FDA Authorizes First COVID-19 Shots for Infants & Preschoolers


The FDA authorized the first COVID-19 shots for infants and preschoolers. The authorization followed its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer. This means about 18 million children under five are eligible for the shots.

The final step is for the CDC to recommend how to use the vaccines. The CDC’s independent advisers will make their recommendations on Saturday. CDC Director Dr. Rochelle Walensky stated a final signoff would happen soon. During a Senate hearing last week, Walensky stated her staff would work over the Juneteenth holiday weekend “because we understand the urgency of this for American parents.”

Unfortunately, Walensky noted that the pediatric deaths from COVID-19 are higher than what is seen from the flu. “So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders,” she said.

Vaccine Preparations for Children

In addition, the FDA authorized Moderna’s vaccines for school children and teens, and the CDC’s review is this week. Pfizer shots were only an option for those age groups. The Biden Administration has prepared for the rollout of vaccines for small children. States, tribes, community health centers, and pharmacies have preordered millions of doses. Now, manufacturers will ship vaccines nationwide with the FDA’s emergency authorization. Shots begin next week.

Parents across the country have put off social gatherings for their tots to keep them safe. “Today is a day of huge relief for parents and families across America,” President Joe Biden said in a statement.

Minor Side Effects For Infants and Preschoolers

Generally, young children don’t get as sick from COVID-19 as older children and adults. However, their hospitalizations surged during the Omicron wave, and FDA’s advisers determined that the benefits from vaccination outweighed the minimal risks. Moderna and Pfizer showed minimal side effects, including fever and fatigue.

“As we have seen with older age groups, we expect that the vaccines for younger children will protect from the most severe outcomes of COVID-19, such as hospitalization and death,” FDA Commissioner Robert Califf said in a statement.

According to the FDA, when testing more minor children, they developed high levels of virus-fighting antibodies in comparison to what was seen in young adults. Moderna’s vaccine was about 40% to 50% effective at preventing infections. “Both of these vaccines have been authorized with science and safety at the forefront of our minds,” Dr. Peter Marks, FDA’s vaccine chief, said at a news briefing.

Dr. Marks wants parents to feel comfortable with the vaccine and advise that their children be vaccinated as soon as possible. This can help aid against worse symptoms if a new variant emerges. (Source: BlackHealthMatters June 22 2022)