FDA’s inaction on children’s vaccines is hurting our children

The ongoing delta variant wave has left parents terrified and desperate to protect their children. Not surprising. At least 358 children have died from COVID-19. Thousands of our children have been hospitalized. Between August and early September, the weekly number of confirmed pediatric cases increased from 71,726 to 251,781. Some hospitals are now overwhelmed by sick children and adults, some of whom have been infected by children.

Very effective vaccines, already given to billions of adults and teens, wait for Food and Drug Administration (FDA) approval for children under 12 years of age. The American Academy of Pediatrics appealed to the FDA to “ensure that COVID19 vaccines for children can be authorized as quickly as possible”.

But the FDA is once again dragging its feet. FDA-approved adult vaccine trials began in March 2020. Given the crisis, safer and riskier phases of adult trials were conducted in parallel, with adolescent trials shortly after. But the FDA has pushed for a conservative approach for children, ostensibly to protect them. The pediatric trials were therefore delayed until March 2021 – a full year after the start of the adult trials. This delay has threatened every American child with long-term morbidity and even death.

Faced with this foreseeable crisis, the FDA reacted by slowing down. Last June, the FDA asked Pfizer to increase the number of registrations for your trial and to increase the post-vaccination surveillance period from two to six months. These actions will significantly delay the deployment of a childhood vaccine. The FDA’s stated rationale is to collect more data on rare side effects. But the chances of getting said side effect conditions are much greater with COVID than with COVID vaccines.

When comparing vaccination to acquired COVID-19 infection, reduced vaccination the risk of myocarditis. This story unfolded through a range of acute health problems induced by the virus, including kidney damage, heart attacks, pulmonary embolism, and other thromboses. Vaccinated people rarely experience these events; COVID survivors do this frequently. The available data underscore the overwhelming safety and efficacy of vaccination.

Trial results in children aged 5 to 12 are expected to be available later this month, with data for children aged 2 to 5 to follow in October or November. This indicates that vaccination of these age groups will not start until 2022. With the spread of the delta variant and the school unmask politicians in states like Florida, many of our schoolchildren can get infected before they’ve even had a chance to get a vaccine.

The FDA delay can claim the lives of many children, hospitalize thousands more and overwhelm our healthcare system. Not only 1 in 100,000 children diagnosed with COVID could die. One in seven could suffer from post-infection symptoms.

In sum, the available data shows that the disease is several orders of magnitude more dangerous than the cure. Tests in adults and adolescents strongly suggest that vaccination will have a strong protective effect in children. Phase 1 trials established a safety dose profile. Ongoing trials rule out antibody-dependent improvement and common side effects.

The virus has time on its side. The longer we wait to act, the more it spreads. What matters now is making tough choices to save lives. Regulators can either extend a still undersized trial while the delta variant propagates and children die or act on the basis of 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.

Laurence Kotlikoff is professor of economics at Boston University.

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