild, or even no, symptoms. But it's becoming clear that some are experiencing symptoms more than a month after they've been infected with SARS-CoV-2, the virus that causes COVID-19. A number of post-COVID conditions have been identified in kids, most notably continued or recurring symptoms referred to as "long-haul COVID," sometimes also called "long COVID" or "Post-Acute COVID-19." Research on this condition continues.
Much is unknown about long-haul COVID-19. Researchers are not certain what causes it, how long it lasts, or who is likely to develop it. There is no specific test to diagnose long-haul COVID-19, so diagnoses and treatment depend on symptoms.
There are a variety of chronic symptoms your child can experience after having COVID-19. The specific symptoms your child has could depend on how severe their COVID infection was.
The most common symptoms include:
- Fatigue and poor physical endurance.
- Difficulty thinking or concentrating, also known as "brain fog."
- Cough.
- Trouble breathing.
- Joint or muscle pain.
- Chest or stomach pain.
- Mood changes.
- Headache.
- Fever.
- Heart palpitations.
- Loss of or changes in smell or taste.
- Lightheadedness when standing up.
What we do know is that COVID-19 affects children. Melissa Lynch, a mother who now serves as the USA Lead Director for the international parent organization Long Covid Kids, shared her daughter's journey from honor roll student to being homeschooled due to fatigue, seizures, and more.
Click the button below to learn more about how to recognize and monitor long-haul COVID-19 and read Lynch's story:
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Vaccine Booster Doses Strengthen Protection |
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An additional dose of a COVID-19 vaccine is recommended for people who are fully vaccinated and might not have had a strong enough immune response. In contrast, a booster dose is recommended for some people who are fully vaccinated and whose immune response weakened over time. |
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The CDC recommends additional doses and booster doses of COVID-19 vaccines in specific instances:
Additional dose: The CDC recommends a third dose of an mRNA COVID-19 vaccine (Moderna or Pfizer) for some people with weakened immune systems. The third dose should be given at least 28 days after your second dose vaccine and should be the same brand as the other two mRNA vaccine doses you were given.
Booster dose: If you have been given both doses of the Pfizer or Moderna COVID-19 vaccines and it’s been at least six months, you might be able to get a booster dose. The CDC recommends a booster dose for people age 65 and older and for people age 18 and older who live in long-term care settings, have an underlying medical condition, or live or work in a high-risk setting.
Booster dose for non-mRNA vaccines: If you have been given one dose of the Johnson & Johnson COVID-19 vaccine and it’s been at least two months, you also might be able to get a booster dose. The CDC recommends a booster dose for people age 18 and older. You may choose which vaccine you get as a booster dose.
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FAQs:
What Do I Need to Know Before I #GetTheShot ?
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Why do some vaccines require two doses?
The Moderna and Pfizer vaccines use messenger RNA (mRNA) to send the body’s cells instructions for making a protein that the immune system is then trained to recognize and attack when attached to the actual virus. The first vaccine dose primes the body, and the second dose strengthens the immune response.
The immune response to two doses of the Pfizer and Moderna vaccines provokes a much stronger immune response than just one dose. The first dose begins the process of building up protection, while the second dose reinforces this. Several common vaccines require multiple doses, including measle-mumps-rubella, hepatitis A and B, and the shingles vaccine.
The Johnson & Johnson vaccine uses a different approach. A harmless adenovirus is engineered to carry genetic code on the proteins to the cells. Once the cells receive this code, they produce a protein to train the body’s immune system to protect against the virus.
I’ve already had one COVID-19 shot. Do I need both?
While it is true that one dose of the vaccine will offer some protection against the virus, it is not nearly as effective as receiving both doses. Mutations such as the Delta variant will also continue to challenge the strength of the original vaccine, making the second shot critical.
I waited too long to get my second COVID-19 shot. Now what?
