The U.S. Food and Drug Administration’s independent advisory committee is meeting Tuesday to consider giving emergency approval to the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.
While it is considered rare for younger children to become seriously ill or die from COVID-19, FDA vaccines chief Dr. Peter Marks told the panel Tuesday that 1.9 million children in the 5 to 11 age group have tested positive and 8,300 have been hospitalized in the United States. Of those hospitalized, one-third needed intensive care and nearly 100 died.
If the children’s dose of the vaccine is approved as expected, officials say they hope it will help close a major gap in the U.S. vaccine campaign that has worried parents, educators and public health leaders.
Last week, the White House said it has already obtained enough vaccine for all 28 million children in the United States who would become eligible, and established a network of pediatricians, pharmacies and other health care providers to quickly distribute the shots.
Pending FDA approval, the Centers for Disease Control and Prevention’s independent advisory committee is expected to consider the proposal next week.
In a related development, U.S.-based pharmaceutical company Moderna said a clinical trial shows that a low dose of its COVID-19 vaccine is safe for children between 6 and 11 years of age.
The company says it inoculated more than 4,700 children with its two-dose vaccine about 28 days apart, with each shot about half the strength given to adults. Preliminary results show the antibody levels in the children were at the same level as those seen in young adults who received a full dose.
Moderna says the children suffered mild side effects such as fatigue, headache, fever and pain at the injection site. The number of test subjects was too small to detect any rare side effects such as myocarditis, an inflammation of the heart, which has been detected mostly among boys and young men who received either the Moderna or the Pfizer vaccine.
The study has not been published by any peer-reviewed journal, but Moderna says it will soon present its findings to the FDA and other global drug regulators.
Some information for this report came from the Associated Press and Reuters.