Pfizer/Biotech's Covid vaccine data looks good enough for FDA, but parents?

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The devil is often in the detail, and no more so when it comes to balancing the risks and rewards of treating children. As such, Pfizer Biontech’s latest phase 2/3 data in 5-11 year old patients, showing that two 10µg doses of the Covid-19 vaccine Comirnaty stimulated similar antibody responses to 16-25-year-olds might not be enough to convince all parents, especially as there were no data on reduction of serious illness. While children are being hospitalised with the Delta variant, the numbers remain very low, and children, particularly younger children, are still at much lower risk than adults of serious illness and complications following Covid-19 infection. Add to this that mRNA vaccines have been linked to myocarditis – albeit in small numbers – this incidence of which in this age group is almost impossible to gauge from a clinical trial setting. If this latest data divides opinion on whether or not to vaccinate young children, trial results in 2-5 year olds and 6-24 month olds, due at the end of the year, could see those divisions widen further. Pfizer, however, is planning a regulatory filing within weeks, for for a vaccine that Evaluate Pharma forecasts will make $31.8bn this year, a consensus figure that looks likely to rise with the prospect of boosters for adults. 

Selected paediatric Covid-19 trials
Project Company/Sponsor Trial Age (years) Enrolment
Comirnaty (BNT162b2)  Biontech/Pfizer NCT04368728 12 - adult 43,998
Comirnaty (BNT162b2)  Biontech/Pfizer NCT04816643 6 months - 11 years 4,500
Ad26.COV2-S J&J NCT05007080 12-17 4,350
Spikevax Moderna/BARDA NCT04649151 12-17 3,732 
Nanocovax Nanogen NCT04683484 12 - adult 620
SARS-CoV-2 vaccine Sinovac NCT04551547 3-17 552
Covaxin (BBV152) Bharat Biotech NCT04471519 12 - adult 755
Vaxzevria (AZD1222) Astrazeneca/Oxford Uni COV006 6-17 300
Source: Evaluate Pharma, clinicaltrials.gov.

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