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The Food and Drug Administration’s panel of vaccine experts has recommended the authorization of Pfizer-BioNTech and Moderna COVID-19 vaccines for children under 6, paving the way for final regulatory approval within days and a rapid rollout of shots.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend the Moderna vaccine for children six months to five years of age as well as the Pfizer-BioNTech vaccine for children from six months to four years of age.
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The morning portion of the meeting was dedicated to the Moderna vaccine for children 6 months to 5 years old. The two-dose series was 53% effective at preventing COVID-19 infection in children under 2, while for children 2 to 5, vaccine efficacy was 36.8%. The Moderna trial prioritized the study of the neutralizing antibody levels produced after two shots to measure the immune response to the vaccine.
Protection against omicron was comparable to that seen in adults, though it was still weaker than the protection afforded against previous variants of concern. Moderna representatives said they already expect a third dose of the vaccine will be necessary to bolster protection against omicron and its various offshoots.
But the Moderna vaccine was not without negative side effects, though the majority were mild or moderate. The rate of fevers following vaccination was higher in children after receiving their second shot. Roughly 59% of children 3 to 5 experienced a systemic negative reaction, such as fever, headache, fatigue, nausea, and muscle pain. The rate of systemic reactions was higher among infants 6 months to 2 years, nearly 74%, though symptoms largely subsided within days.
“The frequencies of systemic reactions were generally comparable across doses and most events were mild to moderate in severity,” said Dr. Robin Wisch, a medical officer in the FDA’s Division of Vaccines and Related Products Applications. “The most common solicited systemic adverse reaction reported in the [infant toddler] vaccine group was irritability and crying.”
The Pfizer-BioNTech vaccine consists of three low doses, as efficacy after two doses only slightly exceeded 28%. Adding a third shot after about eight weeks caused vaccine efficacy to swell to 80%, though this was based on a handful of cases reported in the trial among vaccine and placebo recipients and may not be entirely accurate, officials cautioned. Many children in the company’s trial have not yet received the third dose. An official at the Centers for Disease Control and Prevention raised a concern that children under 5 would not be sufficiently protected against infection until they receive the third shot.
“This time period between the second dose, where there appears to be very little to no effectiveness, and the third dose would essentially mean that these kids would not be protected at all for an additional eight weeks,” said Amanda Cohn, chief medical officer of the National Center for Immunizations and Respiratory Diseases at the CDC.
The three-dose Pfizer-BioNTech regimen caused fewer instances of systemic adverse reactions such as fever compared to the Moderna vaccine series.
“The overall incidence and low severity of systemic symptoms speaks to a favorable tolerability for the Pfizer-BioNTech vaccine,” said Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development. “That should be reassuring to parents and care providers.”
Many parents have become frustrated at the FDA’s pace in authorizing vaccines for the youngest children. One parent, Lauren Dunnington, called in to the meeting during a public comment period in which she said that “vaccinating my kids was not a priority for the FDA.”
Children are far less likely than older people to experience severe illness due to COVID-19, and many cases among young children are asymptomatic. The vast majority of children under 11 — over 75%, according to CDC estimates — have antibodies conferred through previous infection or repeated exposure to the virus over the past two years that offer some protection against severe illness. Still, the omicron wave sent more children to the hospital than in any previous wave caused by another variant. As of May 28, 442 children have died due to COVID-19.
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“We are dealing with an issue where we have to be careful not to become numb to the number of pediatric deaths because of the overwhelming number of older deaths,” said Peter Marks, director of the Center for Biologics Evaluation and Research within the FDA.
