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ATLANTA, Ga. (June 18) — On Friday and Saturday, another milestone was achieved in the COVID-19 vaccine race. Eighteen months after the first COVID-19 vaccine was approved for emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, M.D., M.P.H., endorsed the recommendation that all children 6 months through 5 years of age should receive a COVID-19 vaccine.
This expands eligibility for vaccination to approximately 18 million children and means all Americans ages 6 months and older are now eligible for vaccination with the Pfizer-BioNTech or Moderna vaccines to better protect them from COVID-19. All children, including children who have already had COVID-19, should get vaccinated.
According to the CDC, COVID-19 vaccines have undergone—and will continue to undergo—intensive safety monitoring. Parents and caregivers can play an active role in monitoring the safety of these vaccines by signing their children up for v-safe – confidential health check-ins via text messages and web surveys where they can easily share with the CDC how a child feels after getting a COVID-19 vaccine.
Distribution of pediatric vaccinations for these younger children has started across the country, and will be available at thousands of locations this week. Parents can reach out to their doctor, pharmacy, health department, or visit vaccines.gov to see where vaccines for children are available.
The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise.
The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are three weeks apart followed by a third dose at least eight weeks after the second dose in individuals 6 months through 4 years of age.
In Moderna clinical trial participants, the most commonly reported side effects across all age subgroups included pain, redness and swelling at the injection site, fever and underarm (or groin) swelling/tenderness of lymph nodes in the same arm (or thigh) as the injection. In participants 6 through 36 months (3 years) of age, the most commonly reported side effects also included irritability/crying, sleepiness, and loss of appetite. In participants 37 months through 5 years of age, the most commonly reported side effects also included fatigue, headache, muscle ache, chills, nausea/vomiting and joint stiffness.
The 6 through 11 and 12 through 17 age groups experienced similar side effects.
The most commonly reported side effects in Pfizer-BioNTech clinical trial participants 6 through 23 months of age who received the vaccine were irritability, decreased appetite, fever and pain, tenderness, redness and swelling at the injection site. These side effects were also reported for the vaccine recipients 2 through 4 years age, in addition to fever, headache, and chills.
COVID-19 Vaccine Development, Authorization
FDA Authorization — The FDA reviews and evaluates COVID-19 vaccines for quality, safety, and effectiveness. The FDA then issues EUAs for certain vaccines that meet rigorous, science-based standards. The FDA determines that these vaccines are safe and effective for public use.
CDC Recommendation — After the FDA authorizes the emergency use of a vaccine, an independent panel of medical and health experts called the Advisory Committee on Immunization Practices (ACIP) provides recommendations and guidance to the Director of the Centers for Disease Control and Prevention (CDC) regarding the use of the vaccine.
FDA Approval — When the FDA approves a vaccine, it must undergo the agency’s standard approval process for reviewing the quality, safety and effectiveness. The FDA’s Center for Drug Evaluation and Research conducts an analysis of the benefits and risks to ensure the vaccine meets the FDA’s standards for approval.
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