An expert writes on the scope of the next great COVID-19 vaccine challenge: pediatric assessment and administration.
Now that vaccines that target severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are becoming more available to the public, providing these vaccines to children is an important step in fighting the COVID-19 pandemic. Vaccine development occurred early on during the COVID-19 pandemic in parallel with simultaneous manufacturing.1 This process was expedited by an Emergency Use Authorization by the Food and Drug Administration (FDA) for the COVID-19 vaccine.2 Although this process was significantly quicker than what is expected in traditional timelines, there was significant effort done to ensure the utmost safety and efficacy of these vaccines—just like what would be expected with any vaccine or medical product.
The director of the Center for Biologics Evaluation and Research (CBER) at the FDA, Peter Marks, MD, PhD, reiterated in an interview that the FDA shortened vaccine timelines "without compromising vaccine safety and efficacy."3 Although the timeline was expedited, the process was not any different in terms of the studies and review of data by independent scientific experts that is done with any vaccine. The entire review process was transparent, and there have been several meetings available to the public in which safety and efficacy have been addressed and demonstrated. Industry data are available to the general public, as well. Furthermore, post-deployment surveillance continues for clinical trial participants. The vaccines that have been deployed to the community are safe, and all COVID-19 vaccines currently available in the United States are highly effective at preventing COVID-19 and building protection.4
However—like with any vaccine or medical product—now that we are seeing the benefits in adults with COVID-19 vaccination, the next question many are asking is: when do we start vaccinating children? Early on in the pandemic there were ethical issues brought up with COVID-19 vaccination in minors—notably waiting until safety and efficacy have been established in adults.5 However, it was also thought that by waiting too long, this also had the potential to delay the potential benefits of vaccination for the individual and community. Many authors such as Mintz et al have called for the need for a systematic approach to determine the safest way to enroll pediatric patients in COVID-19 vaccine trials.5
There is a definite need for vaccination in the pediatric population. The American Academy of Pediatrics and the Children’s Hospital Association have been working together to collect COVID-19 data on pediatric patients.6 Current available data are encouraging, as COVID-19-associated hospitalization and mortality are uncommon in pediatric patients. However, a rare but serious medical condition in the pediatric population called Multisystem Inflammatory Syndrome in Children (MIS-C) is still under investigation and causing concern.7
Although COVID-19 cases are declining, there are still millions of children who have tested positive for COVID-19. Un addition to the risks to the children themselves, these infections pose risks when spread to others. There are also financial effects to consider that this pandemic has had on local communities. Quarantining and social distancing alone have caused serious economic consequences globally, and local school districts are not immune to these effects, either.8
The CDC’s Advisory Committee on Immunization Practices (ACIP) meets regularly to provide updates on a variety of vaccine-related issues, but for months now, there has been a call for the need for pediatric COVID-19 vaccine trials.9 Moderna has begun testing its vaccine in children ranging from 6 months of age to 12 years old.10 Pfizer-BioNTech also has vaccine trials that are currently being performed in adolescents.11 Johnson & Johnson is expected to follow suit, and trial investigators have already begun with the Oxford-AstraZeneca vaccine in children 6 years and older.12 The Moderna study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), and the process thus far has been as equally transparent as initial vaccine development.
Getting as many people vaccinated as possible is a major goal to help beat COVID-19 globally—and it is important that we get to a point where vaccines are available to all patients, especially those in the pediatric population. The COVID-19 vaccines available thus far are safe and effective, and vaccinating children will be an important step in continuing the fight against this pandemic.
Eevar B Rossavik, DO, is a chief pediatrics resident who will soon join his program’s faculty to be a pediatrics attending. He has a specific interest in allergy, asthma, and immunology.
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