American drugmaker Pfizer and its German partner BioNTech’s COVID-19 vaccine caused mostly mild side effects for children ages 5 to 11, according to data from the US Centers for Disease Control and Prevention (CDC).
The results of a survey covering 30,000 children, who each received two shots, show adverse reactions which were similar to those seen in clinical trials, the CDC said. The data showed that the most frequent reactions were injection site pain, fatigue and headache.
Another CDC database called the Vaccine Adverse Event Reporting System (VAERS) found that of 8 million doses given, there were 11 verified reports of myocarditis, an inflammation of the heart muscle that has been seen in teens and young adults, particularly males who received a higher dose of the vaccine. Seven of the 11 recovered and four were improving, the CDC said. The data is based on reports from parents, doctors and vaccine manufacturers.
Almost 98 percent of the 4,249 adverse events recorded weren’t serious, including 975 product preparation issues and 675 where the wrong dose was administered. The cases were reported in VAERS and v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination.
Of the 100 serious adverse events recorded in VAERS, 29 reported fever, 21 experienced vomitings and 15 had elevated troponin levels. Troponins are proteins found in the cells of the heart muscle and typically are measured to evaluate chest pain or other symptoms of myocardial damage, the CDC said.
Two deaths were reported in children with multiple chronic medical conditions. The CDC said an initial review did not show a link between the deaths and the vaccine.
The CDC data examined reports from November 3 to December 19. The Food and Drug Administration authorized Pfizer and partner BioNTech’s vaccine for children ages 5 to 11 at the end of October for a smaller dose than the one received by older youths and adults.