If possible, appointments for the second COVID-19 vaccine should be made at the time you receive your first to ensure they are within the required time interval. However, the second dose can be given up to six weeks (42 days) after the first dose. If more than six weeks have passed since your first dose, contact the location at which you received your vaccine to determine if you need to re-start your COVID-19 vaccination process.
What if I want the vaccine, but I don't have transportation?
Difficulty accessing the COVID-19 vaccine, often due to a lack of resources or transportation in rural areas, led to a small but significant share of people skipping a second dose. However, for the Moderna and Pfizer vaccines, completion of the second dose is critical in protecting you from COVID-19. Missouri offers several programs to assist those in need of rides to COVID-19 vaccination appointments.
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Did You Complete Your Primary Dosing? |
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A small but significant share of people have skipped the second dose of their COVID-19 vaccine. However, for vaccines using mRNA (Pfizer and Moderna), the second shot is critical to building protection against the virus that causes COVID-19.
What to know about primary doses:
- Vaccines for primary doses are not interchangeable. You should receive the same product for your two initial shots.
- You should still receive a second shot even if you experienced side effects from the first.
- If you received the Pfizer vaccine, get your second shot 21 days after your first.
- If you received the Moderna vaccine, get your second shot 28 days after your first.
You should receive your second dose as close to the recommended interval as possible. However, your second dose may be administered up to 42 days (six weeks) after the first if necessary. Do not get the second dose early.
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You are considered fully vaccinated, meaning your primary doses are complete, two weeks after the second shot of your mRNA vaccine series OR two weeks after your single shot vaccine. |
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194 million Americans have been fully vaccinated
24.8 million have gone on to receive a booster dose
Less than half of the population in Lafayette County, Missouri (41.8%) has been fully vaccinated. Transmission rates in this area are high, and residents are encouraged to continue wearing masks in indoor public spaces.
Are you ready to return to normal life? Your decision to get vaccinated is your choice, your body, and your business. Join more than 13,000 of your rural neighbors who have done their part to protect themselves and their community.
The Lafayette County Health Department is now offering vaccines for those people ages five and older at their walk-in clinic.
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Vaccine Safety: Debunking Myths about mRNA |
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“COVID-19 vaccines containing mRNA change your DNA.”
Messenger RNA (mRNA) from the Moderna and Pfizer vaccines enters cells for the sole purpose of causing the cell to make protein to stimulate the immune system. The mRNA then quickly breaks down. It does not enter the nucleus of the cells, where DNA resides, and it does not affect your DNA. This technology has been in development for more than two decades, specifically to allow vaccine makers to respond quickly to new illnesses.
“mRNA vaccines can give you COVID-19.”
The two authorized mRNA vaccines, Moderna and Pfizer, instruct your cells to reproduce a protein that is part of the SARS-CoV-2 coronavirus to help your body recognize and fight the virus, should you become infected. COVID-19 vaccines do not contain the virus and cannot give you the virus. These vaccines have undergone the most intensive safety monitoring in U.S. history and the FDA has authorized multiple vaccines for public use due to their safety and effectiveness.
“The ingredients in the COVID-19 vaccines are unsafe.”
The FDA-authorized COVID-19 vaccines contain messenger RNA (mRNA) and other normal vaccine ingredients including fats, salts, and a small amount of sugar. The mRNA technology used has been in development for more than two decades, does not contain the virus, and cannot give you the virus. None of the authorized vaccines contain eggs, metal, fetal tissue, implants, or microchips.
“COVID-19 vaccines were rushed, so they can’t be safe.”
The FDA-authorized COVID-19 vaccines were made using a method that has been in development for years. This technology was created specifically to help vaccine makers respond quickly to a new pandemic illness. There are many reasons the COVID-19 vaccines were developed quickly, but the bottom line remains: they are safe and effective.
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Keep an eye out for our upcoming toolkit with resources to help you strengthen vaccine confidence in your community.
This toolkit will include:
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Social Media Posts and Graphics |
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Editorial, Video, and Additional Media |
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