COVID Vaccines for Children Under 12 Set To Come Midwinter, FDA Says
A Food and Drug Administration (FDA) official on Thursday said that emergency authorization for COVID vaccines in children under 12 could be expected from early to midwinter.
The FDA then plans to then move quickly to full approval of the vaccine for this age group. The agency has not yet granted full approval on the vaccines currently in use.
COVID vaccines that are presently administered are under emergency use authorization. Without the full approval of the FDA, some of the families remain hesitant to have their children vaccinated, NBC News reported.
COVID vaccines have only been authorized for people ages 12 and above, and none has yet to receive full approval. The FDA official said they asked for four to six months of safety follow-up data for children under 12.
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COVID Vaccines
Last month, Pfizer started testing the COVID vaccine in a larger group of children under age 12. Reuters reported that this was after the company picked a lower dose of the shot in an earlier stage of the trial.
The study included 4,500 children at more than 90 clinical sites in the U.S., Poland, Finland, and Spain. Pfizer earlier said that it would test a smaller dose for children, with 10 micrograms in children between five and 11 and three micrograms for the age group of six months to five years old.
The company noted that it expects to have data from the younger age bracket sometime in October or November. Around seven million teens have received at least one dose of the vaccine in the U.S., according to the U.S. Centers for Disease Control and Prevention (CDC).
Including children and young people in the vaccination efforts had been considered significant for reaching "herd immunity" and containing the spread of the coronavirus.
Young Adults Being Vaccinated
A Michigan teenager was reported to be found dead after receiving his second dose of the COVID vaccine. This prompted an investigation among health authorities.
The 13-year-old boy died in his sleep in mid-June, three days after his second dose of vaccine, ABC 4 News reported.
State and county health officials released a statement, saying that they are investigating whether there is a correlation between the teen's death and the vaccine. They added that the vaccine is now at the federal level with the CDC.
According to the boy's aunt, the 13-year-old Michigan boy had received the Pfizer vaccine at a Walgreens store. The teenager's aunt added that her nephew was healthy with no underlying medical conditions. She said the boy only had complained of the common vaccine side effects, such as fever and fatigue.
Meanwhile, health authorities are also looking at the possibility of heart inflammation as a rare side effect in teens and young adults after their second dose.
Teenage boys in several states had reported heart inflammation post-vaccination. However, the relation between the two has not yet been proven, according to another ABC 4 report.
The CDC earlier said that it was looking at reports of heart inflammation in teens and young adults after receiving mRNA vaccines developed by Pfizer and Moderna.
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Written by: Mary Webber
WATCH: Pfizer Begins Their Covid Vaccine Trial In Children Under 12 - From NBC News