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Anxious parents with young back-to-school children may start to time out: a realistic timeline for bringing children ages 5 to 11 seems to be crystallizing.
On Monday, Pfizer announced that a lower dose of Pfizer’s Covid vaccine is safe and generates a “robust” immune response in a clinical trial in children aged 5 to 11. Pfizer is due to submit its data to the Food and Drug Administration for another round of verification, which the drugmaker says it will do in the coming weeks.
Once submitted, the agency will weigh the benefits against any potential harms or side effects, in the same way they would any other pediatric vaccine – but Acting FDA Commissioner Dr Janet Woodcock acknowledges the urgency and worry that parents feel.
“We’ll do it as quickly as possible,” Woodcock said in an episode of the “In the Bubble with Andy Slavitt” podcast Monday.
Woodcock declined to offer a specific timeline, but other experts weighed in on Monday to provide a realistic projection. Here’s what it might look like and what needs to happen between now and then:
When children aged 5 to 11 could realistically be vaccinated against Covid
The FDA could take four or six weeks to review Pfizer’s request, former FDA chief Scott Gottlieb said. CNBC Monday. Assuming the data meets all FDA standards, that means school-aged children could get vaccinated by late October or early November, said Gottlieb, current Pfizer board member. .
The estimate is based on the time it took for the FDA to approve the vaccine for older children, ages 12 to 15.
White House chief medical adviser Dr Anthony Fauci also said the delay was likely. “I think there’s a very good chance it’s before Halloween,” Fauci Recount Hallie Jackson of MSNBC Monday.
Of course, this all depends on the analysis by the FDA. If the agency discovers significant security issues, for example, it will halt the process to investigate them, which will extend the deadline much further.
How vaccines will need to be changed for children
Children are not just little adults; their immune systems react completely differently to vaccinations, which is why children cannot receive the exact same Covid vaccine as adults.
Children’s vaccines require “different wording,” said Woodcock. For the Covid vaccine, she said, that means finding an appropriate dosage for their developing immune system. Dosage is usually determined by factors such as weight, age, and how that particular vaccine travels throughout the body.
Too high a dose of the vaccine could cause serious short-term side effects, including fevers and headaches that are worse than those some adults experience when vaccinated. Too low a dose may be ineffective.
The FDA is also responsible for reviewing manufacturing and verifying quality control, which could become much stricter if children’s vaccines are made at lower concentrations than their adult counterparts.
“We’re going to have to look at the workmanship, if there are lower concentrations, and make sure they’re reliable so that you get the same product every time,” Woodcock said.
Why the FDA still needs to ‘deeply examine’ Pfizer’s data
The FDA must review Pfizer’s clinical data to “ensure that children have responded to the vaccine as expected and that the safety profile is acceptable,” said Woodcock. “In other words, the benefits of the vaccine for children [need to] exceed the potential damage. “
Researchers are particularly looking at the potential risks of myocarditis or inflammation of the heart, which tend to be more common in adolescents than in adults. The disease is a rare side effect of mRNA vaccines – and luckily, Woodcock said, most cases reported by recently vaccinated people are not serious. “But we want to make sure that the safety of the vaccine in young children is fully understood,” she said.
With that in mind, the slow nature of the timeline makes sense: Pediatric vaccines are often approached with special care, with agencies like the FDA ruling out any safety concerns before distributing vaccines to children.
Of course, with high cases of Covid in children, the pressure is on to act as quickly as possible.
“But we have to get it right,” Woodcock said. “So we’ll work on it.”
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