Pfizer begins COVID-19 vaccine testing on young children
pharmafile | March 26, 2021 | News story | Medical Communications | COVID-19, Pfizer, Vaccine
Pfizer have begun testing its COVID-19 vaccine on children under the age of 12, with the trials’ first participants, a pair of nine-year-old twins, being immunised at Duke University on 24 March.
Pfizer intends to enrol 144 children in the first phase of testing, expanding to a 4,500-participant late-stage trial in which they will test the safety, tolerability, and immune response generated by the vaccine, likely by measuring antibody levels in the young subjects.
In a statement, the company said: “Pfizer has deep experience in advancing clinical trials of vaccines in children and infants and is committed to improving the health and well-being of children through thoughtfully designed clinical trials.”
For the first stage of trials the preferred level of dosage will be ascertained for three age groups – between six months and two years old, two and five and from five through to the age of 11. The children will begin by receiving a 10μg dose of the vaccine before progressively moving to higher doses, with the option to take 3μg doses. In adults, Pfizer’s vaccine requires two doses that contain 30μg.
Researchers will then evaluate the safety and effectiveness of the selected dose levels in the next phase of the trial, with participants being randomly selected to receive the vaccine or a placebo. After a six-month follow-up, children who received a placebo will then have the opportunity to receive the vaccine, the company said.
Pfizer’s vaccine has already been authorised for use in people aged 16 and older, and the company hopes to expand vaccination age range by early 2022.
Moderna have also begun vaccine trials in children under the age of 12, making the announcement on 16 March.
Vaccination of children is a vital move towards gaining herd immunity from a disease, so the commencement of paediatric trials is a positive step towards the end of the pandemic.
Kat Jenkins
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