Pros outweigh cons: FDA weighs risks of side effects & hospitalizations of Pfizer jab in 5-11-year-olds
The FDA says the benefits of the Pfizer vaccine in preteens outweigh the risks, but that excess hospitalizations because of the jab may exceed the prevented hospitalizations due to Covid-19 if the transmission levels are low.
In a review of the Pfizer-BioNTech vaccine published on Friday, the US Food and Drug Administration (FDA) seemingly laid the groundwork for extending eligibility for children aged 5-11. The watchdog studied several scenarios of the pandemic, arguing that in four of them, the benefits of full vaccination with two Pfizer doses “clearly outweigh the risks,” while in one scenario, “the model predicts more excess hospitalizations due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations due to Covid-19.”
The scenarios in which there are clear benefits to vaccinating children as young as five are distinguished by a relatively high number of daily Covid cases, with the analysis using the incidence rate from September 11 and one “close to the recent peak of the Delta variant” as benchmarks. Another scenario, in which vaccination is portrayed as clearly the best option, envisions a vaccine effectiveness rate of up to 90% against infections and 100% against hospitalization.
Although the researchers say that if the number of coronavirus cases drops to the lowest recorded levels (June 2021), the excess hospitalizations caused by vaccine side-effects could be higher than prevented hospitalizations due to Covid-19, they claim that “the overall benefits of the vaccine may still outweigh the risks.”
The FDA argued that myocarditis-related hospitalizations are not as dangerous as Covid-19 hospitalizations, pointing to the “different clinical implications” of the two conditions.
The release of the review comes less than a week before the FDA vaccine board is set to decide on whether to recommend greenlighting the use of the vaccine for children aged 11 and younger. The shot has already been approved for those aged 12 and over.
The review also coincided with the publication of early trial results showing that the jab is 90.7% effective against symptomatic Covid-19 in children from 5 to 11. Over 2,000 children participated in the trial, during which they received two doses of 10 micrograms, a third of the dose used for adults.
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