FDA Must Speed ​​Up COVID-19 Vaccine For Children Under 12

If the Food and Drug Administration continues on its current track, a COVID-19 vaccine for children under 12 is unlikely to be available until early 2022 – an eternity in this pandemic. Children infected with the highly contagious Delta variant have overwhelmed children’s hospitals in parts of Florida and Texas. Record number of children – over 1,900 – are hospitalized in the United States

Unless young children are vaccinated, more outbreaks in schools will occur, leading to repeated cycles of closures, quarantines and reopenings. Those who lost one year of school may lose another, as children from low-income families and students of color continue to suffer the greatest losses in education.

In a letter to the chief of the Food and Drug Administration, the American Academy of Pediatrics argued earlier this month that the FDA can expedite the granting of an emergency use authorization, or EAU, for children aged 5 to 11 without compromising safety.

Initially, the FDA wanted to review two months of post-vaccination safety data for children, similarly to the EUA for adults. In July, the FDA said it wanted up to six months of data. The American Academy of Pediatrics says it sees no “biological plausibility for serious adverse events” after two months of childhood immunizations. Evidence gathered from previously vaccinated adults and adolescents confirms this.

In addition, months after the start of Moderna and Pfizer’s Phase 3 trials, the FDA demanded that the number of children participating in the studies be doubled. This will cause further delay for little gain. A larger size is not necessary to detect common side effects such as pain at the injection site and temporary fever.

The most concerning side effects seen in children 12 to 15 years old and adults are so rare that doubling the size of trials would not detect them. The American Academy of Pediatrics urges the FDA to grant the EUA “based on data from the initial cohort enrolled,” without waiting for the results of the expanded study.

The FDA made these slow decisions in the pre-Delta era, when the risk of COVID was much lower, and we believed there was little risk of transmission from children to vaccinated adults. But the world has changed. The American Academy of Pediatrics is unequivocal that the FDA shouldn’t wait to approve vaccines for children aged 5 to 11 and urges the agency to base its decision on the two months of data already collected.

Rare cases of cardiac inflammation (myocarditis and pericarditis) have been linked to the Pfizer-BioNTech vaccine. Researchers estimate that for every million seconds of doses given to boys ages 12 to 17, 70 or fewer cases of myocarditis – most of them mild – could be caused, but 215 hospitalizations and two deaths could be prevented. The risk for girls is even lower.

The rise of the Delta variant makes this small risk worth taking, according to the American Academy of Pediatrics.

FDA should allow EUA to move forward without requiring up to six months of safety data and a significant increase in the number of children in Phase 3 studies. This would allow Pfizer to seek clearance for emergency use for young children in September, as originally planned, and to receive clearance shortly thereafter, well ahead of the FDA’s “midwinter” date.

Faster clearance will save tens of thousands of child hospitalizations, hundreds of child deaths and, with reduced spread, thousands of adult lives.

The Pfizer vaccine for ages 12 and over is expected to receive full FDA approval this week, possibly Monday, which would allow doctors to prescribe it to children under 12 in what’s called “the”. use outside the Marketing Authorization “. This could lead to another COVID-related health disparity, as the benefit of vaccination will likely go to children of parents who have the time and money to seek out doctors offering such vaccinations.

A large off-label vaccination may not emerge if the FDA expedites the vaccine clearance process for young children. Parents who wish to wait for more data could always do so – the safety evidence that will emerge from millions of children who would now be vaccinated.

Finally, the FDA can expedite the review of an EUA application for 5 to 11 years. The emergency use clearance is based on the body of scientific evidence, which includes evidence on biologic pathways, build quality, and side effects that the FDA already has approved COVID vaccines for adults. Israel, which has exceptional data on the Pfizer vaccine, is pushing the company to expedite the submission of its EUA application for children under 12.

When Pfizer’s EUA application is submitted, the FDA must be prepared to convene its advisory group quickly in order to significantly reduce the time required for authorization. The FDA moved quickly to clear emergency vaccine use for adults in late 2020, and again for children ages 12 to 15 earlier this year. It was the right decision either way.

If the FDA reverted to its original vaccination schedule for children aged 5 to 11, it would be government responsiveness at its best.

Bernard Black is Professor of Law and Finance at Northwestern University. He has studied the effect of the pandemic on death rates, particularly in low-income communities. Martin Skladany is Professor of Law at Penn State University. His recent work has focused on health disparities.