How Pfizer Vaccine Prevents 91% of Symptomatic COVID in Young Children : FDA

Late Friday, the agency posted its analysis of data from Pfizer's pediatric study and said that in nearly all models, the health benefits of administering kid-sized doses of the shot to America's 28 million 5- to 11-year-olds far outweighs any potential side effects, the Associated Press reported. The FDA will have a panel of independent experts offer advice on the use of the Pfizer vaccine in elementary school-age children next Tuesday, and a decision from the agency could come soon after. If the U.S. Centers for Disease Control and Prevention agrees, experts there would offer further guidance on a vaccine rollout to children under 12 -- meaning that shots for young children could be administered as soon as early November, the AP said. Children age 12 and older already have access to the Pfizer COVID-19 vaccine, but uptake by younger kids could help prevent rare cases of symptomatic illness and also greatly stem transmission, since children in this age group are thought to be conduits of new infections to adults. The pediatric data submitted to the FDA by Pfizer was largely compiled in August and September, when the highly contagious Delta variant was already the dominant form of virus within the United States, the AP noted. Two doses of the vaccine appeared to prevent 9 out of 10 cases of symptomatic illness in young kids, with no surprises in terms of side effects, which appeared limited to sore arms, fever and achiness. The FDA noted that the study population was not large enough to assess the risk of side effects such as myocarditis, an inflammation of the heart that has been seen in very rare cases in adults. In four different modeling scenarios, uptake of the vaccine by young children clearly prevented many more hospitalizations than might be caused through side effects, the FDA said. According to the AP, severe COVID is extremely rare in young children. The latest data from the American Academy of Pediatrics estimates that nearly 6.2 million American children have been infected with SARS-CoV-2 so far, resulting in a total of 630 deaths in people age 18 and under. A large supply of millions of specially labeled pediatric doses of the Pfizer vaccine have already been stockpiled by the Biden administration, and are ready for shipment throughout the country, the AP said. More than 25,000 pediatricians and primary care providers are enlisted to administer the shots. Help Protect Your Child and Your Family Getting a COVID-19 vaccination can help protect your child from getting COVID-19. Early information shows that the vaccines may help keep people from spreading COVID-19 to others. They can also help keep your child from getting seriously sick even if they do get COVID-19. Help protect your whole family by getting yourself and your children 12 years and older vaccinated against COVID-19. Information about COVID-19 Vaccines for Children and Teens Cases of myocarditis and pericarditis in adolescents and young adults have been reported more often after getting the second dose than after the first dose of one of the two mRNA COVID-19 vaccines, Pfizer-Bio N Tech or Modena. These reports are rare and the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis. Get a COVID-19 vaccine for your child as soon as you can. COVID-19 vaccines are safe and effective. COVID-19 vaccines have been used under the most intensive safety monitoring in U.S. history, which includes studies in adolescents. Your child will need a second shot of the Pfizer-BioNTech COVID-19 Vaccine 3 weeks after their first shot. Children and adolescents receive the same dosage of Pfizer-BioNTech COVID-19 vaccine as adults. There are no patient weight requirements for COVID-19 vaccination, and COVID-19 vaccine dosage does not vary by patient weight. Your child can’t get COVID-19 from any COVID-19 vaccine, including the Pfizer-BioNTech vaccine. Your child may get a COVID-19 vaccine and other vaccines at the same visit or without waiting 14 days between vaccines. Prepare for your child’s vaccination visit. Get tips for how to support your child before, during, and after the visit. Talk to your child before the visit about what to expect. Tell the doctor or nurse about any allergies your child may have. Comfort your child during the appointment. To prevent fainting and injuries related to fainting, your child should be seated or lying down during vaccination and for 15 minutes after the vaccine is given. After your child’s COVID-19 vaccination, you will be asked to stay for 15–30 minutes so your child can be observed in case they have a severe allergic reaction and need immediate treatment. Possible side effects Your child may have some side effects, which are normal signs that their body is building protection. On the arm where you got the shot: What to Expect after Vaccination Animation _ pain Pain Redness Swelling Throughout the rest of your body: What to Expect after Vaccination Animation_ fever Tiredness Headache Muscle pain Chills Fever Nausea These side effects may affect your child’s ability to do daily activities, but they should go away in a few days. Some people have no side effects. Ask your child’s healthcare provider for advice on using a non-aspirin pain reliever and other steps you can take at home to comfort your child. It is not recommended you give pain relievers before vaccination for the purpose of trying to prevent side effects. Get started with v-safe Ask your child’s healthcare provider about getting started with v-safe, a free, smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after your child receives a COVID-19 vaccination. Through v-safe, you can report any side effects your child may have after vaccination. V-safe also reminds you to get your child’s second dose. Learn more about v-safe. Safe, Easy, Free, and Nearby COVID-19 Vaccination The federal government is providing the vaccine free of charge to all people living in the U.S., regardless of their immigration or health insurance status.