The ongoing delta variant wave has left parents terrified and desperate to protect their children. No wonder. At least 358 children have died of COVID-19. Thousands of our children have been hospitalized. Between August and early September, weekly confirmed pediatric cases swelled from 71,726 to 251,781. Some hospitals are now overwhelmed by sick children and adults, some of whom have been infected by children.
Highly effective vaccines, already given to billions of adults and adolescents, await approval by the Food and Drug Administration (FDA) for kids under 12. The American Academy of Pediatrics called on the FDA to “ensure that COVID19 vaccines for children can be authorized as swiftly as possible.”
But the FDA is, once again, dragging its feet. FDA-sanctioned adult vaccine trials began in March 2020. Given the crisis, safer and riskier adult-trial phases were run in parallel, with adolescent trials soon thereafter. But the FDA pushed a conservative approach for children, ostensibly to protect them. So pediatric trials were delayed until March 2021 — a full year beyond the start of adult trials. This delay has threatened every American child with long-term morbidity and even mortality.
Faced with this foreseeable crisis, the FDA responded by hitting the brakes. Last June, the FDA asked Pfizer to increase enrollment in its trial and to increase the post-vaccination surveillance period from two to six months. These actions will significantly delay a child-vaccine rollout. The FDA’s stated rationale is to gather more data on rare side effects. But the chances of getting said side-effect conditions are far greater from COVID than from COVID vaccines.
When comparing vaccination to acquired COVID-19 infection, vaccination reduced the risk of myocarditis. This story has played out across a range of acute virus-induced health problems, including kidney injury, heart attacks, pulmonary embolism and other thromboses. Vaccinated people rarely experience these events; COVID survivors frequently do. Available data underscore the overwhelming safety and efficacy of vaccination.
Results for trials in five-to-12-year-olds should be available later this month, with data for two-to-five-year-olds to follow in October or November. This points to vaccination of these age groups beginning no sooner than 2022. With the spread of the delta variant and school unmasking policies in states such as Florida, many of our school children may become infected before they’re ever given the chance to receive a vaccine.
The FDA’s delay may cost many children their lives, hospitalize thousands more and overwhelm our health care system. Not only could 1 in 100,000 children diagnosed with COVID die. One in seven could suffer post-infection symptoms.
In sum, the available data show that the disease is orders of magnitude more dangerous than the cure. Adult and adolescent trials emphatically suggest that vaccination will have a strongly protective effect in children. Phase 1 trials have established a dose safety profile. Ongoing trials are ruling out antibody-dependent enhancement and common side effects.
The virus has time on its side. The longer we wait to act, the further it spreads. What matters now is making hard choices to save lives. Regulators can either prolong a still undersized trial while the delta variant spreads and children die or act on the best information available. If efficacy is demonstrated this month, the FDA must immediately grant emergency use authorization for Pfizer’s mRNA vaccine in children.
0 Comments