How low can you go in Covid-19 vaccine trials?

Snippets

Astrazeneca’s move to begin a clinical trial of its Covid-19 vaccine AZD1222 in children might seem controversial, but it is not the only company to have done so. Late last year Pfizer/Biontech amended the recruitment criteria of the massive phase III trial of Comirnaty, first to lower its minimum age from 18 to 16, and then to take this down to 12. In December Moderna begun the Teencove trial of mRNA-1273, specifically in adolescents from 12 to 17 years old inclusive. Perhaps what makes Astra’s move especially controversial is that AZD1222 is to be tested in children as young as six. Given that young children who develop Covid-19 tend to do so asymptomatically it could be argued that it is unethical to expose them to the risks of a pharmacological approach – a view that would be mitigated by evidence that vaccination reduces subjects’ infectiousness. Still, away from western economies, Sinovac is testing its vaccine in children as young as three in China; Bharat Biotech and Nanogen are running Covid-19 vaccine studies with a minimum age requirement of 12, in India and Vietnam respectively. No doubt other developers will be watching these developments carefully.

Commercial studies of Covid-19 vaccines and therapeutics that include paediatrics
Project Sponsor Trial Age Enrolment
Vaccines
Comirnaty/BNT162b2  Biontech/Pfizer NCT04368728 12-adult 43,998
Comirnaty/BNT162b2  Biontech/Pfizer NCT04713553 12-adult 1,530
mRNA-1273 Moderna/BARDA NCT04649151 12-17 3,000
Nanocovax Nanogen NCT04683484 12-adult 620
SARS-CoV-2 vaccine Sinovac NCT04551547 3-17 552
Covaxin (BBV152) Bharat Biotech NCT04471519 12-adult 755
AZD1222 Astrazeneca/Oxford Uni COV006 6-17 300
Antibodies
Casirivimab + imdevimab Regeneron Pharmaceuticals NCT04425629 Child & adult 6,420
Bamlanivimab Lilly/Abcellera NCT04701658 12-adult 3,000
Bamlanivimab + etesevimab Lilly/Abcellera NCT04427501 12-adult 3,300
JS016 Shanghai Junshi Bioscience NCT04441918 15-45 40
Other
Remdesivir Gilead NCT04745351 12-adult 1,116
Remdesivir Gilead NCT04431453 0-18 52
Nebulised aviptadil Neurorx NCT04360096 12-adult 288
Source: EvaluatePharma & clinicaltrials.gov.

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