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June 2022 — MHCE Newsletter

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14 | MHCE - News www.mhce.us JUNE 2022 EDITION While the adult trials recruited tens of thousands of volunteers and waited to see if vaccinated people were better protected, the children's vaccine trials were primarily designed to measure immune responses using blood tests. The criteria for success was whether a vaccine provoked a comparable immune response to what was seen among young adults in trials conducted before the widespread emergence of variants. Both the Pfizer-BioNTech and Moderna pediatric vaccines succeeded on that measure, although the significance of that benchmark has shifted with the emergence of the omicron variant. VISIT OUR WEBSITE AT MHCE.US The companies also measured cases of symptomatic illness in the population, and Pfizer and BioNTech said the 80% efficacy finding was preliminary and based on 10 cases of COVID-19 in the study population as of the end of April. Once 21 cases have occurred, the companies will conduct a more formal analysis of efficacy. David Benkeser, a biostatistician at Emory University's Rollins School of Public Health, said the updated data would probably be ready before a decision would need to be made, and that he wouldn't be surprised if the efficacy number declined somewhat as more cases occur. "Even still, it appears the data are so far pointing towards a safe and effective vaccine for young children," Benkeser wrote in an email. Moderna's two-shot vaccine regimen was about 51% effective in children 6 months to 2 years old, and 37% effective in children 2 to 5 years old. If Pfizer's efficacy data holds up, it could pose a conundrum for public health officials, physicians and parents. If both vaccines are cleared by the FDA, the CDC advisory committee could weigh whether one vaccine should be recommended over the other. Moderna is studying a booster given six months after the last shot. TO ADVERTISE contact nathan.stiles@mhce.us In either case, the hope is that children will be fully vaccinated in advance of a potential surge in the fall. On Sunday, before the Pfizer announcement, White House coronavirus response coordinator Ashish Jha predicted on ABC News' "This Week" that children could have access to a shot "in the next few weeks" and that action would be taken on the Moderna vaccine as soon as regulators were finished with their review.

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