Yale School of Medicine Participates in Moderna’s KidCove Phase 2/3 COVID-19 Vaccine Study on Children Ages 12 down to Six Months

Yale School of Medicine Participates in Moderna’s KidCove Phase 23 COVID-19 Vaccine Study on Children Ages 12 down to Six Months

Yale University School of Medicine clinical investigators commenced a clinical trial evaluating the Moderna mRNA-based vaccine now called KidCOVE, a Phase 2/3 trial conducted at 90 trial sites across the USA and Canada. The study will include 6,750 children. At Yale School of Medicine and elsewhere, the effort to investigate the safety and efficacy of COVID-19 vaccines in the youngest of children proceeds full throttle. The ages of this study range from six-months of age to 12 years old.

The Study

This randomized, clinical trial (NCT04796896) is a Phase 2/3 2-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo-controlled, expansion study with an aim of inferring the effectiveness of mRNA-1273 in children 12 years of age all the way down to six (6) months old.  The study commenced last month and runs ongoing until 2023.

A website has been designed for the study at www.kidcovestudy.com, which can be consulted for additional information. Recently, Yale’s Jeanna Lucci-Canapari and Robert Forman updated the world about this critical study.

What is the rationale for having such young children in this study?

According to the study website the sponsor Moderna notes that the vaccine must ultimately protect people of all ages and from all backgrounds against the coronavirus. This is because different populations may respond to the investigational product (again still authorized under emergency use) differently and hence why they seek to test across different age groups, ethnicities, etc.   

What are the primary outcome measures?

The sponsor has established several measures including 1) number of participants with solicited local and Systemic Adverse Reactions to day 36—7 days after the second dose; 2) Number of participants with unsolicited adverse events up to day 57; 3) number participants with Medically-Attended AEs (MAAEs) up to day 394 (one year after the second dose); 4) number of participants with Serious Adverse Events up to 394 days (1 year after the second dose); 5) Number of participants with Adverse Events of Special Interest, such as inflammatory syndrome in children (MIS-C) one year after the second dose and 6) number of Participants with Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of protection from COVID-19 (Day 57 or 1 month after second dose; 7) Geometric Mean (GM) of SARS-CoV-2 specific neutralizing antibody (nAb) measured at day 57 or one month post second dose and 8) Seroresponse rate of vaccine recipients at day 57 or one moth after second dose.

Who is leading vaccine research at Yale?

Onyema Ogbuagu, MBBCh, associate professor of medicine, led Yale’s component of the 12-to-15 trial

Inci Yildirim, MD, PhD, associate professor of pediatrics (infectious diseases) at Yale School of Medicine

Who leads the KidCove study for Yale?

Inci Yildirim, MD, PhD, associate professor of pediatrics (infectious diseases) at Yale School of Medicine

What is the rationale to vaccinate such young kids?

Well, according to Dr. Ogbuagu, who led the Pfizer study studying the vaccine on kids aged 12-15, declared recently, “If kids make up nearly 30 percent of the population and we can vaccinate them with a low margin of error, that puts us on an easier path toward herd immunity.”

While the study lead here at Yale, Dr. Yildirim, declared that evidence suggests that the vaccination of young children could protect their own health more than people assumed when the pandemic began, not to mention a contribution to so-called herd immunity.

“As the pandemic evolved we have learned many things that we didn’t know initially,” says Yildirim. “We learned in fact that children can get infected and develop severe disease requiring intensive care unit admissions. We have seen children transmitting SARS-CoV-2 to other children and adults in summer camp or family gatherings.”

The investigators are also concerned about Long COVID, which Dr. Ogbuagu declared “may have lasting or recurring effects for the children themselves.” Ogbuagu explains, “We know that people have had long COVID symptoms even if they weren’t hospitalized and these symptoms can persist for longer than a typical illness.” He says, “It is yet another reason to want very young children to be vaccinated safely and effectively.”

Is testing these vaccines on young kids more complicated?

Yes. According to Dr. Yildirim, these studies are far more complicated than the adult studies, for example. She noted, “A clinical trial for a children’s COVID-19 vaccine requires the consideration of many additional factors.”  She went on that “Children are not little adults. As children grow and develop, their immune system grows and develops. A 16-month-old is not the same as a 16-year-old. They are both children, but their capacity to respond to the vaccines is not the same.”

Is the National Institute of Allergy & Infectious Diseases involved in this study?

Yes. The organization led by Dr. Anthony Fauci will collaborate with Yale and all the other sites in this study. The protocol was developed in conjunction with NIAID.

How is the study segmented?

In two parts, including 1) determine a safe dosage of the antigen, and 2) test whether the dose is effective. The study, an “age-de escalation/dose escalation” study. The participants are included in three groups, including A) 6 to 12, B) 2 to 6 years old and C) 6 months to 2 years old.

Who will they treat first?

Dr. Yildirim reports that they will treat the older group first and that “Once we show that that dose is safe in that age group, we would go down to the younger age group.” She continued, “Doses begin at the lowest, safest level, and then are increased to determine if a larger dose is more effective, or if the lower dose will provide an adequate response. Throughout, there are multiple safety checkpoints where results will be examined, more than there would be in an adult clinical trial.”

Is safety of paramount importance?

Yes. “The pediatric study will be more complicated because of scheduling and will take longer than adult studies,” says Yildirim. “We have to make sure in introducing a vaccine to younger kids that it is safe, that the vaccine is not interacting with other vaccines, and it is not reducing the impact of other vaccines.”

“We have a dose that we would start in the older group, and once we show that that dose is safe in that age group, we would go down to the younger age group,” says Yildirim. “

Does the study material in the website discuss the risks associated with the emergency use authorization?

Not in any obvious place. They will undoubtedly share that with the parents should they decide to include their children in the study via the informed consent. 

Lead Research/Investigator 

Inci Yildirim, MD, PhD, MSc, Associate Professor of Pediatrics (Infectious Disease); Medical Director, Transplant Infectious Diseases; Associate Professor of Global Health, Yale Institute for Global Health

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Responses

  1. This is simply EVIL! Anyone participating in testing these experimental vaccines on young kids should be jailed, and rot in hell here and in the afterlife. And these fearmongering doctors should be the first. The real evidence takes into account the CONTEXT, RELATIVE to other factors and things in life. From the top of my head, 0-19 years old has a 0.003% COVID IFR, much less infectious than adults especially in transmission to adults, open schools made no difference in COVID infection patterns (with no masks in Sweden), etc, etc, etc. AND on the other side of the equation, we don’t know the long-term safety of these EUA vaccines, and won’t find out for many years to come. So much so, that more and more people are saying that the vaccines pose MORE risks to healthy youth than the COVID disease. Again, from the top of my head, it was one of the Scandinavian countries (I think Norway or Denmark) that recently forbade COVID shots to children. All countries should do the same.