For weeks, questions from worried parents have been pouring in:
Why is the COVID-19 vaccine not yet approved for children under 12? When will a vaccine for children be available? Can the vaccine be administered off-label?
These are all good questions, and the answers are not easy.
After the identification of the SARS-CoV-2 virus at the end of 2019, clinical trials for adults began in mid-March 2020. Eight months later, Pfizer and Moderna applied for an emergency use authorization. of the Food and Drug Administration. The USAs were granted by the agency after a priority review in December 2020. The process took less than a year, but there was a catch: by standard ethics and safety measures, children were excluded from the first. studies.
Immediately after authorization, Pfizer launched pediatric efforts starting with clinical trials for older children in mid-March. This led to clearance until the age of 12 in May, with trials underway for young children throughout the summer. Moderna has also started pediatric clinical trials, and between the two manufacturers, tests are underway for children of most ages.
Importantly, pediatric studies are needed to assess efficacy and safety with respect to dosage levels and symptoms, as the bodies of young children function slightly differently from that of adults. For example, Pfizer’s studies test multiple dosage levels – 10, 20, and 30 micrograms – in various age cohorts of children to determine which is best. This is also a standard process, which takes months or even years, according to the study.
With that in mind, only about five to six months into these trials, it’s unfair to suggest that pediatric studies are taking too long. In fact, Pfizer has said it expects to have data to review by the end of September, a target that could even exceed the 2020 schedule for adult vaccinations.
Many parents experience increased anxiety about how to protect their children when schools reopen. It is for this reason that the analysis of perceived risk has changed.
What is toxic slow, however, is the adult vaccination rate. This heel drag was the main driver of the rapid spread of the delta variant – a mutation in the virus that is better able to infect children. Coupled with leaders refusing to take precautions despite millions of unvaccinated children who are susceptible, many parents experience heightened anxiety about how to protect their children when schools reopen. It is for this reason that the analysis of perceived risks has changed, leading to what would normally be dangerous calls to speed up or even bypass rigorous scientific study.
What’s particularly interesting is that calls to lobby the FDA can be misplaced. Neither Pfizer nor Moderna have yet submitted pediatric efficacy data for the Phase 3 studies. Without these data, it is difficult for anyone to expedite the review, as the experts would not have enough evidence on which to base the review. to draw conclusions.
This is probably one of the main factors explaining why the authorization schedule remains slightly obscure, and why the American Academy for Pediatrics has issued statements against doctors offering off-label vaccinations to children under 12 – even. whether off-label use is now technically legal after the Pfizer vaccine, marketed under the name Comirnaty, was fully approved by the FDA last week. Simply put, without solid pediatric data to draw on, it’s riskier.
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To that end, the real pressure should not be on FDA officials – the FDA has proven its ability to provide priority review via COVID-19 vaccines for adults – but rather on vaccine manufacturers to do so. publish details of the safety profiles and testing as soon as possible. status to date. While the research design should not be compromised, more information would allay parental fears and help experts understand the current situation, potentially even allowing off-label use to be reconsidered.
For now, it looks like parents will have to wait a bit longer before they can immunize their children, relying on masks and vaccines for the adults around them. While the timeline is frustrating, it’s important to understand that the perceived delay is anything but, and it is also a testament to the American public that safety protocols for the vaccine will not be relaxed – not even under political pressure.