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Children Recruited In U.K. For COVID-19 Vaccine Trial
from Humans Are Free:
The University of Oxford’s Jenner Institute and Oxford Vaccine Group in the United Kingdom has announced that its researchers have begun recruiting children aged five to 12 years for phase II and phase III clinical trials testing an experimental COVID-19 vaccine the university is developing in partnership with AstraZeneca plc.1
Oxford’s ChAdOx1 nCov-19 (“chimpanzee adenovirus Oxford 1” novel coronavirus-19) recombinant vaccine is made from a genetically modified adenovirus that infects chimpanzees used as a viral vector into which the COVID-19 genome is inserted so the cells of the human body express the new coronavirus’s Spike Protein (S) and induce antibodies that are supposed to prevent infection.2
Some researchers have noted that, “Viral vector-based vaccines require assessment of efficacy and safety, including immunogenicity, genetic stability, ability to evade pre-existing immunity, replication deficiency or attenuation, and genotoxicity.”3
Others have emphasized that the selection of an appropriate viral vector for a new vaccine depends upon “a thorough knowledge of the infectious agent for which the viral-vectored vaccine is being developed.”4
There are gaps in scientific knowledge about the origin of the new coronavirus and the biological mechanisms involved in the way it infects and causes disease in humans but, like most COVID-19 vaccines being fast tracked to licensure, the vaccine being created by Oxford/AstraZeneca is compressing clinical trials testing into months rather than years.
Phase I, II, III Clinical Trials Of Oxford COVID-19 Vaccine Held Simultaneously
The phase I trial began in April when over 1,000 healthy adult volunteers received their experimental “ChAdOx1 nCoV-19” vaccine.
Phase II expanded the age range to include those aged five to 12 years, 56 to 69 years, and those over age 70 to assess the immune response to the vaccine in people of different ages and find out if the immune system responses of older people and children are different.
The phase III part of the study assesses how the vaccine works in a larger number of people over age 18 in terms of preventing infection and symptoms of COVID-19.
In the U.K., recruitment of children to participate in vaccine trials is usually done through doctors’ offices and by health care workers.
The experimental vaccine being tested in clinical trials is often given at home and parents are asked to take regular temperature readings and a diary of their child’s reaction, with follow-up visits and blood tests.5
There is no financial incentive to join the vaccine trial, and parents can withdraw their child at any point. The clinical trial team also gives the child participant other routine vaccinations during home visits for the length of the study.6
Vaccine Trials Don’t Pick Up All Side Effects
Personal benefit and contributing to “the greater good” are the two most common reasons parents cite for enrolling their children in vaccine trials, according to Shamez Ladhani, MRCPCH, PhD, a pediatric infectious disease consultant at St. George’s Hospital in London, and consultant epidemiologist for Public Health England.
