FDA advisers OK COVID-19 vaccines for youngest kids

In a step eagerly anticipated by families who want an extra tool to protect babies and young children, the Food and Drug Administration (FDA) vaccine advisory group today unanimously approved emergency use of Moderna and Pfizer-BioNTech vaccines for babies and young children.Though the FDA still needs to sign off on the approval and the decision then awaits formal Centers for Disease Control and Prevention (CDC) recommendation, today's decision puts the nation on the cusp of universal vaccination against COVID-19, similar to that for influenza.In global developments, the World Health Organization (WHO) in its weekly update on the pandemic today said cases continued to drop last week, though three regions reported rises.A complex task weighing 2 vaccinesAt today's meeting of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBAC), the group was tasked with evaluating the data for two vaccines with two different profiles, one given in three doses and the other in two.The road to today's deliberations was bumpy and long, partly because young children were the last group to be assessed in vaccine trials.

In February, Pfizer and BioNTech applied for emergency use authorization (EUA), then abruptly withdrew the application to gather more information on two versus three doses of the vaccine, amid doubts about the effectiveness of two doses in children 2 to 5 years old.In May, Pfizer and BioNTech announced that they found strong efficacy with a three-dose regimen and they continued seeking EUA approval.Moderna applied for its EUA in the age-group in April, using a two-dose regimen.