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June 16, 2022 6:06 PM

FDA Recommends Pfizer and Moderna Vaccine for Children 6 months to 5 years of age

(June 16, 2022) – Yesterday, the Food and Drug Administration (FDA) advisory committee voted unanimously to recommend that the agency authorize the Moderna and Pfizer-BioNTech coronavirus vaccines for children 6 months through 5 years of age.

The FDA’s panel voted that the benefits of both vaccines outweigh the risks for children 6 months of age and older, the final group to be authorized to receive the two vaccines. This recommendation initiates a multistep process for approval as the US Centers for Disease Control (CDC) reviews and is expected to authorize the two vaccines for children early next week.
While rates of COVID-19 in this age group are relatively low, rates of hospitalization are slowly increasing, possibly due to the dominance of the Omicron variant. According to the latest data from the CDC, more than 2 million cases of COVID-19 have occurred among children 4 years old or younger since the start of the pandemic, leading to more than 440 deaths. Pfizer’s three-dose vaccine will cover children 6 months through 4 years old, while Moderna’s two-dose vaccine would be for children 6 months through 5 years of age.

“Thousands of children and their families volunteered in clinical trials to help make sure the COVID-19 vaccines for young children are safe and work well,” said Dr. Sharon Grundy, County Chief Medical Officer. “This is an important step to guaranteeing safe and effective protection from COVID, like other vaccine-preventable diseases, for everybody as we learn to live alongside the virus.”

The CDC advisory committee is scheduled to review the data and discuss tomorrow and Saturday to determine whether to make a formal recommendation for vaccination in this age group. The Colorado Department of Public Health and Environment (CDPHE) expects that vaccines for this age group will become available in Colorado the week of June 20. San Miguel County Public Health foresees hosting its first COVID vaccine clinic for this age group by the end of June.

“This is an incredibly important step to limit disruptions for our children moving forward,” said Public Health Director Grace Franklin. “Vaccines add a layer of protection to safely keep this age group in childcare, in school, playing together and enjoying summer safely. It also brings about safe interactions with family members who may have stayed apart until their grandchildren, nieces and nephews could be vaccinated.”

Side effects of vaccination observed during clinical trials were about the same as those observed for COVID-19 vaccines for older children and adults, and similar to other routine pediatric vaccines. Most side effects are mild and go away on their own within a few days. These vaccines can be given safely at the same time as other routine childhood vaccines, like MMR, tetanus, and polio.

Public Health will host an online forum on Wednesday, June 22 at 5:30 pm to present the findings from the FDA and CDC review, discuss the safety and efficacy of the Pfizer and Moderna vaccines and answer questions from the public. The forum will take place on Zoom with Meeting ID 846 7673 1971 and passcode 650 497.

FDA Recommends Pfizer and Moderna Vaccine
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