FDA panel doesn’t invoke confidence with endorsement of COVID-19 vaccine for children

by mcardinal

Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News 


On Oct. 26 the FDA’s independent advisory committee met to discuss and subsequently endorse granting Pfizer-BioNTech’s COVID-19 vaccine for emergency use authorization in children ages 5-11.

If their endorsement is then recommended by the FDA, this authorization would remain in place as long as the COVID-19 pandemic is considered a public health emergency. The committee voted 17-to-0 with one abstention that two 10-microgram doses of the vaccine should be authorized, which they believe will close the gap in care as well as move the nation forward out of this pandemic.

However, with COVID cases declining along with the extremely low rate of COVID side-effects in children many are wondering if a public health emergency or the recommendation is warranted. Most children are considered to be very low risk for serious illness with COVID-19 infection as hospitalizations, death rates, and multisystem inflammatory syndrome in children (MIS-C ) remain rare.

While the panelists voted almost unanimously to make the vaccine available, there was some discussion on which children should be prioritized. James Hildreth, a panelist and the president of Meharry Medical College said “let’s be honest, the best way to protect the health of some kids would be to do nothing at all because they’re going to be just fine,” and added that “there are lots and lots of children who for this vaccine will be the difference between health and even life.”

The FDA, which can make an independent decision regardless of the panel recommendation, will make an official decision in the next few days, after this the CDC’s advisory committee is due to meet to consider the proposal as well. Vaccines could be available as soon as next week.

The White House has obtained enough vaccines for the 28 million children in the U.S. that would be eligible. The program enabling children vaccination has recruited pediatricians, pharmacies, other clinicians, and even some schools as vaccination sites to make sure that they can be quickly distributed.

One point that the committee stressed was that they did not support vaccine mandates for children in this age group and reiterated the importance of making sure that high-risk children had the ability to receive the vaccine, which will ultimately be decided by the CDC.

While the FDA may not issue mandates, politicians have already shown that they have no qualms in doing so. Governor Gavin Newsom has made it clear that COVID-19 vaccination will be a requirement in order for children in California to attend school. 

Another important issue to consider is that of natural immunity, which has been shown to last longer and offer stronger protection than the vaccine, although it has largely been ignored in favor of mass vaccination. 

Data from Pfizer’s clinical trial shows that the vaccine is 90.7% effective at preventing symptomatic infection in children and will be administered in two doses given three weeks apart. However, what is yet to be revealed is how long immunity will last and if children will require a series of booster shots to “maintain” immunity.

The study included about 2,000 children and the side effects were similar to what children aged 12-16 experienced. However, because the study was so small, researchers were not able to identify rare side effects such as myocarditis. This rare side-effect was mostly reported in men under 30 and teenage boys. There is still the potential that the vaccine could trigger this type of severe reaction resulting in vaccine related hospitalizations, however the committee adamantly recommends vaccinating children because the benefits outweigh the risk.

With this in mind, Dr. Eric Rubin of Harvard University said “It’s really going to be a question of what the prevailing conditions are, but we’re never going to learn about how safe this vaccine is unless we start giving it.”

Unfortunately, statements like this do not provide much assurance to the millions of children (and parents) who will be vaccinated by the end of the year, especially when you consider the thousands of injuries reported to VARES after the vaccines became available to adults.

It makes one question whether the experts and Pfizer should have known how safe the vaccine is before recommending it.