Published on in Vaccine Update for Healthcare Providers
In an op-ed published in the Sept. 29, 2021, issue of The Philadelphia Inquirer, VEC Director, Dr. Paul Offit, discussed the COVID-19 vaccine trials in children. Describing the volume of questions he received related to the size of the trials in adolescents, Dr. Offit indicated that most who reached out felt the trials were too small. For example, the Pfizer trials in 12- to 15-year-olds included 2,360 participants divided equally between the vaccine and placebo groups. As vaccines are approved for younger children, this may also be a concern. In the August 2021 Parents PACK, we described the trials in children younger than 12 years of age, which also are not the large clinical trials undertaken in adults.
However, using the COVID-19 and polio vaccine trials as examples, Dr. Offit made an important argument that some may not consider. Specifically, he implored readers to consider the children in these trials who were infected with COVID-19 or polio. Almost exclusively, these children were in the placebo group. During the polio vaccine trial, two children who got paralytic polio were in the vaccine group, compared with 34 in the placebo group. Sixteen additional children died of polio during the trial; all were in the placebo group. In the COVID-19 trial, 18 children, all from the placebo group, were infected with the virus that causes COVID-19. By chance, these children ended up in the placebo group and as a result, did not benefit from the vaccine. The bigger and longer the trials, the more children who will suffer — simply because they end up in the placebo group in a trial for which the vaccine works. Every decision has consequences, including when we have enough information to feel comfortable that a vaccine is safe and effective.
Categories: Vaccine Update October 2021
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