Pfizer asks FDA for COVID-19 vaccine expansion to 5-11 year old kids

Chris Davies - Oct 7, 2021, 11:22am CDT
Pfizer asks FDA for COVID-19 vaccine expansion to 5-11 year old kids

Pfizer’s COVID-19 vaccine could soon be authorized for children aged 5-11, with the pharma company applying to the US FDA for an extension of its current permissions. The expansion, if approved by the Food and Drug Administration, would make Pfizer’s drug – branded Comirnaty – the first vaccination option for children aged under 12 years.

The FDA expanded the existing emergency use authorization (EUA) for the vaccine for use in people aged 12-15 earlier this year. Comirnaty also has full FDA approval, meanwhile, though currently only for those aged 16 years and above.

While the vaccine is the same regardless of age group, the amounts given in each injection vary. For the 5-11 year olds, Pfizer’s trial saw the dose reduced to 10 micrograms each time. The dose for those 12 years or older is 30 micrograms per injection. As with that regimen, two shots are given, 21 days apart.

Study results from that trial, published in September 2021, suggested primarily positive outcomes. Pfizer-BioNTech’s mRNA vaccine “showed robust neutralizing antibody responses” to COVID-19, the research concluded. Side effects, meanwhile, were “generally comparable to those observed in participants 16 to 25 years of age” and most commonly included soreness at the point of injection, together with brief cold or flu symptoms.

Although there was some confusion earlier in the pandemic as to just how much impact COVID-19 had on younger people – including some, subsequently debunked, claims that children weren’t affected by the coronavirus at all – the reality is that, though lower risk, there is still real danger to kids. In addition, even if they’re less impacted by COVID-19, they can still be infectious to others. That presents a heightened risk for things like reopening schools, where children could come into contact with adults who might be more susceptible.

Children in the 5-11 age group have accounted for 5.1 percent of COVID-10 cases in the US so far, according to the CDC. While deaths have been less common – the CDC says that, of the 571,000+ fatalities recorded so far, only 135 were of children aged 5-11 – hospitalization is still a possibility. “Though it is very rare,” the CDC warns, “some children who have had COVID-19 may later develop Multisystem Inflammatory Syndrome in Children (MIS-C), a rare but serious condition associated with COVID-19.”

Before Comirnaty can be given to younger people, though, the FDA will need to hold an advisory committee. That’s been scheduled for October 26. The agency has previously said that it plans to move swiftly, not least in the face of pressure from lawmakers to further remove barriers to returning children to in-person classrooms and childcare.

Previously, the FDA had suggested it could be weeks, not months, before approval for the EUA extension might be granted.


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