Infant and Child COVID Vaccine Studies Proceed; Conditions for Vaccinating Kids Getting Closer (While Investors Do the Math)

Infant and Child COVID Vaccine Studies Proceed; Conditions for Vaccinating Kids Getting Closer (While Investors Do the Math)

As TrialSite reported on March 18, Moderna is launching COVID-19 vaccine trials for those aged six months to 12 years. Despite the fact that folks in this age group rarely get very sick from the virus, a focus is preventing spread from children to others, including family members. That same date, the Motley Fool website took an investor-focused look at the new trials. Titled, “Moderna’s Latest Move May be Key to COVID-19 Vaccine Market Dominance,” the Fool notes that the new studies could lead for an extra billion dollars for the biotech firm. Some already see Moderna as a “market leader”: it was second in getting an EUA, 54 million doses have been given to Americans, and Biden’s government has signed on to, “buy enough Moderna and Pfizer doses to vaccinate the entire US population.” But, the Fool notes, the firms are missing a “whole potential market” due to the FDA’s EUA’s being for adults only. With its trials on those aged six months to 12 years-old, the company is moving at a quick pace that, “might give it a sales edge.”

Moderna Hopes for Back-To-School Vaccine 

In the FDA’s EUA’s, Moderna’s and J&J’s products were allowed for people 18 and up, and Pfizer’s vaccine was okayed for 16-year-olds due to, “satisfactory trial data on participants in that slightly wider age range.” And now both Moderna and Pfizer are running trials for teenagers, with both firms reported that, “teen trials are fully enrolled.” Moderna is hoping for teen approval in time for autumn and kids going back to school. Timewise, Moderna is way ahead: it expects to inject 6,750 people in both the US and Canada in a “phase 2/3 pediatric study.” This is a two-part trial; first, kids 2-11 will get one of two doses of mRNA-1273, and infants and toddlers under two will get one of three various doses. The doses determined appropriately will then, in part two, be given to a vaccine group while others will receive a placebo. Since it is first-in-research, Moderna is likely to be on the pediatric market first. Historically, when doctors and patients are happy with the safety and efficacy of a first-in-market product, “they’re likely to stick with it,” giving a key competitive advantage. 

Capacity to Produce Up to One Billion Doses

Around 15% of the US population is 11 or younger, per data from the National Kids Count, totaling over 48 million young people. If we use the price Moderna got for its mRNA-1273 deal with the feds and factor in two-doses, we can calculate some numbers: “At $15 per dose for about 100 million doses to vaccinate children, Moderna would generate $1.5 billion in revenue in the US market alone. And there’s certainly room for it to grow revenue further by meeting the vaccine needs of younger populations in foreign markets.” As mentioned, a big issue is kid’s role in social immunity, as they rarely get a severe case of the virus themselves. So Moderna is looking like it may be the first to “vaccinate across all age groups.” On a practical level, the firm’s ability to make mRNA-1273 during this year is about 700 million to 1 billion doses. The Fool argues that investors have “reason to be optimistic” about this company and its long-term prospects. Closing their update with some advice, the Fool notes that Moderna is not on its “10 best stocks” despite its preeminence in pediatric COVID-19 research.

When Should Children Be Vaccinated?

An article from the well-considered Seattle Children’s hospital’s research arm offers us some other key information: “Should Kids Be Required to Get a COVID-19 Vaccine? An Ethics Perspective.” Seattle Children’s notes that normally kids aren’t allowed into studies until phase 3 are complete in adults, and argues that this is reasonable given our special duty to protect children. And, “Children are a vulnerable research population because they cannot provide consent, so it is important to minimize the risks to which they are exposed in research.” Going on, they conclude that, “to control this pandemic, kids will need to be vaccinated,” ergo, studies must be done. One expert consulted was Dr. Doug Opel, who is associate director at the Treuman Katz Center for Pediatric Bioethics. Commenting on CDC’s suggesting that vaccine product is unlikely to be available for children early on, Katz notes that, “vaccine trials only began enrolling children recently, so it is important to take the time needed to accumulate the safety and efficacy data of the vaccine that will form the basis for any approval decisions for use of the vaccine in children.” He also posits that mandatory jabs for kids would be ok if: there is evidence of safety with an “acceptable level of risk;” some children did in fact get severe COVID-19 (which is true); and “Vaccinating an infant, child or adolescent against this disease should reduce the risk of person-to-person transmission. At this time, the role of children in person-to-person transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is still poorly understood.”

Call to Action: The TrialSite takeaway to date: eventually children should be vaccinated. However, these mRNA (and other) jabs must be rigorously tested to ensure they are safe for children and adults. In fact, we may want to wait until Moderna et al file for their formal product registration as more time and testing will have generated far more data for a more holistic understanding of the products. Again, to date, no vaccine is formally approved but rather are authorized on an emergency basis—this means, of course, liability protection because the safety is not as certain as it would be under formal approval.