Clinical trials have opened up to test the mRNA-based Moderna COVID-19 vaccine on children from 6 months to 12 years old, making Moderna the first U.S. vaccine maker to test the vaccine on infants. This most recently announced clinical trial will enroll at least 750 children ranging from age 6 months to 12 years old in both the United States and Canada, reports the company. In a Good Morning America interview, pediatrician and head of Moderna’s infectious disease group Dr. Jacqueline Miller shared, “there will be two parts to the study,” including in the first part the quest for an appropriate dose of the investigational product. Note the mRNA-1273 the vaccine product under emergency use authorization by the U.S. Food and Drug Administration (FDA). Both Moderna and Pfizer have enrolled children 12 and older in studies involving the novel mRNA-based vaccines and its hoped that results will be during the summer. Of course, there have been few deaths with children 12 and under but the rationale of these studies is to consider how to stop the transmission of the disease.
Vaccination Status in USA
As of this writing with over 70 million adults now having received at least one of the two vaccine doses of the COVID-19 vaccine this represents about 28%of the adult population reports the U.S. Centers for Disease Control and Prevention (CDC). To date, at least 22 states and the District of Columbia offer vaccine access to individuals 16 and up who are diagnosed with high-risk medical conditions.
Government is establishing a vaccination timeline that initially according to Dr. Anthony Fauci predicted that by the spring or summer high school students would be inoculated with the investigational vaccine products under emergency use authorization (EUA) while kids as young as in the first grade (6) would receive their vaccine by school time (September).
However, the program appears in delay as the Biden administration recently announced via Fauci a revised timeline for the young to receive the vaccines for SARS-CoV-2. On February 19 an administration spokesperson shared that high school students could possibly receive the vaccines by fall but those children of elementary school age would not receive jabs until early 2022. This adjusted timeline pushes back all milestones by approximately five months. Apparently, the government and NIH seek to collect more data with trials still ongoing.
The Study: 6 months & Up Subjects
Perhaps controversial for some, Moderna recently initiated a Phase 2/3 two-part open-label, dose-escalation, “age-de-escalation,” randomized observer-blind placebo-controlled expansion study (NCT04796896) intended to infer the effectiveness of mRNA-1273 (Moderna vaccine) in children aged 6 months to 12 years old.
The two-part study in this case means that the first study segment is open label while the second segment transitions to a randomized and observer blind situation. In Part 1 the young participants will receive 2 intramuscular (IM) injections (jabs) of mRNA-1273 at up to 3 doses pre-specified for the study, 28 days a part on Day 1 and Day 29. While during Part 2 of the study these young participants receive the same two IM injections of the experimental, EUA-vaccine at the dose selected from Part 1 28 days apart at Day 1 and Day 29. During Part 2 there is of course a
What are the endpoints targeted here?
In this study, the first and primary outcome is monitoring for solicited local and systemic adverse reactions up to Day 36 (seven days post second dose). Other endpoints include the number of participants with unsolicited adverse events (AEs) at day 57, one month post second dose. Other endpoints include identification of medically-attended events (1 year after second dose) as well as other longer term impacts including secondary endpoints.
Phoenix Site Participation
Dr. Plimpton was on the record, “We’re not only going to benefit the children by getting them vaccinated, now we’re also going to be protecting those around those children, the teachers, the parents at home, the grandparents” he shared with Good Morning America.
Highlighting the parent view Rachel Guthrie a mom who has enrolled two of her young children shared, “I think it’s very important because we are exposed to people who might be immunocompromised or who haven’t yet had the opportunity to be vaccinated.”
A number of inclusion and exclusion criteria to this study, particularly given the subjects involved. For more, see the link to the study.
Call to Action: Follow the link to the study description. Are there any significant risks above and beyond normal risks associated with this study?