Reply to How close are we to Under 11 vaccines?

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[quote=Anonymous]The trials expanded because not enough kids got COvID in the unvaccinated groups to show efficacy. There is not data to support emergency use authorization. They need to expand to get that approval and/or have sufficient data to support full approval because they can’t get EUA for kids because the risks are so small.  This was discussed in the FDA’s list meeting on this in June - you can go watch the recording on YouTube. This is also consistent with what UK found last week:

https://www.gov.uk/government/news/jcvi-issues-advice-on-covid-19-vaccination-of-children-and-young-people

“ From today, the JCVI is advising that children at increased risk of serious COVID-19 disease are offered the Pfizer-BioNTech vaccine.

That includes children aged 12 to 15 with severe neurodisabilities, Down’s syndrome, immunosuppression and multiple or severe learning disabilities.

The JCVI also recommends that children and young people aged 12 to 17 who live with an immunosuppressed person should be offered the vaccine. This is to indirectly protect their immunosuppressed household contacts, who are at higher risk of serious disease from COVID-19 and may not generate a full immune response to vaccination.

Under existing advice, young people aged 16 to 17 with underlying health conditions which put them at higher risk of serious COVID-19 should have already been offered vaccination.

The JCVI is not currently advising routine vaccination of children outside of these groups, based on the current evidence.

As evidence shows that COVID-19 rarely causes severe disease in children without underlying health conditions, at this time the JCVI’s view is that the minimal health benefits of offering universal COVID-19 vaccination to children do not outweigh the potential risks.

Almost all children and young people are at very low risk from COVID-19. Symptoms, when seen, are typically mild and fewer than 30 children have died because of COVID-19 in the UK as of March 2021.

The Pfizer-BioNTech vaccine is the only vaccine that has been authorised for children in the UK, for those aged 12 or older. This followed a US clinical trial in around 1,000 children aged 12 to 15 that found side effects in this group were generally short lived and mild to moderate.

Real-world data on the safety of COVID-19 vaccines in children is currently limited, but there have been extremely rare reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) following the use of the Pfizer-BioNTech and Moderna vaccines in millions of younger adults.

Until more safety data is available and has been evaluated, a precautionary approach is preferred.”

Read the full thing to understand why the UK approved vaccine rollout to only a subset of kids at this point.
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